WEBVTT

6a66c895-88d8-4dfc-af8c-674c333ed306/200-0
00:00:03.761 --> 00:00:08.272
<v Permana, Paskasari A.>Remember to keep your mics muted and
enter questions into the chat box,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/200-1
00:00:08.272 --> 00:00:12.721
<v Permana, Paskasari A.>so please do not raise your hand to ask a
question during the webinar.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/239-0
00:00:14.221 --> 00:00:18.618
<v Permana, Paskasari A.>All relevant questions will be check
marked and collected at the end of the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/239-1
00:00:18.618 --> 00:00:23.421
<v Permana, Paskasari A.>presentation for the question and answer
session to be answered by the presenters.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/244-0
00:00:23.861 --> 00:00:26.941
<v Permana, Paskasari A.>We encourage emoji reactions during the
presentation.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/251-0
00:00:26.621 --> 00:00:28.741
<v Marsh, Amy V.>You know what?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/258-0
00:00:28.541 --> 00:00:30.781
<v Permana, Paskasari A.>And remind you to complete the.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/259-0
00:00:30.461 --> 00:00:31.781
<v Marsh, Amy V.>Most of my Jessica Braun.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/266-0
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<v Permana, Paskasari A.>I am going to remind everybody else.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/278-0
00:00:55.831 --> 00:00:57.671
<v Kroll, Jessica M.>Hoska we can no longer hear you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/280-0
00:00:57.711 --> 00:00:58.551
<v Kroll, Jessica M.>I think you're on mute.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/289-0
00:00:59.721 --> 00:01:03.537
<v Permana, Paskasari A.>Oh,
I apologize and thank you for letting me</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/289-1
00:01:03.537 --> 00:01:03.961
<v Permana, Paskasari A.>know.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/298-0
00:01:04.041 --> 00:01:07.721
<v Permana, Paskasari A.>I have been having issues with my audio
so thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/324-0
00:01:09.261 --> 00:01:15.523
<v Permana, Paskasari A.>I was just saying that the link to the PR
webinar survey will be posted in the chat</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/324-1
00:01:15.523 --> 00:01:17.461
<v Permana, Paskasari A.>at the end of the webinar.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/350-0
00:01:19.101 --> 00:01:23.248
<v Permana, Paskasari A.>Please submit your feedback to help us
improve and determine the type of topics</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/350-1
00:01:23.248 --> 00:01:27.343
<v Permana, Paskasari A.>for future webinars in a few moments,
I'll upload slides and related documents</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/350-2
00:01:27.343 --> 00:01:29.261
<v Permana, Paskasari A.>for today's presentation in the chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/370-0
00:01:31.051 --> 00:01:35.380
<v Permana, Paskasari A.>Slides and a recording of the webinar
will be made available at the Webinar</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/370-1
00:01:35.380 --> 00:01:38.171
<v Permana, Paskasari A.>archive within about seven days of this
webinar.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/381-0
00:01:39.781 --> 00:01:43.108
<v Permana, Paskasari A.>So tissika,
I'm going to stop sharing if you want to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/381-1
00:01:43.108 --> 00:01:43.861
<v Permana, Paskasari A.>share yours.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/383-0
00:01:46.261 --> 00:01:46.501
<v Permana, Paskasari A.>Slides.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/391-0
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<v Kroll, Jessica M.>Thank you, paska.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/395-0
00:01:49.851 --> 00:01:51.931
<v Kroll, Jessica M.>Give me one second to share my screen.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/396-0
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<v Permana, Paskasari A.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/403-0
00:02:03.981 --> 00:02:06.021
<v Permana, Paskasari A.>So yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/405-0
00:02:05.421 --> 00:02:06.901
<v Kroll, Jessica M.>Are you able to see that pasca?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/408-0
00:02:07.531 --> 00:02:08.811
<v Permana, Paskasari A.>Yes, yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/412-0
00:02:08.811 --> 00:02:09.851
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/455-0
00:02:09.851 --> 00:02:14.591
<v Permana, Paskasari A.>So I am very excited today to to
introduce our presenters,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/455-1
00:02:14.591 --> 00:02:20.536
<v Permana, Paskasari A.>Jessica Crowell from the VA Central,
IRV as well as Michel Cristiano from</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/455-2
00:02:20.536 --> 00:02:24.633
<v Permana, Paskasari A.>Audio Privacy Office to talk about the
Central RV,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/455-3
00:02:24.633 --> 00:02:28.891
<v Permana, Paskasari A.>inform consent form and HIPAA
authorization updates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/462-0
00:02:29.131 --> 00:02:32.131
<v Permana, Paskasari A.>So I'm going to turn this over now to
Jessica.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/472-0
00:02:33.101 --> 00:02:37.061
<v Kroll, Jessica M.>Thank you, Pasca,
and thank you everyone for joining today.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/507-0
00:02:38.861 --> 00:02:43.977
<v Kroll, Jessica M.>As I go through the updates,
I will be covering three topic areas and</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/507-1
00:02:43.977 --> 00:02:47.338
<v Kroll, Jessica M.>that's updates to our consent form
templates,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/507-2
00:02:47.338 --> 00:02:52.381
<v Kroll, Jessica M.>changes to our consent approval stamp and
a new π consent checklist.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/551-0
00:02:56.531 --> 00:02:59.926
<v Kroll, Jessica M.>Before I begin discussing the changes to
our templates,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/551-1
00:02:59.926 --> 00:03:04.656
<v Kroll, Jessica M.>I first want to note that the revisions
were made with the following in mind,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/551-2
00:03:04.656 --> 00:03:08.475
<v Kroll, Jessica M.>and that was to create a more
user-friendly document to ensure</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/551-3
00:03:08.475 --> 00:03:13.083
<v Kroll, Jessica M.>instructions provide clear guidance and
required content and to improve the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/551-4
00:03:13.083 --> 00:03:14.781
<v Kroll, Jessica M.>comprehension of details in.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/554-0
00:03:14.781 --> 00:03:15.371
<v Kroll, Jessica M.>The consent form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/569-0
00:03:16.821 --> 00:03:21.255
<v Kroll, Jessica M.>And throughout the revision process,
multiple stakeholders were engaged to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/569-1
00:03:21.255 --> 00:03:23.501
<v Kroll, Jessica M.>review our changes and offer feedback.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/572-0
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<v Kroll, Jessica M.>So I would like to thank first and
foremost.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/580-0
00:03:26.251 --> 00:03:27.371
<v Kroll, Jessica M.>Michelle Cristiano.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/599-0
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<v Kroll, Jessica M.>The Ord privacy Officer and all the
others listed here,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/599-1
00:03:30.899 --> 00:03:34.931
<v Kroll, Jessica M.>all of the input that we've received was
very much appreciated.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/618-0
00:03:38.331 --> 00:03:43.005
<v Kroll, Jessica M.>So there were general revisions made
across all three templates,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/618-1
00:03:43.005 --> 00:03:45.091
<v Kroll, Jessica M.>and this included formatting.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/643-0
00:03:45.091 --> 00:03:51.529
<v Kroll, Jessica M.>Fixes new guidance and instructions.
Clarification on text colour coding,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/643-1
00:03:51.529 --> 00:03:57.011
<v Kroll, Jessica M.>replacing the term subjects with
participants for consistency.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/665-0
00:03:58.541 --> 00:04:02.802
<v Kroll, Jessica M.>Removing redundant language shortening
sentences and lowering the overall</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/665-1
00:04:02.802 --> 00:04:06.141
<v Kroll, Jessica M.>reading level to make the documents
easier to understand.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/669-0
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<v Kroll, Jessica M.>And finally for the consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/698-0
00:04:08.811 --> 00:04:13.388
<v Kroll, Jessica M.>Only in combined consent templates,
the central IRB stamp was removed from</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/698-1
00:04:13.388 --> 00:04:18.331
<v Kroll, Jessica M.>the bottom right footer and I'll discuss
more of that later in the presentation.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/714-0
00:04:24.281 --> 00:04:28.664
<v Kroll, Jessica M.>So for the next few slides,
I will provide a high level rundown of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/714-1
00:04:28.664 --> 00:04:31.281
<v Kroll, Jessica M.>the content changes to the consent only.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/760-0
00:04:32.661 --> 00:04:35.946
<v Kroll, Jessica M.>In the combined consent and HIPAA
authorization templates,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/760-1
00:04:35.946 --> 00:04:40.568
<v Kroll, Jessica M.>I'm not going to go into all the details
shared on the following following slides,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/760-2
00:04:40.568 --> 00:04:44.855
<v Kroll, Jessica M.>but I will ask that you refer back to the
slides for the full description of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/760-3
00:04:44.855 --> 00:04:45.301
<v Kroll, Jessica M.>changes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/779-0
00:04:45.941 --> 00:04:50.216
<v Kroll, Jessica M.>I will also be posting to the chat into
the Central IRB website a summary of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/779-1
00:04:50.216 --> 00:04:53.381
<v Kroll, Jessica M.>changes document that will cover all of
the information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/781-0
00:04:53.891 --> 00:04:54.971
<v Kroll, Jessica M.>Being shared today.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/812-0
00:04:56.461 --> 00:05:00.885
<v Kroll, Jessica M.>So at the beginning of the consent,
the key information section was</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/812-1
00:05:00.885 --> 00:05:04.203
<v Kroll, Jessica M.>reorganized.
3 new sections were added and clearer</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/812-2
00:05:04.203 --> 00:05:07.261
<v Kroll, Jessica M.>instructions were provided under each
section.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/843-0
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<v Kroll, Jessica M.>For the detailed information section of
the consent template,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/843-1
00:05:13.989 --> 00:05:17.991
<v Kroll, Jessica M.>the following changes were made.
The section how will my private</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/843-2
00:05:17.991 --> 00:05:19.531
<v Kroll, Jessica M.>information be protected?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/850-0
00:05:19.531 --> 00:05:23.971
<v Kroll, Jessica M.>Was revised to provide an updated list of
who records may be shared with.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/861-0
00:05:25.501 --> 00:05:28.941
<v Kroll, Jessica M.>Instructions were added when payment or
compensation is being offered.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/874-0
00:05:30.621 --> 00:05:34.701
<v Kroll, Jessica M.>Injury language was revised to align with
Ord Boilerplate language.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/884-0
00:05:36.381 --> 00:05:39.181
<v Kroll, Jessica M.>A sample signature block was added for
witnesses.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/925-0
00:05:39.491 --> 00:05:45.167
<v Kroll, Jessica M.>To align with VA form 10-0493,
the HIPA authorization and the list of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/925-1
00:05:45.167 --> 00:05:49.140
<v Kroll, Jessica M.>those with authority to act as the
participants.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/925-2
00:05:49.140 --> 00:05:54.411
<v Kroll, Jessica M.>LAR was updated and this is to align with
VHA Directive 1004.01.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/954-0
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<v Kroll, Jessica M.>The other significant changes made to
these two templates includes</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/954-1
00:06:02.023 --> 00:06:05.895
<v Kroll, Jessica M.>clarification on when data will be used
for future research.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/954-2
00:06:05.895 --> 00:06:07.291
<v Kroll, Jessica M.>In other news studies.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/968-0
00:06:07.911 --> 00:06:13.151
<v Kroll, Jessica M.>So the old template had combined this
section with future contact.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/973-0
00:06:13.831 --> 00:06:17.151
<v Kroll, Jessica M.>These are now separated into two separate
sections.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1016-0
00:06:18.571 --> 00:06:24.045
<v Kroll, Jessica M.>In this section where data may be used
for future research and other studies,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1016-1
00:06:24.045 --> 00:06:29.588
<v Kroll, Jessica M.>there's clearer instruction for those
requirements when using the consent only</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1016-2
00:06:29.588 --> 00:06:34.571
<v Kroll, Jessica M.>template versus the combined consent and
HIPAA authorization template.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1020-0
00:06:35.601 --> 00:06:37.441
<v Kroll, Jessica M.>Illustrated in the table on this slide.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1053-0
00:06:38.931 --> 00:06:43.638
<v Kroll, Jessica M.>So the most important guidance that was
added to the templates is a description</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1053-1
00:06:43.638 --> 00:06:48.521
<v Kroll, Jessica M.>of the requirements based on whether the
collection of data for future research is</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1053-2
00:06:48.521 --> 00:06:50.051
<v Kroll, Jessica M.>optional versus mandatory.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1071-0
00:06:50.571 --> 00:06:54.331
<v Kroll, Jessica M.>So for instance,
when banking data is optional,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1071-1
00:06:54.331 --> 00:06:59.971
<v Kroll, Jessica M.>the consent only template must be used
along with Virginia form 100493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1085-0
00:07:01.691 --> 00:07:06.411
<v Kroll, Jessica M.>However, when banking data is mandatory,
the combined consent and HIPAA.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1089-0
00:07:06.681 --> 00:07:08.041
<v Kroll, Jessica M.>Authorization may be used.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1112-0
00:07:10.561 --> 00:07:16.015
<v Kroll, Jessica M.>So as mentioned on the previous slide,
the old template had combined the section</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1112-1
00:07:16.015 --> 00:07:18.641
<v Kroll, Jessica M.>of future contact with future research.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1116-0
00:07:19.041 --> 00:07:21.441
<v Kroll, Jessica M.>And again, these are now separated.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1156-0
00:07:21.441 --> 00:07:26.287
<v Kroll, Jessica M.>So there's a separate section for the
collection of data for future contact,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1156-1
00:07:26.287 --> 00:07:31.133
<v Kroll, Jessica M.>and in this section the guidance is
provided for the requirements when using</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1156-2
00:07:31.133 --> 00:07:35.161
<v Kroll, Jessica M.>the consent only template versus the
combined consent template.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1171-0
00:07:35.891 --> 00:07:39.331
<v Kroll, Jessica M.>And the most important guidance added
here is a description of the required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1187-0
00:07:40.041 --> 00:07:46.458
<v Kroll, Jessica M.>Based on whether the collection of data
for future contact is optional versus</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1187-1
00:07:46.458 --> 00:07:47.281
<v Kroll, Jessica M.>mandatory.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1222-0
00:07:51.041 --> 00:07:56.641
<v Kroll, Jessica M.>The section on specimen or tissue banking
has been revised similarly to that of the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1222-1
00:07:56.641 --> 00:08:00.841
<v Kroll, Jessica M.>data banking sections,
and in this section where specimens may</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1222-2
00:08:00.841 --> 00:08:06.041
<v Kroll, Jessica M.>be used for future research and other
studies. Clearer guidance was provided.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1224-0
00:08:06.481 --> 00:08:07.321
<v Kroll, Jessica M.>That's the theme here.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1258-0
00:08:08.851 --> 00:08:13.756
<v Kroll, Jessica M.>So the most important guidance once again
is the requirements based on whether the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1258-1
00:08:13.756 --> 00:08:18.129
<v Kroll, Jessica M.>collection of specimens for future
research is optional versus mandatory,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1258-2
00:08:18.129 --> 00:08:20.611
<v Kroll, Jessica M.>in which consent templates may or may not.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1260-0
00:08:20.841 --> 00:08:21.521
<v Kroll, Jessica M.>Be used?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1267-0
00:08:24.401 --> 00:08:27.521
<v Kroll, Jessica M.>So moving on to the information sheet
template.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1306-0
00:08:29.051 --> 00:08:33.709
<v Kroll, Jessica M.>This one went through some major
revisions and most importantly,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1306-1
00:08:33.709 --> 00:08:39.299
<v Kroll, Jessica M.>the content within this template was
revised to align with the content of the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1306-2
00:08:39.299 --> 00:08:42.811
<v Kroll, Jessica M.>consent only and the combined consent
templates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1313-0
00:08:42.851 --> 00:08:47.691
<v Kroll, Jessica M.>So there's consistency in terminology and
language across all three now.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1324-0
00:08:48.571 --> 00:08:53.093
<v Kroll, Jessica M.>So there's a lot of updates outlined here,
so I'm not going to go through all of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1324-1
00:08:53.093 --> 00:08:53.931
<v Kroll, Jessica M.>them in detail.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1331-0
00:08:54.521 --> 00:08:56.361
<v Kroll, Jessica M.>I'll briefly mention the following.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1346-0
00:08:57.891 --> 00:09:01.587
<v Kroll, Jessica M.>We added funding source and why
individuals are being asked to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1346-1
00:09:01.587 --> 00:09:02.291
<v Kroll, Jessica M.>participate.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1359-0
00:09:03.931 --> 00:09:07.726
<v Kroll, Jessica M.>We added a new section titled what are
the costs to me if I participate in this</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1359-1
00:09:07.726 --> 00:09:08.011
<v Kroll, Jessica M.>study?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1379-0
00:09:09.691 --> 00:09:14.773
<v Kroll, Jessica M.>And there are new instructions that
describe additional information to be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1379-1
00:09:14.773 --> 00:09:16.971
<v Kroll, Jessica M.>included under certain sections.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1390-0
00:09:17.171 --> 00:09:21.451
<v Kroll, Jessica M.>That would be the section on what will
happen if I participate in this study.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1395-0
00:09:21.811 --> 00:09:23.691
<v Kroll, Jessica M.>Are there any risks or discomfort?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1414-0
00:09:24.961 --> 00:09:28.362
<v Kroll, Jessica M.>The benefits?
Who will see my information and how it</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1414-1
00:09:28.362 --> 00:09:32.277
<v Kroll, Jessica M.>will be protected?
Will I receive payment and who can I talk</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1414-2
00:09:32.277 --> 00:09:33.561
<v Kroll, Jessica M.>to about this study?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1428-0
00:09:36.631 --> 00:09:41.271
<v Kroll, Jessica M.>So that covers the high level review of
changes to our consent templates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1446-0
00:09:41.351 --> 00:09:44.140
<v Kroll, Jessica M.>And again,
I recommend just referring back to these</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1446-1
00:09:44.140 --> 00:09:48.431
<v Kroll, Jessica M.>slides or the summary of changes document
to review the changes in more detail.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1450-0
00:09:49.851 --> 00:09:50.731
<v Kroll, Jessica M.>So what's next?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1460-0
00:09:52.451 --> 00:09:54.371
<v Kroll, Jessica M.>New projects may begin using the new
templates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1473-0
00:09:54.371 --> 00:09:57.996
<v Kroll, Jessica M.>Starting today,
they are currently available in our forms</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1473-1
00:09:57.996 --> 00:09:59.371
<v Kroll, Jessica M.>and templates library.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1486-0
00:10:00.211 --> 00:10:04.414
<v Kroll, Jessica M.>We still have our other templates in
there in the event that they do need to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1486-1
00:10:04.414 --> 00:10:04.851
<v Kroll, Jessica M.>be used.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1495-0
00:10:05.201 --> 00:10:07.601
<v Kroll, Jessica M.>And they're labeled as discontinued.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1499-0
00:10:08.041 --> 00:10:10.481
<v Kroll, Jessica M.>They'll be in there until December 1st.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1516-0
00:10:12.261 --> 00:10:17.732
<v Kroll, Jessica M.>New projects are going to be required to
use the new consent templates starting</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1516-1
00:10:17.732 --> 00:10:18.621
<v Kroll, Jessica M.>December 1st.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1546-0
00:10:20.011 --> 00:10:23.704
<v Kroll, Jessica M.>And for any existing projects,
please know that you will be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1546-1
00:10:23.704 --> 00:10:28.752
<v Kroll, Jessica M.>grandfathered in and you're not going to
be required to update to the new version</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1546-2
00:10:28.752 --> 00:10:30.291
<v Kroll, Jessica M.>of the consent templates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1555-0
00:10:30.371 --> 00:10:34.491
<v Kroll, Jessica M.>We will only be requiring new projects to
submit on these new forms.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1571-0
00:10:39.511 --> 00:10:45.111
<v Kroll, Jessica M.>So the next topic I'm going to talk about
today are changes to the consent approval</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1571-1
00:10:45.111 --> 00:10:45.511
<v Kroll, Jessica M.>stamp.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1592-0
00:10:48.281 --> 00:10:52.538
<v Kroll, Jessica M.>Beginning December 1st,
the central IRB will no longer utilize</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1592-1
00:10:52.538 --> 00:10:53.281
<v Kroll, Jessica M.>the manual.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1609-0
00:10:53.721 --> 00:10:59.641
<v Kroll, Jessica M.>The manual approval stamp that requires
documenting the Pi approval date,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1609-1
00:10:59.641 --> 00:11:03.321
<v Kroll, Jessica M.>LSI approval date and LSI verification
dates.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1640-0
00:11:07.141 --> 00:11:10.840
<v Kroll, Jessica M.>The central Airb will stamp the π and LSI
consents,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1640-1
00:11:10.840 --> 00:11:16.744
<v Kroll, Jessica M.>utilizing the automated IRB net approval
stamp that is based on the effective date</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1640-2
00:11:16.744 --> 00:11:20.301
<v Kroll, Jessica M.>entered for the review of the associated
package.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1686-0
00:11:23.031 --> 00:11:28.340
<v Kroll, Jessica M.>The Pi will continue to enter the version
date in the header of the Pi model</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1686-1
00:11:28.340 --> 00:11:34.133
<v Kroll, Jessica M.>consent and this will be the same version
date used for the LSI consent and will be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1686-2
00:11:34.133 --> 00:11:39.511
<v Kroll, Jessica M.>used by the central IRB to verify the
LSI's utilizing the correct Pi consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1711-0
00:11:42.251 --> 00:11:47.236
<v Kroll, Jessica M.>So the justification for this change
really is that the manual stamp is an</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1711-1
00:11:47.236 --> 00:11:51.091
<v Kroll, Jessica M.>outdated procedure carried over from pre
IRB net process.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1733-0
00:11:52.481 --> 00:11:57.164
<v Kroll, Jessica M.>There's no requirement in the regulations
or VA policy to distinguish between an</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1733-1
00:11:57.164 --> 00:11:59.361
<v Kroll, Jessica M.>approval date and a verification date.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1742-0
00:12:00.121 --> 00:12:03.281
<v Kroll, Jessica M.>This was a process created by the central
IRB many years ago.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1775-0
00:12:04.891 --> 00:12:09.211
<v Kroll, Jessica M.>So we know there's often confusion about
the difference between an approval date</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1775-1
00:12:09.211 --> 00:12:12.624
<v Kroll, Jessica M.>and verification date,
and we're hoping this change will reduce</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1775-2
00:12:12.624 --> 00:12:16.891
<v Kroll, Jessica M.>administrative burden for study teams and
reduce those risks of non compliance.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1789-0
00:12:18.571 --> 00:12:22.611
<v Kroll, Jessica M.>By removing the stamp method,
we anticipate will be easier to identify.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1797-0
00:12:22.921 --> 00:12:25.081
<v Kroll, Jessica M.>The current approved version of the
consent form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1814-0
00:12:26.571 --> 00:12:28.792
<v Kroll, Jessica M.>And lastly,
by eliminating the stamp in the footer,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1814-1
00:12:28.792 --> 00:12:30.971
<v Kroll, Jessica M.>we expect the length of the consent to be
reduced.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1824-0
00:12:33.561 --> 00:12:37.881
<v Kroll, Jessica M.>So with the new approval stamp there come
new requirements.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1840-0
00:12:38.161 --> 00:12:42.783
<v Kroll, Jessica M.>So what is required of existing projects
with a consent form that contain the old</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1840-1
00:12:42.783 --> 00:12:43.121
<v Kroll, Jessica M.>stamp?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1866-0
00:12:44.161 --> 00:12:49.150
<v Kroll, Jessica M.>So first active projects with a consent
that was approved with the old stamp will</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1866-1
00:12:49.150 --> 00:12:53.834
<v Kroll, Jessica M.>be required to update to the new stamp
the next time the Pi model consent is</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1866-2
00:12:53.834 --> 00:12:54.321
<v Kroll, Jessica M.>amended.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1898-0
00:12:55.281 --> 00:12:58.893
<v Kroll, Jessica M.>So this means LSI,
is that utilize the Pi consent form will</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1898-1
00:12:58.893 --> 00:13:03.829
<v Kroll, Jessica M.>also update to this new stamp when they
submit their next amendment or their next</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1898-2
00:13:03.829 --> 00:13:07.561
<v Kroll, Jessica M.>administrative update with a new version
of the consent form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1919-0
00:13:09.081 --> 00:13:11.712
<v Kroll, Jessica M.>Now,
if there are no upcoming changes to the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1919-1
00:13:11.712 --> 00:13:15.102
<v Kroll, Jessica M.>Pi model consent,
then the consent will remain as is with</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1919-2
00:13:15.102 --> 00:13:15.921
<v Kroll, Jessica M.>the old stamp.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1942-0
00:13:17.451 --> 00:13:21.281
<v Kroll, Jessica M.>And please do not submit an amendment or
an administrative update to change the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1942-1
00:13:21.281 --> 00:13:23.771
<v Kroll, Jessica M.>stamp if there are no other changes to
the consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1973-0
00:13:27.291 --> 00:13:31.917
<v Kroll, Jessica M.>So the second requirement will begin as
of December 1st where the central IRB</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1973-1
00:13:31.917 --> 00:13:35.891
<v Kroll, Jessica M.>will require the consent to be submitted
in the following formats.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/1985-0
00:13:36.571 --> 00:13:40.651
<v Kroll, Jessica M.>So that's a clean PDF and a clean Word
document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2005-0
00:13:41.531 --> 00:13:46.980
<v Kroll, Jessica M.>The clean PDF consent is now required in
order to prevent formatting issues when</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2005-1
00:13:46.980 --> 00:13:51.891
<v Kroll, Jessica M.>the central IRB stamps the consent,
so central IRB staff will no longer.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2012-0
00:13:52.611 --> 00:13:54.811
<v Kroll, Jessica M.>Be converting and uploading the document
for study teams.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2026-0
00:13:56.361 --> 00:14:00.508
<v Kroll, Jessica M.>This will allow for the study team to
maintain document history in version</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2026-1
00:14:00.508 --> 00:14:02.001
<v Kroll, Jessica M.>control of their documents.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2044-0
00:14:02.961 --> 00:14:07.894
<v Kroll, Jessica M.>The clean PDF will be approved and
published under board documents and only</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2044-1
00:14:07.894 --> 00:14:09.841
<v Kroll, Jessica M.>the clean PDF will be stamped.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2058-0
00:14:11.371 --> 00:14:15.666
<v Kroll, Jessica M.>The clean word consent will be published
under board documents,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2058-1
00:14:15.666 --> 00:14:17.411
<v Kroll, Jessica M.>but will remain unstamped.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2084-0
00:14:18.841 --> 00:14:23.942
<v Kroll, Jessica M.>This approved unstamped word consent can
be used for future revisions and can also</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2084-1
00:14:23.942 --> 00:14:28.121
<v Kroll, Jessica M.>be shared with LSIS to enter their local
site specific information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2103-0
00:14:29.721 --> 00:14:34.913
<v Kroll, Jessica M.>And when reviewing an existing consent or
I'm sorry when revising an existing</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2103-1
00:14:34.913 --> 00:14:38.641
<v Kroll, Jessica M.>consent track change Word document should
be submitted.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2107-0
00:14:38.641 --> 00:14:40.441
<v Kroll, Jessica M.>So there's no changes here.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2120-0
00:14:40.761 --> 00:14:45.483
<v Kroll, Jessica M.>Track changes are only required on the
Word document and they should not be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2120-1
00:14:45.483 --> 00:14:46.601
<v Kroll, Jessica M.>submitted as APDF.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2131-0
00:14:47.601 --> 00:14:51.681
<v Kroll, Jessica M.>The central IRB will not stamp or publish
the track change version.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2144-0
00:14:55.351 --> 00:15:00.151
<v Kroll, Jessica M.>The third new requirement applies when
revising an existing consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2156-0
00:15:00.871 --> 00:15:06.151
<v Kroll, Jessica M.>So the central IRB will now require the
use of version control and IRB, net.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2178-0
00:15:07.261 --> 00:15:12.819
<v Kroll, Jessica M.>This will be done on the designer page by
selecting the pencil icon next to the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2178-1
00:15:12.819 --> 00:15:15.181
<v Kroll, Jessica M.>existing consent that was revised.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2210-0
00:15:16.221 --> 00:15:21.992
<v Kroll, Jessica M.>Uploading the new consent via the pencil
icon is going to maintain the history of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2210-1
00:15:21.992 --> 00:15:27.129
<v Kroll, Jessica M.>changes for this document rather than
uploading as a brand new document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2210-2
00:15:27.129 --> 00:15:29.381
<v Kroll, Jessica M.>So I want to note the following.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2225-0
00:15:30.911 --> 00:15:35.206
<v Kroll, Jessica M.>All revised consent forms must be
submitted using version control starting</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2225-1
00:15:35.206 --> 00:15:35.951
<v Kroll, Jessica M.>December 1st.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2244-0
00:15:37.671 --> 00:15:42.076
<v Kroll, Jessica M.>If version control was not used,
the package will be unlocked by the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2244-1
00:15:42.076 --> 00:15:44.311
<v Kroll, Jessica M.>central IRB manager for correction.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2286-0
00:15:46.231 --> 00:15:51.263
<v Kroll, Jessica M.>Now I will say it is best practice to
utilize version control in IRB net for</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2286-1
00:15:51.263 --> 00:15:56.230
<v Kroll, Jessica M.>all study documents that are revised,
because this is what helps keep study</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2286-2
00:15:56.230 --> 00:16:01.393
<v Kroll, Jessica M.>documents organized and it allows for
easier identification of the most recent</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2286-3
00:16:01.393 --> 00:16:02.831
<v Kroll, Jessica M.>version of a document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2318-0
00:16:04.311 --> 00:16:07.948
<v Kroll, Jessica M.>As a side note,
next year the central IRB will require</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2318-1
00:16:07.948 --> 00:16:11.651
<v Kroll, Jessica M.>version control for all of our revised
study documents,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2318-2
00:16:11.651 --> 00:16:15.751
<v Kroll, Jessica M.>so I'd say it would be best practice to
begin doing this now.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2328-0
00:16:15.901 --> 00:16:18.674
<v Kroll, Jessica M.>Now, however,
we will be providing more guidance on</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2328-1
00:16:18.674 --> 00:16:19.901
<v Kroll, Jessica M.>that earlier next year.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2351-0
00:16:23.341 --> 00:16:27.394
<v Kroll, Jessica M.>And if anyone is unfamiliar with version
control and IRB net,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2351-1
00:16:27.394 --> 00:16:31.381
<v Kroll, Jessica M.>please refer to IRBnet notes in forms and
templates library.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2361-0
00:16:31.381 --> 00:16:36.741
<v Kroll, Jessica M.>There are training resources that include
a how to guide on how to use this feature.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2376-0
00:16:39.961 --> 00:16:45.081
<v Kroll, Jessica M.>And the last topic I'll be discussing
today is the new Pi consent checklist.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2392-0
00:16:47.061 --> 00:16:52.172
<v Kroll, Jessica M.>So the central IRB created a tool for
researchers to use when creating a new</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2392-1
00:16:52.172 --> 00:16:53.301
<v Kroll, Jessica M.>consent document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2401-0
00:16:54.181 --> 00:16:55.941
<v Kroll, Jessica M.>This tool is a checklist.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2424-0
00:16:55.941 --> 00:17:00.724
<v Kroll, Jessica M.>It's modeled off of the checklist that
our IRB reviewers utilize to ensure all</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2424-1
00:17:00.724 --> 00:17:04.781
<v Kroll, Jessica M.>required elements of informed consent are
present in the document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2461-0
00:17:06.351 --> 00:17:12.225
<v Kroll, Jessica M.>It's important to note that in research
there may be different consent procedures</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2461-1
00:17:12.225 --> 00:17:17.096
<v Kroll, Jessica M.>for multiple subject populations,
and that this checklist it can be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2461-2
00:17:17.096 --> 00:17:22.468
<v Kroll, Jessica M.>completed for any type of consent
document or for any of those populations</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2461-3
00:17:22.468 --> 00:17:23.471
<v Kroll, Jessica M.>or procedures.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2473-0
00:17:23.901 --> 00:17:28.876
<v Kroll, Jessica M.>For a project so this includes
information sheets or verbal consent</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2473-1
00:17:28.876 --> 00:17:29.461
<v Kroll, Jessica M.>scripts.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2507-0
00:17:30.991 --> 00:17:35.842
<v Kroll, Jessica M.>So lastly I do wanna note with this that
this is a tool for your personal use when</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2507-1
00:17:35.842 --> 00:17:40.225
<v Kroll, Jessica M.>developing a consent and this is
something we do not want to see submitted</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2507-2
00:17:40.225 --> 00:17:42.271
<v Kroll, Jessica M.>to the central IRB in your package.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2510-0
00:17:42.271 --> 00:17:44.031
<v Kroll, Jessica M.>This is just for your personal use.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2522-0
00:17:45.711 --> 00:17:50.111
<v Kroll, Jessica M.>And you can find the checklist here in
our forms and templates library.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2533-0
00:17:54.081 --> 00:17:56.601
<v Kroll, Jessica M.>That concludes my portion of this webinar.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2542-0
00:17:56.721 --> 00:18:01.321
<v Kroll, Jessica M.>Thank you everyone for your time today
and I will now pass it over to Michelle.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2547-0
00:18:03.981 --> 00:18:04.941
<v Christiano, Michelle>Thanks, Jessica.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2550-0
00:18:05.581 --> 00:18:07.141
<v Christiano, Michelle>Give me just a moment to switch over.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2568-0
00:18:19.551 --> 00:18:22.720
<v Christiano, Michelle>If I can get a thumbs up from someone
saying that they can see my screen,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2568-1
00:18:22.720 --> 00:18:23.791
<v Christiano, Michelle>I'd really appreciate it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2572-0
00:18:24.541 --> 00:18:25.541
<v Maloni, Heidi W.>We can see it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2577-0
00:18:26.201 --> 00:18:27.761
<v Christiano, Michelle>Awesome. Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2580-0
00:18:28.001 --> 00:18:30.081
<v Christiano, Michelle>Well,
thanks everybody for showing up today.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2621-0
00:18:30.241 --> 00:18:34.473
<v Christiano, Michelle>I know we've had a lot of changes lately
and we're going to have some more.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2621-1
00:18:34.473 --> 00:18:38.203
<v Christiano, Michelle>So as a new grandmother,
I will tell you that you really you know,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2621-2
00:18:38.203 --> 00:18:41.655
<v Christiano, Michelle>when we have change,
even babies don't like change and that's</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2621-3
00:18:41.655 --> 00:18:44.161
<v Christiano, Michelle>when they have a dirty diaper.
So we expect.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2661-0
00:18:44.161 --> 00:18:46.737
<v Christiano, Michelle>Questions.
We welcome the questions and the feedback</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2661-1
00:18:46.737 --> 00:18:50.431
<v Christiano, Michelle>and we hope that we are doing all these
changes so that ultimately it makes</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2661-2
00:18:50.431 --> 00:18:54.319
<v Christiano, Michelle>everything a lot clearer both for our
research teams as well As for our veteran</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2661-3
00:18:54.319 --> 00:18:54.951
<v Christiano, Michelle>participants.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2687-0
00:18:56.941 --> 00:19:01.978
<v Christiano, Michelle>So the main thing I'm going to talk about
today are the revisions to the VA form</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2687-1
00:19:01.978 --> 00:19:04.341
<v Christiano, Michelle>10O493 or the HIPA authorization form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2695-0
00:19:04.701 --> 00:19:08.021
<v Christiano, Michelle>So we want to talk about why we made
revisions.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2700-0
00:19:08.141 --> 00:19:09.661
<v Christiano, Michelle>Who reviewed the revisions?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2706-0
00:19:09.661 --> 00:19:12.061
<v Christiano, Michelle>Trust me, they did not happen in a vacuum.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2746-0
00:19:12.741 --> 00:19:16.705
<v Christiano, Michelle>I want to go over a few of the most
important revisions and then I want to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2746-1
00:19:16.705 --> 00:19:21.039
<v Christiano, Michelle>leave you with some tips and resources to
help you as you make this transition to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2746-2
00:19:21.039 --> 00:19:23.998
<v Christiano, Michelle>the new form,
and then we'll have time for questions at</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2746-3
00:19:23.998 --> 00:19:24.421
<v Christiano, Michelle>the end.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2747-0
00:19:24.541 --> 00:19:24.781
<v Christiano, Michelle>And.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2782-0
00:19:27.271 --> 00:19:31.449
<v Christiano, Michelle>A couple of things to know.
I always tell folks that with my position,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2782-1
00:19:31.449 --> 00:19:36.156
<v Christiano, Michelle>I'm really lucky that I'm the Ord privacy
officer because I work for ordi don't</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2782-2
00:19:36.156 --> 00:19:39.922
<v Christiano, Michelle>work for VHA privacy,
which is a little bit different than most</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2782-3
00:19:39.922 --> 00:19:42.511
<v Christiano, Michelle>of the folks that are out there.
One thing.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2813-0
00:19:42.511 --> 00:19:48.368
<v Christiano, Michelle>To remember is that VHA privacy is the
business owner for the VA Form 10 O 493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2813-1
00:19:48.368 --> 00:19:54.151
<v Christiano, Michelle>We've worked with VHA privacy on these
revisions to meet our researcher needs.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2819-0
00:19:54.831 --> 00:19:56.431
<v Christiano, Michelle>I meet with VHA privacy every Wednesday.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2840-0
00:19:56.821 --> 00:20:01.786
<v Christiano, Michelle>Wednesday and basically we've taken this
opportunity to make things a little bit</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2840-1
00:20:01.786 --> 00:20:06.261
<v Christiano, Michelle>easier on the form itself for
completeness as well As for understanding.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2881-0
00:20:07.341 --> 00:20:12.285
<v Christiano, Michelle>I don't know if you knew this or not,
but there were actually two versions of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2881-1
00:20:12.285 --> 00:20:16.659
<v Christiano, Michelle>the VA form 100493 inactive.
Use the one available from the VA forms</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2881-2
00:20:16.659 --> 00:20:21.223
<v Christiano, Michelle>website actually didn't include page 5,
so if you had optional banking,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2881-3
00:20:21.223 --> 00:20:22.871
<v Christiano, Michelle>you couldn't use that one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2903-0
00:20:23.781 --> 00:20:28.020
<v Christiano, Michelle>Vha privacy discovered that about a year
after it was put up on the VA forms</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2903-1
00:20:28.020 --> 00:20:28.461
<v Christiano, Michelle>website.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2919-0
00:20:28.461 --> 00:20:33.201
<v Christiano, Michelle>So they created their own version of the
form and place it on their SharePoint</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2919-1
00:20:33.201 --> 00:20:34.821
<v Christiano, Michelle>site where it added page 5.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2927-0
00:20:34.821 --> 00:20:37.341
<v Christiano, Michelle>So now you have the option for optional
use.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2960-0
00:20:37.811 --> 00:20:41.746
<v Christiano, Michelle>But then there were issues with
formatting and then some groups such as</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2960-1
00:20:41.746 --> 00:20:45.845
<v Christiano, Michelle>the Cooperative studies program created
their own versions to assist their</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2960-2
00:20:45.845 --> 00:20:48.851
<v Christiano, Michelle>researchers,
especially for large multi site projects.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2980-0
00:20:48.931 --> 00:20:52.515
<v Christiano, Michelle>The main thing to remember is that
because this is a VA form,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2980-1
00:20:52.515 --> 00:20:56.331
<v Christiano, Michelle>only the business owner can approve any
changes that occur to it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/2986-0
00:20:58.741 --> 00:21:00.701
<v Christiano, Michelle>So why were there revisions made?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3005-0
00:21:00.741 --> 00:21:03.723
<v Christiano, Michelle>Well,
the current forms were over 10 years old,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3005-1
00:21:03.723 --> 00:21:07.141
<v Christiano, Michelle>so lots of things have changed over the
past 10 years.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3034-0
00:21:07.141 --> 00:21:10.567
<v Christiano, Michelle>We're certainly not exempt from change in
our world.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3034-1
00:21:10.567 --> 00:21:16.061
<v Christiano, Michelle>A lot of times the fields were not set up
to accommodate any type of text expansion.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3037-0
00:21:16.141 --> 00:21:18.221
<v Christiano, Michelle>So you were having to abbreviate.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3048-0
00:21:20.991 --> 00:21:25.431
<v Christiano, Michelle>Institution names or what the purposes of
disclosures were.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3066-0
00:21:25.701 --> 00:21:29.286
<v Christiano, Michelle>And without guidance on how to properly
abbreviate those,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3066-1
00:21:29.286 --> 00:21:33.181
<v Christiano, Michelle>there may have been inconsistencies used
throughout the field.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3084-0
00:21:34.101 --> 00:21:37.937
<v Christiano, Michelle>From my personal experience,
the best thing about revising the form or</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3084-1
00:21:37.937 --> 00:21:41.341
<v Christiano, Michelle>the feedback that we've gotten from the
research team members.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3120-0
00:21:41.341 --> 00:21:45.980
<v Christiano, Michelle>Field privacy officers field research
compliance officers as well as IRB staff</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3120-1
00:21:45.980 --> 00:21:48.858
<v Christiano, Michelle>and reviewers.
Every time we've gotten feedback,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3120-2
00:21:48.858 --> 00:21:53.555
<v Christiano, Michelle>I keep an Excel spreadsheet where I note,
hey, it would be nice if or you know,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3120-3
00:21:53.555 --> 00:21:55.141
<v Christiano, Michelle>this is really complicated.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3128-0
00:21:55.141 --> 00:21:57.381
<v Christiano, Michelle>It's not clear how do we get that fixed.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3132-0
00:21:57.381 --> 00:21:59.941
<v Christiano, Michelle>So that's where some of the changes came
from.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3139-0
00:22:00.791 --> 00:22:03.191
<v Christiano, Michelle>Another place that the changes come from.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3154-0
00:22:03.741 --> 00:22:07.985
<v Christiano, Michelle>Were from the Privacy compliance
assurance and the Office of Research</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3154-1
00:22:07.985 --> 00:22:09.501
<v Christiano, Michelle>Oversight Audit findings.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3198-0
00:22:09.621 --> 00:22:12.557
<v Christiano, Michelle>So PCA,
for those of you who are not familiar</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3198-1
00:22:12.557 --> 00:22:17.089
<v Christiano, Michelle>with privacy compliance assurance,
that's the audit version of the VHA</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3198-2
00:22:17.089 --> 00:22:22.388
<v Christiano, Michelle>Privacy Office that goes out to each site
and audits those sites and their privacy</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3198-3
00:22:22.388 --> 00:22:26.856
<v Christiano, Michelle>programs, including research,
the Office of Research Oversight or Oro</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3198-4
00:22:26.856 --> 00:22:27.941
<v Christiano, Michelle>goes out and AUD.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3207-0
00:22:27.941 --> 00:22:30.101
<v Christiano, Michelle>The facilities for research compliance.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3214-0
00:22:30.101 --> 00:22:33.261
<v Christiano, Michelle>So when we get copies of those audit
reports.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3233-0
00:22:33.541 --> 00:22:36.662
<v Christiano, Michelle>Or when I'm approached by the field that
says, hey, Michelle,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3233-1
00:22:36.662 --> 00:22:39.381
<v Christiano, Michelle>we have this question we thought we were
doing great.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3236-0
00:22:39.381 --> 00:22:41.541
<v Christiano, Michelle>They find us on this.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3243-0
00:22:41.541 --> 00:22:42.821
<v Christiano, Michelle>How do we fix it?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3251-0
00:22:42.861 --> 00:22:47.141
<v Christiano, Michelle>What's the proper SOP or standard
operating procedure for going forward?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3261-0
00:22:47.141 --> 00:22:50.101
<v Christiano, Michelle>So I track all those audit findings as
well.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3278-0
00:22:50.381 --> 00:22:54.641
<v Christiano, Michelle>Another reason that we made the revision
is that we're trying to standardize</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3278-1
00:22:54.641 --> 00:22:56.301
<v Christiano, Michelle>responses and decrease errors.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3296-0
00:22:56.461 --> 00:22:59.097
<v Christiano, Michelle>Let's be honest,
you can only say Food and Drug</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3296-1
00:22:59.097 --> 00:23:03.327
<v Christiano, Michelle>Administration a couple of different ways
before it starts sounding a little</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3296-2
00:23:03.327 --> 00:23:03.821
<v Christiano, Michelle>official.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3304-0
00:23:03.821 --> 00:23:05.461
<v Christiano, Michelle>And we certainly don't want that.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3325-0
00:23:05.701 --> 00:23:08.533
<v Christiano, Michelle>And then finally,
we really wanted to have clearer</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3325-1
00:23:08.533 --> 00:23:12.421
<v Christiano, Michelle>instructions to aid the research team
members in completing the form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3341-0
00:23:12.501 --> 00:23:14.984
<v Christiano, Michelle>Because if you understand how to complete
the form,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3341-1
00:23:14.984 --> 00:23:18.421
<v Christiano, Michelle>you'll do a much better job of explaining
the form to our participants.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3349-0
00:23:20.191 --> 00:23:22.231
<v Christiano, Michelle>So who reviewed the revisions?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3357-0
00:23:22.471 --> 00:23:25.311
<v Christiano, Michelle>Vha privacy, of course,
as the business owner.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3373-0
00:23:25.631 --> 00:23:30.888
<v Christiano, Michelle>Central IRB staff and reviewers,
I realize I failed to put on here that we</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3373-1
00:23:30.888 --> 00:23:33.271
<v Christiano, Michelle>had other IRB staff and reviewers.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3380-0
00:23:33.581 --> 00:23:35.021
<v Christiano, Michelle>From the field, look at this as well.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3415-0
00:23:35.021 --> 00:23:39.861
<v Christiano, Michelle>So I apologize for that oversight.
I have a group of field privacy officers</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3415-1
00:23:39.861 --> 00:23:43.745
<v Christiano, Michelle>who have been outstanding at getting
information back to me,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3415-2
00:23:43.745 --> 00:23:48.139
<v Christiano, Michelle>and they range from really large,
well established research sites to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3415-3
00:23:48.139 --> 00:23:50.941
<v Christiano, Michelle>complete novices with very little
research.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3425-0
00:23:50.941 --> 00:23:55.261
<v Christiano, Michelle>So it was great to have the feedback from
those different ends of the spectrum.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3446-0
00:23:56.751 --> 00:24:00.904
<v Christiano, Michelle>We had in-depth revision review from
Office of Research Oversight,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3446-1
00:24:00.904 --> 00:24:03.631
<v Christiano, Michelle>Oro during the time that they had the
form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3449-0
00:24:03.631 --> 00:24:04.991
<v Christiano, Michelle>So we were very grateful to them.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3475-0
00:24:05.581 --> 00:24:08.571
<v Christiano, Michelle>And finally,
we had review from the Office of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3475-1
00:24:08.571 --> 00:24:12.861
<v Christiano, Michelle>Governance, Regulations,
appeals and policy or as we call them 10</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3475-2
00:24:12.861 --> 00:24:13.381
<v Christiano, Michelle>BG wrap.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3491-0
00:24:13.741 --> 00:24:17.541
<v Christiano, Michelle>They're actually the ones who format the
document and then place it out on</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3491-1
00:24:17.541 --> 00:24:18.301
<v Christiano, Michelle>Virginia forms.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3519-0
00:24:20.361 --> 00:24:24.717
<v Christiano, Michelle>So Speaking of VA forms,
this is the website that I want you to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3519-1
00:24:24.717 --> 00:24:28.801
<v Christiano, Michelle>use whenever you're going to download the
VA form 10 O 493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3538-0
00:24:28.881 --> 00:24:33.090
<v Christiano, Michelle>The reason I want you to get used to
using this form is that it gives US1</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3538-1
00:24:33.090 --> 00:24:36.161
<v Christiano, Michelle>place to make sure that we have a
consistent version.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3542-0
00:24:36.161 --> 00:24:38.481
<v Christiano, Michelle>That's the version that's officially
approved.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3564-0
00:24:38.721 --> 00:24:42.851
<v Christiano, Michelle>So what you'll want to do is over under
your VA shortcuts,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3564-1
00:24:42.851 --> 00:24:47.191
<v Christiano, Michelle>there's a national tab over there and it
says find a VA form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3597-0
00:24:47.381 --> 00:24:52.765
<v Christiano, Michelle>It's going to take you to this page,
then when you get to that page,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3597-1
00:24:52.765 --> 00:24:58.461
<v Christiano, Michelle>please make sure that you use the search
term form 10 O 49310 dash O493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3623-0
00:24:58.501 --> 00:25:03.063
<v Christiano, Michelle>There's another form that has O 493 in it,
and if you don't put in the 10-0493</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3623-1
00:25:03.063 --> 00:25:07.741
<v Christiano, Michelle>you're going to get more than one form,
and I don't want you to waste your time.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3657-0
00:25:10.161 --> 00:25:16.101
<v Christiano, Michelle>So there's a summary of changes that's
included as a document for you in the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3657-1
00:25:16.101 --> 00:25:21.655
<v Christiano, Michelle>slides that paska's given to you today.
If you need another copy of it,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3657-2
00:25:21.655 --> 00:25:23.121
<v Christiano, Michelle>please let me know.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3664-0
00:25:23.121 --> 00:25:25.081
<v Christiano, Michelle>I'm happy to e-mail it to you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3693-0
00:25:25.081 --> 00:25:27.675
<v Christiano, Michelle>I'm not going to go over all of the
changes,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3693-1
00:25:27.675 --> 00:25:32.286
<v Christiano, Michelle>but I'm going to briefly go over just a
few of the big changes that we put into</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3693-2
00:25:32.286 --> 00:25:34.880
<v Christiano, Michelle>it.
One of the things that's changed is that</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3693-3
00:25:34.880 --> 00:25:38.281
<v Christiano, Michelle>we've updated the title of the form
itself. It used to be.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3699-0
00:25:38.991 --> 00:25:40.271
<v Christiano, Michelle>A really long title, quite frankly.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3742-0
00:25:40.781 --> 00:25:44.751
<v Christiano, Michelle>That was limited to individually
identifiable health information collected</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3742-1
00:25:44.751 --> 00:25:47.927
<v Christiano, Michelle>for VHA research,
so we changed it because we really wanted</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3742-2
00:25:47.927 --> 00:25:50.310
<v Christiano, Michelle>to be consistent with the system of
records.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3742-3
00:25:50.310 --> 00:25:54.015
<v Christiano, Michelle>Notice we wanted to be clearer to our
veterans to make sure that they</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3742-4
00:25:54.015 --> 00:25:56.821
<v Christiano, Michelle>understood that sometimes it's not just
your health.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3753-0
00:25:56.821 --> 00:26:00.701
<v Christiano, Michelle>Information or your data that it also
includes specimens that you'll have.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3780-0
00:26:02.231 --> 00:26:06.354
<v Christiano, Michelle>We went through the form itself and did a
lot of document changes as far as</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3780-1
00:26:06.354 --> 00:26:09.066
<v Christiano, Michelle>formatting,
standardization and changes that went</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3780-2
00:26:09.066 --> 00:26:10.151
<v Christiano, Michelle>through on that way.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3803-0
00:26:10.641 --> 00:26:13.975
<v Christiano, Michelle>If you'll give me just a moment,
I'm going to go at the end of this and</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3803-1
00:26:13.975 --> 00:26:17.864
<v Christiano, Michelle>pull up that document so that you can see
that more clearly and to go into each one</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3803-2
00:26:17.864 --> 00:26:18.281
<v Christiano, Michelle>of those.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3818-0
00:26:20.011 --> 00:26:25.451
<v Christiano, Michelle>Now this is a picture basically of the
new revised VA form 10 O 493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3859-0
00:26:25.491 --> 00:26:28.256
<v Christiano, Michelle>So when we say little things like
formatting,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3859-1
00:26:28.256 --> 00:26:32.764
<v Christiano, Michelle>one of the things that we did was to
combine the VA principal investigator</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3859-2
00:26:32.764 --> 00:26:36.491
<v Christiano, Michelle>name and contact information from 2
separate fields into one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3859-3
00:26:36.491 --> 00:26:41.361
<v Christiano, Michelle>One of the big things that we did is that
we took the Social Security number off</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3859-4
00:26:41.361 --> 00:26:41.601
<v Christiano, Michelle>the.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3877-0
00:26:41.601 --> 00:26:46.581
<v Christiano, Michelle>Form and that's to help with the Social
Security Number Reduction Act as well as</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3877-1
00:26:46.581 --> 00:26:47.811
<v Christiano, Michelle>VA directive 10,004.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3879-0
00:26:48.481 --> 00:26:49.121
<v Christiano, Michelle>We went through.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3911-0
00:26:49.631 --> 00:26:53.658
<v Christiano, Michelle>And did a better job.
I think of delineating out what's a</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3911-1
00:26:53.658 --> 00:26:57.269
<v Christiano, Michelle>disclosure,
which is where in BA information leaves</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3911-2
00:26:57.269 --> 00:27:00.671
<v Christiano, Michelle>the facility versus what's a sharing of
VA data.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3953-0
00:27:00.711 --> 00:27:05.203
<v Christiano, Michelle>So on the old form we used to have under
disclosures page two,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3953-1
00:27:05.203 --> 00:27:11.192
<v Christiano, Michelle>we would list internal things such as Oro
or the central IRB or your facility, IRB.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3953-2
00:27:11.192 --> 00:27:16.111
<v Christiano, Michelle>We moved those to Page 1 and put those
under sharing of information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3962-0
00:27:16.881 --> 00:27:19.361
<v Christiano, Michelle>Under demographic information,
we added things like.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3987-0
00:27:19.711 --> 00:27:23.599
<v Christiano, Michelle>Like Social Security number we added
under banking financial information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3987-1
00:27:23.599 --> 00:27:27.225
<v Christiano, Michelle>So your account numbers are on there now.
So if you're getting paid,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/3987-2
00:27:27.225 --> 00:27:28.591
<v Christiano, Michelle>you have that information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4022-0
00:27:30.081 --> 00:27:33.465
<v Christiano, Michelle>On page two,
we added information about when you have</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4022-1
00:27:33.465 --> 00:27:38.479
<v Christiano, Michelle>required banking versus optional banking
and we added instructions that we hope</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4022-2
00:27:38.479 --> 00:27:41.801
<v Christiano, Michelle>are more clear than what we had on there
previously.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4037-0
00:27:42.521 --> 00:27:45.635
<v Christiano, Michelle>We also added the information,
as Jessica noted earlier,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4037-1
00:27:45.635 --> 00:27:49.841
<v Christiano, Michelle>we added the requirements for when you
have a participant who is physically.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4051-0
00:27:50.351 --> 00:27:55.023
<v Christiano, Michelle>Unable to make their mark to include the
two witnesses that are required to meet</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4051-1
00:27:55.023 --> 00:27:55.831
<v Christiano, Michelle>that standard.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4086-0
00:27:58.671 --> 00:28:02.481
<v Christiano, Michelle>Some deadlines for use and other
information currently required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4086-1
00:28:02.481 --> 00:28:06.407
<v Christiano, Michelle>You state is November 3rd.
I want to clarify the reason I'm saying</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4086-2
00:28:06.407 --> 00:28:11.155
<v Christiano, Michelle>currently in the past two days is people
have gotten out into the field and they</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4086-3
00:28:11.155 --> 00:28:12.151
<v Christiano, Michelle>started using it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4092-0
00:28:12.431 --> 00:28:14.071
<v Christiano, Michelle>There are some errors in the form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4111-0
00:28:14.111 --> 00:28:19.193
<v Christiano, Michelle>We have taken those immediately back to
10 BG wrap and ask them to address those</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4111-1
00:28:19.193 --> 00:28:20.071
<v Christiano, Michelle>errors for us.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4125-0
00:28:20.191 --> 00:28:24.158
<v Christiano, Michelle>One of the errors is on page two.
When you're going into what kind of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4125-1
00:28:24.158 --> 00:28:25.631
<v Christiano, Michelle>required banking you have.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4144-0
00:28:25.671 --> 00:28:28.864
<v Christiano, Michelle>It's currently not allowing you to select
data specimens,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4144-1
00:28:28.864 --> 00:28:30.791
<v Christiano, Michelle>so we're working with them on that.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4158-0
00:28:30.831 --> 00:28:35.933
<v Christiano, Michelle>We've also asked them to expand some text
fields based on feedback from the field</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4158-1
00:28:35.933 --> 00:28:36.431
<v Christiano, Michelle>already.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4193-0
00:28:38.161 --> 00:28:40.995
<v Christiano, Michelle>So if they get all that fixed,
it'll remain November 3rd.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4193-1
00:28:40.995 --> 00:28:44.269
<v Christiano, Michelle>If they don't get it fixed,
I'll get back to the field and let you</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4193-2
00:28:44.269 --> 00:28:46.761
<v Christiano, Michelle>know that we've extended that
implementation date.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4219-0
00:28:47.401 --> 00:28:51.392
<v Christiano, Michelle>So basically,
all new research project submissions to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4219-1
00:28:51.392 --> 00:28:57.601
<v Christiano, Michelle>any of the four CIRB panels will require
the use of the new Virginia form 10 O 493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4269-0
00:28:58.961 --> 00:29:03.916
<v Christiano, Michelle>Any amendments or modifications to the
currently approved form,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4269-1
00:29:03.916 --> 00:29:09.259
<v Christiano, Michelle>if you were using the prior versions of
September 2015 or June 2014,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4269-2
00:29:09.259 --> 00:29:14.989
<v Christiano, Michelle>you'll need to make that change only if
the amendment or the modification</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4269-3
00:29:14.989 --> 00:29:18.241
<v Christiano, Michelle>requires a change to the 100493. So I had.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4295-0
00:29:18.241 --> 00:29:20.969
<v Christiano, Michelle>A question the other day from one of our
IRB members.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4295-1
00:29:20.969 --> 00:29:23.343
<v Christiano, Michelle>When I presented this to them and he said
hey,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4295-2
00:29:23.343 --> 00:29:26.121
<v Christiano, Michelle>do I have to change it to the new version
of the form?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4299-0
00:29:26.241 --> 00:29:27.761
<v Christiano, Michelle>I'm not changing anything else.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4313-0
00:29:27.761 --> 00:29:31.704
<v Christiano, Michelle>Do I have to change it just so the form
dates match and the answer to that is no</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4313-1
00:29:31.704 --> 00:29:32.191
<v Christiano, Michelle>you don't.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4319-0
00:29:32.431 --> 00:29:34.471
<v Christiano, Michelle>And quite frankly, can I ask you not to?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4327-0
00:29:36.001 --> 00:29:37.441
<v Christiano, Michelle>With a little sense of humor there.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4359-0
00:29:37.441 --> 00:29:41.207
<v Christiano, Michelle>The reason I'm asking that is if you
simply change it to keep up with the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4359-1
00:29:41.207 --> 00:29:45.329
<v Christiano, Michelle>current form version date that creates
additional work where we don't need to do</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4359-2
00:29:45.329 --> 00:29:48.841
<v Christiano, Michelle>that. Most of us are are working under,
you know, limited resources.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4373-0
00:29:48.841 --> 00:29:52.695
<v Christiano, Michelle>So if you're making the change because
it's a required change,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4373-1
00:29:52.695 --> 00:29:54.041
<v Christiano, Michelle>let's give an example.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4381-0
00:29:54.081 --> 00:29:58.321
<v Christiano, Michelle>So you've got a new disclosure that
you're doing, maybe your your.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4400-0
00:29:58.591 --> 00:30:03.930
<v Christiano, Michelle>Affiliated faculty member moved from
institution A to institution Z,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4400-1
00:30:03.930 --> 00:30:08.031
<v Christiano, Michelle>and you need to update that.
Put it on the new form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4413-0
00:30:08.071 --> 00:30:12.381
<v Christiano, Michelle>Absolutely. But if you're not doing that,
then just don't worry about it at right</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4413-1
00:30:12.381 --> 00:30:12.591
<v Christiano, Michelle>now.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4421-0
00:30:14.951 --> 00:30:17.151
<v Christiano, Michelle>A couple of tips and resources for you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4429-0
00:30:17.271 --> 00:30:19.791
<v Christiano, Michelle>I don't know if you're not a privacy
officer.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4433-0
00:30:19.791 --> 00:30:20.831
<v Christiano, Michelle>Did you know that?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4449-0
00:30:20.831 --> 00:30:24.768
<v Christiano, Michelle>Your privacy officer is the one who's
actually responsible for approving the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4449-1
00:30:24.768 --> 00:30:25.791
<v Christiano, Michelle>HIPAA authorization.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4481-0
00:30:26.031 --> 00:30:30.919
<v Christiano, Michelle>And that means even if it's the stand
alone VA form 100493 or if it's the HIPA</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4481-1
00:30:30.919 --> 00:30:35.868
<v Christiano, Michelle>authorization language elements that are
added into the combined inform consent</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4481-2
00:30:35.868 --> 00:30:38.776
<v Christiano, Michelle>form.
So always work with the facility Privacy</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4481-3
00:30:38.776 --> 00:30:39.271
<v Christiano, Michelle>officer.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4501-0
00:30:40.191 --> 00:30:45.066
<v Christiano, Michelle>The new form itself is available,
like I said earlier, at find a VA form,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4501-1
00:30:45.066 --> 00:30:48.031
<v Christiano, Michelle>you have a copy of these slides in the
chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4538-0
00:30:48.071 --> 00:30:52.188
<v Christiano, Michelle>You can click into the slides and find
that VA form link directly,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4538-1
00:30:52.188 --> 00:30:56.674
<v Christiano, Michelle>or you can use the national bookmarks
that you most people have on their</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4538-2
00:30:56.674 --> 00:31:00.115
<v Christiano, Michelle>Internet Explorer browser or Edge,
or Chrome or Safari,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4538-3
00:31:00.115 --> 00:31:02.511
<v Christiano, Michelle>whichever one you're going to be using.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4555-0
00:31:04.001 --> 00:31:07.670
<v Christiano, Michelle>So that will give you the direct source
that will allow you to then save the form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4555-1
00:31:07.670 --> 00:31:09.041
<v Christiano, Michelle>You can complete it and use it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4585-0
00:31:09.931 --> 00:31:15.711
<v Christiano, Michelle>Now we did go into the ORP&amp;
E and the central IRB libraries and</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4585-1
00:31:15.711 --> 00:31:20.811
<v Christiano, Michelle>theirs IRB net and add the new form as a
template document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4623-0
00:31:21.051 --> 00:31:25.325
<v Christiano, Michelle>Please don't download it from there,
thinking that you're going to be able to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4623-1
00:31:25.325 --> 00:31:29.710
<v Christiano, Michelle>enter information into it and save it.
Some of you might be able to because you</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4623-2
00:31:29.710 --> 00:31:33.491
<v Christiano, Michelle>have the newer version of Adobe or the
appropriate version of Adobe.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4628-0
00:31:33.811 --> 00:31:36.931
<v Christiano, Michelle>Not everyone has the same version of
Adobe across the VA.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4650-0
00:31:37.311 --> 00:31:41.596
<v Christiano, Michelle>We put those into those sites to give you
a kind of a briefing, an overview,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4650-1
00:31:41.596 --> 00:31:44.490
<v Christiano, Michelle>if you will,
so that you can see what's going to be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4650-2
00:31:44.490 --> 00:31:44.991
<v Christiano, Michelle>required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4660-0
00:31:45.271 --> 00:31:49.911
<v Christiano, Michelle>It's also been placed on the VHA Privacy
SharePoint site for your use as well.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4675-0
00:31:52.481 --> 00:31:56.577
<v Christiano, Michelle>These are some resources for you that I
always like to put out there for privacy</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4675-1
00:31:56.577 --> 00:31:57.841
<v Christiano, Michelle>and research information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4687-0
00:31:59.431 --> 00:32:01.743
<v Christiano, Michelle>And at this point,
if you have any questions,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4687-1
00:32:01.743 --> 00:32:03.351
<v Christiano, Michelle>we'll start going through those.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4704-0
00:32:03.351 --> 00:32:07.251
<v Christiano, Michelle>I'm going to go ahead and go to the next
slide that has mine and Jessica's</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4704-1
00:32:07.251 --> 00:32:10.111
<v Christiano, Michelle>information on it,
and then I'm going to stop sharing.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4725-0
00:32:17.251 --> 00:32:26.243
<v Permana, Paskasari A.>Thank you both Jessica and Michelle for a
great presentation and I am now going to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4725-1
00:32:26.243 --> 00:32:27.651
<v Permana, Paskasari A.>show you the.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4734-0
00:32:30.201 --> 00:32:33.361
<v Permana, Paskasari A.>Questions that have been put in the chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4749-0
00:32:33.761 --> 00:32:39.081
<v Permana, Paskasari A.>Some of them actually have been answered,
so I also tried to post a response.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4751-0
00:32:39.481 --> 00:32:42.241
<v Permana, Paskasari A.>So can everybody see my screen?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4760-0
00:32:43.851 --> 00:32:45.131
<v Kroll, Jessica M.>Yes, thanks paska.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4758-0
00:32:44.081 --> 00:32:44.721
<v Christiano, Michelle>We can.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4759-0
00:32:45.201 --> 00:32:45.881
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4768-0
00:32:47.511 --> 00:32:49.631
<v Permana, Paskasari A.>I guess I will read the first one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4791-0
00:32:49.671 --> 00:32:55.387
<v Permana, Paskasari A.>Will any of these updates for Vsci
Reconsent language need to be</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4791-1
00:32:55.387 --> 00:33:01.191
<v Permana, Paskasari A.>incorporated into future new extra
commercial or NCI RB consents?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4810-0
00:33:03.251 --> 00:33:07.981
<v Kroll, Jessica M.>So I don't know if it needs to be,
but I'll initiate that conversation in</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4810-1
00:33:07.981 --> 00:33:09.451
<v Kroll, Jessica M.>the event that it does.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4812-0
00:33:09.491 --> 00:33:10.811
<v Kroll, Jessica M.>So thank you for bringing that up.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4859-0
00:33:12.051 --> 00:33:17.351
<v Kroll, Jessica M.>I will note that our changes to the
consent form was shared with the Varys</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4859-1
00:33:17.351 --> 00:33:22.862
<v Kroll, Jessica M.>Change Control Board and they will be
reformatting the consents to remove all</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4859-2
00:33:22.862 --> 00:33:28.586
<v Kroll, Jessica M.>of the central IRB multi site information
and those versions will be shared with</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4859-3
00:33:28.586 --> 00:33:30.211
<v Kroll, Jessica M.>the field for for yous.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4874-0
00:33:34.051 --> 00:33:38.738
<v Permana, Paskasari A.>The second question actually has been
responded to by a couple of people,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4874-1
00:33:38.738 --> 00:33:40.131
<v Permana, Paskasari A.>but I do want to just.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4880-0
00:33:43.071 --> 00:33:46.471
<v Permana, Paskasari A.>Read it or just go to the next one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4886-0
00:33:47.461 --> 00:33:49.061
<v Kroll, Jessica M.>I think we can go to the next one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4901-0
00:33:49.521 --> 00:33:52.367
<v Permana, Paskasari A.>OK.
Can you provide an example of when</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4901-1
00:33:52.367 --> 00:33:56.161
<v Permana, Paskasari A.>mandatory tissue banking or data would be
required?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4906-0
00:33:59.151 --> 00:34:01.031
<v Christiano, Michelle>Jessica, I'll take that one if it's OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4923-0
00:34:03.821 --> 00:34:09.969
<v Christiano, Michelle>So mandatory tissue baking or data are
required whenever the protocol says it's</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4923-1
00:34:09.969 --> 00:34:10.661
<v Christiano, Michelle>required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4937-0
00:34:10.661 --> 00:34:14.202
<v Christiano, Michelle>So in order for the individual to
participate in this study,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4937-1
00:34:14.202 --> 00:34:15.421
<v Christiano, Michelle>they have to provide.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4957-0
00:34:16.801 --> 00:34:21.440
<v Christiano, Michelle>Their data for future use or their
specimen with data attached for future</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4957-1
00:34:21.440 --> 00:34:23.321
<v Christiano, Michelle>use or for banking or storing.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4968-0
00:34:23.361 --> 00:34:28.645
<v Christiano, Michelle>It really depends on how the protocol is
written by the investigator or the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4968-1
00:34:28.645 --> 00:34:29.201
<v Christiano, Michelle>sponsor.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4990-0
00:34:32.671 --> 00:34:36.112
<v Permana, Paskasari A.>OK.
The next one will the VA central IRB</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/4990-1
00:34:36.112 --> 00:34:41.231
<v Permana, Paskasari A.>meeting minutes reflect when and if Π is
required to recons?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5009-0
00:34:45.111 --> 00:34:49.862
<v Kroll, Jessica M.>So regardless of the stamp,
the Minutes and the letter will</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5009-1
00:34:49.862 --> 00:34:52.951
<v Kroll, Jessica M.>acknowledge when Reconsent is required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5035-0
00:34:54.741 --> 00:34:58.195
<v Permana, Paskasari A.>OK. Next,
if a model infirm consent form is</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5035-1
00:34:58.195 --> 00:35:03.927
<v Permana, Paskasari A.>approved for a multi site study,
will an administrative change for local</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5035-2
00:35:03.927 --> 00:35:07.381
<v Permana, Paskasari A.>sites need to be updated to the new
format?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5049-0
00:35:10.921 --> 00:35:16.805
<v Kroll, Jessica M.>So for this one,
I want to note that the Pi should update</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5049-1
00:35:16.805 --> 00:35:17.921
<v Kroll, Jessica M.>to the new.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5061-0
00:35:19.401 --> 00:35:26.041
<v Kroll, Jessica M.>Format and if by format you you mean the
stamp, not the revised template itself.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5090-0
00:35:27.641 --> 00:35:31.517
<v Kroll, Jessica M.>So if they're updating to the new format
with the new stamp,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5090-1
00:35:31.517 --> 00:35:36.791
<v Kroll, Jessica M.>that should happen at the Pi level first,
and then any of the local sites that are</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5090-2
00:35:36.791 --> 00:35:38.761
<v Kroll, Jessica M.>utilizing that Pi consent form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5104-0
00:35:39.431 --> 00:35:43.811
<v Kroll, Jessica M.>They will then include the change in
stamp when they submit their</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5104-1
00:35:43.811 --> 00:35:45.271
<v Kroll, Jessica M.>administrative update.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5122-0
00:35:45.551 --> 00:35:51.884
<v Kroll, Jessica M.>We don't want LSI submitting a change in
the stamp format before the lead Pi of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5122-1
00:35:51.884 --> 00:35:53.151
<v Kroll, Jessica M.>the project has.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5126-0
00:35:56.641 --> 00:35:58.801
<v Permana, Paskasari A.>Regarding new requirement #2.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5149-0
00:36:00.321 --> 00:36:05.682
<v Permana, Paskasari A.>So word version uploaded under approved
files could not be used for consenting</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5149-1
00:36:05.682 --> 00:36:10.161
<v Permana, Paskasari A.>because it will not include the new rbnet
approval stem, correct?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5173-0
00:36:12.611 --> 00:36:17.857
<v Kroll, Jessica M.>So the consent forms that are used should
be the consent document that has the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5173-1
00:36:17.857 --> 00:36:19.251
<v Kroll, Jessica M.>approval stamp on it.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5181-0
00:36:19.611 --> 00:36:22.611
<v Kroll, Jessica M.>So that would not be the word version.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5201-0
00:36:22.611 --> 00:36:27.460
<v Kroll, Jessica M.>The word version will remain unstamped
and that will be for tracking future</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5201-1
00:36:27.460 --> 00:36:32.245
<v Kroll, Jessica M.>revisions and for sharing with local
sites to enter their their local site</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5201-2
00:36:32.245 --> 00:36:33.011
<v Kroll, Jessica M.>information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5229-0
00:36:37.391 --> 00:36:42.052
<v Permana, Paskasari A.>If there are specific changes unique to
the local facility,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5229-1
00:36:42.052 --> 00:36:48.111
<v Permana, Paskasari A.>will the version date remain the same as
that of the PIR study chair consent?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5239-0
00:36:48.751 --> 00:36:51.871
<v Permana, Paskasari A.>This could potentially lead to versioning
discrepancies.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5258-0
00:36:52.231 --> 00:36:56.798
<v Permana, Paskasari A.>Would it be more appropriate for the
version to reflect the date when the site</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5258-1
00:36:56.798 --> 00:37:00.151
<v Permana, Paskasari A.>amends their consent,
rather than using the PISC version?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5274-0
00:37:01.891 --> 00:37:06.951
<v Kroll, Jessica M.>Right now the process is that the LSI
will maintain the same version date as</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5274-1
00:37:06.951 --> 00:37:07.411
<v Kroll, Jessica M.>the Pi.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5324-0
00:37:08.531 --> 00:37:14.017
<v Kroll, Jessica M.>We will monitor if there is any instances
that are creating conversion confusion</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5324-1
00:37:14.017 --> 00:37:18.690
<v Kroll, Jessica M.>with what was described here,
but ultimately local site revisions to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5324-2
00:37:18.690 --> 00:37:23.363
<v Kroll, Jessica M.>the consent form is pretty rare,
so I don't see that being an issue,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5324-3
00:37:23.363 --> 00:37:27.291
<v Kroll, Jessica M.>but I do appreciate this being brought up
and if it does.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5333-0
00:37:27.291 --> 00:37:29.691
<v Kroll, Jessica M.>Lead to to any type of discrepancies.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5335-0
00:37:30.331 --> 00:37:30.651
<v Kroll, Jessica M.>We'll reconsider.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5337-0
00:37:31.481 --> 00:37:31.961
<v Kroll, Jessica M.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5340-0
00:37:33.361 --> 00:37:33.921
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5369-0
00:37:34.401 --> 00:37:39.387
<v Permana, Paskasari A.>The next questions actually have been
responded to in the chat,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5369-1
00:37:39.387 --> 00:37:45.464
<v Permana, Paskasari A.>so unless you want either one of you,
Jessica and Michelle want to add to it,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5369-2
00:37:45.464 --> 00:37:47.801
<v Permana, Paskasari A.>I can skip the next questions.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5376-0
00:37:50.961 --> 00:37:53.361
<v Kroll, Jessica M.>I have nothing to add to to 8 or 9.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5377-0
00:37:54.491 --> 00:37:54.691
<v Permana, Paskasari A.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5394-0
00:37:57.251 --> 00:38:02.126
<v Permana, Paskasari A.>Next one is there an automatic date
timestamp where new versions are uploaded</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5394-1
00:38:02.126 --> 00:38:04.251
<v Permana, Paskasari A.>using the version control process?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5403-0
00:38:06.321 --> 00:38:08.761
<v Kroll, Jessica M.>Pasco,
would you mind if I shared my screen?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5424-0
00:38:08.761 --> 00:38:14.664
<v Kroll, Jessica M.>Since we we have a little bit of time,
I I thought maybe I can do a quick demo</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5407-0
00:38:09.661 --> 00:38:10.341
<v Permana, Paskasari A.>Of course.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5423-0
00:38:14.171 --> 00:38:15.971
<v Permana, Paskasari A.>Of course, of course, sure.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5424-1
00:38:14.664 --> 00:38:16.681
<v Kroll, Jessica M.>on this. OK, great. Thanks.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5426-0
00:38:17.441 --> 00:38:18.321
<v Permana, Paskasari A.>I'll stop sharing.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5428-0
00:38:18.411 --> 00:38:18.731
<v Kroll, Jessica M.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5436-0
00:38:20.851 --> 00:38:22.771
<v Kroll, Jessica M.>So that's a great question.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5448-0
00:38:22.891 --> 00:38:27.571
<v Kroll, Jessica M.>So I just want to share where the IRB net
training resources is.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5455-0
00:38:27.571 --> 00:38:30.851
<v Kroll, Jessica M.>So the document for version control is
here.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5463-0
00:38:30.851 --> 00:38:33.979
<v Kroll, Jessica M.>It's notes,
revising documents and managing document</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5463-1
00:38:33.979 --> 00:38:34.451
<v Kroll, Jessica M.>history.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5473-0
00:38:35.401 --> 00:38:39.521
<v Kroll, Jessica M.>And it gives a great example of what that
looks like.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5498-0
00:38:41.131 --> 00:38:44.121
<v Kroll, Jessica M.>So again,
it's selecting the pencil icon and</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5498-1
00:38:44.121 --> 00:38:49.371
<v Kroll, Jessica M.>uploading the new version on top of the
version that was previously submitted.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5533-0
00:38:51.211 --> 00:38:57.026
<v Kroll, Jessica M.>And then what that looks like when you
are in designer is that that document is</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5533-1
00:38:57.026 --> 00:39:02.914
<v Kroll, Jessica M.>then going to have this paper stock icon
and when you click on that paper stock,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5533-2
00:39:02.914 --> 00:39:05.531
<v Kroll, Jessica M.>it's going to bring down this table.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5551-0
00:39:05.761 --> 00:39:08.711
<v Kroll, Jessica M.>And it's going to show all of the
revision history.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5551-1
00:39:08.711 --> 00:39:12.001
<v Kroll, Jessica M.>So in this instance you can see the
protocol was revised.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5561-0
00:39:12.001 --> 00:39:15.481
<v Kroll, Jessica M.>So it maintains the history of the first
one that was submitted.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5590-0
00:39:15.481 --> 00:39:18.596
<v Kroll, Jessica M.>It tells you the last date it was
modified,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5590-1
00:39:18.596 --> 00:39:21.711
<v Kroll, Jessica M.>the package submission date and its
status,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5590-2
00:39:21.711 --> 00:39:25.321
<v Kroll, Jessica M.>and then it'll put the new revised
version on top.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5614-0
00:39:25.601 --> 00:39:29.158
<v Kroll, Jessica M.>So I think it's a really great function
in IRB, net.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5614-1
00:39:29.158 --> 00:39:33.521
<v Kroll, Jessica M.>That's probably not really being utilized
to its full potential.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5617-0
00:39:37.831 --> 00:39:38.151
<v Kroll, Jessica M.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5622-0
00:39:38.231 --> 00:39:40.271
<v Kroll, Jessica M.>I'll pass it back to you, paska.
Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5629-0
00:39:41.261 --> 00:39:42.781
<v Permana, Paskasari A.>Right. Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5632-0
00:39:42.781 --> 00:39:46.061
<v Permana, Paskasari A.>So let me then share my screen again.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5642-0
00:39:49.371 --> 00:39:54.571
<v Permana, Paskasari A.>And let's pick that up on the next
question.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5652-0
00:39:55.131 --> 00:39:58.291
<v Permana, Paskasari A.>It is not clear about the tracking of
documents.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5651-0
00:39:56.971 --> 00:39:57.771
<v Davis-arnder, Marcia M.>Come, come, come, come, come.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5694-0
00:39:59.701 --> 00:40:03.929
<v Permana, Paskasari A.>Once a new ICF is approved and the next
revision happens,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5694-1
00:40:03.929 --> 00:40:09.541
<v Permana, Paskasari A.>the new screen ICF document is then
tracked or is required that there is one</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5694-2
00:40:09.541 --> 00:40:15.373
<v Permana, Paskasari A.>track changes one track changed document
that will go through a lifetime of the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5694-3
00:40:15.373 --> 00:40:17.341
<v Permana, Paskasari A.>study that will be tracked.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5719-0
00:40:19.751 --> 00:40:23.314
<v Kroll, Jessica M.>So to the the latter part,
the second question, no,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5719-1
00:40:23.314 --> 00:40:28.660
<v Kroll, Jessica M.>it is not required that there be one
document tracked for the lifetime of the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5719-2
00:40:28.660 --> 00:40:29.071
<v Kroll, Jessica M.>study.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5754-0
00:40:29.351 --> 00:40:35.018
<v Kroll, Jessica M.>The intent is just to support study teams
and having a clean word version that they</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5754-1
00:40:35.018 --> 00:40:39.471
<v Kroll, Jessica M.>can then make their next round of
revisions on from the IRB side.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5760-0
00:40:39.471 --> 00:40:43.871
<v Kroll, Jessica M.>We only want to see the changes that were
made to.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5775-0
00:40:44.731 --> 00:40:48.334
<v Kroll, Jessica M.>The the most recently approved document,
we wouldn't want to see changes that were</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5775-1
00:40:48.334 --> 00:40:48.811
<v Kroll, Jessica M.>previously.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5779-0
00:40:49.241 --> 00:40:51.161
<v Kroll, Jessica M.>Requested and approved.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5780-0
00:40:53.421 --> 00:40:53.581
<v Permana, Paskasari A.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5783-0
00:40:54.961 --> 00:40:55.361
<v Permana, Paskasari A.>There are.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5798-0
00:40:55.361 --> 00:40:59.817
<v Permana, Paskasari A.>There have been several requests from
research to use patient labels for the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5798-1
00:40:59.817 --> 00:41:00.801
<v Permana, Paskasari A.>informed consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5809-0
00:41:01.161 --> 00:41:05.401
<v Permana, Paskasari A.>Is that appropriate or does it not meet
the SSN Reduction Act?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5827-0
00:41:14.591 --> 00:41:17.672
<v Kroll, Jessica M.>Michelle,
would you have the answer to that or</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5827-1
00:41:17.672 --> 00:41:21.671
<v Kroll, Jessica M.>would we need to come back after risk
getting clarification?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5832-0
00:41:29.161 --> 00:41:31.401
<v Permana, Paskasari A.>Yeah, if you are talking.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5834-0
00:41:31.401 --> 00:41:32.841
<v Permana, Paskasari A.>I we can't hear you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5836-0
00:41:37.431 --> 00:41:38.231
<v Permana, Paskasari A.>All right.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5841-0
00:41:39.921 --> 00:41:42.081
<v Permana, Paskasari A.>Michelle, can you respond?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5858-0
00:41:44.451 --> 00:41:50.131
<v Kroll, Jessica M.>I see her going on and off mute,
so there might be some audio challenges.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5857-0
00:41:46.121 --> 00:41:49.641
<v Permana, Paskasari A.>Yeah. Yes. OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5881-0
00:41:51.691 --> 00:41:54.867
<v Permana, Paskasari A.>Well,
just mark this and then we can go back to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5881-1
00:41:54.867 --> 00:41:58.771
<v Permana, Paskasari A.>it if you know if possible there is a
comment in the chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5893-0
00:41:58.971 --> 00:42:03.891
<v Permana, Paskasari A.>I've looked at the new Virginia form
10/04/93 and these changes were great.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5924-0
00:42:04.131 --> 00:42:08.623
<v Permana, Paskasari A.>A few things that I've noticed that may
need to be updated additionally are that</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5924-1
00:42:08.623 --> 00:42:12.615
<v Permana, Paskasari A.>when you input a date on page one,
it does not populate under remaining</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5924-2
00:42:12.615 --> 00:42:16.331
<v Permana, Paskasari A.>pages and then the facility name,
address and study name does not.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5932-0
00:42:16.641 --> 00:42:18.521
<v Permana, Paskasari A.>Populate deleter pages either.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5940-0
00:42:18.921 --> 00:42:20.780
<v Permana, Paskasari A.>To me,
it would be better than having to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5940-1
00:42:20.780 --> 00:42:22.321
<v Permana, Paskasari A.>handwrite all of this information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5943-0
00:42:23.811 --> 00:42:24.971
<v Permana, Paskasari A.>So it's just a comment.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5949-0
00:42:26.961 --> 00:42:29.441
<v Permana, Paskasari A.>The next one the next.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5952-0
00:42:29.561 --> 00:42:30.281
<v Permana, Paskasari A.>Sorry, go ahead.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5956-0
00:42:30.341 --> 00:42:31.301
<v Christiano, Michelle>Pasta, can you hear me now?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5957-0
00:42:30.601 --> 00:42:33.001
<v Kroll, Jessica M.>Yeah, I was gonna say, if Michelle,
are you?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5959-0
00:42:33.561 --> 00:42:33.841
<v Permana, Paskasari A.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5960-0
00:42:33.701 --> 00:42:34.381
<v Christiano, Michelle>Can you hear me?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5962-0
00:42:35.031 --> 00:42:35.631
<v Kroll, Jessica M.>Yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5964-0
00:42:35.681 --> 00:42:36.601
<v Permana, Paskasari A.>Yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/5967-0
00:42:36.431 --> 00:42:37.711
<v Christiano, Michelle>Great. OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6006-0
00:42:37.951 --> 00:42:43.260
<v Christiano, Michelle>So I just wanted to let you know the form
was designed when we sent it to 10 BG Rep</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6006-1
00:42:43.260 --> 00:42:47.811
<v Christiano, Michelle>that it would do exactly that,
that it would go ahead and auto populate</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6006-2
00:42:47.811 --> 00:42:51.920
<v Christiano, Michelle>once you enter it once.
You should not have to enter it multiple</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6006-3
00:42:51.920 --> 00:42:52.931
<v Christiano, Michelle>times. So thank.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6016-0
00:42:52.951 --> 00:42:55.551
<v Christiano, Michelle>You for that feedback,
I'll take it forward to them.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6025-0
00:42:58.661 --> 00:43:01.501
<v Permana, Paskasari A.>Michelle,
I don't know if you want to address.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6031-0
00:43:02.851 --> 00:43:03.451
<v Permana, Paskasari A.>Question #12.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6034-0
00:43:03.451 --> 00:43:04.451
<v Permana, Paskasari A.>If not, we can move on.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6042-0
00:43:05.241 --> 00:43:07.001
<v Christiano, Michelle>Yes, I I can address that one too.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6049-0
00:43:07.001 --> 00:43:08.721
<v Christiano, Michelle>Thank you all for being patient with me
today.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6047-0
00:43:07.701 --> 00:43:07.821
<v Permana, Paskasari A.>Yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6069-0
00:43:08.721 --> 00:43:14.526
<v Christiano, Michelle>We've had some some fun times this week
in my remote office slash conference room</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6069-1
00:43:14.526 --> 00:43:16.721
<v Christiano, Michelle>on the third floor for item 12.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6082-0
00:43:17.041 --> 00:43:21.920
<v Christiano, Michelle>I'm gonna take that forward to VHA
privacy and get a definitive answer from</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6082-1
00:43:21.920 --> 00:43:22.241
<v Christiano, Michelle>them.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6084-0
00:43:24.321 --> 00:43:25.001
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6105-0
00:43:26.571 --> 00:43:32.491
<v Permana, Paskasari A.>The question #14 I think has also been
answered responded to in the chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6114-0
00:43:33.051 --> 00:43:38.891
<v Permana, Paskasari A.>So unless either one of you want to add
to it, I will go on to the next one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6123-0
00:43:39.951 --> 00:43:42.711
<v Christiano, Michelle>Oscar, I'd like to add to 14 if I could.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6124-0
00:43:42.681 --> 00:43:43.561
<v Permana, Paskasari A.>Of course.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6162-0
00:43:44.211 --> 00:43:50.188
<v Christiano, Michelle>As I noted earlier, when I was talking,
the reason that we put it into the VA</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6162-1
00:43:50.188 --> 00:43:55.322
<v Christiano, Michelle>form 10 O 493 was added to both the CIRB
library and the ORPP&amp;</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6162-2
00:43:55.322 --> 00:43:57.851
<v Christiano, Michelle>E library as a template document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6186-0
00:43:59.531 --> 00:44:04.809
<v Christiano, Michelle>There's two reasons that we added it as a
template #1 depending on what type of</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6186-1
00:44:04.809 --> 00:44:09.691
<v Christiano, Michelle>Adobe Acrobat the individual user has,
they may not be able to do a fill.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6201-0
00:44:10.161 --> 00:44:14.281
<v Christiano, Michelle>And save and then recreate the document
or reproduce the document.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6221-0
00:44:14.281 --> 00:44:18.074
<v Christiano, Michelle>We've noticed that at several of the
sites based on feedback,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6221-1
00:44:18.074 --> 00:44:21.561
<v Christiano, Michelle>so I want everyone to please just use the
VA forms page.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6229-0
00:44:23.051 --> 00:44:24.411
<v Christiano, Michelle>To avoid that issue.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6253-0
00:44:24.451 --> 00:44:27.707
<v Christiano, Michelle>Secondly,
the reason we want you to start using the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6253-1
00:44:27.707 --> 00:44:32.778
<v Christiano, Michelle>VA forms page is that's your definitive
source for using any type of VA national</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6253-2
00:44:32.778 --> 00:44:33.091
<v Christiano, Michelle>form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6261-0
00:44:33.091 --> 00:44:35.531
<v Christiano, Michelle>So it really is where we all should be
going.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6268-0
00:44:36.451 --> 00:44:39.291
<v Christiano, Michelle>I know I'm.
I'm used to doing my shortcuts too.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6285-0
00:44:39.601 --> 00:44:44.125
<v Christiano, Michelle>But I really want to encourage you
strongly to start using the VA forms page</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6285-1
00:44:44.125 --> 00:44:45.241
<v Christiano, Michelle>for VA form 100493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6288-0
00:44:48.071 --> 00:44:48.871
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6304-0
00:44:49.271 --> 00:44:53.183
<v Permana, Paskasari A.>Next question,
what about veterans with dementia who are</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6290-0
00:44:49.421 --> 00:44:49.741
<v Christiano, Michelle>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6304-1
00:44:53.183 --> 00:44:55.791
<v Permana, Paskasari A.>unable to sign, who may sign for them?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6310-0
00:44:58.651 --> 00:44:59.571
<v Christiano, Michelle>Jessica, that's OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6318-0
00:44:59.571 --> 00:45:02.811
<v Christiano, Michelle>I'll start that one and then if you could
jump in with anything that I might miss.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6372-0
00:45:04.331 --> 00:45:09.011
<v Christiano, Michelle>So for veterans with dementia,
depending if you're asking about who can</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6323-0
00:45:04.371 --> 00:45:04.571
<v Kroll, Jessica M.>OK.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6372-1
00:45:09.011 --> 00:45:13.496
<v Christiano, Michelle>sign the VA form, 10 O 493,
that's who is assigned as their personal</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6372-2
00:45:13.496 --> 00:45:16.616
<v Christiano, Michelle>representative,
and the definition for personal</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6372-3
00:45:16.616 --> 00:45:21.491
<v Christiano, Michelle>representative was actually added to the
revised VA form 10 O 493 to give.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6378-0
00:45:21.491 --> 00:45:22.571
<v Christiano, Michelle>That information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6385-0
00:45:22.971 --> 00:45:27.611
<v Christiano, Michelle>It will also depend on who the IRB
approves.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6396-0
00:45:28.041 --> 00:45:31.401
<v Christiano, Michelle>To serve as their surrogate or caregiver
consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6408-0
00:45:31.401 --> 00:45:35.232
<v Christiano, Michelle>So Jessica, at that point,
can you jump in and clarify that from the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6408-1
00:45:35.232 --> 00:45:36.121
<v Christiano, Michelle>IRB perspective?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6419-0
00:45:37.411 --> 00:45:41.482
<v Kroll, Jessica M.>Yeah, you know,
it'll depend on the protocol and the the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6419-1
00:45:41.482 --> 00:45:42.411
<v Kroll, Jessica M.>study design.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6441-0
00:45:42.411 --> 00:45:47.676
<v Kroll, Jessica M.>So that would be something that would be
proposed in the protocol and the consent</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6441-1
00:45:47.676 --> 00:45:52.171
<v Kroll, Jessica M.>process and the board would determine if
that was appropriate or not.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6485-0
00:45:55.431 --> 00:46:00.190
<v Permana, Paskasari A.>Great. Next question,
the Privacy officer at my facility has</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6485-1
00:46:00.190 --> 00:46:06.120
<v Permana, Paskasari A.>been has recently been approved or sorry
has recently approved API to add a</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6485-2
00:46:06.120 --> 00:46:12.674
<v Permana, Paskasari A.>continuation page to via phone 100493 for
extra room to expand upon the information</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6485-3
00:46:12.674 --> 00:46:16.731
<v Permana, Paskasari A.>contained in the disclosure section.
Could this be?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6497-0
00:46:16.731 --> 00:46:21.051
<v Permana, Paskasari A.>A solution for the lack of space
available on pages 2:00 and 5:00.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6521-0
00:46:22.911 --> 00:46:26.933
<v Christiano, Michelle>I will defer to VHA privacy on that
because as I said earlier,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6521-1
00:46:26.933 --> 00:46:29.551
<v Christiano, Michelle>they're the business owner for that form.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6550-0
00:46:29.701 --> 00:46:34.840
<v Christiano, Michelle>We have taken it back to 10 BG wrap and
ask them to expand the spacing in the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6550-1
00:46:34.840 --> 00:46:38.661
<v Christiano, Michelle>text box to give us more room on both
pages two and five.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6550-2
00:46:38.661 --> 00:46:42.021
<v Christiano, Michelle>So hopefully we'll have a resolution to
that soon.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6574-0
00:46:46.411 --> 00:46:51.182
<v Permana, Paskasari A.>I may have missed it,
but given changes to 10 O 493 has boiler</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6574-1
00:46:51.182 --> 00:46:54.211
<v Permana, Paskasari A.>plate IPA language for combined consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6580-0
00:46:54.211 --> 00:46:56.611
<v Permana, Paskasari A.>HIPAA authorization also been updated.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6591-0
00:47:00.451 --> 00:47:03.851
<v Christiano, Michelle>Jessica, I'm happy to start that one with.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6594-0
00:47:03.851 --> 00:47:05.291
<v Christiano, Michelle>Yes, yes it has.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6612-0
00:47:05.291 --> 00:47:08.058
<v Christiano, Michelle>Thank goodness Jessica went over that
earlier,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6612-1
00:47:08.058 --> 00:47:12.651
<v Christiano, Michelle>but I'll defer to her for the specific
changes because those fall under CIRB.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6629-0
00:47:14.681 --> 00:47:20.826
<v Kroll, Jessica M.>So the question is has boilerplate HIPA
language for combined consent also been</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6629-1
00:47:20.826 --> 00:47:21.441
<v Kroll, Jessica M.>updated?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6630-0
00:47:25.061 --> 00:47:25.701
<v Permana, Paskasari A.>Alright.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6633-0
00:47:26.981 --> 00:47:28.701
<v Permana, Paskasari A.>Very clean and simple.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6634-0
00:47:28.801 --> 00:47:29.521
<v Kroll, Jessica M.>Yes.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6656-0
00:47:29.801 --> 00:47:33.643
<v Permana, Paskasari A.>Next, next question,
does any sample storage for future</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6656-1
00:47:33.643 --> 00:47:39.407
<v Permana, Paskasari A.>potential research considered banking and
is it considered a specimen repository if</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6656-2
00:47:39.407 --> 00:47:39.681
<v Permana, Paskasari A.>yes?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6660-0
00:47:43.911 --> 00:47:45.511
<v Christiano, Michelle>I'll take that one first, Jessica.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6712-0
00:47:47.251 --> 00:47:53.307
<v Christiano, Michelle>So as we if you attended David Thompson's
training last week where he went over</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6712-1
00:47:53.307 --> 00:47:58.228
<v Christiano, Michelle>research repositories,
the answer to that question would be yes,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6712-2
00:47:58.228 --> 00:48:04.284
<v Christiano, Michelle>that any storage of a sample or data of
any kind for a future research activity</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6712-3
00:48:04.284 --> 00:48:07.691
<v Christiano, Michelle>not known at the current time would
require.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6722-0
00:48:07.811 --> 00:48:10.251
<v Christiano, Michelle>A research repository to be established.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6739-0
00:48:11.661 --> 00:48:15.219
<v Christiano, Michelle>If you need additional guidance or
information on that,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6739-1
00:48:15.219 --> 00:48:17.061
<v Christiano, Michelle>I will refer you to find pro.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6765-0
00:48:18.731 --> 00:48:23.497
<v Christiano, Michelle>For Ord guidance or if you have a
specific question that your facility</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6765-1
00:48:23.497 --> 00:48:26.451
<v Christiano, Michelle>research office cannot answer,
contact Ord.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6773-0
00:48:26.491 --> 00:48:29.411
<v Christiano, Michelle>But always start with your facility
research office.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6778-0
00:48:29.411 --> 00:48:32.411
<v Christiano, Michelle>They're your best subject matter experts
at the local level.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6797-0
00:48:37.051 --> 00:48:41.180
<v Permana, Paskasari A.>Next question,
can the new version of the 100493 be used</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6797-1
00:48:41.180 --> 00:48:42.411
<v Permana, Paskasari A.>in imedc consent?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6805-0
00:48:44.361 --> 00:48:46.121
<v Christiano, Michelle>That one, I don't know.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6815-0
00:48:46.161 --> 00:48:49.423
<v Christiano, Michelle>That's the answer to that one,
but I will follow up and get that back to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6815-1
00:48:49.423 --> 00:48:50.361
<v Christiano, Michelle>you as soon as I can.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6818-0
00:48:52.141 --> 00:48:52.781
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6835-0
00:48:53.181 --> 00:48:55.932
<v Permana, Paskasari A.>Next,
my team has several pending submissions</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6835-1
00:48:55.932 --> 00:48:59.101
<v Permana, Paskasari A.>with Privacy Officer,
but haven't been approved yet.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6872-0
00:48:59.541 --> 00:49:02.202
<v Permana, Paskasari A.>All of the submissions have an updated
HIPAA.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6872-1
00:49:02.202 --> 00:49:06.714
<v Permana, Paskasari A.>Do we need to wait until the updates are
made to the new template in order to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6872-2
00:49:06.714 --> 00:49:10.820
<v Permana, Paskasari A.>submit and receive approval?
For example data and specimen banking are</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6872-3
00:49:10.820 --> 00:49:11.341
<v Permana, Paskasari A.>required.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6896-0
00:49:16.381 --> 00:49:20.977
<v Christiano, Michelle>I'm reviewing the question to make sure
that I understand it and I'm not quite</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6896-1
00:49:20.977 --> 00:49:24.410
<v Christiano, Michelle>certain that I do,
but my understanding of item 20 is that</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6896-2
00:49:24.410 --> 00:49:25.981
<v Christiano, Michelle>the research team has made.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6942-0
00:49:27.651 --> 00:49:32.929
<v Christiano, Michelle>Several new studies or amendments that
required revisions to the VA Form 10 O</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6942-1
00:49:32.929 --> 00:49:37.124
<v Christiano, Michelle>493, and with that,
they're asking if they need to wait until</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6942-2
00:49:37.124 --> 00:49:42.470
<v Christiano, Michelle>the updates on the new version are made
to the new template in order to submit</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6942-3
00:49:42.470 --> 00:49:43.891
<v Christiano, Michelle>and receive approval.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6943-0
00:49:44.841 --> 00:49:45.001
<v Christiano, Michelle>Well.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6955-0
00:49:45.401 --> 00:49:48.561
<v Christiano, Michelle>If that's if you've already submitted
them, no.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6959-0
00:49:48.561 --> 00:49:51.001
<v Christiano, Michelle>Because the deadline is November 3rd.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6978-0
00:49:52.441 --> 00:49:57.128
<v Christiano, Michelle>If you if you start the process before it
gets to the central IRB, then no,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6978-1
00:49:57.128 --> 00:50:01.321
<v Christiano, Michelle>you don't have to worry about that
because it's already in process.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6999-0
00:50:06.061 --> 00:50:11.241
<v Permana, Paskasari A.>This question why does the disclosure
section now have quote the research</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/6999-1
00:50:11.241 --> 00:50:15.581
<v Permana, Paskasari A.>project sponsor Slash funding source will
also bank UN quote.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7005-0
00:50:16.701 --> 00:50:17.941
<v Christiano, Michelle>I'll take that one too.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7006-0
00:50:17.981 --> 00:50:18.461
<v Christiano, Michelle>The reason?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7032-0
00:50:18.461 --> 00:50:23.371
<v Christiano, Michelle>We added it is because we had so many
questions from the field where it wasn't</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7032-1
00:50:23.371 --> 00:50:26.541
<v Christiano, Michelle>clear that the research project's funding
sponsor.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7045-0
00:50:26.541 --> 00:50:30.006
<v Christiano, Michelle>So let's just, you know,
I'll throw AstraZeneca under the bus</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7045-1
00:50:30.006 --> 00:50:30.341
<v Christiano, Michelle>today.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7076-0
00:50:30.901 --> 00:50:34.352
<v Christiano, Michelle>It wasn't clear that not only are they
paying for this study,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7076-1
00:50:34.352 --> 00:50:38.693
<v Christiano, Michelle>but they're also keeping data and or
specimens from this from the individual.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7076-2
00:50:38.693 --> 00:50:41.755
<v Christiano, Michelle>And we asked.
We added that there to give a little bit</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7076-3
00:50:41.755 --> 00:50:42.701
<v Christiano, Michelle>more information.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7091-0
00:50:43.411 --> 00:50:47.171
<v Christiano, Michelle>Ideally, if it's mandatory banking,
that should match what's already in.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7118-0
00:50:47.641 --> 00:50:50.853
<v Christiano, Michelle>And they informed consent and for
optional banking,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7118-1
00:50:50.853 --> 00:50:54.126
<v Christiano, Michelle>it should supplement what's in the
informed consent.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7118-2
00:50:54.126 --> 00:50:56.041
<v Christiano, Michelle>And on page five of the 100493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7152-0
00:51:00.231 --> 00:51:05.139
<v Permana, Paskasari A.>Next is an LIR permitted to sign a
combined IC, NEPA authorization,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7152-1
00:51:05.139 --> 00:51:09.470
<v Permana, Paskasari A.>a personal representative for signing an
IPO authorization,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7152-2
00:51:09.470 --> 00:51:12.791
<v Permana, Paskasari A.>is not necessarily the same person as an
LAR.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7157-0
00:51:14.311 --> 00:51:15.791
<v Christiano, Michelle>Jessica, I'll take that one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7183-0
00:51:16.441 --> 00:51:20.584
<v Christiano, Michelle>Whenever a informed consent form is
combined with a HIPAA authorization,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7183-1
00:51:20.584 --> 00:51:25.068
<v Christiano, Michelle>then the HIPAA authorization requirements
must be met and a legally authorized</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7183-2
00:51:25.068 --> 00:51:26.601
<v Christiano, Michelle>representative cannot sign.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7189-0
00:51:28.091 --> 00:51:30.251
<v Christiano, Michelle>It must be a personal representative.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7193-0
00:51:32.421 --> 00:51:32.941
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7215-0
00:51:35.151 --> 00:51:37.583
<v Permana, Paskasari A.>Next,
how are study team members supposed to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7215-1
00:51:37.583 --> 00:51:41.908
<v Permana, Paskasari A.>assist veterans or others who sign an
informed consent form in response to this</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7215-2
00:51:41.908 --> 00:51:43.151
<v Permana, Paskasari A.>new mandatory language?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7249-0
00:51:44.871 --> 00:51:48.692
<v Permana, Paskasari A.>Receiving $600.
00 or more for participating in research</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7249-1
00:51:48.692 --> 00:51:54.122
<v Permana, Paskasari A.>in a calendar year might change how much
you owe the government in taxes or your</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7249-2
00:51:54.122 --> 00:51:57.071
<v Permana, Paskasari A.>eligibility for non VA government
benefits.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7261-0
00:51:57.391 --> 00:52:01.565
<v Permana, Paskasari A.>Talk to your side team if you have
concerns about how compensation can</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7261-1
00:52:01.565 --> 00:52:02.271
<v Permana, Paskasari A.>impact your.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7273-0
00:52:02.621 --> 00:52:08.861
<v Permana, Paskasari A.>Finances and I haven't had a chance to
actually put there is.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7274-0
00:52:11.151 --> 00:52:11.191
<v Permana, Paskasari A.>A.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7277-0
00:52:11.861 --> 00:52:13.221
<v Permana, Paskasari A.>A response.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7307-0
00:52:14.221 --> 00:52:20.386
<v Permana, Paskasari A.>Just notify the veterans that they have
to claim it on their taxes if they get</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7307-1
00:52:20.386 --> 00:52:24.366
<v Permana, Paskasari A.>more than $600 a year,
as it is considered income,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7307-2
00:52:24.366 --> 00:52:26.941
<v Permana, Paskasari A.>and then the response to that is.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7324-0
00:52:30.871 --> 00:52:35.315
<v Permana, Paskasari A.>I'm more concerned with explaining to
them quote UN quote loss of benefits and</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7324-1
00:52:35.315 --> 00:52:36.271
<v Permana, Paskasari A.>its implications.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7331-0
00:52:37.751 --> 00:52:39.271
<v Permana, Paskasari A.>Do you have any comments?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7340-0
00:52:38.841 --> 00:52:41.401
<v Kroll, Jessica M.>Yeah, I can reply that to that Pascal.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7349-0
00:52:41.401 --> 00:52:46.001
<v Kroll, Jessica M.>So the language in the consent is
suggested.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7339-0
00:52:41.631 --> 00:52:41.871
<v Permana, Paskasari A.>Yeah.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7350-0
00:52:46.001 --> 00:52:47.441
<v Kroll, Jessica M.>It's not mandatory.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7380-0
00:52:47.601 --> 00:52:53.739
<v Kroll, Jessica M.>So there's just instruction like the
first response is to do the due diligence</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7380-1
00:52:53.739 --> 00:52:59.721
<v Kroll, Jessica M.>and inform veterans that if they get more
than 600, it is considered income.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7389-0
00:52:59.721 --> 00:53:03.904
<v Kroll, Jessica M.>How you write that language and the
information you provide to them is up to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7389-1
00:53:03.904 --> 00:53:04.121
<v Kroll, Jessica M.>you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7394-0
00:53:04.881 --> 00:53:07.361
<v Kroll, Jessica M.>And what you're comfortable with as a
study team?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7409-0
00:53:07.791 --> 00:53:11.711
<v Kroll, Jessica M.>So that language is not required or
mandatory to be written verbatim.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7420-0
00:53:12.861 --> 00:53:18.141
<v Permana, Paskasari A.>OK. And in fact,
there's another comment identifying a</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7420-1
00:53:18.141 --> 00:53:18.621
<v Permana, Paskasari A.>link.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7430-0
00:53:20.111 --> 00:53:23.551
<v Permana, Paskasari A.>To you know,
the VA healthcare income limits.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7439-0
00:53:25.231 --> 00:53:29.631
<v Permana, Paskasari A.>And I'm going to post the next question.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7447-0
00:53:31.351 --> 00:53:33.511
<v Permana, Paskasari A.>Trying to apply here as well.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7453-0
00:53:34.071 --> 00:53:36.991
<v Permana, Paskasari A.>Copy and paste as fast as I can.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7473-0
00:53:37.071 --> 00:53:40.530
<v Permana, Paskasari A.>It's a new stamp.
If the new stamp will override fillable</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7473-1
00:53:40.530 --> 00:53:43.214
<v Permana, Paskasari A.>fields,
that means that we can no longer use</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7473-2
00:53:43.214 --> 00:53:43.751
<v Permana, Paskasari A.>fillable.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7480-0
00:53:44.021 --> 00:53:47.141
<v Permana, Paskasari A.>Fields on our information forms.
Is that correct?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7507-0
00:53:49.801 --> 00:53:53.837
<v Kroll, Jessica M.>So I see some other conversation going on
in the chat,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7507-1
00:53:53.837 --> 00:53:59.121
<v Kroll, Jessica M.>and it does seem like if we stamp APDF,
the fillable fields may remain.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7530-0
00:53:59.321 --> 00:54:07.220
<v Kroll, Jessica M.>So I I might not have the most up-to-date
information on that functionality within</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7530-1
00:54:07.220 --> 00:54:10.361
<v Kroll, Jessica M.>IRB net, but we can provide more.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7548-0
00:54:10.361 --> 00:54:14.708
<v Kroll, Jessica M.>I can connect with veers and confirm and
provide a response to that in chat once I</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7548-1
00:54:14.708 --> 00:54:15.441
<v Kroll, Jessica M.>know for sure.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7550-0
00:54:16.611 --> 00:54:17.291
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7573-0
00:54:18.751 --> 00:54:23.774
<v Permana, Paskasari A.>The next question for our sponsor study
that has the HIPAA language in the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7573-1
00:54:23.774 --> 00:54:27.391
<v Permana, Paskasari A.>informed consent form,
but also has optional banking.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7598-0
00:54:27.471 --> 00:54:32.253
<v Permana, Paskasari A.>Is it OK to still have the HIPAA language
in the consent and also use the 100493</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7598-1
00:54:32.253 --> 00:54:37.271
<v Permana, Paskasari A.>since the separate HIPAA authorization is
required to be used with optional banking?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7600-0
00:54:39.221 --> 00:54:39.901
<v Christiano, Michelle>I'll take that one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7645-0
00:54:41.411 --> 00:54:43.744
<v Christiano, Michelle>If your sponsored study nine times out of
10,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7645-1
00:54:43.744 --> 00:54:47.851
<v Christiano, Michelle>what I see when I look at those for the
studies that are going to the commercial</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7645-2
00:54:47.851 --> 00:54:51.046
<v Christiano, Michelle>IRV that we work with,
the sponsors will put in HIPAA language</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7645-3
00:54:51.046 --> 00:54:54.291
<v Christiano, Michelle>that they have developed that is not VA
language, it should be.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7673-0
00:54:54.291 --> 00:54:57.443
<v Christiano, Michelle>Removed.
They should use instead if they're doing</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7673-1
00:54:57.443 --> 00:55:01.919
<v Christiano, Michelle>any kind of optional banking,
they're required to use the VA form 10 O</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7673-2
00:55:01.919 --> 00:55:02.171
<v Christiano, Michelle>493.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7691-0
00:55:02.211 --> 00:55:06.773
<v Christiano, Michelle>So remove the HIPAA language and then
make sure that the information is covered</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7691-1
00:55:06.773 --> 00:55:07.971
<v Christiano, Michelle>on the VA form 10049.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7708-0
00:55:10.151 --> 00:55:13.485
<v Christiano, Michelle>If you have questions or specific
concerns about a study,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7695-0
00:55:10.551 --> 00:55:10.631
<v Permana, Paskasari A.>So.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7708-1
00:55:13.485 --> 00:55:16.991
<v Christiano, Michelle>you can always reach out to me and I can
look at it for you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7711-0
00:55:18.241 --> 00:55:18.761
<v Permana, Paskasari A.>Thank you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7722-0
00:55:18.761 --> 00:55:26.241
<v Permana, Paskasari A.>This is actually a comment on a previous
question regarding requirement #2.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7730-0
00:55:28.151 --> 00:55:31.511
<v Permana, Paskasari A.>So it's just, you know,
a comment that you can read later.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7744-0
00:55:33.151 --> 00:55:36.911
<v Permana, Paskasari A.>In trying to make sure that we get to as
many questions as possible.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7748-0
00:55:40.981 --> 00:55:42.941
<v Permana, Paskasari A.>Let me get the next one.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7768-0
00:55:46.071 --> 00:55:49.433
<v Permana, Paskasari A.>For the specific information concerning
sensitive diagnosis,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7768-1
00:55:49.433 --> 00:55:53.071
<v Permana, Paskasari A.>I see the subject must check the
applicable boxes before signing.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7787-0
00:55:53.191 --> 00:55:58.224
<v Permana, Paskasari A.>Should the HIPAA submitted to the Privacy
Officer for review indicate which</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7787-1
00:55:58.224 --> 00:56:01.271
<v Permana, Paskasari A.>specific diagnosis the protocol will
utilize?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7814-0
00:56:03.071 --> 00:56:06.982
<v Christiano, Michelle>So if you if you're looking at the VA
form 10 O 493 and let me,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7814-1
00:56:06.982 --> 00:56:10.831
<v Christiano, Michelle>I think I've got it pulled up,
let me share my screen quickly.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7816-0
00:56:10.901 --> 00:56:12.021
<v Permana, Paskasari A.>OK. All right.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7825-0
00:56:13.241 --> 00:56:16.001
<v Christiano, Michelle>So I can kind of show. Yeah, I do have it.
OK, great.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7828-0
00:56:23.931 --> 00:56:25.411
<v Christiano, Michelle>Minimize everyone here.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7836-0
00:56:26.941 --> 00:56:29.101
<v Christiano, Michelle>Hang on while I give you all visual
whiplash.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7847-0
00:56:31.241 --> 00:56:34.081
<v Christiano, Michelle>So the information that we're Speaking of
is right here.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7851-0
00:56:34.191 --> 00:56:36.151
<v Christiano, Michelle>So here under this section.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7864-0
00:56:38.301 --> 00:56:41.901
<v Christiano, Michelle>There's instructions that say the subject
must check the applicable boxes below.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7885-0
00:56:43.561 --> 00:56:46.897
<v Christiano, Michelle>Before signing the form and if they if
they ask the research team to check on</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7885-1
00:56:46.897 --> 00:56:47.881
<v Christiano, Michelle>their behalf, they can.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7913-0
00:56:48.361 --> 00:56:52.485
<v Christiano, Michelle>I don't recommend that you check this
before giving it to your PO.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7913-1
00:56:52.485 --> 00:56:57.287
<v Christiano, Michelle>What I recommend is either you provide
that information in writing to your PO</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7913-2
00:56:57.287 --> 00:56:59.441
<v Christiano, Michelle>via an e-mail or a memo to your PO.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7933-0
00:57:01.561 --> 00:57:05.631
<v Christiano, Michelle>One of the things that I've heard from
the field POS is that e-mail is a much</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7933-1
00:57:05.631 --> 00:57:07.561
<v Christiano, Michelle>better documentation system for them.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7949-0
00:57:07.871 --> 00:57:13.031
<v Christiano, Michelle>Then catching them in the hallway or
asking them over the phone or via teams.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7971-0
00:57:13.031 --> 00:57:15.304
<v Christiano, Michelle>Hey,
really quickly I'm gonna do this or I'm</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7971-1
00:57:15.304 --> 00:57:17.779
<v Christiano, Michelle>gonna do that because they review so much
stuff.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7971-2
00:57:17.779 --> 00:57:20.911
<v Christiano, Michelle>And for most of the field POS research is
an additional task.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7992-0
00:57:20.911 --> 00:57:24.798
<v Christiano, Michelle>It's not their only task that they're
doing. So to answer the question,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7992-1
00:57:24.798 --> 00:57:28.631
<v Christiano, Michelle>I recommend that you put it in an e-mail
or in a memorandum to the PO.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7995-0
00:57:36.511 --> 00:57:38.391
<v Permana, Paskasari A.>Share my screen again.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/7997-0
00:57:40.201 --> 00:57:40.521
<v Permana, Paskasari A.>Umm.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8023-0
00:57:43.611 --> 00:57:48.283
<v Permana, Paskasari A.>There is actually a comment that you know
it is more easy to edit subject</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8023-1
00:57:48.283 --> 00:57:51.251
<v Permana, Paskasari A.>information in all pages.
In the word version.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8051-0
00:57:52.721 --> 00:57:56.814
<v Permana, Paskasari A.>To avoid possible errors and then
consider to include the new ivnet</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8051-1
00:57:56.814 --> 00:57:59.161
<v Permana, Paskasari A.>approval stem to the word word version.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8057-0
00:57:59.281 --> 00:58:02.481
<v Permana, Paskasari A.>This is regarding, I think,
fillable fields.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8060-0
00:58:03.561 --> 00:58:04.601
<v Permana, Paskasari A.>Oh, I apologize.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8065-0
00:58:04.601 --> 00:58:08.001
<v Permana, Paskasari A.>I think I did go through through that,
I apologize.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8077-0
00:58:09.681 --> 00:58:14.721
<v Permana, Paskasari A.>This is another comment to this is the
response to the failover fields.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8098-0
00:58:15.031 --> 00:58:21.044
<v Permana, Paskasari A.>We have found here at West Haven CSPCC
that stem documents have been returned to</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8098-1
00:58:21.044 --> 00:58:23.791
<v Permana, Paskasari A.>us with fillable fields still intact.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8112-0
00:58:24.351 --> 00:58:29.243
<v Permana, Paskasari A.>We have also done it where we over refill
the fields on STEM documents so it is</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8112-1
00:58:29.243 --> 00:58:29.671
<v Permana, Paskasari A.>doable.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8130-0
00:58:31.161 --> 00:58:34.870
<v Permana, Paskasari A.>This is another comment on the sling
provided that this is a very helpful</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8130-1
00:58:34.870 --> 00:58:35.321
<v Permana, Paskasari A.>resource.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8145-0
00:58:35.601 --> 00:58:39.876
<v Permana, Paskasari A.>Study team can also refer participants to
other other state or federal benefits</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8145-1
00:58:39.876 --> 00:58:42.281
<v Permana, Paskasari A.>offices to clarify eligibility
requirements.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8161-0
00:58:43.131 --> 00:58:48.162
<v Permana, Paskasari A.>This will become more of a concern in
proportionate amount of per year study</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8161-1
00:58:48.162 --> 00:58:49.011
<v Permana, Paskasari A.>compensation.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8162-0
00:58:50.801 --> 00:58:51.801
<v Permana, Paskasari A.>And.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8168-0
00:58:53.041 --> 00:58:55.121
<v Permana, Paskasari A.>I'm just going to skip.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8182-0
00:58:55.121 --> 00:58:59.114
<v Permana, Paskasari A.>There are several links in the chat that
is provided,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8182-1
00:58:59.114 --> 00:59:01.481
<v Permana, Paskasari A.>but I'm going to go to the next.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8194-0
00:59:03.001 --> 00:59:05.418
<v Permana, Paskasari A.>Question.
Where do we find the revised Hiba</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8194-1
00:59:05.418 --> 00:59:07.121
<v Permana, Paskasari A.>language for combined consents?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8199-0
00:59:07.201 --> 00:59:09.001
<v Permana, Paskasari A.>Is it also in the VA forms?</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8242-0
00:59:14.651 --> 00:59:19.637
<v Kroll, Jessica M.>Typically we don't release attract,
change version of revisions that were</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8242-1
00:59:19.637 --> 00:59:22.804
<v Kroll, Jessica M.>made,
but I can check with Michelle after this</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8242-2
00:59:22.804 --> 00:59:26.779
<v Kroll, Jessica M.>call if we want to share that information
we and if we do,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8242-3
00:59:26.779 --> 00:59:32.371
<v Kroll, Jessica M.>we can put that in chat specific to the
the revision to the HIPAA language, but I.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8261-0
00:59:32.361 --> 00:59:37.094
<v Kroll, Jessica M.>Will note the old version and the new
versions are still available in the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8261-1
00:59:37.094 --> 00:59:40.291
<v Kroll, Jessica M.>library.
If you wanted to do a comparison side by</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8261-2
00:59:40.291 --> 00:59:40.611
<v Kroll, Jessica M.>side.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8279-0
00:59:43.631 --> 00:59:46.097
<v Permana, Paskasari A.>There are still several questions in the
chat,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8279-1
00:59:46.097 --> 00:59:48.511
<v Permana, Paskasari A.>but I noted that this is the end of the
hour.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8306-0
00:59:48.671 --> 00:59:53.429
<v Permana, Paskasari A.>I'm going to ask the presenters if you
want to have a few more minutes or I can</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8306-1
00:59:53.429 --> 00:59:57.949
<v Permana, Paskasari A.>still collect all the questions and then
the answers can be provided by the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8306-2
00:59:57.949 --> 01:00:00.031
<v Permana, Paskasari A.>presenters in a written form later.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8330-0
01:00:00.811 --> 01:00:03.758
<v Kroll, Jessica M.>Unfortunately,
I have an IRB agenda called to get to.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8330-1
01:00:03.758 --> 01:00:06.595
<v Kroll, Jessica M.>So if we could collect the the remaining
questions,</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8330-2
01:00:06.595 --> 01:00:09.651
<v Kroll, Jessica M.>Michelle and I can respond to them
following this call.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8377-0
01:00:09.481 --> 01:00:13.191
<v Permana, Paskasari A.>Yes,
and thank you everybody for participating</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8377-1
01:00:13.191 --> 01:00:18.086
<v Permana, Paskasari A.>in today's webinar.
And I would again encourage you to please</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8377-2
01:00:18.086 --> 01:00:24.006
<v Permana, Paskasari A.>submit your feedback in the link for
survey that I have just posted in the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8377-3
01:00:24.006 --> 01:00:24.401
<v Permana, Paskasari A.>chat.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8389-0
01:00:24.401 --> 01:00:27.273
<v Permana, Paskasari A.>And again,
I will collect all the questions and the</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8389-1
01:00:27.273 --> 01:00:29.041
<v Permana, Paskasari A.>presenters will get back to you.</v>

6a66c895-88d8-4dfc-af8c-674c333ed306/8405-0
01:00:30.561 --> 01:00:36.241
<v Permana, Paskasari A.>Presumably in the as a written answer in
the chat later. Thank you.</v>