If you have questions at any point in the submission or approval process, contact the HSP Office.

A study may be closed when all of the following apply: All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing). All subject specimens, records, or data have been obtained (no further collection of data/information from or about living individuals will be obtained). No further contact with subjects is necessary (all …read more

Any active study is subject to a post-approval review via our post-monitoring program (PMP). The purpose of the PMP is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and …read more

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to protect identifiable, sensitive information participant information collected in the course of a research study. Identifiable, sensitive information is defined as information that is about an individual and that is gathered or used during the course of research where the following may …read more

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All IRB initial applications must include a detailed plan for how participants will be identified and recruited. All activities and materials must be non-coercive and the potential subjects must voluntarily participate in the recruitment process. Therefore, the Institutional Review Board (IRB) must approve the recruitment plan and all materials (flyers, email solicitations, advertisements, brochures, letters, …read more

The Principal Investigator The Principal Investigator (PI) is the primary individual responsible for the ethical design and conduct of a research study including the supervision of co-investigators and study personnel. While the PI may delegate tasks to members of their research team, they remain ultimately responsible to ensure all research activities are designed and carried …read more

Once approved, any changes to the protocol (regardless of the scope of the change) may not be implemented by the research team until they have been reviewed and approved by the HSP Office.

Review The Level of review an application receives is based on the risk assessment conducted during the pre-review process. The levels of review are outlined below. Plan ahead:  It is important that you have all required supporting documents in place before you submit your application so as not to delay the review process. Some documents …read more