2011-07-25

The U.S. Department of Health and Human Services (HHS) has announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects.

Before making changes to the regulations – which have been in place since 1991 and are often referred to as the “Common Rule” – the government is seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. A chart comparing current rules and the proposed changes may also be found on the HHS website.

HHS notes that the current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects. ASH has identified a number of specific challenges facing clinical investigators in both malignant and benign hematology and made recommendations for overcoming each specific challenge in the Society's Statement on Clinical Research and Trials.

Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways. Comment is being sought on the following:

1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
3. Updating the forms and processes used for informed consent.
4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
5. 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.
6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
7. Providing uniform guidance on federal regulations.

All comment received will considered by HHS as it develops new proposed rules, which will also be made public for comment.

ASH will be reviewing this issue in detail and submitting comments in response to the ANPRM. All ASH members are encouraged to submit any particular concerns or comments on this issue to ASH Research Advocacy Manager Tracy Roades at troades@hematology.org.

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