Carroll College, Helena Montana

Applying for the IRB Review

Getting Started

If a project requires IRB approval, that approval must be obtained prior to initiation of the project. All investigators should consult the Carroll College IRB Policy & Procedures Manual for detailed instructions about the application and review processes. The manual and all necessary forms can be downloaded from this site. Please give special attention to following the procedures and guidelines for preparing your research proposals. Proposals that are incomplete or poorly written will not be approved, and will be returned to the applicant with notification that the IRB will be unable to review the application during the current review cycle.

Thank you for attending to this important matter. We wish you much success in your research and ask that you protect the rights, welfare, and basic human rights of any persons involved in your research.

Application Review Period

Research proposal applications are reviewed throughout the academic year, but summer reviews may take significantly longer.  Principal investigators should submit their applications during the semester prior to the period in which they hope to begin their research.  

Required Online Ethics Training Course

Before initiating a research project, investigators must receive appropriate education on the protection of human subjects. All investigators who will be involved in the proposed project must complete the NIH-sponsored "Protecting Human Research Participants" training course, available free online at the National Institute of Health website. The course takes approximately 2 hours to complete.

The site's "completion certificate", printable (literal and digital) upon completion of the course, is acceptable as documentation of training. Every investigator who will be involved in the project (a) must be listed on the application and (b) must submit a copy of their completion certificate as part of a complete application.

The Carroll College IRB accepts certifications earned within three years of applying to the IRB.

Note: All faculty directors of student research must also submit their human subjects certification forms along with the application packet.

The Application Packet

The first step in the application process is the compilation of an application packet, the contents of which will vary according to the proposed project. All application packets should include a completed Application for IRB Review of Human Subjects Research as well as ethics training course "completion certificates" for all investigators involved in the project. Listed below are additional forms and supporting documentation that should be included when appropriate:

  • Research proposal, protocol, or grant application supporting the proposed project
  • The Consent Process & Consent Documentation (including waivers; template available here)
  • Informed Consent Form (template available here)
  • HIPAA Authorization Form (template available here)
  • Questionnaires, surveys, measuring devises, or other materials pertinent to data collection but not fully described in the proposal.

The principal investigator is responsible for completing all applicable forms as well as securing appropriate signatures. Proposals that are incomplete or unclear will be returned to the investigator for completion or clarification, thus delaying the review and approval process.

Download the application packet here.  

How to Fill Out IRB Forms

Carroll College IRB application forms are designed to be downloaded from the Carroll College website and completed electronically. These forms are not designed to be printed and then completed manually, as they do not provide sufficient space for all responses. Blank or partially-completed forms may be saved on your computer to complete at a later date. Once completed, forms must be printed out by the applicant so that appropriate signatures can be obtained prior to submission. See below for submission instructions. Questions about application forms should be directed to the IRB Chair, Dr. Alan Hansen at ahansen or 406.447.5401.

Submitting the Application

For each application for review, applicants must submit one hard copy of the complete packet, with all required signatures, to Maria Larson in the Office of Academic Affairs, O'Connell Hall. The review cannot occur until the signed hard copy of the application, and NIH certificates of all investigators listed on the application, have been received. Once a hard copy of the application and all required NIH certificates are on file, providing detailed instructions for uploading the application to the IRB Moodle page will be sent to applicants. Applicants will then upload electronic copies of the complete packet (without signatures, in Microsoft Word), including all supporting documents, to the Moodle IRB page. The IRB review process will begin once digital copies of the application and supporting documents are uploaded to the IRB Moodle page.