Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

Public Comments

Comments provided on: January 15, 2025

Comments provided to: Chief Counsel, National Telecommunications and Information Administration

Description: The NTIA’s proposed rule on the “Ethical Guidelines for Research Using Pervasive Data” aims to increase U.S. privacy protections with a heightened focus on responsible use. In response, the MRCT Center has submitted a public comment that recommends enhancing safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address data advancements and mitigate risks to individuals and communities. 

Public Comments submitted: “Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons”

Public Comments

Comments provided on: November 29, 2024

Comments provided to: U.S. Department of Justice

Description: The DOJ Notice of Proposed Rulemaking (NPRM), “Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” (DOJ-NSD-2024-0004) aims to safeguard sensitive U.S. personal- and government-related data from countries of concern or covered persons, emphasizing national security and data protection. MRCT Center comments highlighted the need to balance these security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and the advancement of science, medicine, and individual and public health. 

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

Public Comments

Comments provided on: August 9, 2024

Comments provided to: National Institutes of Health

Description: The MRCT Center submitted public comments on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with the communities where they intend to conduct research prior to, during, and after the research. Researchers should cultivate bi-directional partnerships with the communities, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response. 

Public Comments submitted: “Request for Information on the National Institutes of Health Draft Public Access Policy”

Public Comments

Comments provided on: August 19, 2024

Comments provided to: National Institutes of Health

Description: We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences.

The PubPeer conundrum: Administrative challenges in research misconduct proceedings

Publication

Published on: August 13, 2024

Published in: Accountability in Research

Description: Mark Barnes and colleagues at Ropes & Gray, and Barbara Bierer published an article that discusses the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing burden on institutions tasked with their investigation.

Public Comments submitted: “Declaration of Helsinki Public Comment Period Two”

Public Comments

Comments provided on: June 24, 2024

Comments provided to: World Medical Association

The MRCT Center submitted public comments in response to the World Medical Association’s (WMA’s) second phase of proposed revisions to the Declaration of Helsinki (DoH). Mark Barnes, MRCT Center Faculty Co-Director, attended the last working meeting on the DoH. In direct response to concerns discussed internally and with our Executive and Steering Committees, we recommended substantial revisions to the WMA Workgroup’s proposals, including recommending comments specific to vulnerable populations, research ethics committees, informed consent, and post-trial access. Both Mark Barnes and Barbara Bierer have been invited to attend the final WMA revision discussion meeting in Washington, D.C. this August.

Proposed Increases in Government Authority Over Research Misconduct Proceedings

Publication

Published on: June 20, 2024

Published inJAMA

Summary: The article examines a proposed increase in government authority over research misconduct proceedings and notes that academic and medical institutions should understand the public, political, and ethical pressures on the Office of Research Integrity (ORI) to enhance oversight of research integrity. Institutions can alleviate some of these pressures by making their research misconduct processes more exacting, efficient, and, when possible, more transparent regarding the outcomes of specific cases. This can lead to improved public trust in the scientific research enterprise.

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.