The COGR and APLU preliminary findings present a detailed analysis of 2,186 public comments in response to the 2015 Notice of Proposed Rulemaking (NPRM) on revisions to the Common Rule, the federal policy governing human subjects research. The main areas of proposed change included expanding the definition of "human subject" to encompass non-identified biospecimens, mandating broad consent for secondary research on biospecimens, restricting IRB waivers of consent, requiring a single IRB for multi-site studies, extending the Common Rule to all clinical trials at federally funded institutions, instituting standard security safeguards, and requiring posting of clinical trial consent forms online. The report finds substantial opposition to most major proposals, particularly from patients, researchers, academic institutions, and relevant professional bodies, with the primary concern being severe negative impacts on biomedical research and public health, particularly due to anticipated reduced availability of biospecimens and increased administrative and financial burdens. Specific criticisms highlight the NPRM's complexity, lack of supporting data, and insufficient consideration of logistical and ethical ramifications, especially with respect to rare diseases and underserved populations.
Despite strong opposition to changes involving biospecimens and consent requirements—often grounded in fears of hindering scientific progress and compromising patient care—public opinion and advocacy positions were more divided. General public responses were influenced by high-profile media, leading to a near-even split on some issues, though those most impacted by disease research tended to oppose the changes strongly. Support for broad consent and expanded human subject definitions was more commonly rooted in ethical or privacy concerns rather than practical implications. Proposals such as standardized security safeguards received broader support. Mandating the use of a single IRB elicited mixed reactions, with efficiency and streamlining cited in support, but practical challenges and loss of local oversight cited in opposition. There was notable opposition to requirements to post consent forms publicly, attributed to concerns over administrative burden without compensating benefit. The analysis concludes with recommendations for substantial revisions to the NPRM, increased attention to stakeholder input, and a call for simplification and clearer evidence-based policymaking, emphasizing that regulatory changes should be carefully balanced to promote both ethical standards and scientific progress.
