Non-Consenting Adults

[didymus]

Slate:

Non-Consenting Adults

Sixty-five years ago in Nuremberg, Germany, American prosecutors  confronted the Nazi physicians who had subjected Jews and others to a  murderous regime of medical research. The "doctors' trial" was the first  of the war crimes trials; one of its outcomes was the famous [Nuremberg Code, a set of ethical guidelines for human experimentation](http://ohsr.od.nih.gov/guidelines/nuremberg.html).


                      The first tenet of the code is very clear: "The voluntary consent of the human subject is absolutely essential."


                      Today, the Nuremberg Code is the most important influence on U.S. law  governing human medical research. Even so, marginalized groups have  frequently been coerced into studies that violate their right to  consent. A recent review of the bioethics of human research in the U.S.  offers little prospect for change.

                      My book [*Medical Apartheid*](http://www.amazon.com/gp/product/076791547X/ref=as_li_ss_tl?ie=UTF8&tag=slatmaga-20&linkCode=as2&camp=1789&creative=390957&creativeASIN=076791547X) documents many cases. In 1994, for example, the Medical University of South Carolina in Charleston was accused of [enrolling poor black women into narcotic-treatment research](http://articles.baltimoresun.com/1994-01-21/news/1994021188_1_south-carolina-hospital-prenatal-care-women-for-drug) without their knowledge. The next year in Los Angeles, an [experimental measles vaccine](http://articles.latimes.com/1996-06-17/news/mn-15871_1_measles-vaccine)  was tested on children, mostly black and Hispanic, without their  parents' consent. In 1994 and 1995, New York City law enforcement  officials helped researchers coerce black parents into enrolling their  boys into a [study](http://www.nytimes.com/1998/04/15/nyregion/experiments-on-children-are-reviewed.html)  that sought to establish a genetic propensity for violence, again  without their consent. And in 2001, the Kennedy Krieger Institute in  Baltimore was [found guilty by a Maryland court](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1470603/)  of encouraging black families to move into lead-contaminated housing as  part of a study on lead levels in children (the verdict was later  overturned).

Since the 1980s, around 20 U.S. research projects have won legal  waivers allowing them to bypass any form of consent. From 1990 until  2005, for example, the Department of Defense obtained a waiver that  allowed it to force 8.9 million ground troops to accept inoculation with  experimental anthrax vaccines.


                      Civilians' rights are violated too. In 1996, [U.S. law was changed to permit non-consensual research on trauma victims](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf) on the pretext that they are unconscious and unable to give their consent.


                      Private companies, for whom time is money when seeking approval to  sell their products from the U.S. Food and Drug Administration (FDA),  were quick to see the advantages in enrolling subjects who could not  refuse. In 2003, biotechnology company Northfield Laboratories set up a  nationwide trial of its blood substitute PolyHeme. The substance was  randomly administered by ambulance crews to unconscious victims of car  accidents, shootings and cardiac arrests.

[sigh]

One would have hoped such practices stopped with the Tuskegee experiments.

 

[Trader]

Slate:

[sigh]

One would have hoped such practices stopped with the Tuskegee experiments.

This does not even include experimentation on human embryos. They don’t count. They never complain. They never survive the experiment.

 

[odile53]

I had seen a consent form once for a clinical trial, and instantly recognized it as lifted directly out of the transcripts of the Nuremberg Trials.

What concerns me almost as much as the nonconsensual experimental subjects is those people who get recruited into a clinical trial with half truths and scare tactics. It would seem that “informed consent” is sometimes “misinformed consent.”

To the poster who said that (s)he had hoped that this had all ended with Tuskegee, think again: Desperate people get recruited into clinical trials, often by some hope for an amelioration of symptoms, etc, as well as the promise that they can always back out. However, I have actually seen people wanting out of a trial cajoled into remaining in the study group, by the insinuation on the part of the researcher that their treatment would change, possibly for the worse, if they withdrew from participation. Remember, these people are desperate: They usually stay in, accepting treatment that may or may not work, and at usually increased pain and suffering. I don’t know what anyone else calls it, but in my book, that’s coercion and manipulation.

I’d really advise anyone who is being recruited for a clinical trial to have their attorney review the documents before signing on for anything whatsoever.

 

[musicality]

As far as trauma research goes, the only way to study the efficacy of treatments on humans in emergency situations is to study the treatments on humans who are inherently incapable of giving consent. The regulations that the studies must pass are quite rigorous before they get to the human level (in vitro and in vivo with live model organisms). If these studies did not exist, there would be no progress in the realm of emergency medicine.

That being said, in cases where patients are able to give consent, they should obviously have the option.