October 26

Efforts to Expand Emergency Exception from Informed Consent

Efforts to Expand Emergency Exception from Informed Consent

Thu, 6 Oct 2005

The following announcement posted to the IRB Forum by Dr. Robert Nelson, a KOL (key opinion leader) within the close-knit IRB community– who serve as gatekeepers of human research –demosntrates that the culture of secrecy is entrenched in the clinical trial establishment. And unless the public raises cain–more and more unsuspecting people will be dragged when they’re unconscious into medical experiments that are more than likely to put their lives at increased risk of harm. [An Infomail updating the controversy over the non-consensual experiment conducted on 861 critically ill patients at ARDS Network centers will follow]

From: irbforum Sent: Monday, October 03, 2005 12:02 PM To: irbforum Subject: [IRB Discussion] Issues Raised by the Emergency Exception from Informed Consent?

We are in the planning phase of an “invitation only” NIH workshop that will explore issues raised by the emergency exception from informed consent. I am soliciting input from the members of The IRB Forum so that the agenda may capture the issues of importance from an IRB perspective (among others).

Although the focus of the workshop will be pediatric research, there is no need to limit your comments to this population. So please send me (either privately or to the list) any and all issues you think are important in the interpretation and application of the emergency exception from informed consent. For those of you who are not familiar with this regulation, you may refer to http://www.fda.gov/ora/compliance_ref/bimo/err_guide.htm or http:// www.fda.gov/ora/compliance_ref/bimo/emrfinal.pdf. Thank you .

Robert “Skip” Nelson, MD PhD

[The IRB Forum is an internet chatroom whose members are institutional review board members and government officials. The IRB Forum is administered by a faculty member of the Bioethics Center of the University of Pennsylvania.]

This “invitation only” meeting is being convened by the government (National Institutes of Health). Participants from industry, government and academia all have a considerable financial and professional stake in clinical trials. The subject to be discussed behind closed doors by those with a vested financial stake in clinical trials, is non-consensual experiemnts on patients whose incapacity renders them vulnerable to exploitation by stakeholders who see their very incapacity as an opportunity for enrolling patients without having to go through the process of informed consent. Those barred from the meeting are representatives of precisely the population from which human subjects are sought.

Of note: these same corps of research gatekeepers have been sprinkling their public pronouncements with the phraseology of “transparencey” and “openness” but have continued to operate behind an iron curtain of secrecy.

The following post in response to announcement was rejected as being “polemic.”

Promoting Openness, Full Disclosure, and Accountability

So much for talk about transparency!

I don’t believe that an elite self-selected group of reseasrch stakeholders–academcis included–should hold deliberations affecting fundamental public health policy issues by invitation only–behind closed doors! What trade secret is being discussed?

The shroud of secrecy enveloping biomedical research is precisely the dark facilitator of corrupt research practices that have penetrated every aspect of clinical research– These include misrepresenting (or concealing) the hazards; inflating (or inventing) potential benefits, and publishing fraudulent claims about positive results which have led to the marketing of defective, lethal drugs.

Should physicians – IRB folks really be a party to “invitation only” government workshops to explore a radical, contencious change in policy which the stakeholders want to keep under wraps behind closed doors. This smacks of an exploration for finding a way to “sell” a morally questionable policy to the public.

Let’s not foreget that the very frirst experiment conducted under FDA’s “emergency exception” tested artificial blood and the hapless subjects died. The experiment was halted. That should be the red flag against such overreaching.

In an essay in Plos Medical Journal, Richard Smith, former editor of the BMJ (for 25 years) writes about the seminal report by the health committee of the UK Parliament, noting:

“Recommendations: Let the Sun Shine In

The committee came up with 48 conclusions and recommendations, and I have listed some of the highlights in Box 2. The committee’s main recommendation for the problems it identifies is transparency: let the sun shine in. It begins by recommending that there be a clinical trials register, maintained by an independent body and containing full information. Companies should be required to put the information on the register at launch as a condition of the marketing licence. The committee also wants regulatory authorities and ethics committees (the British equivalent of institutional review boards) to help with the design of trials to make sure that they are answering real questions. It didn’t, however, recommend more public funding of trials. I believe that such funding is necessary in order to ensure that trials are addressing the most important questions including head-to-head comparisons and trials of new drugs against older drugs and non-drug treatments. Advice to companies is unlikely to be effective.”

See: Curbing the Influence of the Drug Industry: A British View By Richard Smith http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020241

It seems especially disheartening to witness how entrenched are the bad habits and the pervasive culture of arrogance among the movers and shakers in the US clinical trial enterprise. How revealing that this enterprise cannot conduct business execept behind closed doors.


Contact: Vera Hassner Sharav

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