Published on: March 7, 2022
Published in: Cell Reports Medicine
MRCT Center colleagues Barbara E. Bierer, Laura G. Meloney, Hayat R. Ahmed, Sarah A. White authored a commentary in Cell Reports Medicine on “Advancing the inclusion of underrepresented women in clinical research.”
Published on: March 4, 2022
Published in: The Journal of Law, Medicine & Ethics
Joseph Liss, former Legal Fellow at the MRCT Center, David Peloquin, Mark Barnes and Barbara Bierer co-authored “Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate,” published in The Journal of Law, Medicine & Ethics. Title VI of the Civil Rights Act of 1964 prohibits federally-funded educational institutions and health care centers from engaging in discrimination “on the ground of race, color, or national origin.” The authors argue that the Department of Health and Human Services (HHS) “has not used the full arsenal of legal and policy tools at its disposal to push for equal rights” to obligate institutions that receive federal funding for clinical research “to provide equal access to participation in clinical trials to racial and ethnic minority communities.”
Published in: June 2022
Published in: Contemporary Clinical Trials
Dr. Barbara E. Bierer and MRCT Center Program Manager, Laura G. Meloney, co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to consider to address the problem.
Published on: April 28, 2022
Published by: American Journal of Bioethics
MRCT Center Senior Advisors, Luke Gelinas and David Strauss, MRCT Center Faculty Director, Barbara E. Bierer, and others co-authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making.
Released on: February 2, 2023
Developed by: MRCT Center Bioethics Collaborative
Published on: January 28, 2023
Published in: Pediatric Research
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
Presented on: December 14, 2022
Presented at: “MRCT Center Annual Meeting, Ropes & Gray, Boston, MA
The objective of this workshop was to agree on a consensus list of “key selection standards or criteria for sites and Principal Investigators,” to propose methods to quantify the importance of these criteria, and to make recommendations for the MRCT Center’s role moving these issues forward
For more information please see the links below.
2012-09-18 Principle Investigator Workshop Proceedings
2012-09-18 Principle Investigator Workshop Agenda
