The blog of the Presidential Commission for the Study of Bioethical Issues

Frustration grows over long list of rules for trials

Researchers and federal officials today gave an overview of a confusing array of the numbers of federal controls and regulations of human subject trials before the Presidential Commission for the Study of Bioethical Issues.

Commission member Dr. Christine Grady, deputy chief of the Department of Bioethics at the National Institutes of Health Clinical Center, said in a presentation that a “proliferation” of federal guidelines exist for U.S.-funded trials. “For someone going to do research in the U.S., (the list of rules) ends up being unfortunately a little overwhelming. For those doing research, there is a growing frustration with the number of rules, and the inconsistency in the rules.”

Grady said some researchers found the growing number of regulations so problematic that they are “outsourcing the details of following the rules. They hire someone to do the work, which creates a culture of not understanding what the rules are.”

In addition, she said researchers doing work in other countries also followed rules of those  countries, and sometimes the rules differed significantly from U.S. regulations.  “You can see why investigators trying to do federally supported research might be frustrated,” Grady said.

Commission member Dr. Anita L. Allen, a professor of law and philosophy at the University of Pennsylvania,asked whether the public could look at a single site to “find a list of federal guidelines?”

One online source for the rules of  US-funded trials is The International Compilation of Human Subject Protections, which can be found here. The compilation lists more than 1,000 human subject laws, regulations, and guidelines in 101 countries. It has been published since 2006 and is updated annually.

President Obama has asked the Commission for a review of whether the current federal standards adequately “guard the health and well-being of participants” of federally funded studies domestically and internationally. He made his request following revelations last year that a U.S.-funded study in the 1940s in Guatemala deliberately infected people with sexually transmitted diseases and in some cases did not treat them.

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1 Comment to Frustration grows over long list of rules for trials

  1. Name withheld's Gravatar Name withheld
    May 18, 2011 at 1:34 pm | Permalink

    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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