Evidence Development & Decision Science

The systematic production and application of medical knowledge to clinical practice. LDI Senior Fellows analyze the process by which data affect coverage and clinical decisions, and conducts comparative effectiveness and cost effectiveness studies.

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence

Jul. 12, 2019

Holly Fernandez Lynch, Leslie E. Wolf, Mark Barnes

Abstract [from journal]

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however,