IRB Submission Package

The IRB submission package (including the IRB Review Form and supporting materials) is designed to collect information the IRB needs to determine the level of review required and the disposition of your proposed activity.

If your activity falls into either the expedited or full board review category (see IRB Decision Tree), in order to approve your study, the IRB must determine that:

the risks to participants are minimized
the risks are reasonable in relation to any anticipated benefits to the participant and to the advancement of knowledge
the selection of participants is equitable
if applicable, informed consent will be sought and documented
there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data
where any of the participants are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect participants
if applicable, appropriate site permission is secured
if applicable, IRB approval from collaborating site is secured

The following sections provide information that will assist you with your IRB Review Form and your supporting documents, reducing the likelihood that the IRB will request additional information or modifications.