WASHINGTON – As the Energy and Commerce Subcommittee on Oversight and Investigations examines the role of independent institutional review boards (IRBs) that oversee research on human participants, U.S. Rep. Diana DeGette (D-CO), Vice Chair of the Committee on Energy and Commerce, today offered her support for increased federal regulation and oversight of IRBs during a hearing titled, “Institutional Review Boards that Oversee Experimental Human Testing for Profit.” Yesterday, U.S. Rep. DeGette introduced the Protection for Participants in Research Act, legislation that would strengthen federal regulation and oversight to protect people who participate in research such as clinical trials.

The Government Accountability Office today released a new study that found that the IRB system is vulnerable to unethical manipulation.

Below is U.S. Rep. DeGette’s opening statement as prepared for delivery:

“Patient safety in research situations, is, like food safety, a critical concern for this subcommittee. One thing you can be sure of is that a crisis is looming just around the corner.

“In 1999, a young man named Jesse Gelsinger died while participating in a gene therapy trial at the University of Pennsylvania.

“A Food and Drug Administration investigation concluded that the scientists involved in the trial, including the lead researcher, who had a potential financial interest in the results of the trial, broke several rules of ethical conduct including inadequate informed consent procedures.

“In 2006, the antibiotic Ketek caused liver failure and death in patients who used it.  An investigation showed that investigators had given fraudulent data to FDA to gain approval of Ketek.

“A whistleblower who learned of the fraud contacted the institutional review board that was responsible for approval of the Ketek clinical trial.  But the IRB allegedly did nothing to report the fraud and stop the use of Ketek.  And now here we are again today.

“Research is the key to innovation and discovery, including curing deadly diseases.  But, as this whole panel agrees, that research must be conducted ethically so that participants understand the risks and make informed decisions about volunteering.  That’s why we need to upgrade our entire patient protection system in this country.

“I’ve introduced legislation, the Protection for Participants in Research Act, in every Congress in the last six years.  It reforms federal regulation and oversight of research on human participants by:

·    Making federal regulations applicable to all research that is in or affects interstate commerce

·    Strengthens the education and monitoring of institutional review boards

·    Harmonizes FDA regulations and the Common Rule, the two major sets of federal regulations governing research participant protection

·    Strengthens protections against conflicts of interest by investigators or institutional review board members

·    Improves monitoring of research risks and reporting of adverse events and unanticipated problems

“We have reintroduced this legislation this session of Congress, and I would urge every member of this subcommittee on both sides of the aisle to look at the bill and think seriously about cosponsoring it.

“I think one thing we can all agree on in a bipartisan way is that we need to encourage medical experimentation but we need to do it in a way that both protects the patients and gives them informed consent about what they are getting into.

“I don’t want to be here for thirteen hearings, like we have been on food safety. I want to get this done.  We’ve been working on it for a number of years, we know the problem, we know the solutions, and I’m looking forward to working with everybody on this committee to improving research so that we have a robust system but at the same time protect the participants.”

 
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