Certain research activities involving human subjects qualify for an expedited review process.

The decision to approve projects submitted for expedited review will be made by the Chair of the IRB, or his/her designee, and two additional member of the review board.

Projects submitted for expedited review that are not recommended for the expedited process will be submitted to the IRB for a full review.

Research Projects that have already been reviewed and approved by the IRB of another institution or agency to undergo expedited review.

If the project has been reviewed and approved by another IRB and/or all activities involve no more than minimal risk to human subjects in one or more of the qualifying categories,
then the investigator should submit the protocol for expedited review.

Research Projects that involve only minor changes in previously approved research, where the changes occur during the approved project period, to undergo expedited review.
Where the project has NOT been reviewed by another IRB and/or all activities DO involve more than minimal risk to human subjects in one or more of the qualifying categories, however, the project must be submitted to the IRB for full board review.

According to the IRB Manual there are two levels of IRB evaluation that a research study may undergo, depending on the level of risk to human subjects. These levels are:

1.Full Board (convened) review and,
2.Expedited and Exempt IRB review.

A.Therapeutic and non-therapeutic studies, in addition to research studies that involve greater than minimal risk for human subjects this includes:

Some research involving children or other vulnerable populations.
Research that involves experimental drugs or devices.
Research that involves invasive procedures, for example blood donation.
Some survey research.
Or interviews that involve sensitive questions, information about HIV, or result in stress for human subjects.
Research studies requesting waiver of consent.

B.Research studies that might require a frequent review which has to be done at least annually.

Type of Research Qualifying for Expedited Review:

In research studies qualifying for expedited review, human subjects incur no more than minimal risk. Special abbreviated consent form formats are available for tissue collections that meet criteria for expedited review.
Research activities that may qualify for expedited review are:

1. Certain kinds of research on drugs and devices;
2. Collecting blood by stick or venipuncture with limits for age, health status; etc.
3. The prospective collection of specimens for research purposes by non- invasive means;
4. Data collected through non-invasive means(not involving general anaesthesia or sedation) routinely employed in clinical practice, excluding X-rays and microwaves;
5. Materials that have been collected solely for non-research purposes;
6. Voice, video, digital or image recording made for research purposes;
7. Research on individual or group characteristics or behaviour or research employing survey, interview, oral history, focus group, program or human services evaluation, and quality assurance methodologies.
Note: The level of evaluation can only be determined by the IRB, in accordance with Clinical Research guidelines. Even if an investigator believes a study is exempt, no research should begin until the IRB reviews the protocol and makes the final determination.
All research studies require full (convened) Board review and approval.
An Exempt is defined as being exempt from further review and approval beyond the IRB Chairman or Co-Chair. It doesn't mean that your proposed research is exempt from being reviewed.