The MRCT Center recently authored ‘Universal Funder Responsibilities That Advance Social Value’ in the American Journal of Bioethics.
This article outlines the responsibilities of, and specific recommendations for, research funding organizations to promote the novelty, significance, rigor, and impact of research they fund.
To read the article, click here.
Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.
Dr. Bierer also co-authored Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India which has recently been published by the Journal of Medical Internet Research.
Mr. Mark Barnes, MRCT Center Faculty Co-director, co-authored Will Consent be Disfavored as a Bases for Processing Personal Data in Clinical Research Under EU Data Protection Law? recently published by Bloomberg Law. The article may be accessed by navigating to his bio and scrolling to the bottom of the page for his publications.
The MRCT Center Bioethics Collaborative has published a framework and toolkit entitled Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians, and Institutional Review Boards.
This document, which is tailored to sponsors, treating physicians, and Institutional Review Boards/ Research Ethics Committees, includes a set of principles, considerations, and practical tools. It addresses expanded access to investigational products for seriously ill patients who are unable to participate in a clinical study and for whom no equivalent or satisfactory treatment options are available.
The MRCT Center, in collaboration with Harvard University and the Association of American Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.
As we promote the value of cooperation and data sharing, the MRCT Center is conscious of the significant contributions of data generators who voluntarily make their data available for others in the service of public health and scientific advancement. We are aware of both the increasing calls to make data accessible and the absence of a system of credit and recognition for data sharing.
In this just published NEJM Sounding Board, MRCT Center Faculty Co-Director Dr. Barbara Bierer and collaborators from Harvard University and the Association of American Medical Colleges (AAMC) put forward the concept of data authorship as a means for providing academic credit to data generators and incentivizing the sharing of data. This proposal rests on the foundational work of others who have advanced data citation and the FAIR principles, which have made progress possible in the first place.
Read more about the Sounding Board in the New England Journal of Medicine
In January 2017, MRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, JD, co-authored with Abram Barth and David Peloquin an article entitled, “HHS Finalizes Comprehensive Revisions to the Common Rule” published in Bloomberg BNA Life Sciences Law & Industry Report.
Continue reading “New Publication by MRCT Center Faculty Co-Directors”A multi-stakeholder team, convened by the MRCT Center, published an article detailing use of a Protocol Ethics Toolkit to facilitate effective recognition, consideration and deliberation of critical clinical ethical issues in clinical trial protocols.
The publication, “Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees” has just been released by the Journal of Medical Ethics.
To read the article, click here.
To read a related blog posting, click here.
To learn more about the MRCT Center’s work on Protocol Ethics, click here.
MRCT Co-directors Mark Barnes and Barbara Bierer co-authored a recent publication in the Bloomberg BNA Medical Research Law & Policy Report.
The publication provides an overview of the new EMA draft policy and likely impact on clinical research.
A copy of this publication is available here.
