Office of the Clinical Director

Pao, Maryland

Abstract

The NIMH OCD coordinates a wide range of essential clinical, administrative, and research-related support services including: 1)administrative oversight of NIMH inpatient units and outpatient clinics through audits of FDA regulated studies, monitoring of high risk protocols, chart auditing, monthly patient care meetings and weekly meetings with clinical investigators and staff;2) provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, seven days/week;3) credentialing of members of the NIMH professional staff;and 4) education, training and monitoring of DHHS, NIH, NIMH IRP, CC and other regulatory agencies'policies related to human subjects safeguards during the conduct of clinical research. The OCD established and implemented a competency training program for NIMH Intramural Research Training Awardees (IRTAs) to assure staff with patient contact are competent for interacting with research subjects. The OCD created """"""""Labs to Life,"""""""" an interactive program between NIMH basic and clinical researchers, to enhance translational research in psychiatry. The NIMH Clinical Director (CD) is Chair of the CC MEC and is an ad hoc member of the CC ABCR. She serves on the NIH Directors Task Force on Diversity and the NIH Work Group on Mental Health. The MCRU is responsible for facilitating comprehensive and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. Services include: creating branded, unified recruitment materials, websites and advertising schedules, and event planning for investigators'presentations to advocacy groups, school systems, and health care providers. The MCRU also reviews recruitment materials approvals for compliance with IRB guidelines. Our community outreach program made nearly 200 appointments and worked with over 1,700 community contacts. The MCRU hosted free seminars for the public with over 100 attendees each and coordinated NIMH participation in the USA Science Festival in DC. A new newsletter initiative Featured Topic: Quick Links was created for nationwide distribution to better inform the public on mental health disorders, latest research findings and available research opportunities. The MCRU has created 78 ads, 47 flyers, eight brochures, 10 direct mail plans, and placed 105 print advertisements. The MCRU maintains and promotes a patient recruitment website and assists investigators with effective web placement;it was awarded an Evaluation Set-Aside Award by the Office of Program Evaluation and Performance (NIH/OD/DPCPSI) to support a project titled """"""""Usability Testing of the NIMH Division of Intramural Research Programs Website,"""""""" hopefully to be funded in FY12. The MCRU staff received a 2011 NIMH Directors Award for outstanding service in support of patient recruitment efforts in the NIMH Intramural Research Program. HUMAN SUBJECTS PROTECTIONS ACTIVITIES;SUPPORT OF THE CNS IRB: The NIMH continues to participate in the CNS IRB, which reviews almost 600 clinical research protocols (135 are NIMH protocols). The original CNS staff members, including several NIMH OCD staff, received a 2011 NIH Directors award for its successful creation and implementation. The OCD provides administrative, regulatory, educational, ethical and scientific support to investigators to ensure human subjects protections from initial protocol submission through continuing annual reviews to study completion and publication. The NIMH CD reviews all NIMH IRP protocol actions, serves as a member of the Committee for Scientific Review of Protocols, the CNS IRB and PTMS Steering Committees. The HSPU members, composed of social workers and nurses, monitors the informed consent process (312 in FY11), and performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (133 in FY11), performed 24 assessments of surrogate understanding, and conducted 15 assessments of subjects'ability to appoint a Durable Power of Attorney. HSPU members consulted to investigators on human subjects'protections issues on 64 protocols, and monitored all NIMH inpatient subjects (average daily census 22.7 in FY11 YTD). HSPU members provide training and education of researchers in other NIH Institutes (1-2 per month) and used their expertise to develop an informed consent training video for all NIH investigators that is accessible on the NIH CC Intranet as well as the NIMH IRP website, and is used by a broad range of NIH staff in preparation for obtaining informed consent. Given the unique setting of the NIH CC where all patients are enrolled in research protocols, the OCD and HSPU developed an Observed Structured Clinical Evaluation (OSCE) on the informed consent process for the NIH Graduate Medical Education Committee. The OSCE was developed to assist Accreditation Council for Graduate Medical Education (ACGME) programs at NIH in educating trainees in the core competency areas of professionalism and interpersonal and communication skills, in addition to the informed consent process itself. HSPU continues to collaborate with the CC Bioethics Department in monitoring the process of how vulnerable subjects and their families make decisions regarding research participation. TRAINING AND EDUCATION: The NIMH OCD, in conjunction with the NIMH IRP Office of Fellowship Training, received a 2011 NIMH Directors Award for outstanding training in the IRP. The OCD coordinates several training programs, including a unique one-year research-oriented, ACGME-accredited post-graduate year (PGY)-4 psychiatry residency;clinical research fellowships in basic and translational laboratories for psychiatrists who have completed their residencies;resident and medical student rotations;a collaborative Psychosomatic Medicine Fellowship training program with Georgetown University Medical Center and the Washington Hospital Center;and a three year joint clinical-research child psychiatry fellowship training program with Children's National Medical Center. The NIMH PGY4 psychiatry residency program mid-cycle review was conducted this year by the NIH Graduate Medical Education Committee. The ACGME approved psychiatry program also sponsors the CC's new and expanding Pain and Palliative Care (PPC) Training Program. 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 IRP jointly sponsored with the NIMH Office of the Director the third annual """"""""Brain Camp"""""""" at Cold Spring Harbor, NY. This focus group of leading neuroscientists and outstanding psychiatric residents nominated from leading U.S. medical institutions met to develop a relevant clinical neuroscience curriculum to be implemented in psychiatric residencies. Development of education web tools highlighting relevant neuroscience for psychiatrists commenced and the first module is available on the NIMH home page. CC LIAISON: The NIMH OCD provides a variety of clinical support services including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill patient (>550 new consultations);2) provision of emergency medical/psychiatric coverage to NIH research participants 24 hours/day, seven days/week;3) a new neuropsychological testing service(144 patients YTD);4) providing education to multidisciplinary teams on behavioral health topics;5) participating in the CC Behavioral Health Units Partners working group;and,6) providing consultation and expertise to the CC to support NIH/community efforts such as the DC-NIH Partnership for AIDS Progress. This interdisciplinary, cross-institutional research collaborative effort with local investigators will enhance knowledge on the mental health aspects of HIV/AIDS.