Concordia College, Moorhead, MN

Institutional Review Board

The policies and procedures outlined here are in effect starting September 1, 2004

We wish to thank and give credit to the Office of Human Research Protection at the University of Nevada, Reno for granting us permission to use their website as a resource for Concordia College’s IRB policies, procedures, and forms.

What is the IRB?

Is What I Do Subject to IRB Review?  

Department Chair's Responsibilities to the CC IRB

Summary of the Belmont Report

Guidelines for Ethical Human Subjects Research

Additional Guidelines for Ethical Research on Children, Pregnant Women, Fetuses, Neonates, and Prisoners

CC IRB Required Education for Principal Investigators, Key Research Personnel, IRB Members, and IRB Delegates

What is “Exempt”, “Expedited,” and “Full-Board” Research?

Classroom Information Gathering Activities

CC IRB Policies and Procedures for Exempt Research

CC IRB Policies and Procedures for Expedited Research

CC IRB Policies and Procedures for Full-Board Research  

Protocol Submission Deadlines

CC IRB Review Criteria

Forms

Exempt Research Forms

Review Categories Checklist (to be submitted for all research)

Application Form for Exempt Protocols

Description of Study Form (for use by researchers who prefer the checklist format)

Model Informed Consent Form When Signature Required (a reference for use by all researchers)

Instructor Application Form for Student Projects (to be submitted by course instructors who wish to obtain approval of exempt research studies conducted by several of their students in partial fulfillment of course requirement, rather than having individual students submit their research protocols separately for approval)

Expedited Research Forms

Review Categories Checklist (to be submitted for all research)

Application Form for Expedited and Full-Board Protocols

Description of Study Form (for use by researchers who prefer the checklist format)

Model Informed Consent Form When Signature Required (a reference for use by all researchers)

Final Report Form (to be submitted at the completion of Expedited Research and research that was reviewed by the Full-Board)

Full-Board Research Forms

Review Categories Checklist (to be submitted for all research)

Application Form for Expedited and Full-Board Protocols

Description of Study Form (for use by researchers who prefer the checklist format)

Model Informed Consent Form When Signature Required (a reference for use by all researchers)

Final Report Form (to be submitted at the completion of Expedited Research and research that was reviewed by the Full-Board)

Other Forms

 Model Informed Consent Statement When Signature Waived (a reference for use by researchers not using a signed consent form in their study)

Model Informed Consent to Be Audio/Videotaped Form (a reference for use by researchers planning to record their subjects)

Model Description of Study (a reference for use by all researchers)

Model Debriefing Statement (a reference for use by all researchers)

Chairperson's Report of Approved Departmental Exempt Research (to be submitted by department chairs at the end of each semester)

CC IRB Protocol Review Checklist (a reference for use by all researchers)

Protocol Modification Request Form (for use by researchers who already had their research approved but wish to introduce a slight modification to the research protocol)

Adverse Events Report Form (for use by researchers who had an adverse event involving subjects occur in the course of conducting their research)

HIPAA Authorization Form (for use by researchers who will access medical records of research subjects)

HIPAA Waiver of Authorization Form (for use by researchers who will access medical records of research subjects)

HIPAA De-Identification Form (for use by researchers who will access medical records of research subjects)

Research Status Report Form (to be submitted annually for continuing Expedited Research and continuing research that was reviewed by the Full-Board)