Proposed regulations for research with biospecimens: Responses from stakeholders at CTSA consortium institutions

Abstract

Secondary research with biospecimens acquired through clinical care and through research is often conducted without the informed consent of individuals from whom the specimens were acquired. While such uses are consistent with the current federal regulations, surveys of the general public suggest that many individuals would prefer more information and choice regarding research use of biospecimens. The federal government issued an Advance Notice of Proposed Rulemaking (ANPRM) in 2011 that proposed a number of potential changes in the regulations governing human subjects. These proposed regulations are particularly pertinent to institutions committed to research involving human subjects – including institutions in the NIH-funded Clinical and Translational Science Awards (CTSA) consortium. In this study, we reviewed public responses by CTSA-funded institutions and CTS-affiliated organizations and groups regarding the proposed changes in the ANPRM with respect to research with biospecimens. Our results indicate that the majority of responses to the ANPRM from CTSA institutions were not supportive of the proposed changes. While many responses acknowledge a need to change current research practices regarding biospecimens, the proposed changes in the ANPRM received only limited support from this subgroup of academic research institutions.

IRB practices and policies regarding the secondary research use of biospecimens

“…All of these issues may become increasingly problematic if the U.S. Department of Health and Human Services (DHHS) issues a regulation that would require informed consent from donors (or biospecimen contributors) for any future uses of all specimens. Released in 2009, the Advance Notice of Proposed Rule Making (ANPRM) proposes a brief, general consent for any future uses of biospecimens, even if they are stripped of identifiers [ 16 - 18 ]. Because of these proposed changes, IRBs may start seeing more protocols proposing to use stored biospecimens in anticipation of potential policy changes.…”

A Proposed Process for Reliably Updating the Common Rule

“…Most of the criticism of the ANPRM and NPRM surrounded changes to rules about the secondary use of biospecimens in research. A study of universities that received funding from the National Institutes of Health (NIH) Clinical and Translation Science Awards found that the majority of institutions that commented on the ANPRM opposed the proposed biospecimen rules (Botkin et al 2014). Some argued that, despite this sustained negative feedback from research institutions, the subsequent NPRM proposal on biospecimens still did not address concerns raised during the first comment period (Grizzle 2015).…”

CTSA Institution Responses to Proposed Common Rule Changes: Did They Get What They Wanted?

“…At least two research studies characterized these responses. A study by Botkin et al (2014) concluded that the majority of comments affiliated with institutions in the National Institutes of Health’s (NIH) Clinical and Translational Science Awards (CTSA) consortium did not support the proposed changes. Specifically, 68% of CTSA institutions and affiliates were opposed to the requirement for informed consent for future unspecified research use of biospecimens.…”