Application Process IRB Webpage

IRB Initial Application

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

Submission Process

  1. The principal investigator(s) (faculty, staff, director) and student investigator(s) must complete CITI training. Click HERE for directions to access CITI and which courses to select. Download each course certificate and name it as follows: InvestigatorLastName_Course (Bobenko_RCR_HSR or Bobenko_SBR or Bobenko_Biomed).
  2. Complete the application cover page. Click HERE to access the cover page.
    • After reviewing the exemption categories, if you think your application meets one or more of the exempt categories, indicate the category number(s) on your cover sheet. An exempt category notation 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 will decide whether a protocol is exempt from federal regulations and by which category.
    • Please name the file as follows: PrincipalInvestigator’sLastName_Cover
  3. Complete the IRB application. The application can be accessed HERE. The application must be formatted as presented. All questions within the application must be answered.

    Briefly, the IRB application must contain the following (please see the IRB application for more details):
    1. A brief description of the research project.
    2. Subject Selection – A description of the subjects and how they will be recruited.
    3. Procedures – This is a detailed 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 maintain the 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 interest.
    9. HIPAA Compliance – Information pertaining to protected health information.
      • Please name the file as follows: PrincipalInvestigator’sLastName_Application
  4. Please submit the CITI training certificates, cover page, and application to the Chair of the IRB via email: JCBobenko@umes.edu.
  5. The IRB Chair will confirm receipt of the application and accompanying documents via email to the principal investigator only.
  6. Please allow for up to three weeks for an initial review of your application. The IRB Chair will contact you via email to request revisions and clarifications, and provide you with a determination/approval notice.

Renewals and Amendments

Applications that are not deemed exempt are approved for a maximum of 364 days. At the end of the approval period, all research must cease if a renewal has been granted by the IRB. If a renewal is required, please contact the IRB office for assistance. Renewal applications must be made at least one month prior to the end of the protocol approval date. It is the responsibility of the Principal Investigator to monitor the IRB approval and expiration dates for their study.

Amendments to protocols can be made to an active protocol at any time. A memorandum should be submitted to the IRB detailing the rationale of the amendment.

Click HERE for an example of an amendment.

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