Comments on: Frustration grows over long list of rules for trials http://blog.bioethics.gov/2011/05/18/wanted-a-single-place-for-rules-of-u-s-funded-trials/ The blog of the Presidential Commission for the Study of Bioethical Issues Mon, 17 Jun 2013 22:23:17 +0000 hourly 1 By: Name withheld http://blog.bioethics.gov/2011/05/18/wanted-a-single-place-for-rules-of-u-s-funded-trials/#comment-1220 Name withheld Wed, 18 May 2011 17:34:22 +0000 http://blog.bioethics.gov/?p=146#comment-1220 I’ve been looking into this topic recently, and it seems that there should be one stopping place for Federal oversight of human subjects research conducted in the US or by US-based institutions, regardless of whether funding sources. This should not be done to create more bureaucracy but rather to protect human subjects. Nobody’s research interests trump human rights, ever. I thought that was the lesson from the Nuremberg Trials.

It appears that the deceptive studies on unwitting victims conducted by several agencies in the 1950s, 1960s and 1970s lead to the formulation of more federal regulations but for example the Common Rule was not adopted by all agencies. No one was prosecuted, institutions that were involved were spared exposure as part of the “Privacy Act,” and victims who were harmed by involuntary experimentation are probably mostly unknown.

These are some of the basic problems with government regulations as I see them: the Common Rule has not been adopted by all Federal agencies and is not mandatory when studies are not federally funded. States are irregular in their legislation of human subjects research and do not necessarily have centralized oversight for studies conducted in the state. Private institutions are not only lacking government oversight but are protected in ways that the Federal institutions are not – for example, they would be exempt from FOIA requests and other open government initiatives.

Meanwhile in this country human subjects protections acts have not passed despite their introduction into Congress in the late 1990s (Senator Glenn) and several times in the 2000s (Rep. DeGette). Why is that?

Furthermore, I think it is critical to place a ban on all human subjects experimentation conducted in the US or with US based sponsorship that is involuntary and involves more than minimal risks regardless of the funding source. I can’t imagine why someone would oppose such a ban or criminalization of studies that are intended to harm human subjects.

If a person is on a nonconsensual interventional study with deception as a central element, how would they know what institution or group is behind the study, who they could sue for damages and whether that research even falls under Federal research legislation.

Ask me why I even had to find out what the rules were. Before you consider the bureaucracy faced by researchers, consider the types of damages unjustly caused to human beings in research that they did not consent to. Posthumous profuse apologies are best avoided by real justice.

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