Office of Research & Development

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ORPP&E Sample Draft Documents

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 refer to the VA Central IRB section for all instructions and forms to be used for submissions to the VA Central IRB

Please send questions to VHACOORDRegulatory@va.gov for questions regarding these documents.


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Topic

Document

Document Type

CFR/ Handbook

Amendment

Amendment Reviewer Worksheet/Checklist

Checklist

None

Conflict of Interest

Conflict of Interest SOP (HRPP Appendix 16)

SOP

None

Continuing Review

Continuing Review Application

Form

None

Continuing Review

Continuing Review Reviewer Worksheet/Checklist

Checklist

None

Continuing Review

Continuing Reviewer Checklist: IRB Reviewer

Checklist

None

Continuing Review

Humanitarian Use Device Continuing Review Form

Form

21 CFR 56

Coordinating Center

Coordinating Center Supplement for New Research Applications

Form

None

Devices

Humanitarian Use Device Initial Application

Form

21 CFR 56; 21 CFR 814

Exempt

Exempt Category 1

Algorithm

None

Exempt

Exempt Category 2

Algorithm

None

Exempt

Exempt Category 3

Algorithm

None

Exempt

Exempt Category 4

Algorithm

None

Exempt

Exempt Category 5

Algorithm

None

Exempt

Exempt Category 6

Algorithm

None

Exempt

Exempt Category 7

Algorithm

None

Exempt

Exempt Category 8

Algorithm

None

Exempt

Exempt Determination Letter (excludes Limited IRB Review)

Letter/ Documentation

38 CFR 16; Handbook 1200.01

Exempt

Exemption Request Form

Form

45 CFR 160; 45 CFR 164

Exempt

Status Report Update for Studies Not Requiring IRB Continuing Review(1-24-2019)

Form

None

Expedited

Transitioning Expedited Category 5 to Exempt Category 4

Algorithm

None

General HRPP

HRPP Document

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

HRPP

Human Subjects Research Determination (HRPP Appendix 15)

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

Organization Chart - Sample (HRPP Appendix 1)

Algorithm

None

HRPP

Responsibility Matrix (HRPP Appendix 11)

Algorithm

Handbook 1200.05; VHA Handbook 1058; Handbook 6500

Informed Consent

Combined Informed Consent Form and HIPAA Template

Form

None

Informed Consent

Informed Consent Template For Use With LAR - No Combined HIPAA

Form

38 CFR 17

Informed Consent

Informed Consent Template with HIPAA Authorization Elements

Form

38 CFR 17

Informed Consent

Informed Consent/Broad Consent Reviewer Checklist

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

IRB SOP

SOP

Handbook 1200.05

IRB

Limited IRB Review

Algorithm

VHA Directive 1200.05; 38 CFR 46.109

IRB

Limited IRB Review Approval Letter

Letter/ Documentation

38 CFR 16; Handbook 1200.01

IRB

Limited IRB Review Reviewer Worksheet/Checklist

Checklist

38 CFR 16

IRB

PI New/Initial Project Application

Form

21 CFR 812; Handbook 1058.01; Handbook 1605.1; Handbook 1200.05; Handbook 1200.12

IRB

PI New/Initial Project Reviewer Form/Checklist

Checklist

21 CFR 312; 21 CFR 812; 38 CFR 116; 38 CFR 16; Handbook 6500

IRB

Project/Study Closure Report

Form

Handbook 1200.12

IRB

Protocol Template

Form

None

IRB

Transition Checklist (2018 Requirements) – IRB Review Documentation

Checklist

38 CFR 16

IRB

Transitioning Studies to 2018 Requirements

Algorithm

21 CFR series

Recruitment

Non-Veteran Subjects Request Form (HRPP Appendix 17)

Form

Handbook 1605.04

Safety

Laboratory Safety – Hazardous Agents Control Program

SOP

29 CFR 1910; Handbook 1200.06

Safety

Safety Training Manual (2019)

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

Research Involving Pregnant Women: Supplement

Form

38 CFR 16; 45 CFR 46; Handbook 1200.05

Vulnerable Populations

Research Involving Prisoners: Supplement

Form

Handbook 1200.05


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