PHS IRB Studies

Full Board Review – Studies involving more than minimal risk merit Full Board Review. These studies require a review of the proposed research at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members present.

Expedited Review –Research involving no more than minimal risk and/or for minor changes in approved research. Expedited review is performed by the IRB chair, a designated voting member, or a group of voting members rather than by the entire convened IRB.

Exempt Review –Low-risk research is exempt from the requirements in the Federal regulations concerning IRB review and approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights. The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution. Researchers should check with their institution's guidelines or IRB policies to determine who will make the determination of exemption for a proposed study.

The following are the six exempt categories as listed in 45 CFR 46.101(b):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
   1. Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to them.
   2. Any disclosure of the human participant's responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
   1. The participants are elected or appointed public officials or candidates for public office.
   2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified, directly or through identifiers linked to them
5. Research and demonstration projects conducted by or subject to the approval of Federal department or agency heads and designed to study, evaluate, or otherwise examine public health benefit or service programs
6. Taste and food-quality evaluation and consumer acceptance studies

These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or newborns. Further, the exemption in item 2 above does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed. Interviews, surveys, and interactive observations are not exempt, while educational tests and noninteractive observations are.