The document provides a comprehensive summary of public feedback on the Notice of Proposed Rulemaking (NPRM) as of May 2016, focusing on proposed revisions to the Common Rule governing human subjects research. Over 2,100 comments were received, significantly outpacing responses to the earlier Advance Notice of Proposed Rulemaking in 2011. Most responses were submitted by individuals, many of whom did not specify professional affiliations, while institutional comments largely came from medical and academic organizations. Several broad concerns emerged regarding the NPRM, including its complexity, lack of key supporting materials (such as templates and guidance documents), perceived internal inconsistencies, and the discretionary authority granted to investigators.
The proposals generating the most feedback were those related to expanding the definition of human subjects to include non-identified biospecimens, stricter waiver criteria for biospecimens, and the implementation of broad consent—all of which faced strong opposition from a wide array of stakeholders. Additional topics eliciting significant comment included the single IRB review mandate (with institutions largely opposing and individuals more supportive), the exemption determination tool, and proposed changes to informed consent practices. While streamlining documentation and eliminating certain continuing review requirements were met with approval, concerns were raised regarding increased procedural complexity and the adequacy of privacy safeguards—especially as many standards had not yet been developed. Overall, the comments reflect a divided and nuanced response, highlighting both widespread apprehensions about increased burdens and complexity, and support for measures aimed at reducing administrative requirements and enhancing the protection and transparency in human subjects research.
