SOP 009: Approval in Principle

Purpose

This SOP outlines the WVU IRB process for applications and proposals lacking definite plans for the involvement of human participants.

Overview

1. Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that human participants may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.
2. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human participants’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
3. Except for research waived under 45 CFR 46.101(i) or exempted under 45 CFR 46.104, no human participants may be involved in any research project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution (WVU OHRP or WVU PI), to the Federal department or agency component supporting the research.

References

Federal Regulations:
45 CFR 46.118