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Exempt Certain broad categories of research projects that involve human participants and are exempt from full IRB review. The Federal regulations "exempt" some types of research from the review regulations governing human subjects; however, the UMBC IRB believes ethical oversight of research project still applies. Federal regulations permit the principal investigator to make the initial determination as to whether the project is exempt; final determination rests with the IRB chair who review and approve all requests to determine that an exemption is appropriate.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. General examples of research conducted at UMBC, to help plan a study, as well as examples of what projects might not require IRB review may be found here. The following are instructions for preparing an application for Exempt Review: 1) Complete the Collaborative Institutional Training Initiative (CITI) training program 2) Make the preliminary determination that a research project is eligible for exempt. This judgment should be made with care - review the Human Subject Regulations Decision Charts from OHRP. Questions of interpretation may be directed to the Human and Animal Protections Research Office (HARPO@umbc.edu). 3) Download and 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. · Exemption Certificate Application · Instructions for developing a consent form 4) Electronically submit the protocol, informed consent document and any accompanying documents (tools, questionnaires, etc.), if applicable to irbsubmissions@umbc.edu. 5) Once the electronic submission has been performed, a copy of the completed application signature page, signed by the investigator(s), may be scanned and sent to irbsubmissions@umbc.edu or faxed 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. NOTE: Student researchers conducting research in independent class projects, senior theses, master's projects and doctoral dissertations: You must complete the application form, sign and forward to your faculty advisor for review and signature before the electronic submission process. It is expected the faculty advisor will review the application before submission to the IRB. His/her signature on the application indicates the appropriate review has taken place. Applications for exempt review may be submitted at any time to the IRB Support 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 of following submission. |
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Last updated 01/08/2008 |
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Questions about completing an application form? Send an Instant Message to AIM Screen name HARPO246 |
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