The document provides an initial analysis of public comments received in response to proposed revisions to the Common Rule, focusing on a review presented at the Council on Governmental Relations Meeting in February 2016. Out of approximately 2,190 comments, the majority came from individual patients, the general public, and representatives or associations, with significant contributions also from researchers, academic institutions, industry groups, and advisory entities. The review methodically categorized comments by respondent group and subject matter, particularly centering on contentious areas such as the expanded definition of human subject (notably regarding biospecimens), the introduction of broad consent, the mandating of a single Institutional Review Board (IRB), the extension of the Common Rule to all clinical trials, security safeguards, and the posting of informed consent forms.
The feedback, especially from universities and medical centers, was predominantly critical of the key proposed changes. For instance, there was overwhelming opposition to redefining human subjects to include all biospecimens, as well as to the introduction of broad consent and mandated single IRBs; only a handful expressed unqualified or partial support. Similarly, most respondents opposed using notice or opt-out procedures as alternatives to broad consent, as well as changes to waiver processes, extending the Common Rule universally, new safeguard requirements, and posting consent forms. Comments from patients and their families—especially those affected by rare tumors—largely echoed the institutional opposition, particularly against changes related to the use of biospecimens and waiver requirements. A recurrent theme across respondent groups was the perception that the proposed revisions (NPRM) were insufficiently developed, with many recommending substantive revisions or clarifications. Overall, the summary reflects considerable stakeholder concern about increased regulatory burden, practicality, and unintended consequences of the proposed reforms.
