Plain Language for Health. A Writing and Design Workshop for Health Research and Practice (March 28-29)
The MRCT Center co-sponsored a two-day workshop held by Tufts on March 28th-29thfocused on how to use plain language principles to improve research-related communications. Approximately 70 attendees from academic medical centers, the public health field and pharmaceutical companies attended.
Our very own Health Literacy in Clinical Research workgroup co-chair, Christopher Trudeau, focused an entire day of the workshop on how to develop informed consent forms using health literacy principles given the recent Common Rule revisions. In addition, Sarah White and Sylvia Baedorf Kassis sat on two separate panels to share their perspectives on how health literacy can be integrated into consent processes and clinical trials at large, respectively.
NASEM Roundtable on Health Literacy. A Workshop on Health Literacy in Clinical Trials: Practice and Impact (April 11)
On April 11, Barbara Bierer gave the opening keynote at the National Academies of Science, Engineering, and Medicine Roundtable on Health Literacy “Workshop on Health Literacy in Clinical Trials: Practice and Impact.” The need for health literacy in clinical research was described as an ethical imperative and a practice that could benefit participants andresearch studies. The connection between health literacy and diversity efforts was made even more evident over the course of the day’s discussions. Inclusive community engagement and research education at various points of an individual’s healthcare journey, were identified as critical to supporting research awareness, understanding, and participation. A repeated theme of the day was the need for greater sensitivity when considering the context within which research information is presented and discussed. A summary report of the workshop will be released by the Roundtable on Health Literacy later this year.
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 health care 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 use; the extent to which third-party payors, or agents of those payors, may be involved in research recruitment; and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
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.
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 health care providers may receive payment for permitting secondary uses of their data, the extent to which third-party payors, or agents of those payors, may be involved in research recruitment, and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
The R3 meeting took place on Thursday, March 7, from 10:00am – 3:00pm at the Washington, D.C. offices of Ropes & Gray LLP.
In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project.
The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
Roundtable attendees considered the advantages and drawbacks of the two pathways by which patients may request access to investigational therapies.
Among other things, participants explored the impact of each pathway on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies on Right to Try and Expanded Access.
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
For additional information about sponsoring and participating in the R3, please contact the MRCT Center.
Dr, Carmen Aldinger, MRCT Center Administrative and Training Manager, will present on Sharing Aggregate and Individual Results of Clinical Trials with Study Participants.
In collaboration with Ropes & Gray LLP, the MRCT Center hosted a closed, one-day roundtable on Monday, July 30th.
This meeting covered the Application of the General Data Protection Regulation (GDPR) to Research: Legal, Practical and Strategic Implications. Convening over 110 representatives from academia, industry, and government, this roundtable explored the impact of the EU GDPR on human subjects research by highlighting the challenges posed by the GDPR to clinical research, biobanking and data banking, and big data research.
