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Exempt Review

Some projects such as clinical trials require ongoing IRB oversight (otherwise known as “Full Review”), while others are eligible to be declared exempt from further review.  Researchers who plan to conduct human subject research that they believe is exempt from IRB review must nevertheless submit a full application to the IRB prior to conducting research activities or contact one of the IRB co-chairs to render a written decision about whether the project is human subjects research that needs review.  Federal regulations state that only the IRB may determine whether a research activity is exempt from full review (45 CFR §46.101).

Exempt from further review are projects that involve no deception or coercion of the participants, involve risks no greater than those ordinarily encountered in daily life, and fall into one of the following categories:

  • The activity is conducted in an established educational setting and involves normal education practices in order to evaluate or compare educational instructional practices, curricula, or methods.
  • The research involves the use of standard educational tests (cognitive, diagnostic, aptitude, or achievement) and information taken from those tests will be recorded so that participants cannot be identified directly.
  • The research involves surveys, interviews, or observation of public behavior, the responses will be recorded so that either: a) participants cannot be identified directly or indirectly by their answers or b) the responses could not damage or harm a subject’s interests, including financial interests, employability, or reputation.
  • The research is limited to using existing data to which the investigator has access, and the information will be recorded so that participants cannot be identified directly or indirectly.

Full Review

Full reviews will be conducted in accordance with the guidelines provided by the Office for Human Research Protections (OHRP) of the US Department of Health and Human Services (Protection of Human Subjects, 45 CFR §46.109). The PR will lead the discussion of the proposal at meetings of the IRB. The PR will complete a full review form that reports the decision of the IRB and advises the principal investigator of required changes to the protocol or consent forms. The same PR will lead annual and ongoing reviews of revised proposals and consent forms.

In some cases, the IRB may require submission of research reports and analyses as part of the full review. If Spelman College is to be mentioned in any publications or presentations, a preliminary draft of the manuscript must be submitted to the IRB.