National Institute of Mental Health, Intramural Research Program, Bethesda, MD
Submitted by: Catherine A. Roca, M.D.

The following information was submitted by the applicant for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose. Institutions interested in adopting or adapting the practice would be well-advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes.

Description: Central Office for Recruitment and Evaluation (CORE) for its efforts to improve human subject’s protections for patients participating in studies at the National Institute of Mental Health.

Genesis: The need for independent assessment of capacity to give informed consent and the use of consent auditors for certain types of research or patient populations led to the establishment of CORE.

Experience: The CORE was formed in July 1999. Its capacity assessment program was implemented in 2000. By the end of 2001, the NIMH IRB began mandating CORE involvement for certain types of research as an additional patient protection.

Compliance: This program exceeds the requirements of the current Department of Health and Human Services: 45 Code of Federal Regulations 46 Subpart A. 111. CORE program extends additional protections to participants with mental disorders.

Protection of human subjects: The CORE demonstrates a sustained commitment by the NIMH Clinical Director’s Office to the protection of research participants with mental illness.

Monitoring and evaluation/outcomes: The CORE’s effectiveness is evaluated yearly by the NIMH Clinical Director’s Office and the Office of the Scientific Director.

Innovation: Based on published data, this is the first independent program for routine capacity assessment, consent monitoring, and protocol monitoring in the country.

Replicability: The CORE program is currently conferring with the NIH Clinical Center to see how to best export the CORE model to other Institutes.

Applicant’s justification for award: This is a pioneering step in patient protections in mental health research that can be applied to other populations.

For additional information:
Catherine Roca, MD
Ph: 301-594-0860
Fax: 301-402-2588
Email: roca@intra.nimh.nih.gov