• The Certificate of Confidentiality Application: A View from the NIH Institutes
    with Jola Zandecki and Bernard Lo
    IRB: Ethics & Human Research 26 (1): 14. 2004.
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    Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law
    with Catherine M. Hammack, Erin Fuse Brown, Kathleen M. Brelsford, and Laura M. Beskow
    Journal of Law, Medicine and Ethics 48 (1): 126-141. 2020.
    Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying …Read more
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    Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence
    with Holly Fernandez Lynch and Mark Barnes
    Journal of Law, Medicine and Ethics 47 (2): 213-231. 2019.
    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 app…Read more
  •  6
    The Practice of Islam in America: An Introduction
    Journal of Islamic Studies 30 (2): 282-285. 2019.
  • IRB policies at 121 U.S. medical schools obtained from relevant Web sites were examined to determine whether the policies addressed matters involving investigator finders’s fees and role conflicts in recruiting participants for research. Analysis of the policies reveals that IRBs vary considerably in how they approach issues related to investigator conflicts. Most ban recruitment payments, but few restrict recruitment when role conflicts exist. While IRBs often acknowledge concerns about role co…Read more
  • When IRBs Review Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources
    with Nicole Sirotin, Lance Pollack, Joseph Catania, and M. Dolcini
    IRB: Ethics & Human Research 32 (5): 10-19. 2010.
    We interviewed 85 institutional review board chairs from a national sample of IRBs that review mental health research, asking them to rate the helpfulness of various resources that might be accessed when reviewing an ethically challenging research protocol. Each resource was rated on a four-point scale, and spontaneously offered comments were recorded, transcribed, and analyzed as well. A majority of IRB chairs indicated that talking to scientific colleagues and experts, participant representati…Read more
  • Conflicts of Interest in Research: How IRBs Address Their Own Conflicts
    with Jolanta Zandecki
    IRB: Ethics & Human Research 29 (1). 2007.
    We conducted this study to determine whether medical schools address conflicts of interest among their IRB members and staff, and, if so, in what ways. We analyzed the conflict of interest policies for 121 U.S. medical schools whose research is funded by the National Institutes of Health. About three-quarters of the schools we studied have written policies that address IRB conflicts of interest, and almost 80% of them defined the term, although their definitions varied substantially. The majorit…Read more
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    Recent Developments in Health Care Law: Partners in Innovation (review)
    with Roberta M. Berry, Lisa Bliss, Sylvia Caley, Paul A. Lombardo, Jerri Nims Rooker, and Jonathan Todres
    HEC Forum 22 (2): 85-116. 2010.
    This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future att…Read more