Sally Kornbluth, PhD, vice dean for research, distributed the following memo seeking faculty comments (by Aug. 31) on proposed changes to the federal Common Rule that regulates human subjects research.
[toggle title_open="Click to toggle closed" title_closed="Click to read memo" hide="yes" border="yes" style="default" excerpt_length="0" read_more_text="Read More" read_less_text="Read Less" include_excerpt_html="no"]The U.S. Department of Health and Human Services has announced proposed changes to the Common Rule, which are the federal regulations for human subjects research. The goal of these changes is to enhance the protection of research subjects and improve the efficiency of the review process.
As part of the process of changing these regulations the government is seeking public input on the proposed changes. Rob Califf and I are preparing a response on behalf of Duke and we would welcome any concerns, comments, or discussion of issues to help in our formulation of Duke’s institutional response.
Please send any comments to Beky Branagan (rebeka.branagan@duke.edu) with the subject line "common rule" by Aug. 31 to allow incorporation of comments into Duke's response before the comment period closes on Sept. 26.
In brief, the proposed regulatory changes are:
- Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
- Using a single Institutional Review Board review for all domestic sites of multi-site studies.
- Updating the forms and processes used for informed consent.
- Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
- Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
- Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
- Providing uniform guidance on federal regulations.