Staff IRB IACUC Biosafety Training

 

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

 

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. Note also that an informed consent process may be required even if a project is determined to be eligible for exemption.

 

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.

 

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

 

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

 

2) Complete the below appropriate forms that are applicable to your project; at the minimum complete the Exemption Certification Application and Informed Consent documents. Be sure to follow all instructions on the forms.

 

Click to download the:

 

Exemption Certificate Application

Blank Consent Form

Instructions for developing a consent form

 

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.

 

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