Public Comments
Comments provided on: April 29, 2024
Comments provided to: U.S. Food and Drug Administration
Resource Type: Public Comments
Comments Submitted: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (FDA-2016-D-3561)
Public Comment
Submitted on: April 29, 2024
Submitted to: U.S. Food and Drug Administration
Comments Submitted: Draft Guidance, Key Information and Facilitating Understanding in Informed Consent; FDA-2022-D-2997
Public Comment
Submitted on: April 30, 2024
Submitted to: U.S. Food and Drug Administration; HFA-305
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The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219).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 We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA.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.
Master Protocols for Drug and Biological Product Development
Public Comments
Comments submitted on: March 20, 2024
Comments submitted to: U.S. Food and Drug Administration
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 regarding regulations to title II of the Americans with Disabilities Act: Accessibility of Medical Diagnostic Equipment of State and Local Government Entities
Public Comment
Submitted on: February 7, 2024
Submitted to: U.S. Department of Justice, Civil Rights Division
Comments on the Public Health Service Policies on Research Misconduct Notice of Proposed Rulemaking
Public Comments
Submitted on: January 4, 2024
Comments provided to: The Office of Research Integrity
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.