Exempt Review

Certain broad categories of research projects that involve human participants may be exempt from full IRB review and may qualify for "exempt" review. Please examine the Exempt Category Example Chart to determine if the research fits into one or more of the exempt categories.  If the research does not fit into one of the categories, it may not be considered "research" (as defined by the federal regulations) or it will require review via expedited review.

The study procedures must fit into the review categories described in the below Exemption Certificate Application and be subsequently be approved by the IRB Chair. The IRB reserves the right to deny exemption requests whenever there is a concern for the welfare of human subjects. Ongoing review is not required once a determination of exemption is made, unless the research is changed so that it no longer meets the exemption criteria.

Using the consent process in exempt review

Although a study is granted an exemption from IRB review, investigators are ethically bound to follow the principles listed in the Belmont Report, particularly the first principle, respect for persons, which emphasizes the importance of ensuring that subjects are fully informed about the nature of a research project in order to make an informed decision to participate. The use of a signed consent document, for example in cases of anonymous data collection, would not be required, but those participants must be informed about the purpose of the study. An investigator will provide a participant an IRB approved information sheet or use an oral consent script explaining the purpose of the study, how the data will used, how the data will be kept anonymous, etc. Please consult the Consent and Assent Gudielines page and then view the Consent Template page to choose the appropriate format to informing participants about a study.

Please contact the Human and Animal Protections Research Office (HARPO@umbc.edu) to answer any questions.

The following are instructions for preparing an application for Exempt Review:

1) Complete the Collaborative Institutional Training Initiative (CITI) training program

2) Complete the Exemption Certificate Application. Be sure to follow all instructions on the forms and inlcude the applicable consent documents

3) Electronically submit the protocol and any accompanying documents to irbsubmissions@umbc.edu. The Human and Animal Protections Research Office prefer applications submitted in MS Word format, but Adobe Acrobat versions will be accepted also. Please do not submit “hard-copy” or paper documents.

Student investigators performing independent research or conducting senior theses, master's projects and doctoral dissertation research - please review the application and review information found here.

Please be sure to include the applicable pages with the signature of the investigators. A scanned version as a PDF document is acceptable. If that's not possible, fax that page (and that page only) to the Human and Animal Protections Research Office at (410) 455-3868. Protocol applications will not be processed until this face page is received. Copies of approval documentation from collaborating institutions, which must accompany the protocol submission, may be faxed if electronic versions are not available.

Applications for exempt review may be submitted at any time to the Human and Animal Protections Research Office preferably two (2) weeks before an investigator intends to begin a project. This will allow sufficient time for the review and approval process to take place.

Investigators will be notified of the IRB's decision of approval approximately one week following submission.

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Didn’t find what you needed? Contact the HARPO staff at 410-455-2737, HARPO@umbc.edu or Instant Message to AIM Screen name HARPO246