April 2023 Newsletter

In the Spotlight

IRR Case Study Release and Webinar: May 2

Since the updated Individual Return of Results toolkit was released last year, the MRCT Center has continued collaborating with leaders from academia, patient advocacy groups, and industry to create a series of case studies. These cases detail the experiences of five organizations planning and implementing procedures to return individual research results and data to participants, highlighting ethical, scientific, operational, regulatory, and technical considerations that should be considered.

We invite you to join us on May 2 at 12 PM ET for a moderated conversation with case study authors who will share their experiences, successes, and challenges. To register, please click here.

Accessibility by Design (AbD) Toolkit Release and Webinar: May 4

Globally, over one billion people, including 240 million children, have a disability. In the US alone, more than 61 million people with disabilities make up the largest minority group in the nation. Yet, clinical trials can often exclude them. Therefore, clinical research stakeholders committed to inclusion must act affirmatively and concertedly to anticipate, identify, and accommodate the needs of individuals with disabilities.

To this end, the MRCT Center has developed an Accessibility by Design in Clinical Research Toolkit in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research. We will release the toolkit at a webinar on May 4 at 11 AM ET. We will present the background, structure, and key themes of the AbD Toolkit. Invited speakers will then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.

Click here to register.

Please note: a webinar recording and transcript will be posted to the MRCT Center website following the webinar. All registrants will receive a follow-up email with a direct link to these materials. We look forward to continuing the dialogue to support inclusivity and accessibility for all. 

ICH E6 (R2) Training Modules: Making a Broad Impact

The MRCT Center launched the introductory online course INTERPRETATION AND APPLICATION OF ICH E6 (R2) in early 2020. Since then, approximately 3,500 individuals from more than 100 countries have enrolled, with numbers increasing monthly.

Countries with the highest enrollments are the US, India, Canada, Brazil, and China.

Events & Presentations

April 27 

Sarah White, Executive Director of the MRCT Center, presented at CTTI’s April Steering Committee meeting in Washington, DC. Sarah joined colleagues from CTTI, FasterCures, and the National Academies of Sciences, Engineering, and Medicine in a fireside chat that described a collaborative project called Diversity Convergence, a new initiative that the MRCT Center will co-lead.

April 28

Dr. Willyanne DeCormier Plosky, MRCT Center Program Director, presented “Equitable Inclusion of Persons with Disabilities in Research” at the University of Minnesota Ethics Grand Rounds. 

May 2: 12 – 1 PM ET

Return of Individual Results Case Studies Release and Webinar (see Spotlight above).

Click here to register.

May 4: 11 AM – 12 PM ET

Accessibility by Design (AbD) in Clinical Research Toolkit Release and Webinar (see Spotlight above).

Click here to register.

May 12: 8:50 AM ET

Dr. Barbara Bierer will present “The Evolving Role of Decentralized Clinical Trials” at the inaugural Baptist Health Biomedical Research Symposium in Miami, Florida.

May 16-18

Dr. Barbara Bierer will present “Ethical Review of Decentralized Clinical Trials” at the AAHRPP Annual Conference in Baltimore, MD.

Hayat Ahmed, MRCT Center Project Manager, will present a poster on “Tools & Resources for Incorporating DEI in IRB/HRPP Processes” at the AAHRPP Annual Conference.


April 4, 2023: Drs. Nora Hutchinson, Luke Gelinas, and Deborah Zarin evaluated a cross-section of interventional clinical trials registered on with publicly available informed consent forms; only 56.6% acknowledged the possibility of trial termination. Their study resulted in a coauthored research letter, “Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials,” published in JAMA.

April 7, 2023: Sylvia Baedorf Kassis, Kayleigh To, Sarah White, and Dr. Barbara Bierer coauthored an article, “Use Plain Language to Increase Understanding: the MRCT Center Clinical Research Glossary,” with Rhonda Facile of CDISC in DIA’s Global Forum about a recent collaboration with CDISC to expand access to the Clinical Research Glossary as a new global standard.

April 14, 2023: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.

May 2023: MRCT Center Faculty Director Dr. Barbara Bierer co-authored an article, “Data sharing in the context of community-engaged research partnerships,” in Social Science and Medicine in response to a new NIH data-sharing policy. In an era of growing efforts to engage diverse communities in research, the impact of data sharing for all research participants and the communities they represent requires the reassessment of data-sharing principles, incorporating principles of community-engaged research. The article outlines these considerations and proposes new models of benefit sharing.