The sponsoring agency wants to see that the study has IRB approval prior to releasing funds, but I haven't finished developing my study yet. What should I do?
Approval in Principle is granted to satisfy sponsoring agency requirements or to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects. Funds may not be used to conduct research with human subjects until a study-specific protocol has been reviewed and approved.
Under the federal regulations (§46.118) and in accordance with the OSU IRB’s Standard Operating Procedures, certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.
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 subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
These applications need not be reviewed by an IRB before an award may be made. However, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB.