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Energy & Commerce Oversight Committee Holds a Hearing on NIH Human Tissue Research Policy and Practices; Implication for Potential NIH Reauthorization Legislation

Legislative Update
June 14, 2006

On June 13 and 14, the House Energy and Commerce Oversight and Investigations Subcommittee held two days of hearings on tissue handling procedures at the National Institutes of Health (NIH) as part of its intramural research programs.

The immediate focus of the hearings was the actions of a National Institute of Mental Health (NIMH) researcher and the alleged mishandling of spinal fluid samples by this researcher.

The larger focus of the hearings centered on the tissue sample tracking policies and procedures of the NIH as a whole. Currently, there is no centralized database for tracking all donated tissue samples - either currently in storage at the various NIH Institutes (estimated to be in the millions) or new samples collected in connection with current research. Tissue sample tracking is generally left to the individual researcher.

Although this was a subcommittee investigation and the hearings were run by subcommittee chairman Edward Whitfield (R-KY), full committee chairman Joe Barton (R-TX) made an opening statement the first day and questioned the NIMH panel on the second day. He, along with other subcommittee members, mentioned the need for NIH reauthorization, saying that he expected to have a bill out for the public "within a month, if not sooner".

Barton also pursued the subject of creating a central registry for tracking all human tissue samples, asking if this should be included as part of NIH reauthorization. NIMH Director Dr. Thomas Insel didnít firmly answer yes or no, responding that the magnitude of the task made it something that should be approached carefully.

One of the results of this issue, which NIMH Director Insel emphasized, was that policies regarding transfer of tissue samples to outside companies have been strengthened to prevent a similar matter from occurring. Also, policies regarding researchers having outside business dealings with companies have been clarified.