Geisinger Commonwealth Research Compliance
Research Compliance is dedicated to maintaining the high ethical standards of research and education at Geisinger Commonwealth School of Medicine (GCSOM). 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.
Research Compliance responsibilities
Review and approval of project proposals and applicable forms by the Institutional Biosafety Committee (IBC) and the Geisinger Institutional Review Board (IRB) are mandatory. Research Compliance is the coordinating office for committees overseeing the federally mandated areas of responsible conduct of research.
All faculty and student research projects require a GCSOM Research Approval Number (RAN) prior to commencement. To obtain a RAN, please contact Laura Mayeski, manager of Research Compliance, and provide the name of the mentor/PI, the title of the project and the names of everyone involved in the project. CITI training for everyone listed on the research project must be current and up-to-date.
Projects subject to any of these requirements will not be authorized to start without such approvals. Research Compliance provides support to maintain ongoing post approval monitoring and protocol expiry notices.
Human subjects research and IRB
Geisinger Commonwealth has a Federal Wide Assurance, FWA #00000063 that designates the Geisinger IRB (IRB00008345) as the medical school’s IRB of record. Geisinger IRB and contact information: firstname.lastname@example.org or 570-271-8663.
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
Training and auditing program
- Semiannual policy and procedure review
- Maintain laboratory compliance
- Facilitate educational support utilizing training programs for faculty, students and staff on the Geisinger Commonwealth portal training page and specified modules on the CITI Program website