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Application Process


  • IRB Initial Application (PDF)


    At the University of Maryland Eastern Shore , all research that involves the use of human subjects requires review and approval by the Institutional Review Board (IRB) prior to the initiation of the research.

    IRB Application Protocols

    Researchers must complete the IRB Application which is available by clicking on IRB Initial Application (PDF).

    Briefly, the IRB application must contain the following (please see the IRB application for more detail):

    1. A brief description of the research protect.

      2. Subject Selection - A description of the subjects and how they will be recruited.

      3. Procedures - Explanation of what will be done to the subjects, methods and procedures in terms of what will be done to the subjects, and copies of the questionnaires or handouts used in the research.

      4. Risks and Benefits - A list of the risks and/or benefits possible to the subjects.

      5. Confidentiality - Explain how the procedures will adequately provide to protect the privacy of subjects and to maintain confidentiality of identifiable information. An explanation of data storage, data location and duration, description of persons with access to the data, and method of destroying the data when completed.

      6. Consent Forms - Statement of what information will be provided to the subjects about the investigation.

      7. Plan for data collection, storage and data analysis.

      8. Conflict of Interest - Description of potential conflict of interests.

      9. HIPAA Compliance - Information pertaining to protected health information.

      IRB Application Process Page: After reviewing the exemption categories, if you determine your application meets one of the exempt categories, write the category number(s) on your cover sheet and explain why your proposal is exempt. An exempt category natation it does NOT mean that the application is exempt from being reviewed and approved by the IRB. Thus, your notation of this category is simply a helpful recommendation; the IRB must decide whether a protocol is exempt and by which category.

      Signatures

      All individuals listed on the cover page as investigators must sign.


      Submission of Application

      Please email the application materials to: jlhearne@umes.edu Please keep a copy of these documents for your records.


      Timeline and Process:

      Once an application arrives to the IRB, please allow two or three weeks for processing; exempt applications tend to require a shorter amount of time. Unless otherwise requested, the IRB will send principal investigators written notification when their applications are approved. Usually within two weeks after a meeting, investigators will receive notice from the IRB setting forth its decision concerning the application. For approved applications where no changes are requested, investigators will simply receive the approval documents; however, there are instances when the IRB may need further information and/or may request changes be made to the protocol (for protection of human subjects) before an approval will be granted.

      Renewals and Modifications

      Protocols are approved for a maximum of 364 days. At the end of the approval period, all research must cease if no extension has been granted by the IRB. If you need an extension, contact the IRB office for assistance. Requests for extensions should be made no later than two (2) weeks prior to the end of the protocol approval date. It is the responsibility of the Principal Investigator (PI) to monitor the IRB approval and expiration dates for his or her study.

      Modifications to protocols (addenda) can be made to an active protocol at any time. A letter should be written to the IRB detailing the specifics of the addenda. Information which should be included are: rationale for the changes, detailed description of the procedures, and justifications for the subjects and the subject numbers.