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). Four licensed independent practitioners updated their clinical privileges to be able to care for research subjects receiving Conscious Sedation for a new protocol. No untoward clinical events, related to practitioner practice, occurred on any protocol during this report period. The Clinical Director also actively participated as a member 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. (2) Perform clinical competency assessment of staff and trainees: A new program was developed and implemented to list and track appropriate competencies for registered nurses and trainees. Four registered nurses and 14 trainees completed competency assessment. (3) Liaison with the Clinical Center to perform professional credentialing of clinical providers: An NINR system was developed to list and track credentialing items and renewal dates. Working with the Clinical Center Office of Credentialing Services, seven NINR licensed independent practitioners had their clinical privileges renewed or updated. (4) Execute pre-IRB as well as ongoing protocol reviews: No new protocol was submitted for pre-IRB scientific review during this report period. The NINR Medical Officer and Clinical Director met with each NINR Principal Investigator during this report period to evaluate protocol recruitment and accrual, and address any protocol-related questions. (5) Implement and oversee the regulatory and quality management of protocols: A system was developed to perform annual audits on all NINR protocols, according to the NINR Data and Safety Management policy. Contract resources were acquired and used to do this. All current protocols were audited per policy. Plans were established to expand the NINR Quality Management Program and add an NIH employee for this service in the next fiscal year. (6) Evaluate resource use for protocols: This was performed prior to the start of new protocols to determine use of Clinical Center as well as NINR resources. It was also done on an on-going basis when the Medical Officer and Clinical Director did annual protocol reviews with Principal Investigators (see also #4). (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 Director served as a member of the Clinical Neuroscience IRB.