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.
800 Boylston Street Boston,
Massachusetts
02199United States
The use of social media in clinical research carries many potential benefits—for example, it enables the creation of valuable support and communication networks for research participants. However, it also carries potential risks, including the possibility that participants may share information online in ways that permit themselves, other participants, and/or the research team to be unblinded to key aspects of the research data. These potential risks, as well as the practical approaches by which they may be mitigated, were the topic of the January 22nd meeting of the Bioethics Collaborative.
800 Boylston Street Boston,
Massachusetts
02199United States
The widespread use of mobile smart devices and wearables has the potential to change how clinical research is conceptualized and conducted. Participants’ data may now be leveraged for a variety of health purposes, including the development of remote screening and diagnostic tools, early intervention programs, and the promotion of public health. While these developments can make research participation less burdensome, they also raise ethical and regulatory challenges around acceptable levels of privacy risk, necessary precautions for safeguarding participants’ confidentiality, and the optimal approach to risk mitigation. The promises and potential barriers to integrating mobile devices and wearable technologies in clinical trial workflows was the focus of the May 2, 2019, meeting of the MRCT Center Bioethics Collaborative. View Summary >
800 Boylston Street Boston,
Massachusetts
02199United States
Adaptive and platform trials may promise greater efficiency and scientific sophistication, but they also raise ethical questions about the principles of informed consent, clinical equipoise, and justice, in addition to practical challenges. Attendees engaged and expanded upon these ethical issues and considered strategies for addressing the theoretical and practical challenges they raise for investigators, sponsors, IRBs, participants, and other stakeholders.
Ropes & Gray and the MRCT Center will be co-hosting a breakfast roundtable discussion regarding the impact of GDPR on clinical research with Paul Mills from the United Kingdom’s National Health Service Health Research Authority on Monday, January 7, 2019 from 9:30 a.m.-11:00 a.m. at the Ropes & Gray office in San Francisco.
Dr. Mills, who is an official within the United Kingdom’s primary human research and clinical trials regulatory agency, has been working for the past nine months in advising commercial and non-commercial sponsors of research on approaches to take in implementing GDPR in research across the United Kingdom. As part of this process, he has reviewed the transparency language of approximately 170 research sponsors from around the globe and has helped to implement processes to minimize any disruption imposed by GDPR on the conduct of health research in the United Kingdom.
Dr. Mills has agreed to address questions from attendees during the roundtable. Please send questions in advance to David Peloquin (david.peloquin@ropesgray.com) and Leslie Thornton (leslie.thornton@ropesgray.com), the two Ropes & Gray attorneys who will be moderating the roundtable. We expect a frank and engaging discussion.
The MRCT Center will be facilitating didactic and case-based learning, presentations, and open discussion for regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations
Learning Objectives:
Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, with particular focus on how the guidelines are applied by Health Canada.
Use case studies, to apply the changes of ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
Demonstrate practical approaches that Health Canada may take to fulfill the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards
For Regulators:
Describe and demonstrate best practices to assess clinical trial regulatory submissions by Health Canada, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
Describe inspection methodologies that may be taken by Health Canada to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
For other Stakeholders:
Gain better understanding and knowledge of Health Canada expectation with regard to compliance with the Canadian clinical trial regulations.
Gain better understanding and knowledge of Health Canada GCP inspection processes to better prepare for an inspection
