Institutional Review Board

IRB Forms & Sample Documents



FORMS:
  • IRB Protocol Form - All researchers conducting research with human subjects, or their data, must complete this document and submit to the IRB Administrator. The researcher (PI :Principle Investigator) submits 3 hard copies. Documents must be typed. All questions answered in complete sentences, include all necessary attachments, and obtain all signatures.
  • Attachment to include additional research team members - this form maybe be used as an attachment to the IRB Protocol Form when the project includes more research team members than can be listed on the IRB Protocol Form.
  • Request for Exemption - The "exempt" category does not mean that a project is exempt from IRB review. The AUM IRB will review the project and determine if it fits in this category (or expedited or full board review). The PI may request exemption through use of this form. Survey instruments and any other instruments will still need to be included as attachments. See Policies and Procedures for definition of Exempt research. Submit a single hard copy to the IRB Administrator.
  • Request for Continuation - The IRB will conduct continuing review of projects that last longer than 12 months. The PI will need to complete a Request for Renewal and document all progress and any changes. Submit at least 2 weeks prior to scheduled end of project. Send by email or hard copy to the IRB Administrator.
  • Request for Modification - Any modification to the project must be requested prior to implementation in the study. These changes may effect the risk or benefits to the participants. Modifications include, but are not limited to recruitment, consent process, targeted population, scope of study, change of team members. Send by email or hard copy to the IRB Administrator.

    SAMPLE DOCUMENTS: 

    •  Participant Informed Consent (for adults) - the age of majority is 19 in Alabama. This document can be used as a guide to develop an Informed Consent specific to a research study. *

    Researchers should remember that consent is a process and not an individual document. Consent documents should be age appropriate and comprehension levels must be considered when preparing consent documents.
                45 CFR 46.116(a)&(b) 
     

    •  Information Letter for Adults - This document can be used as a guide when the IRB has determined that the requirements for a signed consent form can be waived.
    •  On-line Information Letter for an Electronic Survey - An on-line information letter may be used for anonymous, electronic survey when it is determined by the IRB that the requirements for a signed consent form can be waived. This sample may be used as a guide to develop an electronic information letter specific to the study.
       
    •  Parental Consent Template - This sample can be used as a guide to develop an Informed Consent document when minors are the research participants.
    •  Minor Assent - This sample can be used as a guide to develop and Assent document to obtain assent for participants under the age of 19 (in the State of Alabama)
    •  On-line Readability Formulas - This site provides free tools that analyze writing samples for readability. We recommend PI's test their Consent documents here for reading level analysis. As a general rule, consent documents (for adults) should not exceed an 8th grade reading level.

     

     Diagram of the IRB review process

    Terms used in Human Subjects Research

    Training for researchers (policy)
    CITI Collaborative Institutional Training Initiative (link to site)
     

    Contact Information

    Debbie Tomblin (MPA)
    Research Compliance Manager, IRB Administrator
    dtomblin@aum.edu 
    334-244-3250

    Dr. Glen Ray
    IRB Chair
    gray@aum.edu
    334-244-3690
     
     Dr. Michele Olson
     Assistant IRB Chair
     Molson@aum.edu  334-244-3791