Geisinger Commonwealth Research Compliance
The Office of Research Compliance is dedicated to maintaining the high ethical standards of research and education at Geisinger Commonwealth School of Medicine. It is responsible for the development and implementation of Geisinger Commonwealth policies in compliance with federal, state and local regulations.
Geisinger Commonwealth is committed to providing a safe and healthful environment. Among its highest priorities are the health and safety of all faculty, staff and students, the visiting public and members of the neighboring community.
Office of Research Compliance responsibilities
Review and approval of project proposals and applicable forms by the Geisinger Commonwealth Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), the Radiation Safety Committee and the Wright Center Institutional Review Board (IRB) are mandatory. Research Compliance is the coordinating office for committees overseeing the federally mandated areas of responsible conduct of research.
Projects subject to any of these requirements will not be authorized to start without such approvals. The Office of Research Compliance provides support to maintain ongoing post approval monitoring and protocol expiry notices.
Animal Resource Program
The Animal Resource Program (ARP) and the Institutional Animal Care and Use Committee (IACUC) are responsible for the care and well-being of laboratory animals at Geisinger Commonwealth School of Medicine. The goal of ARP is to support the continued growth in the development of biomedical research by providing state-of-the-art animal facilities and husbandry, proper veterinary care and assurance that all procedures involving animals are successfully performed and monitored. The ARP and the IACUC at Geisinger Commonwealth assist researchers with the tasks needed to be successful in initiating and conducting animal research.
The following activities are handled by IACUC:
- Review all protocols for approval.
- Process all animal use protocol paperwork.
- Maintain training records for principal investigators and technicians.
- Assist researchers with meeting regulatory requirements.
The IACUC is a standing committee that oversees and evaluates all aspects of the institution’s animal care and use program. The committee’s composition and responsibilities are mandated by the Animal Welfare Act (Public Law 99-198).
Human subjects research and IRB
Geisinger Commonwealth has a Federal Wide Assurance, FWA # 00012586 that designates the Wright Center for Graduate Medical Education (WCGME) IRB as the college’s IRB of record.
Research using human subjects must receive review, sign off and be sent by Geisinger Commonwealth Office of Research Compliance for IRB submission.
Environmental health and safety
The Environmental Health and Safety Committee (EHS) has multiple subcommittees developed to review protocols applicable to the safety from hazards that pose risks to the research staff and the community. The EHS subcommittees are described below:
- Chemical: Addresses safety issues associated with the storage, use and waste management of all chemicals and reagents
- Biosafety: Addresses safety issues associated with microbial pathogens, viruses, rDNA and animal research. This subcommittee acts as the institutional biosafety committee (IBC)
- Bloodborne Pathogen: Addresses safety issues associated with bloodborne pathogens specifically to identify the technical operations regarding human subjects research
- Radiation: Addresses safety issues associated with research using radioactive materials
Training and auditing program