Office of the NINR Clinical Director

National Institute Of Nursing Research

Investigators

Abstract

1) Ensure safe and competent clinical and research care of research participants: Registered nurses, nurse practitioners, and trainees underwent appropriate training to be able to perform necessary clinical skills, and also had their competence evaluated for these skills (see also #2 below). The Clinical Director actively participated as a member and Chair of the Clinical Center Medical Executive Committee, which develops policies for standards of medical care and represents and acts for the clinical professionals in the Clinical Center. During NINR Trainee Orientation,the Clinical Director provided quarterly sessions on Clinical Care and Safety at the NIH. A staff member in the Clinical Director's office is designated as the NINR Patient Safety liaison, is a member of the Clinical Center Patient Safety and Clinical Quality Secretariat, is a member of the Clinical Center Falls Committee, and also attends daily Clinical Center safety huddles. The NINR Research Nurse/Safety & Quality Committee meets bimonthly to include focused safety huddles and review of any safety/quality trends. (2) Perform clinical competency assessment of staff and trainees: The Clinical Director's office continued to list and track appropriate competencies for registered nurses, nurse practitioners and trainees. Two nurse practitioners, four registered nurses, and one psychologist completed new or revised competencies and ten trainees completed competency assessments. (3) Liaison with the Clinical Center to perform professional credentialing of clinical providers: Working with the Clinical Center Office of Credentialing Services, five NINR licensed independent practitioners had their clinical privileges started, updated, or renewed. (4) Execute pre-IRB as well as ongoing protocol reviews: NINR and the Clinical Center Nursing Department have a combined Scientific Review Committee. Two new NINR protocols were submitted for pre-IRB Scientific Review during this report period. The Clinical Director reviews each protocol Amendment, Continuing Review, and Event Report before IRB submission and during the response to stipulations' process. (5) Implement and oversee the regulatory and quality management of protocols: All current protocols underwent a planned monitoring review, either internal or external, as per NINR policy. Activities of an external, contracted Clinical Research Organization (CRO) continue, and each NINR research team receives services of a protocol navigator from this contract. The NINR Quality Manager is an integral member of the NIH Clinical Center Quality Assurance Professional Advisory Committee. (6) Evaluate resource use for protocols: This was performed prior to the start of two new investigations to determine use of Clinical Center as well as NINR resources. (7) Participate in collaborations with other Institutes and Centers for shared resources: The NINR Medical Officer served as a member of the NIH IRB and also as a Lead Associate Investigator on a NINDS trial. The NINR statistician collaborated with the NINDS Clinical Trials Unit statisticians. Three support staff from the Clinical Director's office collaborated with NINDS staff on the development and implementation of a new protocol in NINDS. The Clinical Director's office collaborated with the Clinical Center Office of Research Support and Compliance for on-going follow-up on two Investigational New Drug applications.