Comments Sought on Changes to Human Subject Protections: NCI Cancer Bulletin for August 9, 2011 - National Cancer Institute

Comments Sought on Changes to Human Subject Protections

The U.S. government is considering changes to the rules governing research involving human subjects and is seeking public input on proposed changes related to the ethics, safety, and oversight of human research. The proposed changes are designed to strengthen protections for human research subjects.

The current regulations governing human subject research, often called the Common Rule, were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multisite studies have highlighted ambiguities in the current rules and have led to questions about whether the regulatory framework is keeping up with the needs of researchers and research subjects.

Comment is sought on the following:

- 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 multisite 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

The deadline for comments is September 26. To submit a comment, visit http://www.regulations.gov, enter HHS-OPHS-2011-0005 in the "Enter Keyword or ID" field, and click "Submit a Comment."

NCI Cancer Bulletin for August 9, 2011 - National Cancer Institute