Division of Research

HRPP Toolkit

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HRPP Toolkit

The Human Research Protection Program (HRPP) Toolkit is a centralized resource for investigators, research staff, IRB members, and institutional partners involved in human subjects research. It includes key forms, templates, standard operating procedures (SOPs), worksheets, and checklists to support the work of the HRPP, IRB staff, and the broader research community.

This toolkit offers access to essential documents that promote compliance with ethical standards, federal regulations, and institutional policies.

To support transparency and help research teams stay informed, a Change Log has been created to track all process updates. This spreadsheet will be updated and dated as new changes are finalized.

View the change log

Please refer to the categories below to find the resources you need. If you have questions or require assistance, contact the HRPP office directly at irb@brown.edu.

Commonly Used Items

Title	Number
IRB Member Manual	109
Waiver or Alteration of Consent Process	410
HIPAA Waiver of Authorization	441
Template Consent Document	502
Additional Consent Language	502a
Template Protocol	503
Template SBS Protocol	503a

All Items

Standard Operating Procedures

Standard operating procedures (SOPs) describe policies and procedures related to the HRPP/IRB review, management, or function of human subjects research.

Title	Number
Definitions	001
Observation of Consent Process	012
Legally Authorized Representatives, Children and Guardians	013
Incoming Items	020
Pre-Review	021
Emergency Use, Compassionate Use, Individual Patient Expanded Access	023
New Information	024
Investigations	025
Suspension or Termination Issued Outside of Convened IRB	026
Emergency Use, Compassionate Use, Individual Patient Expanded Access Post-Review	027
Designated Reviewers	030
Non-Committee Review Preparation	031
Non-Committee Review Conduct	032
IRB Meeting Preparation	040
IRB Meeting Conduct	041
IRB Meeting Attendance Monitoring	042
IRB Meeting Minutes	043
Not Otherwise Approvable Research	044
Conflicting Interests of IRB Members	050
Consultation	051
Post-Review	052
Institutional Conflicts of Interest	054
Financial Conflicts of Interest	055
Annual Evaluations of the HRPP	060
Quarterly Evaluations of the HRPP	061
Daily Tasks	062
Expiration of IRB Approval	063
NIH GDS Institutional Certification	064
Response Plan for Emergencies - Disasters Impacting the HRPP	065
IRB Records	070
Toolkit Management	071
IRB Records Retention	072
IRB Formation	080
IRB Removal	081
IRB Membership Addition	082
IRB Membership Removal	083
IRB Meeting Scheduling and Notification	084
Informed Consent Process for Research	090
Written Documentation of Consent	091
Use of Sexual Orientation and Gender Inclusive Language
Children in Research

General Documents

These general documents include manuals that lay out the expectations of and requirements for the review and/or conduct of research by IRB staff and members, and investigators and research personnel, participant brochures, and decision flowcharts.

Title	Number
Huron HRPP Toolkit Table of Contents	100
Human Research Protection Program Plan	101
Flowcharts	102
Investigator Manual	103
Site Investigator Manual	103p
Should I Take Part in Research Brochure	104
OHRP-FDA Written Procedure Crosswalk	105
Study-Specific Emergency-Disaster Risk Mitigation Planning Decision Guide	108
IRB Member Manual	109

Forms

IRB staff and members, and investigators and research staff use forms as resources for IRB submissions. These forms reflect E-Form pages in Huron and should be used as a reference tool.

Title	Number
IRB Member Information	202
Basic Study Information	211
Continuing Review	212
Modification	213
Reportable New Information	214
Basic Site Information	811
Site Continuing Review	812
Site Modification	813
Site Reportable New Information	814
Institutional Profile	815
External IRB Study Update	816

Worksheets

IRB staff and members refer to these downloadable worksheets when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.

Title	Number
Review Materials	301
Approval Intervals	302
Communications of Review Results	303
IRB Composition	304
Quorum and Expertise	305
Drugs and Biologics	306
Devices	307
Pre-Review	308
Ancillary Review Matrix	309
Human Research Determination	310
Engagement Determination	311
Exemption Determination	312
Expedited Review	313
Criteria for Approval	314
Criteria for Consent	314a
Advertisements	315
Payments	316
Short Form of Consent Documentation	317
Additional Federal Agency Criteria	318
Limited IRB Review and Broad Consent	319
Scientific or Scholarly Review	320
Review of Information Items	321
Emergency Use	322
Criteria for Approval for HUD	323
Contracts	324
Device Compassionate Use	325
Performance Evaluation for IRB Chairs	326
Annual Performance Evaluation Criteria for IRB Members	327
Annual Performance Evaluation for IRB Staff	328
HIPAA Authorization	330
FERPA Compliance	331
NIH GDS Institutional Certification	332
Certificate of Confidentiality	333
Protocol-Specific Emergency/Disaster Risk Mitigation Planning	351
Additional Emergency-Disaster Review Considerations	352
Research-Supported Apps	354
Noncompliance Outcomes	357
RCA CAPA	358

Checklists

IRB members and staff use these downloadable checklists to assess and document regulatory items and enhance compliance with federal, state and local requirements.

Title	Number
Pre-Review	401
Non-Committee Review	402
Waiver or Alteration of Consent Process	410
Waiver of Written Documentation of Consent	411
Pregnant Women	412
Non-Viable Neonates	413
Neonates of Uncertain Viability	414
Prisoners	415
Children	416
Adults with Impaired Decision-Making Capacity	417
Non-Significant Risk Device	418
Waiver of Consent Process for Emergency Research	419
Investigator Quality Improvement Assessment	430
Minutes Quality Improvement Assessment	431
HIPAA Waiver of Authorization	441

General Templates

Investigators and research staff preparing IRB submissions use templates for protocols and consent documents.

Title	Number
Template Broad Consent (not in use at this time)	500
Template Minutes	501
Template Consent Document	502
Additional Consent Language	502a
Template Protocol	503
Template SBS Protocol	503a
Template NHSR Protocol	503b
School Permission to Conduct Research	504
Template SOP	505
Template Consent Document – Expanded Access	506
Template Consent Document – Short Form	507
Template Site Supplement	508
Template Participating Site Supplement	508p
Template Reviewing Site Supplement	508r
Template VA Minutes Supplement (not in use at this time)	509

Single IRB Documents

Title	Number
Template - Participating Site Supplement	508p
Template - Reviewing Site Supplement	508r
SOP - Establishing Authorization Agreements	801
SOP - Institutional Profile Management	802
SOP - External IRB Post-Review	804
SOP - External IRB Updates	805
SOP - Review Request to Rely on External IRB	806
Form - Basic Site Information	811
Form - Site Continuing Review	812
Form - Site Modification	813
Form - Site Reportable New Information	814
Form - Institutional Profile	815
Form - External IRB Study Update	816
Form - Site Supplement Continuing Review	822
Worksheet - Communication and Responsibilities	830
Worksheet - Considerations for Relying on an External IRB	832
Worksheet - Considerations for Serving as the sIRB	833
Questionnaire - Local Context	888
Form - Reliance Cover Page	899

Appendices and Supporting Documents

Appendices must be submitted with a New Application as applicable and may also be required if details of the research change after approval is granted.

Download	When to use	Updated
Appendix I: Human Subjects Research Advisor (DOCX)	When a graduate or medical student is the Principal Investigator	October 2023
Request to Serve as a PI (DOCX)	Individuals who are not automatically eligible for PI status by virtue of their appointment or employment type must submit this form to the appropriate institutional officials and be approved for PI eligibility	June 2020
External Investigator FCOI (DOCX)	When Brown is serving as the IRB under an Individual Investigator Agreement (IIA) or an Organizational Authorization Agreement (OAA) an External Investigator FCOI form must be submitted for each Principal Investigator and any Co-Investigators	May 2023
Continuing Review Supplement		October 2025

Self-Determination Tools

Form	When to use	Updated
IAA Investigator Checklist (Google Doc)	Use this checklist to ensure all procedural requirements are met before submitting an IAA Application reliance request for collaborative research.	July 2021
Research Data Management Offboarding Checklists Study Closure Leaving Brown	Use these checklists when closing out studies or before leaving Brown to ensure compliance with research data management, sharing, storage, transfer, and retention.	These documents are available on the Research Data Management website.

Form

When to use

Updated

IAA Investigator Checklist (Google Doc)

Use this checklist to ensure all procedural requirements are met before submitting an IAA Application reliance request for collaborative research.

July 2021

Research Data Management Offboarding Checklists

Study Closure
Leaving Brown

Use these checklists when closing out studies or before leaving Brown to ensure compliance with research data management, sharing, storage, transfer, and retention.

These documents are available on the Research Data Management website.