Office of the Clinical Director

National Institute Of Mental Health

Investigators

Linked publications & trials

Abstract

I. NIMH DIRP CLINICAL SUPPORT SERVICES: The NIMH DIRP Office of the Clinical Director (OCD) coordinates a range of clinical and research-related support services to the Institute including: 1) administrative oversight of NIMH inpatient units and outpatient clinics through chart auditing, review of occurrence reports involving NIMH subjects, monthly performance improvement meetings and weekly meetings with clinical investigators and their staff to review the clinical status of protocol participants; 2) the provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, 7 days/week; 3) credentialing of all members of the NIMH medical staff; and 4) education, training and monitoring of DHHS, NIH, NIMH DIRP, Clinical Center and other regulatory agencies' policies related to human subjects safeguards during the conduct of clinical research. II. HUMAN SUBJECTS PROTECTIONS ACTIVITIES INCLUDING SUPPORT OF THE CNS IRB: NIMH is one of five Institutes participating in the CNS IRB. The OCD provides administrative, regulatory, educational, ethical and scientific support to help investigators write and review protocols and to ensure human subjects protections (with patient subjects and healthy volunteers) from initial protocol submission through continuing annual reviews to study completion and publication. The Deputy Clinical Director served as the Vice-Chair of the CNS IRB from its inception (2006) through July 1, 2008 and appointed a new Vice-Chair to the white panel beginning July 1, 2008. The NIMH Clinical Director reviews all NIMH DIRP protocols and serves as a member of the Committee for Scientific Review of Protocols (CSRP), the CNS IRB Steering Committee, the Human Subjects Research Advisory Committee (HSRAC), and the CC Medical Executive Committee (MEC).[unreadable] The Human Subjects Protections Unit (HSPU), formally the Central Office for Recruitment and Evaluation (CORE), is an award-winning team that was created to protect vulnerable human subjects participating in mental health research. The HSPU members, composed of advanced practice social workers and nurses, monitor the informed consent process (286 in FY08), perform decisionmaking capacity assessments for studies involving potentially impaired subjects (23 in FY08), consult to investigators on human subjects protections issues, and monitor all NIMH inpatient subjects (average daily census of 21 in FY08). Given the Unit's success, we have been involved in training and education of researchers in other NIH Institutes. The HSPU is developing an informed consent training video for NIMH investigators and CC staff. The Marketing and Community Relations Unit (MCRU) is responsible for facilitating NIMH subject recruitment in a variety of ways including direct targeted advertisements and arrangement of presentations by investigators for local and national community organizations, mental health advocacy associations, and schools. III. TRAINING AND EDUCATION: The NIMH DIRP OCD, in conjunction with the NIMH Office of Fellowship Training, coordinates several training programs including a unique one-year research oriented American College of Graduate Medical Education (ACGME) accredited Post-Graduate Year (PGY)-4 psychiatry residency; clinical research fellowships in basic and translational laboratories; Psychosomatic Medicine Fellowship, a collaborative training program with Georgetown University Medical Center and the Washington Hospital Center; a joint clinical-research fellowship training program with Children's National Medical Center; and resident and medical student rotations. The OCD is responsible for overseeing ongoing education in clinical training activities including the curriculum of trainees. In addition, OCD staff members prepare and conduct training in protocol preparation, human subjects protection, and the conduct of informed consent with investigators and other NIMH DIRP research staff. IV. CC LIAISON ACTIVITIES: The NIMH DIRP OCD provides a variety of clinical support services to the CC and other Institutes including: 1) providing psychiatric consultation and liaison services to medically- and surgically-ill patient subjects enrolled in clinical research (500 new psychiatric consultations to other Institutes in FY08); 2) providing education to members of the multidisciplinary teams caring for research participants in behavioral health related topics; 3) participating in the CC Behavioral Health Units Partners working group in order to meet regulatory standards (i.e., Joint Commission for Accreditation of Hospital Organizations, Office of Human Subjects Research); and 4) providing consultation and expertise to the CC (e.g., Chief of Radiology Department Search Committee, Chief of Spiritual Ministry Department Search Committee, Research Participant Satisfaction focus group moderator). V. RESEARCH: Research in Psychosomatic Medicine strives to integrate the rapidly evolving knowledge derived from basic neuroscience and molecular medicine with state-of-the-art clinical care in order to better understand and treat psychiatric conditions in the medically- and surgically-ill. The NIMH DIRP OCD participates in multiple collaborative clinical research projects ( 08-M-N070) as well as academic endeavors (23 local, national and international presentations; 6 posters; 4 papers and 4 chapters) to achieve this goal.