Clinical and Translational Science Awards (CTSA) Program representatives recently collaborated with patient advocacy groups to host four national meetings promoting public engagement in the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects.
The NPRM was released by federal agencies, including the U.S. Department of Health and Human Services, in September 2015. The goal was to garner public comment on proposals to improve and modernize what is known as the Common Rule, which is a set of federal regulations to protect human subjects involved in trials while facilitating valuable research and reducing burden, delay and ambiguity for investigators.
In coordination with FasterCures, the Center for Information & Study on Clinical Research Participation, Genetic Alliance and other organizations, CTSA Program representatives planned and executed the meetings within a two-month period in fall 2015 to coincide with the Common Rule public comment period. The meetings were held in Nashville, San Diego, Chicago and Philadelphia, and each was thematically organized to focus on a different aspect of the proposed changes. The goals were to:
- Enhance understanding of the NPRM.
- Facilitate a robust exchange of ideas among a broad range of research stakeholders about the proposed changes and their implications.
- Promote informed public engagement in the policy making process.
Following extensive outreach to more than 170 stakeholder groups, the combined attendance for all four meetings exceeded 1,400, with 240 attending in person and more than 1,100 participating via webinar. Every effort was made to achieve diversity among participants and to ensure the attendance and active participation of all stakeholder groups, particularly patient advocacy organizations, underrepresented minorities, underserved groups and vulnerable populations. The majority of attendees were from academic medical centers, and private citizens composed the next largest group. Evaluation surveys indicated an increased level of understanding of the NPRM following each event.
Posted March 2016