Ethics Research Oversight in the US; Current Practice and its Discontents: 

The Topic of the January 31, 2018 ethics training session is ethics research oversight in the U.S. The goals are to understand the basics of the system of IRB oversight to which human subjects researchers are presently subject and to consider the pros and cons of that system. We will focus on the nuts and bolts of the present system and on a research mishap that led to considerable soul-searching about ethic research oversight, the death of Jesse Gelsinger in a University of Pennsylvania phase I gene transfer trial in 1999.

My hope is to conduct the session primarily as a discussion rather than as a lecture. Below are some questions for discussion and some resources to inform your thoughts about the questions. I recommend you look at the short slide presentations and consider how you might respond to the questions; I don’t expect you to read all the additional references but you may wish to dip into them to illuminate your responses to particular questions.

Questions for discussion will include:

In regard to the IRB system of research oversight:

1. Our present system was a response to perceived infringements on the rights and welfare of research subjects in the 60s and before; are the wrongs perpetrated in that era:
A danger at the present time?
Such that the present system would prevent them?
2. What kinds of ethical dangers threaten research practice today? Is the IRB system a plausible remedy?
Did the oversight skeptics of the 60s and 70s have a point? Or not? How so?
3. Do IRBs focus on the right issues?
4. Could the system be improved? If so how?

In regard to the Penn gene transfer study:
1. Are the criticisms of the Penn study valid?
2. Should or could Penn’s IRB have corrected any errors/ethical lapses on the part of the investigators?
3. Is this a case of research gone ethically awry or of a tragically bad outcome of a kind inevitable if science is to progress? Or both? How so?
4. If the investigators did wrong in ways the present oversight process could not have detected or corrected, are there practical changes in the process that could be made that would make the process effective in preventing future such errors/wrongdoing?



Slide presentation; “Research oversight; ethics and practice
Slide presentation; “The Gelsinger Case

Basic Background

McCarthy, Charles R. “The Origins and Policies that Govern Institutional Review Boards” in The Oxford Textbook of Clinical Research Ethics (Oxford University Press, 2008)

More history than you likely want, but a nice overview of the story leading up to the regulations establishing the IRB regime in 1981.

Steinbrook, Robert. “The Gelsinger Case” in The Oxford Textbook of Clinical Research Ethics (Oxford University Press, 2008)

Early Academic Skepticism

McDermott, W. “Opening Remarks” from “The Changing Mores of Biomedical Research; A Colloquium on Ethical Dilemmas from Medical Advances” Annals of Internal Medicine 1967;67 Suppl 7(3) Part II: 39-42.

Ingelfinger F. “The Unethical in Medical Ethics” Annals of Internal Medicine 1975;83: 264-69.
(Especially the section titled “bureaucracy of ethics”)

These pieces nicely illustrate what in retrospect seems the striking God-complex afflicting the mandarins of the academic clinical research establishment in the mid-20th century. 

Criticism of the current system; it's too onerous

Whitney, Simon N. "The Python's Embrace: Clinical Research Regulation by Institutional Review Boards" Pediatrics 129.3 (2012): 576-578.

This piece reads ironically in light of what was to happen in 2013, when the OHRP issued its determination letter regarding the SUPPORT study. If you’re aware of the SUPPORT controversy, think about the author’s rationale for criticizing informed consent requirements in this study. 

Criticism of the current system; it's insufficiently rigorous

Gelsinger, Paul, and Adil E. Shamoo. "Eight Years after Jesse's Death, Are Human Research Subjects Any Safer?" Hastings Center Report 38.2 (2008): 25-27.

Consider which if any of Gelsinger’s list of continued problems, if corrected, would have prevented the Gelsinger study bad outcome. 
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