HRPP Huron Toolkit Library

General Documents  |  Brown-Specific Documents  |  Standard Operating Procedures  |  Worksheets  |  Checklists  |  Forms & Templates  | Toolkit Feedback  


The HRPP Toolkit Library is a set of documents for the Human Research Protection Program (HRPP), IRB staff, IRB members, and members of the research community. Researchers may find documents, like the standard operating procedures for consent processes and documentation (HRP-090, HRP-091), particularly helpful. Below are the general descriptions of the tools in each section - follow each one for the resources below. If you have a question and need further guidance please email [email protected].

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.

Brown-Specific Documents
Brown-specific documents are tools to support all individuals involved in the conduct of human subjects research under the auspices of Brown University. These materials are available on the HRPP Forms and Templates website and HRPP Guidance and Policies website.

Standard Operating Procedures
These standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, or function.

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

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

Forms & Templates
IRB staff and members, and investigators and research staff use forms as resources for IRB submissions. Investigators and research staff preparing IRB submissions use templates for protocols and consent documents.

Toolkit Feedback
Share your feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates, by emailing [email protected]. Feedback is reviewed monthly by HRPP leadership to determine whether changes are needed. Future updates will be mentioned in OVPR’s monthly Research Notes newsletter, with greater detail on the Toolkit Changes webpage.
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General Documents  |  Brown-Specific Documents  |  Standard Operating Procedures  |  Worksheets  |  Checklists  |  Forms & Templates   

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.

Number

Title

Updated

101

Human Research Protection Program Plan

February 2024

102

Flowcharts

February 2024

103

Investigator Manual

February 2024

103p

Site Investigator Manual

February 2024

104

Should I Take Part in Research Brochure

February 2024

105

HHS-FDA Written Procedure Crosswalk

February 2024

108

Study-Specific Emergency-Disaster Risk Mitigation Planning Decision Guide

February 2024

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Brown-Specific Documents

Brown-specific documents are tools to support all individuals involved in the conduct of human subjects research under the auspices of Brown University. These materials are available on the HRPP Forms and Templates website and HRPP Guidance and Policies website.

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Standard Operating Procedures

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

Number

Title

Updated

001

Definitions

February 2024

012

Observation of Consent Process

February 2024

013

Legally Authorized Representatives, Children and Guardians

February 2024

020

Incoming Items

February 2024

021

Pre-Review

February 2024

023

Emergency Use, Compassionate Use, Individual Patient Expanded Access

February 2024

024

New Information

February 2024

025

Investigations

February 2024

026

Suspension or Termination Issued Outside of Convened IRB

February 2024

027

Emergency Use, Compassionate Use, Individual Patient Expanded Access Post-Review

February 2024

030

Designated Reviewers

February 2024

031

Non-Committee Review Preparation

February 2024

032

Non-Committee Review Conduct

February 2024

040

IRB Meeting Preparation

February 2024

041

IRB Meeting Conduct

February 2024

042

IRB Meeting Attendance Monitoring

February 2024

043

IRB Meeting Minutes

February 2024

044

Not Otherwise Approvable Research

February 2024

050

Conflicting Interests of IRB Members

February 2024

051

Consultation

February 2024

052

Post-Review

February 2024

054

Institutional Conflicts of Interest

February 2024

055

Financial Conflicts of Interest

February 2024

060

Annual Evaluations of the HRPP

February 2024

061

Quarterly Evaluations of the HRPP

February 2024

062

Daily Tasks

February 2024

063

Expiration of IRB Approval

February 2024

064

NIH GDS Institutional Certification

February 2024

065

Response Plan for Emergencies - Disasters Impacting the HRPP

February 2024

070

IRB Records

February 2024

071

Toolkit Management

February 2024

072

IRB Records Retention

February 2024

080

IRB Formation

February 2024

081

IRB Removal

February 2024

082

IRB Membership Addition

February 2024

083

IRB Membership Removal

February 2024

084

IRB Meeting Scheduling and Notification       

February 2024

090

Informed Consent Process for Research

February 2024

091

Written Documentation of Consent

February 2024

801

Establishing Authorization Agreements

February 2024

802

Institutional Profile Management

February 2024

804

External IRB Post-Review

February 2024

805

External IRB Updates

February 2024

806

Review Request to Rely on External IRB

February 2024

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Worksheets

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

Number

Title

Updated

301

Review Materials

February 2024

302

Approval Intervals

February 2024

303

Communications of Review Results

February 2024

304

IRB Composition

February 2024

305

Quorum and Expertise

February 2024

306

Drugs and Biologics

February 2024

307

Devices

February 2024

308

Pre-Review

February 2024

309

Ancillary Review Matrix

February 2024

310

Human Research Determination

February 2024

311

Engagement Determination

February 2024

312

Exemption Determination

February 2024

313

Expedited Review

February 2024

314

Criteria for Approval

February 2024

315

Advertisements

February 2024

316

Payments

February 2024

317

Short Form of Consent Documentation

February 2024

318

Additional Federal Agency Criteria

February 2024

319

Limited IRB Review and Broad Consent

February 2024

320

Scientific or Scholarly Review

February 2024

321

Review of Information Items

February 2024

322

Emergency Use

February 2024

323

Criteria for Approval for HUD

February 2024

324

Contracts

February 2024

325

Device Compassionate Use

February 2024

326

Performance Evaluation for IRB Chairs

February 2024

327

Annual Performance Evaluation Criteria for IRB Members

February 2024

328

Annual Performance Evaluation for IRB Staff

February 2024

330

HIPAA Authorization

February 2024

331

FERPA Compliance

February 2024

332

NIH GDS Institutional Certification

February 2024

333

Certificate of Confidentiality

February 2024

351

Protocol-Specific Emergency/Disaster Risk Mitigation Planning

February 2024

352

Additional Emergency-Disaster Review Considerations

February 2024

830

Communication and Responsibilities 

February 2024

832

Considerations for Relying on an External IRB

February 2024

833

Considerations for Serving as the sIRB

February 2024

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Checklists

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

Number

Title

Updated

401

Pre-Review

February 2024

402

Non-Committee Review

February 2024

410

Waiver or Alteration of Consent Process

February 2024

411

Waiver of Written Documentation of Consent

February 2024

412

Pregnant Women

February 2024

413

Non-Viable Neonates

February 2024

414

Neonates of Uncertain Viability

February 2024

415

Prisoners

February 2024

416

Children

February 2024

417

Cognitively Impaired Adults

February 2024

418

Non-Significant Risk Device

February 2024

419

Waiver of Consent Process for Emergency Research

February 2024

430

Investigator Quality Improvement Assessment

February 2024

431

Minutes Quality Improvement Assessment

February 2024

441

HIPAA Waiver of Authorization

February 2024

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Forms & Templates

IRB staff and members, and investigators and research staff use forms as resources for IRB submissions. Investigators and research staff preparing IRB submissions use templates for protocols and consent documents.

Quick Access: Brown-Specific Documents Forms | Investigator Manual | Templates

Forms

Number

Title

Updated

202

IRB Member Information

February 2024

211

Basic Study Information

February 2024

212

Continuing Review

February 2024

213

Modification

February 2024

214

Reportable New Information

February 2024

811

Basic Site Information

February 2024

812

Site Continuing Review

February 2024

813

Site Modification

February 2024

814

Site Reportable New Information

February 2024

815

Institutional Profile

February 2024

816

External IRB Study Update

February 2024

Templates

Number

Title

Updated

500

Template Broad Consent

Not in use at this time

501

Template Minutes

February 2024

502

Template Consent Document

February 2024

503a

Template SBS Protocol

February 2024

504

School Permission to Conduct Research

February 2024

505

Template SOP

February 2024

506

Template Consent Document – Expanded Access

February 2024

507

Template Consent Document – Short Form

February 2024

508

Template Site Supplement

February 2024

509

Template VA Minutes Supplement

Not in use at this time

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