The role of the Davidson College Human Subjects IRB is to assure that human research subjects are treated with dignity, respect and with due regard for their welfare. All research involving the use of human research subjects (participants) must be reviewed and approved by the Davidson IRB before the research can be initiated.
Please note that the IRB cannot approve a protocol submitted after the research is initiated, nor can the IRB sanction any human subjects data collected without approval.
Information on submitting a protocol to the IRB is provided below.
All submissions must be complete prior to review and approval. The following items are necessary for a complete submission:
All applications and forms must be submitted electronically to the Davidson College IRB. Incomplete applications will result in a delay of approval.
Two forms are available for submission of new protocols. One form is tailored for non-exempt research and the other is for exempt research. The Exemption Status Decision Tree (PDF) provides guidance in making the determination of the type of review you need to request.
Some research projects using human participants raise no substantial risk to anyone. These projects receive limited IRB review and, if approved, are exempted from further oversight. For exempt review, use Request for IRB Review of Exempt Research Involving Human Subjects form (Word).
Protocols that do not meet the criteria for exempt review (i.e., minimal or greater than minimal risk studies) receive more extensive IRB review, and must be renewed annually if research is ongoing. For non-exempt review, use Application for IRB Review of Research Involving Human Subjects form (Word).
Use the sample consent forms as a guide for your informed consent documents. If you are requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent, indicate this in the application and fully complete relevant sections.
When a student is the principal investigator for a study, it is their responsibility to:
Once the complete application package and Faculty Sponsor Assurance form has been received electronically by the IRB, the protocol will be processed and sent out for review.
The IRB should be notified before a change is made to a protocol. Some changes require IRB review and approval, and others do not. If you have a question about the need to submit a modification, contact Prof. Clark Ross, IRB Chair or Sharon Byrd, IRB Vice Chair.
Modifications that require IRB review and approval:
Things that may require IRB notification only:
Items that need to be submitted for a modification:
Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months.
Items that need to be submitted for an annual renewal: