Diversity, Inclusion, and Equity in Clinical Research
Framework:
Developed on: June 2022
Developed by: IRB taskforce on Diversity, Equity, and Inclusion
The EbD Metrics Framework is designed to provide a straightforward and engaging overview of DEI in clinical research, to prompt reflection for harmonized organizational DEI efforts, and to orient users toward potential entry and follow-up strategies. The framework is organized around seven key themes (see image). Quantitative and qualitative measures are proposed for each theme, which can be disaggregated into detailed measures and tailored by users. The level of detail explored will depend on the user’s purpose.
MRCT Center Project Manager Walker Morrell, Barbara Bierer and colleagues co-authored “When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research” in Ethics & Human Research. Digital applications (apps) used in research may be updated while the research is ongoing, potentially necessitating ethics review. The authors argue that the review process should depend on the nature of the change, any potential change in risk or benefit, and consideration of confidentiality and safety.
Presented on: March 24, 2022 at 1:00 pm to 2:00 pm ET
Location: Virtual
The practice of returning IRR is consistently identified by participants as something that participants not only desire but also expect. Returning IRR demonstrates participant-centricity and respect.
A taskforce was convened during 2021 to update and further develop the MRCT Center’s guidance on Returning Individual Research Results to Participants – these resources and tools are ready to be shared, on a new, easy-to-navigate, dedicated website.
This one-hour webinar will include a review of IRR and its importance, a patient advocate describing her own lived experience with IRR, and a live demonstration of the new tools and website.
MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner.
Published in:Therapeutic Innovation & Regulatory Science
The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.
The Proceedings from the National Academies of Science, Engineering and Medicine (NASEM) workshop “Adoption of Health Literacy Best Practices to Enhance Clinical Research and Community Participation” were released in March. Barbara Bierer, M.D, Elizabeth Cahn, Ph.D., and Sylvia Baedorf Kassis, M.P.H., are featured.
