Making Submissions

Principal Investigators (PI) submit an electronic copy IRB Protocol Submission Form and related documents with all required signatures, including:

  • PI and co-investigator (if applicable);
  • Faculty Advisor (if the PI is a student)

See instructions for sending the Protocol Submission Form and related documents/forms:

Complete instructions (link) for making submissions to the IRB. Please read carefully; requests that do not follow instructions will be returned without review.

IRB Process

The Review Process

Administrative Review

The purpose of the administrative review is to identify issues that are either incomplete or unclear, thereby preventing or delaying approval by the IRB. Once issues are identified, the PI must respond to and/or revise the protocol before it can be referred on for IRB review.

A protocol will be considered complete and accepted for review if it meets all the following criteria:

  • the protocol and all related documents and materials for participants;
  • the protocol provides a clear and complete explanation of the procedures to be used in the research;
  • any materials for an award for externally sponsored research; and
  • Training completion certificates for the PI and all research personnel.

Protocols that require extensive revision or are missing a significant amount of information will take longer to review.

IRB Review

Exempt Determinations

The Common Rule specifies the categories of research that are exempt from the human subjects protection regulatory requirements “Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule. For more information see the IRB manual.

Expedited Reviews

Applications are accepted and reviewed as they are received. The Common Rule specifies conditions under which research may be reviewed by the IRB under expedited review procedures (review by a single member). The standard requirements for study approval, including informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited review or full board review--utilized by the IRB.

Full Board Review

Protocols accepted for review which require full committee review are placed on the agenda of the next scheduled meeting.

The PI will receive an email from the RCA indicating the date of the meeting at which their protocol will be reviewed. PIs may be invited to the meeting to address any IRB questions or concerns.

After IRB Approval or Determination of Exemption

Principal Investigators will need to ensure any and all other approvals (such as an approval from the research site) which are needed are obtained before starting participant recruitment. Principal Investigators also need to ensure they maintain their responsibilities to the IRB