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Program InformationClinical Research Resources Links ON THIS PAGE: SEE ALSO: Through the General Clinical Research Centers (GCRC) program, NCRR funds a national network that providing settings for medical investigators to conduct safe, controlled, state-of-the-art, in-patient and out-patient studies of both children and adults. GCRCs also provide infrastructure and resources that support several career development opportunities. Investigators who have research project funding from NIH and other peer-reviewed sources may use GCRCs. To request access to a GCRC facility, eligible investigators should initially contact a GCRC program director, listed in the Clinical Research Resources Directory. Because the GCRCs support a full spectrum of patient-oriented scientific inquiry, researchers who use these centers can benefit from collaborative, multidisciplinary research opportunities. To ensure research diversity at the GCRCs, no single group of investigators at a center may utilize more than 33 percent of the resources. The individuality of each GCRC is determined by the research strengths and needs of its host institution. GCRC resources include highly trained research personnel, a core laboratory, a bioinformatics system, and a metabolic kitchen. The GCRC research staff--nurses, dietitians, biostatisticians, skilled technicians, and administrative personnel--help investigators by facilitating the day-to-day research process and assisting the research patients in a supportive and efficient environment. A GCRC grant supports the components essential to clinical research: operating expenditures, hospitalization and ancillary laboratory costs, and salaries of key personnel including nurses, research bionutritionists, administrators, core laboratory staff, biostatisticians, and computer personnel. Funds for renovation and equipment also may be provided. Confidentiality NoticeCertificates of Confidentiality are issued by the National Institutes of Health to protect the privacy of research subjects by preventing investigators and institutions from being compelled to release information that could be used to identify individuals who are participating in a research project. These certificates, issued to institutions where research is being conducted, allow investigatorsand others who have access to research recordsto refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. The availability of such a document frequently helps an investigator to accrue participants into a protocol that addresses issues that are of a particularly sensitive nature. READ MORE Usually, a request for a certificate of confidentiality is addressed to the NIH Institute funding the clinical study. However, in cases where the research project is not funded by NIH and the protocol is being performed within a GCRC, the investigator should request assistance from the Certificate of Confidentiality coordinator at the National Heart, Lung and Blood Institute. Human Subjects ProtectionNIH requires all investigators who apply for or receive funds for research involving people to be educated on human subjects protection. Accordingly, NIH has developed a Web-based, continuing education program on the protection of human participants in research. This course provides continuing medical education (CME) credit for physicians and contact hours for nurses and other members of biomedical research teams. The course offers up to two hours of category 1 credit of the Physicians Recognition Award of the American Medical Association. Cine-Med, Inc., a continuing medical education provider, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor the credits. Application for nursing contact hours is in progress. Access the course. Federal regulations and policies protect subjects in clinical research protocols, ensuring that their safety is given the highest priority. These regulations complement the policies of academic institutions that host the GCRCs. Proper performance of research consent and oversight procedures makes demands on the time of already-busy clinician researchers. To address these demands, the NCRR has created a Research Subject Advocate position within each GCRC. The purpose of this position is to ensure that studies on the GCRC are designed and conducted safely and ethically with protection of human subjects accorded the highest priority. Program GuidelinesPDF files require free Acrobat Reader) Current Guidelines (674KB PDF) Contact InformationFor more information about the General Clinical Research Centers program, contact: Bernard Talbot, M.D., Ph.D. |
National Institutes of Health (NIH) Bethesda, Maryland 20892 |
Department of Health and Human Services |