We Accelerate Discovery

You are here




Early Program Meetings

Protection of Human Subjects HHS Meeting, August 2013
The Department of Health and Human Services (HHS) held a public meeting to seek input and comments on how certain provisions of the HHS requirements related to the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.   HHS specifically requested input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.  The public meeting took place August 28, 2013 from 9:00 am to 5:00 pm. Download transcripts of the meeting.

Coordinating Center-Organized Meeting, July 2013
The NIH HCS Collaboratory hosted a “Cluster Randomized Trials: Ethical, Regulatory and Practical Issues” workshop on July 29, 2013.   The objectives of the workshop were:

  • To describe the ethical issues related to cluster randomized trials
  • To determine the extent to which existing guidelines and policies related to cluster randomized trials are appropriate for research conducted in the United States or funded by the US government
  • To capture the findings in a white paper and/or peer-reviewed publication.

Representatives from a broad cross-section of the clinical trial enterprise including regulators, government sponsors of clinical research, academia, industry, patient advocates, clinical investigators, and other interested parties were in attendance.


Archived Meetings

Archived Activities

Up to Top