Human Subjects IRB

Institutional Review Board (IRB)

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.

General Protocol Submission Guidance

All submissions must be complete prior to review and approval. The following items are necessary for a complete submission:

  • An application form that is fully completed and signed electronically per the instructions on the form (i.e. type name and date)
  • Informed consent documentation (when applicable)
  • All recruiting materials
  • All questionnaires or surveys (when applicable)
  • If the principal investigator is a student, a Faculty Sponsor Assurance form completed by the student's faculty sponsor
  • Some studies may require other items, such as documentation of permission to conduct research in a location other than Davidson College, IRB approval from a collaborating institution, etc.

All applications and forms must be submitted electronically to the Davidson College IRB. Incomplete applications will result in a delay of approval.

New Protocols

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.

Exempt Review

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).

Non-Exempt Review

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).

Informed Consent

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.

Students and Faculty Sponsors

When a student is the principal investigator for a study, it is their responsibility to:

  • Complete the appropriate application form (i.e., Request for IRB Review of Exempt Research Involving Human Subjects form or Application for IRB Review of Research Involving Human Subjects form).
  • Indicate student status on the application form and indicate the faculty sponsor for the study.
  • Have the faculty sponsor review the protocol application.
  • The faculty sponsor will indicate they have reviewed the protocol application and supplemental documentation and approve of the research project by signing the Faculty Sponsor Assurance Form (Word).  The faculty sponsor must then email the completed form to the Davidson College IRB from their on-campus email address.
    • Before forwarding the Faculty Sponsor Assurance form to the faculty sponsor, the student should prepopulate the information block at the top of the form regarding the protocol, principal investigator and faculty sponsor.
    • If this form is mailed from the faculty sponsor's Davidson e-mail account, a handwritten signature is not needed. Faculty sponsor need only type in their name and date and e-mail as an attachment to the Davidson College IRB.

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.

Modifications to an Approved Protocol

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. Meghan Griffith, IRB Chair, or Sharon Byrd, IRB Vice Chair.

Modifications that require IRB review and approval:

  • Change in study design (for example, adding a new type of study activity)
  • New location for conduct of the study
  • A change in investigators

Things that may require IRB notification only:

  • Changes to questionnaires that are consistent with the approved questionnaire
  • Changes to recruiting materials that are consistent with the approved materials

Items that need to be submitted for a modification:

Continuing Review/Annual Renewal

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:

  • Copy of the original application or an updated application if modifications have been made
  • Consent form

Questions?

Please contact the IRB Chair or Vice Chair

Prof. Meghan Griffith at (704-894-2403) or Sharon Byrd at (704-894-2158)