With the increasing demand for research opportunities, Lahey Hospital & Medical Center realized the inherent need to create one centralized office comprised of professional medical staff solely dedicated to clinical trials. In 1994, The Office of Research Administration (ORA) was established. The ORA continues expansion into widening areas of medical research.
STAFF & SERVICES
Lahey’s ORA serves as a central resource to encourage, facilitate, support and oversee research with expert staff dedicated to ensuring compliance with federal regulations, sponsor requirements, and clinic policies. ORA works closely with Lahey Clinic Inc.’s Institutional Review Board (IRB) to review and monitor any human subject research taking place at Lahey Hospital & Medical Center.
Research Administration is comprised of a diverse group of experienced administrative and clinical professionals consisting of:
- Research Director
- IRB coordinators
- Agenda coordinators
- Research study coordinators
- Clinical research associates
- Clinical research specialists
- Research administrative assistants
- Quality Analysts
- Financial analysts
To learn more about the roles and ORA staff, click here.
Investigators, study coordinators, clinical research associates and regulatory associates attend comprehensive training. Training involves review of proper management of clinical studies, Good Clinical Practice (GCP's), participant safety, maintenance of study data, regulatory forms, completion of case report forms (CRF's) and research quality assurance. All investigators and research staff participating in clinical trials must complete a research study session that includes Lahey-sponsored education and the CITI Research program with certification renewals every three years. Staff is encouraged to attend workshops and training as part of continual education
INSTITUTIONAL REVIEW BOARD (IRB)
Lahey Clinic Inc.’s Institutional Review Board (IRB) reviews and monitors any research taking place at Lahey Hospital & Medical Center that involves human subjects.
The primary responsibility of the IRB is to protect the rights and welfare of research subjects. The IRB follows rules that are defined in the United States Code of Federal Regulations.
The Lahey Clinic, Inc. IRB is composed of a diverse combination of Lahey Hospital & Medical Center colleagues together with lay members from the community. The board meets as a full committee on the second Wednesday of each month. At these meetings, the committee reviews applications that require Full Board Review. For time-sensitive protocol reviews, a Secondary IRB will meet within 10 working days at the request of an investigator. Some submissions qualify for review by a single IRB member, through an expedited process; these submissions are reviewed on a weekly basis.
In 2013 Lahey Clinic, Inc. IRB implemented the use of IRBNet for all IRB correspondence.
If you have questions about the Lahey Clinic, Inc. IRB or about your rights as a research subject, please contact the Office of Research Administration at (781) 744-8027.
For more information on Research Administration and complete services provided, please contact the Director of Research Administration, Antonia Holway, PhD at Antonia.H.Holway@Lahey.org