NHGRI/DIR Clinical Support Services

National Human Genome Research Institute

Investigators

Linked publications & trials

Abstract

The NHGRI Office of the Clinical Director manages Clinical Support Services for Genetics and Genomics in a variety of ways. 1. The Office provides extensive administrative support for medical personnel in their performance of clinical research (all of which is conducted through independently IRB-approved research protocols that are managed through different clinically-oriented PIs and research groups) into rare and other genetic diseases and health conditions. This includes credentialing of health care professionals, support of their state licenses, provision of parking spaces for acute care providers, scheduling and logistic management of patients and their tests, arranging contracts for clinical testing, and providing reimbursement for travel, outside medical testing, and especially genetic testing. 2. The Office also provides academic support and infrastructure for clinical investigators, including the setting of policies for the Institute, assisting in patient recruitment, handling patient, physician, and Congressional inquiries by phone, FAX, or e-mail, providing advice regarding clinical protocol writing, tracking protocols through the Institutional Review Board (IRB) approval system, managing monitoring of the Institute's clinical protocols, establishing and supporting a Data Safety and Monitoring Board and arranging its regular meetings according with NIH and study requirements, and creating and maintaining a Statistical Consultation Service for the entire Institute. The Clinical Director also supervises the administrative personnel as well as research nurses and nurse practitioners for the Institute, and schedules consultation coverage with trainees, genetic counselors, and attending physicians. The Clinical Director provides financial and administrative supervision of the Bioethics Core and the IRB, and the Scientific Review Committee (SRC) operates out of the OCD. The SRC reviews clinical protocols for scientific merit as one component of protocol management involved in the overall IRB submission and approval process. The NHGRI IRB recently became part of the NIH-wide Medicine I IRB, with transfer of the data system from PTMS to IRIS. 3. The NHGRI Clinical Director supports the Clinical Center by contributing to the hospital's policy formation and implementation, participating in biweekly meetings of the Medical Executive Committee, and representing the Clinical Center to distinguished visitors. Each Monday, members of the OCD conduct paper rounds of NHGRI patients seen in the past week and scheduled for the coming week (during the COVID-19 pandemic, these rounds have been conducted "virtually," and have included best practices during the pandemic. The NHGRI OCD attends daily morning Clinical Center rounds to ensure awareness of daily clinical activities and developments. 4. The NHGRI OCD manages the Institute's recent initiatives regarding patient safety, protocol monitoring, event reporting, and data management. This past year, as part of a larger contracting process, the OCD renewed contracts for clinical database data entry support, protocol monitoring, and handling of IND correspondence with the FDA (as well as separate statistical support). The OCD also sets policies and manages the assignment of Staff Clinicians to the status of either Assistant, Associate, or Senior Staff Clinician. The OCD verified adverse event training for the entire NHGRI clinical staff, and the Clinical Director makes regular reports to the NHGRI Director and Scientific Director. 5. The Office of the Clinical Director oversees the NHGRI Residency and Fellowship training programs, which includes clinical and laboratory-based trainees undergoing ACGME-accredited training in clinical, biochemical, and laboratory genetics and genomics, as well as programs that are combined with other disciplines, such as pediatrics/genetics and REI/genetics. These trainees train at the NIH as well as multiple other healthcare, laboratory, and research facilities in the area, and require educational and clinical/regulatory oversight. Dr. Cynthia Tifft serves as the interim Training Director while a formal search is underway; it is anticipated that a permanent Training Director will be identified and hired during the next fiscal year. 6. The OCD provides some administrative support to the NIH UDP, headed by Dr. William Gahl (Senior Investigator, NHGRI), along with Dr. Cynthia Tifft (Deputy, Clinical Director, NHGRI) and Dr. David Adams (Staff Clinician and Deputy Director, Clinical Genomics, NHGRI) and also to the Unit on Glycosphingolipid Storage Disorders, headed by Dr. Cynthia Tifft (Deputy Clinical Director, NHGRI) and the Medical Genomics Unit, headed by Dr. Benjamin Solomon (Clinical Director, NHGRI). The scientific accomplishments of those entities are presented in separate Annual Reports. The OCD also helps provide ad-hoc, flexible administrative support to other research sections and units as needed and per request by the study investigators and staff.