The objective of this meeting was to provide an update to all stakeholders regarding current initiatives and progress, engage regulators in the MRCT Center initiatives and mission, obtain feedback from regulators and stakeholders on MRCT Center’s ongoing and planned initiatives, and discuss the 2013 Budget and Proposed Goals.
The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.
The Harvard MRCT Annual Meeting 2014 focused on the Guidance Document and Toolkit that the Harvard MRCT workgroup developed for returning aggregate results to study participants and included a panel with various stakeholder perspectives on returning of results. In addition, Harvard MRCT co-directors introduced their work of addressing regulatory, trial causality and compensation issues in India.
The MRCT Center 2015 Annual Meeting was held on 15 December 2015. The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency.
Key themes of the meeting were: Discussion of the impact of the newly released ICH E17 Guidelines, and Data Transparency (sharing data with researchers and individual participants). This meeting is for all MRCT Center stakeholders.
Henrietta’s Table, Charles Hotel, 1 Bennett St, Cambridge, MA 02138
5:30 pm – 8:30 pm — Conference Dinner
Invited guests include: Executive and Steering Committee Members, Conference Speakers and Discussants, and Individual Return of Results Working Group Members
Preregistration is required.
Wednesday, December 7, 2016
Loeb House, 17 Quincy Street, Cambridge, MA 02138
7:30 am – 8:00 am — Breakfast and Registration
8:00 am – 8:15 am — Welcome and Introductions
8:15 am – 9:15 am — Discussion of the Impact of Draft ICH E17 Guidelines
Laurie Letvak, Head of Clinical Policy and Medical Ethics, Chief Medical Office, Novartis Pharmaceuticals Corporation
William Wang, Executive Director, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
Moderator: Mark Barnes, Faculty Co-Director, MRCT Center, Partner, Ropes & Gray Followed by group discussion and Q&A
9:15 am – 10:45 am — Data Sharing and Data Transparency
Keynote Session: Data transparency today and tomorrow: current state, issues, and vision
Murray Stewart, Chief Medical Officer, GlaxoSmithKline
Progress in 2016 and outlook to 2017
Rebecca Li, Executive Director, MRCT Center; Instructor in Medicine, Center for Bioethics, Harvard Medical School
Responses from key stakeholders
Jeffrey Drazen, Editor-in-Chief, New England Journal of Medicine
Amita Gupta, Associate Professor of Medicine and International Health, Center for Clinical Global Health Education, Johns Hopkins University
Murray Stewart, Chief Medical Officer, GlaxoSmithKline
Moderator: Rebecca Li, Executive Director, MRCT Center; Instructor in Medicine, Center for Bioethics, Harvard Medical School Followed by group discussion and Q&A
11:00 am – 12:30 pm — Individual Return of Results Working Group
Remit of the Working Group and Overview of IRR Principles
Debra JH Mathews, Assistant Director for Science Programs, Berman Institute of Bioethics, Johns Hopkins University
David Pulford, Genetics TA Head Rare Diseases, GlaxoSmithKline
Sandra Prucka, Innovation Lead, Clinical Innovation, Eli Lilly and Co.
Responses from key stakeholders
Atul Gawande, Director, Ariadne Labs, Professor, Harvard T.H. Chan School of Public Health
Barbara LeStage, Steering Committee Member, Clinical Trials Transformation Initiative
Alvaro Pascual-Leone, Director, Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Professor of Neurology, Harvard Medical School
Holly Taylor, Core Faculty Member, Berman Institute of Bioethics, Johns Hopkins University, Associate Professor, Department of Health Policy and Management, Bloomberg School of Public Health
Moderator: Barbara Bierer, Faculty Co-Director, MRCT Center; Professor of Medicine, Harvard Medical School
Followed by group discussion and Q&A
12:30 pm – 12:45 pm — Closing Remarks
12:45 pm – 1:15 pm — Lunch
Meeting of the Executive Committee and Steering Committee
1:15 pm – 5:00 pm — Update and discussion of ongoing MRCT Center projects
800 Boylston Street Boston,
Massachusetts
02199United States
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.
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
@
10:00 am
–
August 2, 2019
@
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.
