March 2, 2023 @ 1:00 pm – 3:30 pm
The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization
The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization
As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal and state regulations. Key regulatory frameworks include DEA regulations on the use of controlled substances in research studies, FDA IND regulations, and state law. Proposed federal legislation may also affect the conduct of research involving cannabis. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of DEA and FDA regulations relating to research involving cannabis, reviewed recent legislative developments, and discussed state-level policies and challenges using New York state as an example.
Released on: September 20, 2022
Topics: 1) Legal and Regulatory Perspectives of For-Profit Research Sites, and 2) The Regulation of Research Involving Cannabis
Convening representatives from academia, industry, and government, this conference explored the impact of the EU GDPR on human subjects research, highlighting the challenges posed by the GDPR to clinical research, biobanking and databanking, and big data research, particularly in light of the limited guidance available to date from EU and EU member state authorities.
Released on: July 30, 2018
Topic: Application of the General Data Protection Regulation (GDPR) to Research: Legal, Practical and Strategic Implications
October 2021: Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data
September 2021: Comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
October 2020: How to Fix the GDPR’s Frustration of Global Biomedical Research
April 2020: Comments to the European Commission on the Challenges that GDPR Raises for Research
March 2020: Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data
February 2019: Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered
January 2019: Letter to the European Data Protection Board on the Board’s November 2018 Draft Guidance on the Territorial Scope of the GDPR
July 2018: Impact of GDPR on Clinical Research
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.
Released on: November 8, 2018
Topic: Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
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.
Released on: March 13, 2019
Topics: (1) Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity (2) EU General Data Protection Regulation (GDPR)
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.
Released on: August 1, 2019
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.
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.
Released on: August 1, 2019
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.
Released on: November 7, 2019
Topics: I) Regulatory Challenges for Decentralized Clinical Trials, II) Revised Common Rule
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.
Released on: November 7, 2019
Topics: I) Regulatory Challenges for Decentralized Clinical Trials, II) Revised Common Rule
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