Review Process Procedures

Exempt from Informed Consent

• To obtain approval utilizing the Exempt From Informed Consent application, the principal investigator is responsible for completing and submitting ONE copy of the appropriate application materials to the IRB representative from his/her school. If a school representative is not listed below for a specific university school or department, submit the application to the IRB Committee Chair.
• The School representative (or IRB Chair as stated above) serves as the primary reviewer and will either review the application or select another IRB member to review the application.
• The principal investigator has the responsibility of submitting a COMPLETE application, and FINALIZED questionnaires/survey (not draft copies) or other appropriate materials (if applicable).
• The IRB application checklist also must be submitted and include the principal investigator's signature. IF PROJECT IS CONDUCTED BY A STUDENT, the application materials are to be reviewed by the faculty preceptor/advisor who will sign the checklist form, indicating the application is complete and ready for review by the IRB member.
• The primary reviewer will only review the IRB application once ALL the FINALIZED application materials have been submitted.
• In the event the reviewer has any questions, the principal investigator may be contacted for clarification.
• Upon completion of the review process, the primary reviewer may approve the application on behalf of the entire IRB.
• In the event that the primary reviewer cannot approve a study, the principal investigator may be asked to submit an expedited or full IRB application.
• School representatives that serve as IRB members and primary reviewers are as follows:

Arts & Sciences - Theresa Davidson, Ph.D., David Dedo, Ph.D., or George Keller, Ph.D.
Business - Bill Belski, Ph.D.
Education - Alan Jung, Ph.D. or Jonathan Davis, Ph.D.
Law - Joe Snoe, J.D.
Nursing - Nina McLain, Ph.D., C.R.N.A.
Pharmacy - Robert Riggs, Ph.D., Stuart Capper, Dr. Ph., or Maisha Kelly Freeman, Pharm. D., BCPS
IRB Chair - Gretchen McDaniel, D.S.N.
IRB Chair-Elect - Patti Wood, Ph.D.

• After the research project is completed, the principal investigator is required to submit an Application Closure Form to the primary reviewer (or IRB Chair as stated above).
• Exempt Table without entire application

Expedited Reviews

• Expedited review is allowed for research activities which involve no more than minimal risk to the human subjects and can be placed in one or more of the categories listed on the application form.
• The principal investigator is responsible for completion of the Expedited Review application and The Human Subjects Protocol.
• The ORIGINAL PLUS 2 COPIES of these documents,plus the FINALIZED Subject Informed Consent form, along with any questionnaires, specimen release forms, or drug release forms (if applicable) are to be submitted to the following person:
  • Investigators from Education and Nursing, send to: Chair-elect, Patti Wood, School of Education, pfwood@samford.edu, 726-4287.
  • Investigators from all other university schools/locations, send to: Chair, Gretchen McDaniel, School of Nursing, gsmcdani@samford.edu, 726-2626.
• The principal investigator has the responsibility of submitting a COMPLETE application, and FINALIZED questionnaires/survey (not draft copies) or other appropriate materials (if applicable).
• Please allow at least 2 weeks from the time the application is submitted to final approval. Applications have been approved within 2 weeks from the submission date; approval time is dependent upon the application being complete (i.e., items on the checklist are completed).
• The IRB application checklist also must be submitted and include the principal investigator's signature. IF PROJECT IS CONDUCTED BY A STUDENT, the application materials are to be reviewed by the faculty preceptor/advisor who will sign the checklist form, indicating the application is complete and ready for review by the IRB member.
• The IRB Chair or Chair-Elect will select at least two IRB members to review each project who have the responsibility of examining the application, Subject Informed Consent form, questionnaires, and other appropriate materials. The principal investigator may be contacted for clarification if needed.
• Upon completion of the review process, the IRB Chair or Chair-Elect may approve the application at which the finalized Subject Informed Consent form will be stamped with the IRB approval stamp.
• The Subject Informed Consent form with the official Samford University IRB approval stamp will be duplicated and used in the research project. No changes to this form will be allowed after the approval stamp is imprinted.
• All Subject Informed Consent forms must be kept by the principal investigator. Those forms are subject to review by an IRB Committee member.
• In the event that the reviewers cannot approve a study as an expedited review, the principal investigator will be asked to submit the study for full board review.
• After the research project is completed, the principal investigator is required to submit an Application Closure Form to the IRB Chair.

  Full Review Process

• The IRB requires that the scientific and clinical validity of the proposed research be examined by a project review panel.
• It is the responsibility of the principal investigator to propose a panel of three appropriate persons not involved with the research project to serve as a project review panel to critically review the protocol before it is presented to the IRB.
• If the subject population has a significant medical condition that is to be studied or that could be affected by participation in this study, the panel should include at least one individual with specific professional competence pertinent to the area of study.
• After ascertaining their willingness to serve, the principal investigator should send a memo requesting approval of the panel to the IRB Chair listing the names of the proposed panel members with a brief statement of their qualifications (see sample memo).
• Upon approval of the panel by the IRB chair, the investigator must meet face-to-face with this panel to review the protocol.
• Upon completion of the review process, the report of the Project Review Panel must be completed and signed by the panel.
• Should changes in the panel membership be necessary, please notify the IRB Chair by letter and request approval of the new panel.
• Finally, the principal investigator should submit the ORIGINAL PLUS 13 COPIES (Collated into 14 separate packages of the following materials to the office of the IRB Chair: (a) human subjects' protocol signed by the investigator; (b) report of the project review panel with panel members' signatures; (c) Subject Informed Consent form; (d) any questionnaires to be used (if applicable); and (e) any special approvals (if applicable).
• The principal investigator has the responsibility of submitting a complete application and finalized questionnaires/survey (not draft copies) or other appropriate materials (if applicable).
• The IRB application checklist also must be submitted and include the principal investigator's signature. IF THE PROJECT IS CONDUCTED BY A STUDENT, the application materials are to be reviewed by the faculty preceptor/advisor who will sign the checklist form, indicating the application is complete and ready for review by the IRB member.
• The application materials should be submitted to the IRB Chair at least two weeks prior to the next scheduled IRB meeting.
• The IRB Chair will distribute a copy of the application materials to each IRB member who will examine the application and all supporting materials. Should a board member have a question, she/he may contact the principal investigator for clarification.
• The IRB Chair or designee will notify the primary investigator of the scheduled committee meeting dates so that he/she may be present for any discussion.
• After discussing the application materials with the primary investigator and among the IRB members, a vote will then be taken. Approval requires a favorable vote by the majority of members in attendance.
• Upon completion of the review process, the IRB Chair may approve the application at which the finalized Subject Informed Consent form will be stamped with the IRB approval stamp.
• The Subject Informed Consent form with the official Samford University IRB approval stamp will be duplicated and used in the research project. No changes to this form will be allowed after the approval stamp is imprinted.
• All Subject Informed Consent forms must be kept by the principal investigator. Those forms are subject to review by an IRB member.
• The principal investigator is responsible for reporting any subject adverse events/effects that occur during the research project. These must be submitted to the IRB Chair, even if the subject adverse events/effects may not be related to the research protocol.
• After the research project is completed, the principal investigator is required to submit an Application Closure Form to the IRB Chair.