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 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 a session on Clinical Care and Safety at the NIH. A staff member was designated as the NINR Safety Liaison and participated in the Clinical Center Safety and Clinical Quality Committee as well as attended daily Clinical Center safety huddles. An NINR committee was established for Safety and Quality. Two nurse practitioners were hired to assist investigators with clinical care of subjects, and a statistician was contracted to provide competent consultation on research statistical plans. (2) Perform clinical competency assessment of staff and trainees: Clinical Competency assessment continued to list and track appropriate competencies for registered nurses and trainees. One registered nurse and four trainees completed competency assessments. (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, six NINR licensed independent practitioners had their clinical privileges started or renewed. (4) Execute pre-IRB as well as ongoing protocol reviews: Two new protocols and one new protocol amendment were submitted for pre-IRB scientific review during this report period. The NINR Medical Officer and Clinical Director met with NINR Principal Investigators 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: All current protocols were audited per NINR policy, and two protocols were audited as part of the NIH-wide quality improvement audit review. The Clinical Director's office coordinated and tracked all mandatory training for Event Reporting and for preparation for the accreditation visit from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The Clinical Director's office coordinated all meetings of an investigator's Independent Monitoring Committee. An individual was contracted to the Clinical Director's office to provide protocol navigation support to an NINR clinical trial that is evaluating an Investigational New Drug (IND). A contract was developed, bidders were evaluated and one organization was chosen to provide protocol management support for NINR protocols. (6) Evaluate resource use for protocols: This was performed prior to the start of two 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 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 collaborated with NINDS staff on the implementation of a new protocol.