Institutional Review Board for Research with Human Subjects

All students doing research with human subjects must go through an Institutional Review Process and complete their Certification Training (see link below) before any type of subject recruitment or data collection can begin. For students, this process officially begins after the successful defense of the dissertation or thesis proposal. It is essential that you familiarize yourself with the human subjects policies and procedures guide available from the links below, before you construct your methodology section (Chapter 3) and proceed with your proposal defense.

The St. Mary's University IRB website offers extensive information regarding each step of this process. While the St. Mary's IRB committee attempts to review all applications in a timely manner, please remain flexible in your planning as to avoid any unnecessary frustrations.

The St. Mary's University IRB website is very explicit and comprehensive so read through each link carefully before proceeding with the creation of the methodology for your study and your IRB process and application.

Steps in the process:

1. Familiarize yourself with the St. Mary's Human Subjects Research Policies and Procedures.
2. Complete Training Certificatse provided by the National Institute of Health "Protecting Human Research Participants" (4 modules).
3. Obtain approval by dissertation or thesis committee, or in the case of class research projects or independent research practica, approval by the instructor.
   At this point, the proposal should be free of errors and conform to the APA Guide to Publications.
4. Complete the Institutional Review Board (IRB) Human Subjects Request for Proposal Review. See Proposal Review Checklist for required materials.
   
   
   • Proposals are due in the department by the first of each month for consideration in that month's meeting.
   • Submit two (2) signed original IRB Human Subjects Request for Proposal Review to the Administrative Assistant of the Counseling Department, Francis Farrell.
     
     
     • Signatures needed at this point are the Principal Investigator (in the case of a dissertation or thesis proposal, this is the student) and the Faculty Advisor.
     • If this is a research project with more than one Principal Investigator, all PIs need to sign (i.e. multiple faculty members, faculty members and multiple students, or faculty members and researchers from other institutions).
   • The complete Request for Proposal Review consists of:
     
     
     • Request for Proposal Form, sections A through O
     • Principal Investigator signature and research advisor signature
     • Human Subjects Assurance Training certifications for each researcher
     • Informed Consent forms you will use
     • Biographical sketch or CV of subject matter expert, if required
     • Permissions or letters of support for any non-St. Mary's sites involved in research. This includes IRB review from a collaborating institution, if required.
     • Proposal Review Checklist
   • The additional signatures of the Department Chair and the Area Representative will be obtained during the review process.
   • Attach a digital copy of the IRB Request for Proposal Review, sections A through O, and a digital copy of the approved thesis or dissertation to the IRB, Counseling Dept Blackboard site.
5. The IRB Area Representative, Dr. Dan Ratliff, writes a transmittal letter for the IRB summarizing the project and evaluating the risks and benefits and sends one copy of the hard copy to the committee. An electronic copy will accompany the hard copy as well.
   
   
   • The IRB Request for Proposal is evaluated according to Proposal Approval Checklist, available on IRB website.
   • If the IRB Area Representative has questions or clarifications, he will return the document for revision.
   • Allow two weeks for review by the IRB Area Representative. You will receive an email after the review has been completed.
6. Full Institutional Review Board reviews proposal.
   
   
   • IRB operates only during the Fall and Spring semesters. The final meeting is in March; the deadline for Proposal Review to the CN Dept Area Representative is March 1.
   • IRB review of expedited or full review research can take several months.
   • IRB response:
     
     
     • Additional questions, clarifications
     • Approval letter
     • Deny
7. Any substantial changes in research protocol, unanticipated problems, or adverse events must be reported immediately to the IRB Area Representative by the responsible investigator. A form, Incident Report, Unanticipated Problem(s), for reporting unanticipated problems or adverse events is available on the IRB website. The amended protocol must be approved by IRB before study may continue.
8. At the conclusion of the data collection, researchers complete a Final Research Closure Report.