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  1. Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence.Holly Fernandez Lynch, Leslie E. Wolf & Mark Barnes - 2019 - Journal of Law, Medicine and Ethics 47 (2):213-231.
    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, regulators decided to (...)
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  • Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight.Holly Fernandez Lynch, Swapnali Chaudhari, Brooke Cholka, Barbara E. Bierer, Megan Singleton, Jessica Rowe, Ann Johnson, Kimberley Serpico, Elisa A. Hurley & Emily E. Anderson - 2023 - Research Ethics 19 (1):62-77.
    The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical (...)
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