800 Boylston Street Boston,
Massachusetts
02199United States
Attendees discussed the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies. Among other things, we considered the impact of each avenue on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies, considering the perspectives of both pharmaceutical companies and large academic healthcare facilities.
The third Research, Development, and Regulatory Roundtable (R3) was held at the Washington, D.C. offices of Ropes & Gray LLP on March 7, 2019. Stakeholders convened to discuss Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity. Afterward, attendees were updated on developments related to the application of the EU General Data Protection Regulation (GDPR) to research.
“The use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether the companies have authority to use healthcare data for these secondary purposes; whether health care providers may receive payment for permitting secondary uses of their data or for the results of these secondary uses; the extent to which third-party payors, or agents of those payors, may be involved in research recruitment; and which contact patients directly to discuss possible enrollment in a clinical trial. During this session, we discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
Topics: (1) Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity (2) EU General Data Protection Regulation (GDPR)
August 1, 2019
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10:00 am
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August 2, 2019
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9:00 am
Ropes & Gray, Boston, MA
800 Boylston Street Boston,
Massachusetts
02199United States
An increasing number of companies and research institutes wish to enroll their own employees and students in research studies. While employees can serve as a convenient source of potential study participants, enrolling one’s own employees and students in research can raise several legal and ethical issues, including the following:
Coercion, undue influence and subject/employee privacy considerations Maintenance of health information on employees in compliance with the American with Disabilities Act, the Genetic Information Nondiscrimination Act of 2008, and corresponding state laws Notifying employees of actionable health conditions Unlicensed practice of medicine Licensure of health care facilities Mandatory reporting of notifiable diseases to departments of public health
Attendees identified the ethical concerns with an institution conducting research on its own employees or students- undue influence, coercion, and risk to privacy. Relevant legislation was introduced, and participants were provided with a set of recommendations for conducting this type of ethically complex research.
Topics: (1) Exporting from China for Research: Biospecimens, DNA and Data, and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies.
800 Boylston Street Boston,
Massachusetts
02199United States
China’s new Regulation of Human Genetic Resources (HGR) took effect on July 1, 2019. The regulation closely scrutinizes all HGR-related activity from upstream collection of human biospecimens to downstream exploitation and sharing of the biomaterials and any data obtained therefrom. The regulation additionally formalizes the approval requirements pertinent to research collaborations between Chinese and foreign-owned (including both partially and wholly foreign-owned) entities to avoid uncertainty during the approval process. It also significantly increases and expands penalties for various violations of the regulation. This session will provide an overview of the changes made by the regulation and then discuss some practical strategies for complying with the regulation’s requirements.
Participants reviewed updates to China’s Human Genetic Resources (HGR) regulation and discussed how the changes will alter work with Chinese biospecimens and biospecimen data. The HGR updates were contextualized within China’s broader evolving legislation that aims to protect national security by protecting data.
Topics: (1) Exporting from China for Research: Biospecimens, DNA and Data, and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies.
Attendees focused on regulatory ambiguities surrounding sIRB usage as research enterprises prepare to transition to full compliance with the Revised Common Rule. Attendees also addressed interpretations of the phrase ‘key information’ and examined how much authority an IRB retains after designating research for limited review.
Regulatory Challenges for Decentralized Clinical Trials
Decentralized trials promise to modernize the research landscape, optimizing the trial experience for participants, investigators, and sponsors by increasing access to experimental and other therapies and rendering trials more convenient and accessible. However, clinicians and investigators must navigate long-standing regulations that vary across state and national borders and are often incongruent with virtual care and research. Relevant issues include healthcare licensure in different jurisdictions, requirements for face-to-face interactions between physician and participant, differences in data privacy laws, differences in the standard of care in different locations, risks to privacy and safety posed by home visits, and drug shipment laws. During the R3 meeting, we will discuss each of these issues from a legal and regulatory perspective, providing clarity when possible and identifying ambiguity when necessary.
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.
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.
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.
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?
