Journal of Law, Medicine and Ethics 47 (2):213-231 (2019)

Leslie Wolf
College of DuPage
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 largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1177/1073110519857277
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 72,607
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

View all 8 references / Add more references

Citations of this work BETA

Introduction.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):189-193.

Add more citations

Similar books and articles

Waving Goodbye to Waivers of Consent.Jeffrey R. Botkin - 2015 - Hastings Center Report 45 (6):inside back cover-inside back co.
Conscience, Courage, and “Consent”.Mark A. Hall & Nancy M. P. King - 2016 - Hastings Center Report 46 (2):30-32.
Broadening Consent--And Diluting Ethics?B. Hofmann - 2009 - Journal of Medical Ethics 35 (2):125-129.
Biobanks--When is Re-Consent Necessary?K. S. Steinsbekk & B. Solberg - 2011 - Public Health Ethics 4 (3):236-250.
Key Information in the New Common Rule: Can It Save Research Consent?Nancy M. P. King - 2019 - Journal of Law, Medicine and Ethics 47 (2):203-212.


Added to PP index

Total views
8 ( #1,013,600 of 2,533,631 )

Recent downloads (6 months)
1 ( #389,998 of 2,533,631 )

How can I increase my downloads?


My notes