Certain broad categories of research projects that involve human participants may be exempt from IRB review and may qualify for “exempt” review. These levels of review are based on the level of risk to participants. If the research does not fit into one of the federally defined exempt categories, it may not be considered “research” (as defined by the federal regulations and needing IRB review) or it will require expedited review.
Exempt Study Categories
UMBC uses the below categories for review; approval is provided by the IRB Chair. The IRB reserves the right to deny exemption requests whenever risks are identified that go above “minimal” or there is a concern for the welfare of human participants. Ongoing review is not required once a determination of exemption is made, unless the research has significantly changed so that it no longer meets these exemption criteria:
- Research, conducted in established or commonly accepted educational settings – (§46.104(d)(1))
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior – (§46.104(d)(2))
- Research involving benign behavioral interventions in adult subjects – (§46.104(d)(3))
- Taste and food quality evaluation and consumer acceptance studies – (§46.104(d)(6))
The ORPC has created a list of exempt category definitions to assist investigators in the preparation of an IRB application.
The following are instructions for preparing an application for Exempt Review:
1) Complete the Collaborative Institutional Training Initiative (CITI) training program
2) Please access the Kuali Protocols Portal to create an Exemption Research protocol application. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.
The IRB has created two (2) distinct exemption application processes – see below. Explanations of each selected review categories are found in Kuali protocols. Choose carefully the exempt category under which your research applies.
Research in topics such as educational practices, benign interventions, surveys, interviews, or observations of public behavior and food studies. – exempt categories 1, 2, 3, 5, and 6
Secondary data use research involving private data, documents, records or biological samples or specimens that have already been collected (pre-existing) – exempt category 4 and expedited category 5
3) Upload to the Kuali Protocols record the proposed questions and/or measures, recruitment scripts/fliers and applicable consent documents . Please upload in the Attachments Section of the Kuali Protocols.
Review and approval of exempt protocols will take approximately two weeks. The length of time a protocol will take to be approved and an approval letter received depends on the type or level of review required. The ORPC staff, working in concert with the IRB, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. The ORPC will send comments to investigators within one week if there are revisions required. Final versions are then forwarded to the IRB for review. If you have any questions, please contact us at compliance@umbc.edu.
Using the Consent Process in Exempt Review
Although a protocol 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, may not be required, but those participants must be informed about the purpose of the study. An investigator will provide a participant an IRB approved consent document with information explaining the purpose of the study, how the data will be used, how the data will be kept anonymous, etc. Please consult the Consent and Assent Guidelines page to choose the appropriate format to informing participants about a study.
Exemption Determination Renewals
Certain exemption determinations (e.g., student led research) are assigned an expiration date; if so, investigators receive this automated notice from Kuali to submit a renewal request. If notified, please submit a continuation report for review by the ORPC.
For the most part, renewals are not required for exemption determinations. In either case, however, the IRB will require notification of updates, modifications or changes throughout the term of the exemption approval period. Please submit an amendment before implementing via Kuali.
Protocol Amendments
Investigators are required to inform the IRB of any changes planned for previously approved research. Kuali IRB uses the term “amendment”, rather than “modification”. Please access the Kuali Protocols Portal to create an amendment to a previously approved protocol. These changes must be submitted at least two (2) weeks beforehand. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist creating this amendment.