Review Type
Before starting an eProtocol application, investigators
must identify the appropriate Review
Type. This determines which questions are prompted for on the application.
Expedited review is for minimal risk* studies meeting specific criteria. Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.
Exempt status is for minimal risk studies meeting specific criteria. These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.
Regular review is for protocols that involve more than minimal risk or do
not meet the criteria for Exempt or Expedited. They are reviewed at a
convened IRB meeting. Examples of protocols requiring initial regular
review are studies using FDA investigational test
articles, randomized double-blind placebo-controlled studies, Phase
I, II, III and IV clinical trials, and studies using x-rays.
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Once the review type has
been identified, an eProtocol application can be submitted. A protocol application consists of:
- Personnel information
- General protocol information (subject population, procedures, etc.)
- Responses to questions on the application
- Attachments as applicable: Consent and assent form(s), other documents.
To help prepare an application, text-only samples are available:
