Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

Public Comments

Comments provided on: April 15, 2024

Comments provided to: U.S. Food and Drug Administration

The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219). In broad strokes, our comments recommended expanded guidance on the role Data Monitoring Committees can play in actively fostering the safety of trial participants – whether by communicating directly with trial sponsors, IRBs, or with offices within FDA. We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA. As with all our interactions with the FDA, we commend their commitment to setting the global pace when it comes to ensuring the conduct of scientifically sound, risk appropriate, ethical clinical research.

Public Comments submitted: VolREthics initiative – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials

Public Comments

Comments provided on: March 30, 2024

Comments provided to: VolREthics initiative

The MRCT Center submitted a response to a draft ethics charter intended to protect healthy volunteers in clinical trials published by the French National Institute of Health and Medical Research (“INSERM”). The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. Broadly, the MRCT Center wholly supports the development of an ethical charter to protect healthy trial participants. Our comments reflected our support for the broader endeavor while remaining dedicated to helping INSERM craft language that reflects their well-intentioned goal.

Public Comments on Declaration of Helsinki: Phase 1

Public Comments

Comments provided on: February 7, 2024

Comments provided to: World Medical Association (WMA)

The WMA’s Declaration of Helsinki is an often-referenced, foundational guidance document for the clinical research enterprise. The MRCT Center submitted targeted recommendations to the WMA on areas such as health literacy, accessibility, informed consent, participant autonomy, and post-trial responsibilities (among others) in the first of two public consultation periods. We await the second public consultation with interest.

Comment on the NPRM Request of the Office for Civil Rights (OCR) re: Discrimination on the Basis of Disability in Health and Human Services Programs or Activities

Public Comment

Submitted on: November 11, 2023

Comments provided to: Office of Civil Rights, U.S. Dept. of Health and Human Services

The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office for Civil Rights (OCR) for comments on the draft, “Discrimination on the Basis of Disability in Health and Human Service Programs or Activities. The MRCT Center applauds OCR’s considerations of the rights of people with disabilities and OCR’s effort to clarify and strengthen Section 504 of the Rehabilitation Act of 1973. The MRCT endorsed several key areas in the proposed rule Center presented some suggestions for further clarification.