Institutional Review Board (IRB)

The Davidson College Human Subjects Institutional Review Board (IRB) reviews and approves all research involving the use of human subjects.  Research can begin after the IRB approves the project (non-exempt) or exempts it from further review.  The review of a protocol application typically takes five to ten business days.  The IRB will not approve human subjects' research retroactively, after data has already been collected.

Revisions to the Federal Policy for the Protection of Human Subjects

January 21, 2019 is the compliance date for the Revised Common Rule which replaces current regulations that have been in place since 1991.  One of the Revised Common Rule's main purposes is to facilitate the conduct of minimal risk research.

Significant Changes

  1. Elimination of continuing review: Projects that are approved by an Expedited Review (see 4.0 IRB Policy) that extend for more than a year will no longer have to apply for renewal.
  2. Exclusion of "scholarly and journalistic activities that focus on a specific individual" (e.g., oral histories) from HSIRB oversight.
  3. Allowance of deception in exempt research if the subject prospectively authorizes it, i.e., subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
  4. Requirement that key information essential to decision-making receive priority in informed consent by:
    • being presented first in the consent discussion;
    • appearing at the beginning of the consent document.

Revised, Expanded & New Exempt Categories

Exempt Category 1: Educational Setting (PDF)

Exempt Category 2: Surveys, Tests, Observations (PDF)

Exempt Category 3: Benign Behavioral Interventions (PDF)

Exempt Category 4: Secondary Use of Identifiable Data or Specimens (PDF)

Due to the potential for conflict of interest, investigators are not authorized to make an independent determination that their human subjects' research is exempt.

Research Requiring Prior IRB Approval

Research that:

  • Will be or could be, publicly presented;
  • Involves vulnerable human subjects (e.g., children, immigrants, homeless individuals);
  • Is grant-funded: internally (e.g., DRI, Abernethy, FS&R, Dean Rusk), or externally (e.g., NSF, NIH).

Documents & Forms

Does my project proposal need to be submitted to the IRB? (PDF) (student, faculty and staff research projects)

Does my course-related project need to be submitted to the IRB? (PDF) (Faculty)

IRB Application for Exempt Research (DOC)

Standard IRB Application for Non-Exempt Research (DOC)

Faculty Sponsor Assurance Form (DOC)

Sample Informed Consent/Assent and Debriefing Form

Modification of an Approved Protocol (DOC)

Reporting Adverse or Unanticipated Events (DOC)