Meeting attendees discussed the clinical research regulatory landscape during the COVID-19 pandemic, identifying areas that could be improved upon to foster less burdensome and higher-quality research.
Released on: July 7, 2020
Topics: I) Legal and Regulatory Issues Related to COVID-19 in Human Subjects Research, II) Foreign Influence in Clinical Research, and III) Impact of Fraud and Abuse Laws on Clinical Research
The second part of the meeting will address the effect on clinical research of fraud and abuse laws, including the Anti-Kickback Statute and the Beneficiary Inducement provisions of the Civil Monetary Penalty Law, as well as their state law counterparts. Briefly stated, fraud and abuse laws place limitations on remuneration provided to health care providers and patients to prevent third-party payors of healthcare services from paying for medically unnecessary or excessive services and to prevent patients from being induced to select a particular healthcare provider. While these laws are not explicitly directed towards the research environment, they have major implications for clinical research conducted in the United States, affecting practices ranging from research sponsors paying for copayments or deductibles associated with standard of care services required under a clinical trial protocol, to payments from life sciences companies to physicians to collect data for registry studies, to the provision of “smart devices” to patients as part of a research study.
Attendees learned about the impact of fraud and abuse laws on clinical research, overviewing research situations that may violate these laws and discussing how these laws relate to recruitment, compensation, and financial aid for research participants.
Released on: July 7, 2020
Topics: I) Legal and Regulatory Issues Related to COVID-19 in Human Subjects Research, II) Foreign Influence in Clinical Research, and III) Impact of Fraud and Abuse Laws on Clinical Research
The first part of the meeting will address the ongoing National Institutes of Health (NIH) and U.S. Department of Defense (DoD) investigations into foreign influence in American research. The NIH and DoD investigations have focused on scientists in the United States who have received and not properly disclosed foreign appointments and remuneration. The NIH has named 180 scientists at 71 institutions as targets of investigation and asked their respective institutions to investigate them. The government appears concerned that researchers who receive federal funding have failed to disclose foreign financial interests and time commitments, thus misleading the U.S. government when it evaluates research awards, thus harming the federal fisc and the American research enterprise. In addition, the U.S. government fears that foreign influence on scientific research is allowing the transfer of intellectual property to foreign countries without being subject to export regulations set forth by the U.S. Department of Commerce. While the investigations have to date primarily affected academic organizations, their impact may well spread to industry as academic investigators who conduct research for industry sponsors come under investigation and the scope of the government’s investigation widens.
Attendees learned about the NIH and DoD investigations into foreign influence in clinical research and discussed how research activities within academia and industry may have to adapt to accommodate the government’s concerns.
Released on: July 7, 2020
Topics: I) Legal and Regulatory Issues Related to COVID-19 in Human Subjects Research, II) Foreign Influence in Clinical Research, and III) Impact of Fraud and Abuse Laws on Clinical Research
When an academic institution or life sciences company becomes aware of allegations of research misconduct (i.e., fabrication or falsification of data and/or images, and plagiarism) relating to their researchers, a challenging and time-intensive process of review typically ensues. Academic institutions frequently utilize the detailed investigational framework that is required when the allegation relates to federally funded research, while life sciences companies typically are not restricted by these requirements but nevertheless have additional relevant legal and ethical obligations (for example, securities law, FDA and EMA submission implications, and published scientific papers). Throughout the process, issues of privacy, confidentiality, and reputation must be addressed. This session will deal with some of the most vexing problems in complex research misconduct cases, especially those that lie at the intersection of industry and academia.
Attendees discussed the most vexing problems in complex research misconduct cases, especially those that lie at the intersection of industry and academia. For example, how should an academic institution investigate research misconduct allegations in research collaborations between in-house industry labs/scientists and academic investigators? What are the attendant liability risks for informing or not informing the successor employer of a scientist who has been found to have engaged in research misconduct?
Released on: November 5, 2021
Topic: Legal Perspectives on Scientific Misconduct in Academia and Industry
Pragmatic clinical trials (PCTs) compare or assess interventions in real-world practice settings, hoping to deliver data on effectiveness and safety that more closely resembles clinical care than explanatory clinical trials that focus on demonstrating efficacy in a highly controlled setting. PCTs obscure the distinction between research and clinical care more than traditional randomized control trials (RCTs), which in turn raises novel ethical questions concerning informed consent, data privacy, incidental findings, and other issues.
Ethical questions relating to the work of patient advocates in clinical research have been given insufficient attention. What experience and training must a person have to participate in patient engagement in clinical research? What does it mean for an advocate to be representative, and to what extent are advocates expected to represent the full range of perspectives of patients with the condition or that may be impacted by the proposed research? Are there conflicts of interest (financial and otherwise) that affect patient engagement in clinical research, and if so, how can they be managed?
AI technologies may be used to facilitate certain aspects of clinical trials, or AI may be the intervention under investigation in a clinical trial or an observational study. Both applications raise questions about data privacy, the risks of non-representative and/or biased data, and the appropriate oversight mechanisms for AI in clinical research.
Released on: November 30, 2022
Developed by: MRCT Center Bioethics Collaborative
See Meeting Summary:
Artificial Intelligence in Clinical Research Meeting Summary
The MRCT Center Annual Meeting will be held virtually this year. We will review and discuss ongoing MRCT Center projects and emerging issues. This meeting is open to the public. If interested, please register here.
Agenda to include:
For agenda, speaker biographies, proceedings and slides, please see Annual Meeting page.
Topic: The FDA Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck).
Drs. Bierer and Clark will introduce the recently released MRCT Center’s Diversity Framework, titled Achieving Diversity, Inclusion, and Equity In Clinical Research. After providing a brief introduction, background, and contextual orientation to listeners, Drs. Bierer and Clark will highlight the ways in which stakeholders can contribute to increasing diverse representation in clinical research and, ultimately, improving health equity and public health domestically and abroad.
Topic: MRCT Leaning In Webinar: Community Awareness, Access, Knowledge
Find webinar info here.
