The preliminary findings from COGR and APLU synthesize responses provided by biorepositories, affiliated organizations, and consultants to the proposed revisions of the Common Rule as they pertain to biospecimen research. The reviewed respondents, primarily large biobanking networks and groups supporting biospecimen research, expressed significant concern about the proposed expansion of the definition of “human subject” to include non-identified biospecimens, the broad consent requirement for secondary research use, and restrictions to IRB waivers of consent. A majority opposed these changes, citing insufficient rationale for treating biospecimens differently from data, potential negative impacts on biomedical research and patient care, increased costs, and practical challenges for hospitals, particularly smaller institutions and underrepresented populations.
Specifically, most respondents opposed expanding the definition of a human subject to non-identified biospecimens, with some instead supporting a more targeted approach involving whole genome sequencing. The majority also opposed mandatory broad consent, highlighting logistical, financial, and inclusivity concerns, as well as emphasizing the need for better governance and oversight rather than relying primarily on consent. There was general opposition to restricting IRB waiver criteria, with comments underscoring the complexity and ambiguity such changes would introduce, potentially hindering valuable research using archived specimens. The respondents largely did not address other proposed regulatory changes, with the exception of one note of opposition regarding proposed data security safeguards. Overall, the findings reflect broad apprehension among biorepositories and affiliated organizations regarding the practical, ethical, and scientific implications of the proposed regulatory changes.
