The document presents a detailed preliminary analysis conducted by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) of over 2,100 public comments submitted in response to the 2015 Notice of Proposed Rulemaking (NPRM) regarding revisions to the Common Rule, which governs the protection of human subjects in research. The analysis encompasses major proposed changes such as the expansion of the definition of "human subject" to include non-identified biospecimens, mandated broad consent for secondary research, restrictions on IRB waivers of consent, single IRB use for multisite studies, extending the Common Rule to all clinical trials regardless of funding source, implementation of standard security safeguards, and requirements to post clinical trial consent forms online. The analysis found significant opposition to most of the major proposals across nearly all respondent groups—particularly from patients, researchers, universities, and biorepositories—who argued that the changes would reduce the availability of biospecimens, hinder medical research, increase operational and financial burdens, and potentially harm advancements in human health. There was mixed support for single IRB requirements and modestly greater support for enhanced security safeguards.
A central point of contention involved redefining "human subject" to include all biospecimens regardless of identifiability, with widespread concern that such changes would substantially impede research efforts, particularly in rare disease and precision medicine contexts, without yielding commensurate benefits in autonomy or privacy. While some public and advocacy group respondents supported changes on ethical or privacy grounds, the majority—including several bioethics and advisory bodies—questioned the evidentiary basis and practical impact of the proposals. Alternative proposals limiting regulatory expansion to whole genome sequencing or certain high-risk biospecimens attracted some conditional support as less harmful alternatives. Furthermore, the financial analysis raised concerns about the underestimated costs associated with implementing broad consent and tracking infrastructure, with predicted expenses potentially reaching several billion dollars over a decade. Other NPRM elements, such as the requirement to post consent forms and mandates for a single IRB, elicited significant concerns about increased administrative complexity, operational feasibility, and inadequate regard for special populations. A recurring recommendation from several expert groups was for substantial revision, simplification, and renewed consultation before proceeding, criticising the NPRM for its complexity, lack of supporting data, and reliance on yet-to-be-developed guidance or regulatory tools. Overall, the document captures a strong consensus that, as initially drafted, the NPRM’s major proposals are perceived as disproportionately burdensome, insufficiently justified, and likely to hinder both the protection of human subjects and the advancement of biomedical research.
