The first determinant of review type is the risk of the project: you must decide if you think the project poses minimal risk to subjects, or greater than minimal risk. Minimal risk is defined as the following:
Minimal risk means 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 the risks of all research procedures do not meet this definition, your research should be considered greater than minimal risk, and you should click the following link for instructions on how to submit for Full Board review. If your research does meet this definition of minimal risk, proceed to 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:
- Research on standard educational methods or techniques
- Research using surveys, interviews, educational tests or observation of public behavior
- 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).
- Research endorsed by DHHS examining public benefit or service programs
- 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:
- 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.
- Blood draws of limited volume and frequency
- Collection of biological samples, where the collection methods are minimal risk
- Non-invasive procedures to collect data (specifically excludes radiation/X-rays)
- Use of data or records, or use of samples collected for purposes other than research
- Data collected by photograph, digital image, or digital recording
- 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.