Office of the Clinical Director

Pao, Maryland

Abstract

HUMAN SUBJECTS PROTECTIONS: The Human Subject Protections Unit (HSPU) is dedicated to ensuring adequate protections are in place for all NIMH intramural research participants. Established in 2005, this team of Clinical Research Advocates (CRAs) works with PIs, the IRB, the CC Bioethics Department, and individual participants to identify and ameliorate risks for vulnerable subjects. Activities include: 1) Consent Monitoring: CRAs monitor the informed consent process for potentially vulnerable patients as stipulated by the IRB. Thus, a CRA is present during the consent process and observes the quality of the process, ensuring that all required elements (45CFR46) are discussed; 2) Protocol Monitoring: All inpatient research participants are further protected by our protocol monitoring program in which each patient is assigned a CRA who meets with the participant at least weekly to reaffirm their interest in continuing in the study; 3) Capacity Assessment: For some particularly high-risk studies, a capacity assessment must be completed prior to study participation. Capacity assessments are completed with various patient populations such as Fragile X syndrome, Alzheimer's Disease and some cancer, HIV, and neurological populations; 4) Ability to Appoint an NIH Advanced Directive/Durable Power of Attorney: For protocols approved to include subjects without decision-making capacity, HSPU and the CC Bioethics Department, form the Ability to Consent Assessment Team (ACAT). These clinicians assess a subjects ability to appoint a Durable Power of Attorney (DPA) or Legally Authorized Representative (LAR); 5) Training and Education: In 2008, the HSPU developed an informed consent training, Elements of a Successful Informed Consent, which is required for investigators approved to obtain informed consent. To date, over 800 staff have completed the Elements of a Successful Informed Consent training. In 2010, an educational video and a computer-based training program were created highlighting the best practices in obtaining informed consent. The video is accessible on the web at http://nimhconsentvideo.nimh.nih.gov. This site has had over 4000 hits since it was originally posted. CLINICAL RESEARCH SUPPORT SERVICES: An important mission of the OCD is to ensure that subjects participating in NIMH protocols receive the highest quality clinical care. The OCD is responsible for the oversight of all clinical aspects of the DIRP including: 1) Risk Management/Patient Safety of the overall clinical program: The OCD administrative team meets regularly with the medical directors and nursing leadership to review census, discuss clinical concerns and plan for future initiatives. The OCD coordinates a monthly patient care meeting focused on patient safety, quality improvement and quality assurance in patient care. It also serves as a forum for communication of hospital-related policies and regulations; 2) Management of the NIMH protocol review process: The OCD coordinates the scientific review of protocols prior to IRB submission and provides protocol navigation services to DIRP investigators. The navigation team provides direct support to individual investigators for all aspects of IRB submissions. This includes drafting and writing initial review submissions, submission of annual continuing reviews (CR) applications and preparation of protocol amendments; 3) In addition the OCD provides a centralized Marketing Communications and Recruitment Unit (MCRU): 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. From 2010-2015, our Community Outreach Program reached over 5000 individuals through over 450 meetings with providers, consumers, community members, 203 scientific seminars, and electronic mailing subscribers to reach local and national audiences. Social media efforts produced 23 products (Twitter Talks, webinars, podcasts); 4) Quality Assurance (QA) Program: QA efforts focus on compliance with regulatory requirements and Good Clinical Practice (GCP). The OCD coordinates a Data and Safety Monitoring Board (DSMB) that oversees several DIRP protocols; 5) Authorization of medical staff credentials: The OCD is responsible for vetting of all clinical personnel and is involved in maintaining competence of all health care professionals within the Institute. This includes oversight of the hospital credentialing process for all NIMH professional staff. In 2014, the OCD implemented an evaluation tool to supplement the hospital-required Ongoing Professional Practice Evaluation (OPPE) prior to renewal of credentials; 6) Allocation of CC resources: The OCD serves as the link between the hospital and the Institute. The OCD is responsible for the implementation of CC policies and standard operating procedures (SOPs). The OCD participates in annual CC budget planning meetings with the CC Director and coordinates hospital initiatives such as preparation for Joint Commission accreditation visits, annual flu shot compliance, etc. TRAINING AND EDUCATION: The NIMH OCD works in partnership with the NIMH Office of Fellowship Training (OFT) and the Office of Clinical Research and Training in Medical Education (OCRTME) to oversee and participate in several programs that: 1) provide research training for qualified physicians who intend to pursue scientific research careers; 2) allow advanced psychiatry residents to jump start their research training; and 3) educate medical students about clinical neuroscience research. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. Lastly, we develop, promote and organize scientific programs or curriculum materials that educate psychiatrists about recent advances in neuroscience research relating to serious mental illnesses. See OCD Training report MH ZIE-MH002939-03 for additional details. CONSULTATION LIAISON: The NIMH Psychiatry Consultation Liaison Service (PCLS) is a multidisciplinary team that provides clinical services to patients enrolled in clinical protocols at the NIH CC. The core PCLS team consists of psychiatrists, psychologists, neuropsychologists, social workers and psychosomatic medicine fellow trainees. PCLS consultants evaluate and manage patients in need of routine or emergency mental health assessments in adult and pediatric patients participating in clinical research. The PCLS Neuropsychology Consultation Service is responsible for providing (1) clinical neuropsychological evaluations to assist with diagnosis and treatment recommendations for patients enrolled in clinical research throughout the CC on a referral basis, and (2) formal neuropsychological evaluations for selected NIH protocols in order to assist with neurocognitive phenotyping of various disorders and conditions, or for the purposes of matching subject groups and assessing for change in cognition over time. PCLS consultants also provide education, training and outreach in the CC on the larger NIH-campus. PCLS consultants conduct clinical research through active collaborations with investigators from other NIH Institutes as well as with national and international research groups. See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-07 for additional details.