Responsibilities of the Principal Investigator (PI)
- Applicability: This procedure defines the standards and parameters for conduct of the Principal Investigator (PI) in social and behavioral research and biomedical research. The PI is a full-time or adjunct GCU faculty member, a doctoral student or under the supervision of a GCU faculty member or an approved external researcher with the primary responsibility for the protection of human subjects and conduct of the research. The PI is ultimately responsible for those acting on his/her behalf even if any of the PI's responsibilities are delegated to members of a research team.
- Responsibilities:
- Ensures compliance with research protocols, and applicable federal, state, and local laws and regulations, GCU University policies, and IRB policies and procedures. Oversees the research process and is responsible for the conduct of co-investigators and/or research staff at all study sites.
- Ensures that informed consent is appropriately obtained from all subjects and that subjects are treated with respect and dignity.
- Completes all required human subjects protection training, and if applicable, HIPAA training, and ensures that co-investigators and key study personnel complete required training.
- Reviews all GCU IRB policies and procedures prior to conducting human subject’s research. Routinely reviews the GCU IRB Research Center for new or revised IRB forms, policies and procedures.
- Reviews scientific literature to ensure that protocol interventions are consistent with current research data and do not place subjects at risk.
- Ensures the adequacy of all submissions to the IRB including protocol applications and protocol amendments.
- Ensures compliance with the protocol's data and safety monitoring plan and reports adverse events to the GCU IRB, study sponsor, and appropriate federal agencies.
- Ensures the timely continuing review of protocols and the submission of all continuation applications before the protocol's expiration date. Reports protocol expirations promptly to the IRB.
- Submits proposed changes to the research in the form of protocol amendments to the IRB before the changes are implemented, except when such changes must be implemented immediately to ensure the health and well-being of research subjects.
- Responsible for the protection of subjects' privacy and confidentiality according to applicable HIPAA and FERPA policies, GCU policies, and IRB policies and procedures.
- Maintains all study-related documentation in accordance with GCU policies, IRB policies, and federal regulations.
DEPARTMENT: Office of Academic Research
PROCEDURE NUMBER: 1.2
SECTION: IRB 1.0 General Policies for Human Subjects Protections
REVIEW RESPONSIBILITY: IRB Director
ORIGINAL CREATION DATE: December 19, 2010
APPROVAL DATE: February 2, 2011
REVISION DATES:
Adapted with permission from Yale University, Office of Research Administration and Human Research Protection Program, Research Affiliates Policies (2011).