Office of the Clinical Director

Pao, Maryland

Abstract

I. NIMH DIRP CLINICAL SUPPORT SERVICES: The NIMH DIRP Office of the Clinical Director (OCD) coordinates a range of clinical, administrative, and research-related support services to the Institute and Scientific Director 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, seven 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. The OCD also developed a new training program for NIMH Intramural Research Training Awardees (IRTAs) to assure competence in working with research subjects. The NIMH Clinical Director serves as a member of the Intramural Working Group and the NIH Work Group on Mental Health, as well as the Advisory Board for Clinical Research. II. HUMAN SUBJECTS PROTECTIONS ACTIVITIES INCLUDING SUPPORT OF THE CNS IRB: NIMH is one of seven Institutes participating in the CNS IRB which reviews over 600 clinical research protocols (120 are NIMH protocols). 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 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, and is the current Vice-Chair of the CC Medical Executive Committee (MEC). The Human Subjects Protections Unit (HSPU) 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 (303 in FY10), perform decision making capacity assessments for studies involving potentially impaired subjects (85 in FY10), perform assessments of surrogate understanding (17 in FY10), and assessments of a subject's ability to appoint a Durable Power of Attorney (15 in FY10). HSPU members consult to investigators on human subjects'protections issues on 51 protocols, and monitor all NIMH inpatient subjects (average daily census 21.5 in FY10). The HSPU provides training and education of researchers in other NIH Institutes and has used their expertise to develop an informed consent training video for all NIH investigators. Since spring of this year, HSPU has worked collaboratively with the CC Bioethics Department to monitor the process of how vulnerable subjects and their families make decisions regarding research participation. The Marketing and Community Relations Unit (MCRU) is responsible for facilitating comprehensive and collaborative NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. Services include creating branded and unified recruitment materials, websites, advertising schedules, event planning for investigators'presentations, and presentations to advocacy groups, school systems, and health care providers, among other services. MCRU also reviews and assists with material approvals to meet IRB guidelines. In FY10, our community outreach program made over 300 appointments with community groups and providers, including nine area providers groups, eight area school systems and specialty schools, 12 area hospitals, and others. In addition, investigators made 29 community outreach presentations, 22 information booths were exhibited at mental health fairs, and three evening events for the general public were held with over 100 attendees each time. 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 for psychiatrists and other physicians who have completed their residencies;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 ACGME approved psychiatry program also sponsors the new and expanding Clinical Center (CC) Pain and Palliative Care (PPC) Training Program. The OCD supported the development and implementation of the CC Neuropsychiatry Nurse Fellowship Program and the Psychiatry Consulation Liaison Service( PCLS) faculty and fellows teach in a monthly CC seminar series on mental health aspects of nursing care of medical patients. The OCD is responsible for overseeing ongoing education in clinical training activities including the curriculum of trainees from high school students to postdoctoral fellows. The NIMH DIRP jointly sponsored with the NIMH Office of the Director the second annual """"""""Brain Camp"""""""" at Cold Spring Harbor. This focus group of leading neuroscientists and outstanding psychiatric residents nominated from leading U.S. medical institutions met in an effort to develop a relevant clinical neuroscience curriculum to be implemented in psychiatric residencies. Development and implementation of the curriculum will begin Fall 2010. In addition, OCD staff members prepare and conduct training in protocol preparation, human subjects protection, the conduct of informed consent and FDA mandated Good Clinical Practice (GCP) training with NIMH 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 (more than 600 new psychiatric consultations to other Institutes in FY10);2) the provision of emergency medical/psychiatric coverage to all NIH research participants 24 hours/day, seven days/week;3) the development of a new neuropsychological testing service for clinical and research information;4) providing education to members of the multidisciplinary teams caring for research participants in behavioral health related topics;5) 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 6) providing consultation and expertise to the Clinical Center to support NIH/community efforts such as the District of Columbia-NIAID HIV Initiative. V. RESEARCH IN PSYCHOSOMATIC MEDICINE (Psychiatric Consultation Liaison Service) strives to integrate 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 further described in MH002922-01.