May 25, 2001
NCRR Advisory Committee Approves "Advocates" for Patient Safety in GCRCs
The advisory committee to the NIH's National Center for Research Resources (NCRR) met on May 17, where it unanimously approved a series of recommendations intended to strengthen the protection of human subjects in research based at General Clinical Research Centers (GCRCs). The NCRR currently supports 79 GCRCs at academic medical centers around the nation.
Dr. M. Louise Markert, program director of the GCRC at Duke University Medical Center, presented the recommendations of a recent GCRC program review, the overall thrust of which she claimed is to provide an infrastructure for assuring compliance to existing regulations on human subjects protection. The report's major recommendation would create a patient safety advocate, or "ombudsman,"position within the GCRCs to support compliance with all requirements on human subjects protection. NCRR plans that creation of the ombudsman position will be supported by the GCRC program budget.
Among its other recommendations, the patient safety report proposes that adverse event reports transmitted to FDA or NIH, as required by regulation or policy, also be copied to a GCRC if the event involves research at that center. Such reporting would assist the GCRC in monitoring and assessing patient risk in on-going research projects. Dr. Markert noted that adverse event reports copied to GCRCs would need to be anonymized or otherwise masked to protect the confidentiality of patient medical records. The advisory committee strongly endorsed the report. Several members suggested that campus workshops accompany implementation of the report, and that these workshops be open to all clinical researchers on each campus, not just those affiliated with the local GCRC. This concept was unanimously endorsed by the committee.
The advisory committee also received a status report on the new National Institute for Biomedical Imaging and Bioengineering (NIBIB). Donna Dean, Ph.D., currently senior advisor to the NIH director, will serve as acting director of NIBIB until a permanent head and advisory committee are in place (expected by early next year). Many aspects of the institute remain to be determined. For example, it is not decided yet if the NIBIB will have an intramural program. A panel of NIH institute directors advised on how best to implement the legislation creating the new institute [see Washington Highlights, Jan. 5] and determined that bioimaging programs currently serving disease-specific research in other NIH institutes and centers (ICs) should remain in those respective ICs. NIBIB's mission will rather focus on hypothesis-testing research in biomedical technologies, an area that advocates for the new institute believed was not adequately addressed by engineering oriented or applied research within other NIH institutes.
Dr. Michael Marron, director of NCRR's division for biomedical technology, reported on continuing research projects within NCRR's own portfolio that will be considered for transfer to the new institute. These will most likely include research projects involving 1) biomedical imaging and device management, 2) biomaterials, 3) biosensors, and 4) nanotechnology. NCRR estimates that about one third of its R01 and R21 grants within the biomedical technology division will be affected. Centers grants, such as the P41 biotechnology resource grants, will most likely not be affected. Until the new institute is funded and fully operational, the NCRR and its advisory committee will act as "foster parents" of new bioimaging research applications.
NCRR Director Judith Vaitukaitis, M.D., presented the Administration's budget request for FY 2002, which includes requests of, on average, 14 percent across the NCRR's programs for research instrumentation and infrastructure. A welcome addition is the request of $10 million to launch a High-End Instrumentation (HEI) program supporting institutions' purchase of crucial new technology, such as top-of-the-line mass spectrometers and NMR imagers, costing in excess of $1 million.
Information: Steve Heinig, AAMC Division of Biomedical and Health Sciences Research, 202-828-0488.
