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Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.

Part 3: What’s an IRB to do?

EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment?  This distinction is important for patients’ rights and welfare.

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Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 here.

Part 2: Possible Value of “Real World Data” Collected from Expanded Access

Real world data (RWD) are data relating to patient health status and/or the delivery of health care such as medical bills/claims, electronic health records, and product/disease registries. RWD are derived from sources outside of randomized controlled trials (RCTs). Real world evidence (RWE) may be derived from the analysis of quality RWD.

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Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance.

Part 1: What is Expanded Access and How Does it Work?

Expanded Access (EA) is a regulatory mechanism that allows patients, through their physicians, to request the use of an unapproved medical product in a treatment setting.

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A Proposal for Localized Review to Safeguard Genetic Database Privacy

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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Black Lives Matter To Human Research–Lessons From ‘On The Run’

On-the-Run-w-Goffman

By Michele Goodwin

In her recent publication, On The Run, University of Wisconsin sociology professor, Alice Goffman writes about embedded research from 2002-2007 in a “ghetto” community she names 6th Street (located in Philadelphia).  The African American residents of this community are mostly poor and tethered to the  criminal justice system as parolees, on probation, and in and out of jail.  Goffman’s human research subjects comprised the jailed, imprisoned, and minors–IRBs generally describe these populations as “vulnerable.”

On The Run is hailed as original, creative, and transgressive because of Goffman’s lengthy stay in such a descriptively chilling, dangerous, and Black neighborhood–where frequent gun battles teach kids to dive for cover, the women are teen mothers or crack addicted, and law enforcement incessantly polices the community. Indeed, she moves into the neighborhood and lives with three of the 6th Street boys.  Much could be gained from documenting the challenges in such a community, particularly given the troubling patterns of mass incarceration in the U.S.  However, the book raises questions about what represents credibility, quality, and rigor in social science research; the book lacks an index, bibliography, and meaningful citations.  I write about these concerns and more in a forthcoming Texas Law Review essay, which can be found here.

Reviewers lauded the rigor and ignored ethics of the book, agreeing with Goffman’s Princeton advisor, Professor Mitchell Duneier, and his NY Times assessment that  “[t]he level of immersion is really unusual,” because “[s]he got access to the life of the ghetto and came to understand aspects of it we don’t ever get to see.”  Yet, therein resides a significant problem. Fascination with the ghetto and perceptions that life in inner-cities is so bad that researchers can’t possibly expose those human subjects to risks and harms may have blinded the book’s many reviewers to the fact that Black lives matter, including in human research.  It might have also implied a lower standard for rigor; it is rare that an academic book lacks a bibliography and index.  Goffman also destroyed her field notes. These concerns becomes starkly relevant when she writes about her desire and collaboration with “Mike” to kill a man from the neighboring 4th Street.

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