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.
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.
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.
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The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219).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 We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA.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.
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.
Barbara Bierer, Deborah Zarin, and Luke Gelinas described in “Deprioritization of Ongoing Clinical Trials” the importance, ethical considerations, and challenges of ensuring that clinical trials continue to exhibit scientific relevance and value once initiated. Published in Ethics and Human Research, they suggested a framework to monitor ongoing trials and potential actions for responding to those findings of periodic review.
Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application, and proposing a framework and factors to consider in recklessness determinations.
Dr. Barbara Bierer co-authored a commentary, “The Unresolved Challenge of Triage,” exploring the ethical and legal challenges of allocating limited care resources in a disaster setting in JAMA.
