Office of Research & Development |
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The following templates are to help assist your individual VA Human Research Program. The draft tools were developed by a working group including representatives from ORD, ORO, and VA Facilities. The documents comprise of samples such as standard operating policies and procedures, forms, and letters that continue to be refined and updated. These samples can be incorporated with the requirements of VHA Handbook 1200.05 (January 7, 2019), the 2018 Requirements, and Best Practices.
Please note that none of these tools replace the forms used by the VA Central IRB. Please note that none of these tools replace the forms used by the VA Central IRB. All forms are currently located on IRBNet. More information on IRB submissions can be found here VA Central IRB Submissions.
Please send questions to VHACOORDRegulatory@va.gov for questions regarding these documents.
View by Topic |
View by Document Type |
Topic |
Document |
Document Type |
CFR/ Handbook |
Amendment |
Checklist |
None |
|
Conflict of Interest |
SOP |
None |
|
Continuing Review |
Form |
None |
|
Continuing Review |
Checklist |
None |
|
Continuing Review |
Checklist |
None |
|
Continuing Review |
Form |
21 CFR 56 |
|
Coordinating Center |
Coordinating Center Supplement for New Research Applications |
Form |
None |
Devices |
Form |
21 CFR 56; 21 CFR 814 |
|
Exempt |
Tool |
VHA Directives 1200.01 and 1200.05 |
|
Exempt |
Letter |
38 CFR 16; VAH Directive 1200.05 |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Algorithm |
None |
|
Exempt |
Letter/ Documentation |
38 CFR 16; VHA Directive 1200.05 |
|
Exempt |
Form |
38 CFR 16; VHA Directive 1200.05 |
|
Exempt |
Status Report Update for Studies Not Requiring IRB Continuing Review(1-24-2019) |
Form |
None |
Exempt |
Checklist |
38 CFR 16; VHA Directive 1200.05 |
|
Expedited |
Algorithm |
None |
|
General HRPP |
Form |
38 CFR 16; 38 CFR 17; 21 CFR 56; 38 CFR 16; 38 CFR 7332; 21 CFR 50; 45 CFR 160; 45 CFR 164 Handbook 1200.12 Handbook 1058; Handbook 1004; Handbook 1200.17 Handbook 1200.01; Handbook 1605.01; Handbook 1200.08; Handbook 1200.02 |
|
HIPAA |
Form |
45 CFR 164.512(i); VHA Directive 1200.05 |
|
HRPP |
Algorithm |
38 CFR 16; 32 CFR 219; 38 CFR 16 |
|
HRPP |
Converting an ongoing study to the 2018 Requirements – Decision Aid |
Algorithm |
None |
HRPP |
Education Requirements for Research Staff Conducting Human Subjects Research (HRPP Appendix 6) |
Form |
None |
HRPP |
Algorithm |
None |
|
HRPP |
Algorithm |
Handbook 1200.05; VHA Handbook 1058; Handbook 6500 |
|
Informed Consent |
Form |
None |
|
Informed Consent |
Informed Consent Template For Use With LAR - No Combined HIPAA |
Form |
38 CFR 17 |
Informed Consent |
Form |
38 CFR 17 |
|
Informed Consent |
Checklist |
None |
|
Informed Consent |
Waiver of Documentation of Informed Consent (Application and Reviewer Form) |
Form |
None |
Informed Consent |
Waiver or Alteration of Informed Consent (Application and Reviewer Form) |
Form |
None |
International Research |
Director's Certification: International Research (HRPP Appendix 13) |
Letter/ Documentation |
Handbook 1200.05 |
IRB |
SOP |
Handbook 1200.05 |
|
IRB |
Algorithm |
VHA Directive 1200.05; 38 CFR 46.109 |
|
IRB |
Letter/ Documentation |
38 CFR 16; Handbook 1200.01 |
|
IRB |
Checklist |
38 CFR 16; VHA Directive 1200.05 |
|
IRB |
Form |
21 CFR 812; Handbook 1058.01; Handbook 1605.1; Handbook 1200.05; Handbook 1200.12 |
|
IRB |
Checklist |
21 CFR 312; 21 CFR 812; 38 CFR 116; 38 CFR 16; Handbook 6500 |
|
IRB |
Form |
Handbook 1200.12 |
|
IRB |
Form |
None |
|
IRB |
Transition Checklist (2018 Requirements) – IRB Review Documentation |
Checklist |
38 CFR 16 |
IRB |
Algorithm |
21 CFR series |
|
R&D Committee |
Letter/Documentation |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Tool |
VHA Directive 1200.01 |
|
R&D Committee |
Tool |
VHA Directive 1200.01 |
|
R&D Committee |
Tool |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Form |
VHA Directive 1200.01 |
|
R&D Committee |
Oversight Committee Review and Reporting Procedures for Research Involving Human Subjects |
Tool |
VHA Directive 1200.01 and VHA Handbook 1058.01 |
Safety |
SOP |
29 CFR 1910; Handbook 1200.06 |
|
Safety |
Other |
Handbook 1200.06; 29 CFR 1910; 29 CFR 1200 |
|
Safety |
Subcommittee on Research Safety and Security (SRSS) SOP (Appendix 3) |
SOP |
Handbook 1200.01; Handbook 1200.08; |
Stem Cell |
Human Embryonic Stem Cell Use – Reviewer Checklist (HRPP Appendix 9) |
Checklist |
None |
Vulnerable Populations |
Director's Certification: Pregnant Women/Fetus/Neonate (HRPP Appendix 12) |
Letter/ Documentation |
Handbook 1200.05 |
Vulnerable Populations |
Director's Certification: Research Involving Children (HRPP Appendix 14) |
Letter/ Documentation |
Handbook 1200.05 |
Vulnerable Populations |
Director's Letter of Support: Research Involving Prisoners (HRPP Appendix 4) |
Letter/ Documentation |
45 CFR 46; 45 CFR 45; Handbook 1200.05 |
Vulnerable Populations |
Form |
38 CFR 16; 45 CFR 46; Handbook 1200.05 |
|
Vulnerable Populations |
Form |
Handbook 1200.05 |