IRBs are responsible for protecting the rights and well-being of research participants, guided by the principles of respect for persons, beneficence, and justice as outlined in the Belmont Report. In fulfilling this duty, IRBs must balance safeguarding vulnerable populations from harm with ensuring the inclusion of underrepresented groups in research. While IRBs are not primarily tasked with overseeing representation in clinical research, they play a crucial role in ensuring that these principles are addressed in clinical studies.
The role of IRBs in promoting representation has historically been underappreciated. To address this, IRBs need clear guidance, tools, and methods to incorporate representation in research. A key first step is for IRBs to set reasonable expectations for representative inclusion at study approval, during ongoing reviews, and at study closeout. While setting these expectations can be challenging due to factors like study focus, population, local context, and resources, achieving a balance between participant protection and inclusive representation requires understanding the context, asking the right questions, and fostering open dialogue. Collaboration among IRBs, HRPPs, institutions, investigators, sponsors, and participants is essential to developing best practices for inclusive research.
In response, the MRCT Center, with guidance from IRB and HRPP representatives, has developed a suite of resources for IRBs, HRPPs, and investigators to help initiate this work. These resources serve as a starting point and will be refined and expanded based on feedback. Please share your comments or questions with us at MRCT@bwh.harvard.edu.
IRB Resources
IRB Membership Self-Assessment Template (Self-Evaluation Survey)
An IRB membership self-assessment survey that provides sample questions for institutions to use or adapt to understand the demographic diversity of their members and their members’ perspectives and opinions.
IRB Statement of Commitment to Inclusion
A concise template example for an IRB statement of commitment to diversity, inclusion, and equity. This example can be adopted and/or adapted by IRBs.
HRPP and IRB Statement of Commitment to Inclusion
A template example for HRPPs’ and IRBs’ statement of commitment to diversity, inclusion, and equity. This example can be adopted and/or adapted by HRPPs and IRBs.
Approaches to Support IRB members
This document provides different approaches for how support IRB members, particularly non-affiliated IRB members.
IRB Health Literacy Training
Health literacy resources specifically for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs).
Institutional Review Board Oversight Points to Consider for IRB Reviewers to assess DEI factors at Initial and Continuing Review
This document is a resource IRBs can use to evaluate whether the protocols they review incorporate DEI principles and optimize inclusion.
A Resource for HRPPs: Planning a Strategy to Address Diversity, Equity, and Inclusion
This is a resource for HRPPS to utilize when outlining an approach to incorporate DEI efforts into Clinical Research/Trials.
Resources for IRBs/HRPPs to provide to Investigators/Research Teams
Procedural & Logistical Checklist
This resource is a checklist of logistical and procedural considerations to enhance representation of diverse populations in research. It is intended for HRPPs/IRBs to provide to investigators and their research teams.
An IRB Resource for Participants: Costs and Payments
This document is a resource for participants to consult and familiarize themselves with questions to ask about payment(s) in clinical research. This document can be disseminated by HRPPs or IRBs to participants via online portals, resource libraries, and/or through investigators and study teams. This document should be adapted and revised to align with institutional policies and procedures.
An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants
This document provides an overview of why investigators and sponsors should consider providing payments to research participants, the different types of payment, the tax implications associated with each (with specific reference to current US regulations), and suggestions for appropriate communication with research participants regarding payment. This document was created as a resource for HRPPs and their IRBs to adapt when developing guidance for investigators on payments to research participants. Developed guidance should align with institutional policies and should be reviewed by HRPPs/IRBs in advance of dissemination to investigators.
An IRB Resource for Investigators and Research Teams: Including the Community Voice in Clinical Research
This document lists available resources for IRBs to provide to investigators and their research teams on how to begin and implement community engagement and partnership in clinical research.
Incorporating DEI into Clinical Research Protocol Templates
This document provides considerations for diversity and inclusion when drafting a clinical research protocol. This overview may be used concurrently with any detailed protocol template or as a stand-alone guidance for incorporating DEI elements into a clinical research protocol.
Diversity & Inclusion Overlay: TransCelerate’s Common Protocol Template
The TransCelerate Biopharma Inc. protocol template was annotated by the MRCT Center to highlight specific protocol areas where diversity and inclusion can be further considered and enhanced.
Diversity & Inclusion Overlay: NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template
The National Institute of Health (NIH) and Food and Drug Administration (FDA) protocol template was annotated by the MRCT Center to highlight specific protocol areas where diversity and inclusion can be further considered and enhanced.
Integrating Considerations for Diversity, Equity, and Inclusion (DEI) into a Recruitment Strategy Document
This template document has been updated to aid stakeholders (e.g., sponsors, CROs, research teams, sites and IRBs) to incorporate robust DEI initiative into their recruitment strategies.
Acknowledgements
| John Baumann | Indiana University |
| David Borasky | WCG |
| Quincy Byrdsong | Lipscomb University |
| Linda Coleman | Yale University |
| Michelle Feige | AAHRPP |
| David Forster | WCG |
| Lindsay McNair | WCG |
| Owen Garrick | CVS Health |
| Nanibaa Garrison | University of California, LA |
| Luke Gelinas | Advarra |
| Christine Grady | NIH* |
| Elisa Hurley | PRIMR |
| Martha Jones | Mass General Brigham |
| Sarah Kiskaddon | Dana-Farber / Harvard Cancer Center |
| Susan Kornetsky | Boston Children’s Hospital |
| Freda Lewis-Hall | Independent |
| Robert Nobles | Emory University |
| Tina Young Poussant | Boston Children’s Hospital |
| Suzanne Rivera | Macalester College |
| Stephen Rosenfeld | NorthStar IRB |
| Jessica Rowe | Yale University |
| Michele Russell-Einhorn | Advarra |
| Sana Shakour | University of Michigan |
| Benjy C Silverman | Mass General Brigham |
| Megan Singleton | Johns Hopkins University School of Medicine |
| David Strauss | Columbia University |
| Elyse Summers | AAHRPP |
| Holly Taylor | NIH* |
