Learn more about NIH HCS Research Collaboratory Grand Round
Coordinating Center Organized Meeting, July 2013
NIH HCS Research Collaboratory hosts grand rounds which are archived on the Collaboratory website. The archived files for all grand rounds can be found here.
Protection of Human Subjects HHS Meeting, August 2013
The Department of Health and Human Services (HHS) announced 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 is requesting 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 will be held on August 28, 2013 from 9:00 am to 5:00 pm.
The NIH HCS Collaboratory will be hosting a “Cluster Randomized Trials: Ethical, Regulatory and Practical Issues” workshop on July 29, 2013. The objectives of the workshop are:
- 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.
The objectives of the workshop were 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.
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