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Step 2: Do I qualify for Exempt review?


Now that you have determined that your study meets the definition of "human subject research" as defined in Step 1, you must submit for COMIRB review. You must also decide which type of review is most appropriate.

The potential level of risk to the subjects of a study determines the level of oversight by COMIRB. The three levels of oversight defined in federal regulation 45 CFR 46  are determined by the relative risk of the study to subjects. These levels of oversight are: Exempt review, Expedited review, and Full Board review.

Studies that are of "minimal risk" to subjects as defined in the federal regulations can be exempted all together from the federal rules governing "human subject research", provided that they fall into one of the 5 "Exempt Categories" outlined in the federal regulations. COMIRB must grant the exemption; investigators cannot exempt their own research.

Other studies that are considered "minimal risk", but do not qualify for one of the 5 "Exempt Categories", are subject to the federal rules governing "human subject research".

If your study does not qualify for an exemption from federal regulations, it may qualify for Expedited review provided that it fits into one of 7 "Expedited Categories".  You will learn more about Expedited reviews in Step 3. All research that is considered more than "minimal risk" must be reviewed by a Full Board panel. You will learn about Full Board reviews in Step 4. 


 The accordion folders below will help you determine if your study is "minimal risk", and if your study falls into any of the 5 "Exempt Categories". 

 

Please be aware that there are limitations to Exempt review if your study includes potentially vulnerable populations whose status may create additional risk for study participation, including children and prisoners. *Studies involving prisoners cannot qualify for an exemption.

 
Is my study "minimal risk"?

Definition of "minimal risk":

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.

If your study does not meet the definition of "minimal risk", than it must be submitted for Full Board review. Please be aware that your interpretation of "minimal risk" may not be the same as our Panel members. We recommend that you continue to review the "Exempt Categories" provided in the next accordion folder, and review the "Expedited Categories" included in Step 3, before proceeding to the Full Board review submission instructions provided in Step 4.

If your study does meet the definition of "minimal risk", proceed to the next accordion folder to determine if your study is eligible for Exempt review based upon the 5 "Exempt Categories" outlined in the federal regulations.

Does my study fit into one of the 5 "Exempt Categories"?

The following link includes a document the outlines the limitations on Exempt Categories, and the 5 Exempt Categories. The document also provides some guidance as to examples of studies that would fit into each category: Exempt Review Criteria.

Further Available Resources:

If you are unsure whether or not your study qualifies for an exemption. This decision tree from the Office of Human Research Protection may be helpful. Please call the COMIRB Help Line at 303-724-1055 with any questions.

Next Steps:

If you have determined that your study is eligible for an exemption, given the limitations listed in the document above for vulnerable populations, proceed to the submission instructions below.

If you have determined that your study is not eligible for an exemption please proceed to Step 3 by scrolling to the top of this page and clicking the link in the grey column to the left of the page.

Further guidance for Exempt Category 4 (recording data in a way that is de-identified)

Am I recording data in a way that is de-identified?

After reviewing the Exempt Review Criteria in the accordion folder above, a common question that arises is whether or not an investigator is properly recording identifiable data in a way that is de-identified so as to qualify for an exemption. Please note that if the investigator receives data that has already been properly de-identified, this data is not considered to involve a "human subject".

The 2 criteria COMIRB uses to determine if data recorded by the investigator is de-identified are:

1. Data becomes identifiable when one or more data elements can be combined with other reasonably available information to identify the person. Identifying information may be linked to specific individuals either directly or indirectly through coding systems. The size of the subject population can often be an important factor in determining if specific pieces of information would identify an individual (i.e. a smaller subject population would make it easier to identify an individual with less information).

2. COMIRB has determined that data is usually identifiable if the investigator records any of the 18 identifiers listed in the Health Information Portability and Accountability Act (HIPAA) Important: Even though HIPAA only applies to Protected Health Information, COMIRB uses the same 18 identifiers and de-identification standards to determine if any data, regardless of the type of data, has been identified.

(The first section entitled "De-identifying Protected Health Information Under the Privacy Rule" at the following link outlines the standards by which COMIRB considers all data to be de-identified. The following page also includes other information about the use of Protected Health Information that is not relevant to determining if data has been de- identified. Please click here and review the first section of the following page.)

Exempt review submission instructions

Select the appropriate instructions below for information on how to proceed:

My study is not eligible for one of the 5 "Exempt Categories" listed in the accordion folder above:

Please proceed to Step 3 to determine what type of COMIRB review is appropriate by scrolling to the top of the page and clicking the link in the grey column on the left side of the page.

I believe my study qualifies for one of the 5 "Exempt Categories" listed in the accordion folder above:

Click here for an Initial Submission Checklist and Submission Instructions.

There is currently no fee for Exempt reviews. Exempt applications are reviewed on a continual basis, in the order they are received. The investigator will be notified of the review findings by email. Research may not begin until the investigator has received notification from COMIRB that the research qualifies for exemption. If the research involves the VA, the project may not begin until it is approved by COMIRB and then the VA R&D Committee.

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