Who Approves Affected Activities?

IRB Application

In general, you will submit an application that includes sufficient information regarding the research study to an appropriate IRB for review. Each IRB has its own tailored application form, and you are advised to contact the relevant IRB about the review process and the forms you will need to complete.

For example, an IRB application may include the following types of forms:

• Request for IRB Action Form. By submitting this form, you are formally requesting a date for the research review. It is your responsibility to request a review date that allows sufficient time for review and approval before you conduct research involving human subjects. Check with your IRB for its submission deadlines.
• Protocol Review Form. This form provides the IRB with relevant information such as the objectives of the research study, procedures for obtaining consent, procedures for maintaining confidentiality, and the potential risk to human subjects. Make sure you submit supporting documentation with the form, including consent forms; relevant sections from grant applications or contract proposals; letters, advertisements, and other materials used to recruit potential subjects; information packets about the research that are distributed to its subjects; and full protocols, questionnaires, and other data collection forms.

The forms included in appendix B (PDF 101 KB) are samples only. Obtain the forms and supporting documentation that you will need to include in your application from your IRB.