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.