IRBs are charged with safeguarding the rights and well-being of human participants in accordance with the foundational principles outlined in the Belmont Report: respect for persons, beneficence, and justice. But IRBs have the difficult responsibility of balancing protecting vulnerable populations from harm while helping to ensure the inclusion of underrepresented participants in research. While IRBs are not primarily responsible for diversity, equity, and inclusion (DEI) in clinical research, IRBs do serve as an important checkpoint with the authority to require attention to the principles of DEI.
The notion that IRBs have, as a matter of justice, a role in and a responsibility to diversity and inclusion has been historically underappreciated. There is a need, therefore, for guidance and the development of tools, resources, and methods to approach this responsibility. As a first step, IRBs must set reasonable expectations for diversity and inclusion as a condition of study approval, at continuing review, and at study close out.
Setting expectations for diversity and inclusion is difficult, however, and depends on the epidemiology of the condition, specific study question, population, local context, resources, and other factors. But finding the balance between participant protection and inclusion starts with understanding the context, asking the right questions, listening and learning. IRBs and institutions should engage in discussion, deliberation, and collaboration with one another, with investigators, with participants, with sponsors and others to develop best practices in the field.
In response, and with guidance from IRB and HRPPs representatives, the MRCT Center has developed a suite of resources for IRBs, HRPPs, and investigators to adapt or use to help initiate this work. The resources below are not exhaustive, but a starting point. As feedback is received, the resources will be refined, revised, and expanded. Feel free to submit your comments, questions, or feedback to MRCT@bwh.harvard.edu.
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.
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.
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.
This document provides different approaches for how support IRB members, particularly non-affiliated IRB members.
Health literacy resources specifically for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs).
This document is a resource IRBs can use to evaluate whether the protocols they review incorporate DEI principles and optimize inclusion.
This is a resource for HRPPS to utilize when outlining an approach to incorporate DEI efforts into Clinical Research/Trials.
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.
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.
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.
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.
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.
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.
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.
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.
The MRCT Center would like to acknowledge the following members of the Task Force to Promote Justice in Review and Oversight of Clinical Research for their contributions to the development of this content and associated resources:
| 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* |
*Participation and/or contribution from members does not indicate that materials have been endorsed by the NIH, DHHS, or any branch of the federal government.