Table 2.

Overview of Proposed Changes to Federal Regulatory Framework for Human Subjects Protection

Ensuring risk-based protections	-Refinement of existing risk-based regulatory framework -Calibration of the levels of review to the level of risk -New mechanism for protecting subjects from informational risks
Streamlining IRB review of multi-site studies	-Utilization of single IRB review for domestic sites of multi-center studies
Improved informed consent	-Improved consent forms -Waiver of informed consent or documentation of informed consent in primary data collection -Strengthened consent protections related to reuse or additional analysis of existing data and biospecimens
Strengthening data protections to minimize information risks	-Consistent characterization of information with respect to potential for identification -Standards for data security and information problems
Data collection to enhance system oversight	-Establishment of an improved, more systematic approach for the collection and analysis of data on unanticipated problems and adverse events
Extension of Federal regulations	-Regulatory protections to all research, regardless of funding source, conducted at U.S. institutions that receive Federal funding from a Common Rule agency for human subjects research
Consistency across Federal regulations	-Improvement in the harmonization of regulations and related agency guidance

Adapted from: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Advance Notice of Proposed Rulemaking. Federal Register. July 26, 2011 2011;76(143):44512–44531