New Study Application
A new study application is used for any study that is being considered for initial review and approval.
Defining human subjects research
Human subject research is defined by the Office of Human Research Protections in 45 CFR 46.102. A clinical investigation is defined by the Food and Drug Administration in 21 CFR 50.3(c). Research that meets either of these definitions must be reviewed by URochester IRB.
Only OHSP and URochester IRB have the authority to determine whether the research URochester faculty, staff, and students are conducting is considered human subject research. Individual investigators cannot make human subject research determinations on their own.
New Study Application Requirements
Investigators applying for any initial approval of a proposed research protocol must submit a completed New Study Application form. The form is submitted via the Click IRB system.
Consent documents, recruitment materials, questionnaires/surveys, interview scripts, and other documents that may be required for review are uploaded as part of the application in Click IRB.
The Principal Investigator is responsible for the overall conduct of the research, including submission of the IRB application. While individual tasks, such as completing the application forms, may be delegated to research team members, the information submitted is the responsibility of the PI.