Carroll College, Helena Montana
IRB

Institutional Review Board

What Types of Projects Require IRB Approval?

As a student, faculty or staff member of Carroll College, research (including class projects and honors theses) involving collection of information or data about human subjects, or research that tests and/or measures human participants in any way, potentially requires approval by the Institutional Review Board (IRB). Following are general regulations of the IRB:

Federal regulations and Carroll College policies require IRB approval for research and projects involving the gathering of information about living human subjects. These regulations and policies serve to protect the rights and welfare of human participants and apply to human subjects research conducted individually or collectively (i.e. as a class or in groups) by Carroll College faculty, staff, or students. Projects requiring IRB approval must have approval before human participants are involved at any stage of research. The IRB cannot review research that has already been conducted.

Independent student research projects in which human subjects are involved, either directly or through use of data about them, always require IRB approval. Examples of such projects include research projects conducted by Carroll College honors students in conjunction with honors thesis requirements; projects by students individually enrolled in an independent study or research practicum with a professor; and projects by students planning to present their findings at a state, regional, or national conference.

Some class projects that involve human subjects will require IRB approval. Faculty should consult the "IRB Guidance for Class Projects" document (available on MyCarroll; see the right side bar for access instruitons) to determine if their planned project will require IRB approval. Research without IRB approval may not be recognized by Carroll as fulfilling academic requirements.

Research not involving information about human subjects does not require IRB approval.

Review Process

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 (available on MyCarroll; see right side bar for access instructions) for detailed instructions about the application and review processes. Generally, the process works as follows: (1) The applicant prepares the application according to instructions on the Application form (available on MyCarroll; see the right side bar for access instructions). The application is designed to be completed digitally. (2) The applicant completes the application and creates all required supporting documents (e.g. consent forms, recruitment scripts, survey materials, etc.). (3) The applicant prints the application and retrieves all necessary signatures for the original form. The applicant prints all supporting documents (e.g. NIH certificates [see below], consent forms, recruitment scripts). (4) The applicant scans the application and all supporting documents as one .pdf document. (5) The applicant takes the original, signed document to Maria Larson, Academic Affairs (O’Connell Hall). (6) The applicant uploads the scanned .pdf to the Moodle IRB using the instructions referenced on the IRB Application.

Application Review Period

Research proposal applications are reviewed throughout the academic year, but summer reviews may take significantly longer. Ideally, the investigator would submit an application during the semester prior to the period in which research is set to begin. Note that proposals that are incomplete or poorly written will be returned to the applicant; this will lead to inevitable delays in the review process.

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.

Getting Started

The first step in the application process is to compile 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.

All documents, including an Introduction to Applying to the IRB, the Application Packet and templates for commonly-required supporting documents, are found on the MyCarroll intranet site. (See the right side bar for access instructions.)

IRB Mission Statement

The primary purpose of the IRB is to assure the safety, rights, welfare and dignity of human subjects. The mission of the IRB is to determine whether research conducted by faculty, staff, employees, and students affiliated with Carroll College complieswith applicable law, institutional policies, and standards of professional conduct and practice while embracing the mission of Carroll College. Specifically, the IRB is the group given responsibility by Carroll College to review research proposals that involve the use of human participants.

Download IRB Documents from MyCarroll (password required)

Contact Information

For information concerning application for IRB review, or to report problems with this site, please contact IRB Chair, Dr. Alan Hansen at ahansen@carroll.edu or 406.447.5401.

For information about how to submit an applicaiton, contact Maria Larson at mjlarson@carroll.edu or 406-447-5510.

Additional Resources

“The Belmont Report”

The Office for Human Research Protections (OHRP)

Title 45, Code of Federal Regulations, Part 46