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 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 Vice-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 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 and is a member of the Clinical Center Patient Safety and Clinical Quality Secretariat and also attended daily Clinical Center safety huddles. This staff member attended an outside course from the Maryland Patient Safety Center on Six Sigma Green Belt Certification. The Research Nurse committee was combined with the NINR Safety and Quality Committee to streamline and highlight patient safety efforts with the appropriate research staff personnel. (2) Perform clinical competency assessment of staff and trainees: The Clinical Director's office continued to list and track appropriate competencies for registered nurses and trainees. Four registered nurses completed new or revised competencies and ten trainees completed competency assessments. The tracking process is currently being automated from a manual paper process to a digital storage process. (3) Liaison with the Clinical Center to perform professional credentialing of clinical providers: Working with the Clinical Center Office of Credentialing Services, four 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 developed a combined Scientific Review Committee that met monthly. Four new NINR protocols were submitted for pre-IRB scientific review during this report period. The Clinical Director reviews each protocol Amendment and Continuing Review 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, per NINR policy. One Investigational New Drug (IND) protocol underwent FDA monitoring and a close-out monitoring visit by an external monitor. The Clinical Director's office coordinated and tracked all mandatory training for Event Reporting. The Clinical Director's office coordinated all meetings of an investigator's Independent Monitoring Committee. Activities of an external, contracted Clinical Research Organization (CRO) began, and each NINR research team received services of a protocol navigator from this contract. (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 Clinical Director actively participated in meetings for the following resources: Clinical Neuroscience IRB and the Protocol Tracking and Management System. The NINR Medical Officer served as a member of the Clinical Neuroscience IRB. The NINR statistician collaborated with the NINDS Clinical Trials Unit statisticians. Staff from the Clinical Director's office directed and collaborated with NINDS staff on the implementation of a new protocol. Investigators on an NINR protocol requiring a Data and Safety Monitoring Committee (DSMB) collaborated with the NIMH for use of this service. The Clinical Director's office collaborated with the Clinical Center Office of Research Support and Compliance to develop a process for shared IND follow-up.