Chapter 2

Exemptions

In addition to IRB review, WCG IRB offers a service to determine if research is exempt from, or does not require, IRB review.

Research that is not a clinical investigation of an FDA-regulated product (drugs, devices, biologics, food including supplements, cosmetics, etc.) may not require IRB review. Projects that do not require IRB review include where all research activities:

  1. Do not involve a human subject [45 CFR 46.102(e)(1)].
  2. Do not meet the definition of research [45 CFR 46.102(l)].
  3. Fit in the categories of research that are exempt from IRB review (45 CFR 46.104).

OHRP has decision charts here to help you determine if research requires IRB review. Please note, these charts do not replace consideration of the full regulation and other institutional, sponsor, or local requirements.

OHRP also notes here that the regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). However, OHRP recommends that, because of the potential for conflict of interest, investigators not be the ones who make a determination that human subjects research is exempt. In addition, many publications require some form of IRB determination for research results to be published.

If you would like WCG IRB to determine if research is exempt from, or does not require IRB review, please submit through the “new study” pathway on ClinSphere® eReview Manager  or WCG IRBNet. Please note that submission of an investigator is not required for exempt research to be reviewed/approved or conducted.

If research is determined to be exempt or not human subject research, that determination will be communicated in IRB outcome documents in the same manner as IRB review, through an approval on the Certificate of Action

WCG will review and make exemption determinations only for prospectively conducted studies and will not review a study which is already completed or started.

Single patient case report publication/presentation in a de-identified manner can be reviewed for non-human subject research Exemption (NHSR). Also see section on Single Patient Case Reports – Dissemination of Clinical Study Data by Investigators for Education and Research Purposes in this Guide.

For WCG-determined IRB exempt studies, sponsors and investigators may use their own independent translation services to translate WCG-reviewed materials, and submission of the translated materials to WCG is optional.