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Step 3

Decide Whether to Submit for Exempt, Expedited, or Full Board Review


​Now that you have determined that your project is human subject research and requires COMIRB review, you must decide if you should submit for Exempt determination, Expedited review, or Full Board review, as the forms to fill out differ somewhat between these submission types. The text below will guide you through the process of deciding how to choose your submission type; you may also wish to use the decision trees from OHRP in determining if Exempt initial review or Expedited initial review is possible.
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Step 1 
Step 2

If your research does pose minimal risk to subjects, according to this definition, you will need to decide between Exempt and Expedited review.  Please note that if an Expedited reviewer does not agree with your assessment of risk, if you are enrolling prisoners, or if you are performing certain types of drug or device research, your protocol may still be deferred to full board for review, even if it is ultimately determined to be minimal risk.

1. Exempt research: Research that is exempt from the federal regulations tends to be ultra-low risk to lacking risk because of the way it is carried out or the subject matter that is being researched.  To qualify for Exemption, all procedures must fit into one the Exempt categories.  Look at the list below, and if you think your research might be Exempt, please read over the details and limitations of the appropriate Exempt category/categories before proceeding:

  1. Research on standard educational methods or techniques
  2. Research using surveys, interviews, educational tests or observation of public behavior
  3. Use of data, records, or documents that are already in existence at the time of research application. Note that COMIRB does not currently recognize Exempt research using existing biological specimens; the research may be non-human subject research (if the samples are anonymous upon receipt by the investigator from someone not involved in the collection of the samples) or Expedited (if the samples are potentially identifiable to the investigator).
  4. Research endorsed by DHHS examining public benefit or service programs
  5. Food taste/quality/consumer acceptance studies

After reviewing the details of these categories, if you think your research qualifies for Exemption, click the following link for directions on applying for Exempt determination.

2. Expedited research: Research eligible for Expedited review must be minimal risk and all research procedures must fit into at least one the seven Expedited categories.  Look at the list below, and if you think your research might be eligible for Expedited review, please read over the details and limitations​ of the appropriate Expedited category/categories before proceeding:

  1. Research of drugs that does not require an IND, or research of devices that does not require an IDE issued by the FDA.  Note that it is difficult to be giving drugs to subjects and have the risk still be minimal.
  2. Blood draws of limited volume and frequency
  3. Collection of biological samples, where the collection methods are minimal risk
  4. Non-invasive procedures to collect data (specifically excludes radiation/X-rays)
  5. Use of data or records, or use of samples collected for purposes other than research
  6. Data collected by photograph, digital image, or digital recording
  7. Use of questionnaires, interviews, psychological tests, or educational tests

After reviewing the details of these categories, if you think your research qualifies for Expedited review, click the following link for directions on applying for Expedited review​.

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