Implementing ICH E6(R3): Practical Risk-Proportionate Strategies for IRBs, Investigators, and Study Teams (September 23), co-presented with PRIM&R.

Good Clinical Practice in Practice: Implementing ICH E6(R3) (May 22).

On Demand: Returning Summary Results to Participants: Lessons from the Research Community

On October 27, as NIH finalizes a policy requiring plain-language summaries for all NIH-supported clinical research, the MRCT Center presented a webinar on returning summary results to study participants. It builds on the Center’s ongoing work on returning both aggregate and individual results. Barbara Bierer opened with background on the topic, then introduced Sylvia Baedorf Kassis, who moderated a discussion on how researchers return summary results to the people who took part in their studies. The panel welcomed Lawrence Appel (Johns Hopkins University), who has returned results to participants for more than 30 years; Abby Gregory (ASCO), who supervises ongoing plain language summaries of the TAPUR Study; and Deborah Mascalzoni (Eurac Research and Uppsala University), whose Cooperative Health Research in South Tyrol (CHRIS) cohort of 13,500 people uses dynamic consent as a governance structure to support results return.

Click here to view the recording, slides, and related resources.

Read the MRCT Center’s comments on the NIH draft policy, submitted on October 26 by Barbara Bierer and Sylvia Baedorf Kassis.

Publications

September 7: The TRACE Author Group, led by Kara L. Neil and Jeanine Condo and including Barbara Bierer, Willyanne DeCormier Plosky, and Sarah White of the MRCT Center, published “Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative” in Nature Medicine. The authors report early results from the TRACE Project in Kenya, Nigeria, Rwanda, Tanzania, and Zimbabwe, where coordinating ethics and regulatory review into a single, parallel process drove the fastest gains in trial readiness. In Zimbabwe, a joint electronic platform linking the medicines regulator and the national ethics review function reduced approval times by at least 20%. The authors recommend that parallel review become standard practice across African clinical trial systems.

October 6: Willyanne DeCormier Plosky and Barbara Bierer published “Exclusion of Participants for Substance Use in Clinical Trials,” in Clinical Pharmacology & Therapeutics with Benjamin C. Silverman and David H. Strauss. The authors found that of 254 ClinicalTrials.gov interventional protocols analyzed, 43% excluded people who use substances, and that substance use was defined inconsistently, varying by level, timing, and type of substance. Most of those studies (63%) gave no rationale or none specific to substance use. The authors argue that inclusion should be as broad as the study question allows, and exclusion only as narrow as participant safety and scientific validity require. They call for guidance that standardizes how eligibility criteria define and assess substance use.

October 7: Ava Glazier (formerly MRCT Center), Willyanne DeCormier Plosky, and Barbara Bierer, MRCT Center, published “Reproductive Privacy Risk Disclosure in US Clinical Trial Informed Consent Forms After the Dobbs Decision,” in JAMA Network Open. The study examined whether informed consent forms explained to participants the possible privacy risks associated with pregnancy monitoring after the Dobbs decision. Of 195 US interventional trials that began after the 2022 decision and posted a consent form on ClinicalTrials.gov, more than half (59%) required pregnancy testing, yet none addressed reproductive privacy risks. The authors call for guidance on when and how to explain these risks, site-specific consent language for multisite trials, and a coordinated, nationwide effort to give all participants clear, consistent disclosure.

Public Comment

October 26: The MRCT Center submitted a public comment to the NIH Office of Science Policy on its draft policy requiring that plain-language, summary-level study results be shared with individuals who have participated in clinical research. The MRCT Center fully endorsed the policy and its scope, and focused its comments on making it feasible, durable, and harmonized. The MRCT Center emphasized that meaningful communication of research findings should be considered a core component of the research relationship. The recommendations focus on making the policy workable across diverse study types by providing clear guidance, supporting accessibility and health literacy, aligning with other regulatory frameworks, and ensuring adequate resources for implementation. The MRCT Center offered to work with NIH to adapt its Return of Aggregate Results Guidance Document and Toolkit for the policy.

Events & Presentations

October 5: Meeting of the Bioethics Collaborative. Topic: “What’s Mine is Mine and What’s Yours is Yours: Data Ownership and Sovereignty.” For more information about the Bioethics Collaborative and how to join this ongoing forum, click here.

October 5-8: Sylvia Baedorf Kassis presented on returning individual results and data to participants at the Innovation Network Gathering in West Chester, PA.

October 15: Sylvia Baedorf Kassis presented “Transforming Clinical Research Through Patient Collaboration” in the opening plenary session of the virtual IACRN 18th Annual Conference.

October 26: Lisa Koppelman joined a pediatric-focused panel, “Advancing Pediatric Clinical Trials: Innovation, Regulation, and Operational Excellence,” at DIA Canada’s Annual Meeting in Ottawa.

October 21-22: MRCT Center Annual Symposium. Resources, including recordings, slides, and related content, will be posted to the MRCT Center website soon.

October 27: Health Literacy Month webinar: Returning Summary Results to Participants: Lessons from the Research Community. See Spotlight above.

November 1-4: Barbara Bierer partnered with Holly Fernandez Lynch and Holly Taylor to organize a 3½-day meeting, hosted by the Banbury Center, entitled, “IRB/HRPP Reform: Priorities to Promote Participant Welfare and Scientific Innovation.” A small expert group of ethics enthusiasts will meet to identify the current institutional review board (IRB)/human research protection program (HRPP) requirements and practices that burden research without meaningfully improving participant protection or research quality. The group will then develop a set of prioritized, actionable reforms and determine the next steps to advance them.

November 17, 12:00 – 1:00 PM ET: Operationalizing ICH E6(R3) Data Governance webinar. Free. See Spotlight above.

November 17-19: As a member of the World Health Organization (WHO) Technical Advisory Group on Clinical Research Ecosystem Strengthening, Barbara Bierer will participate in a November 17 meeting at the WHO headquarters in Geneva, Switzerland, followed by a two-day meeting of the Global Clinical Trials Forum (GCTF) Network.

The MRCT Center at the PRIM&R 2026 Conference:

• November 17, 10:45 AM – 12:00 PM MT: Sylvia Baedorf Kassis will join Caroline Hagedorn of the NIH Office of Science Policy and Jason Malone of the University of Washington to present “From Best Practice to Standard Practice: Returning Summary Research Results to Participants.”
• November 17, 2:00 – 3:15 PM MT: Trevor Baker will join Karli Storm-Närväinen of the University of Nebraska Medical Center and Amanda Higley of Advarra to present “Dangerous Data? Emerging Privacy Challenges in the Digital Age.”
• November 17, 3:45 – 5:00 PM MT: Sylvia Baedorf Kassis will join Marianna Azar of 1Day Sooner and Christine Suver of Sage Bionetworks to present “Beyond the Signature: Enhancing Respect for Persons with AI Across the Research Lifecycle.”

December 1, 1:00 – 3:00 PM ET: Biannual Meeting of the Joint Task Force for Clinical Trial Competency (JTF). Agenda: Mayo Clinic: Using the JTF Framework to educate clinical research coordinators; ACRP: Recognizing clinical research as a profession; Daiichi Sankyo: Clinical research coordinator workforce challenges; Consultant from Puerto Rico: A platform to educate the public about clinical research. This meeting is free and open to all registrants. Register here.

December 3: Sylvia Baedorf Kassis will be a webinar panelist for “Patient Centricity and Participant Safety: Redefining Ethical Clinical Research in India,” hosted by Krystelis.

MRCT Center Updates

Jack Kilshaw joined the MRCT Center in October 2026 as a Student Researcher. In this role, he supports the Center’s work in Artificial Intelligence and Clinical Research while exploring how AI and novel technologies can improve internal processes and workflows.