Types of IRB Review

Depending on the level of risk of the research protocol and the participant population, IRBs may conduct either full board review or expedited review.

Expedited Review

For certain kinds of research involving no more than minimal risk, and for minor changes in approved research, the IRB Chair or a designated voting member or group of voting members review the proposed research rather than the entire IRB. It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others.

Full Board Review

When full board review is necessary, the research proposal is presented and discussed at a 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 voting members present.  (Note that, in effect, an abstention counts as a negative vote.)

Research Exemptions from IRB Review

Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared exempt from review by the IRB. *This determination must be made by the IRB prior to the research being conducted.

Certain 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.

Note that when research is conducted in countries outside the United States by foreign Principal Investigators, the rules for IRB review and exemption may differ if the bases for the institutional assurances are founded upon documents other than the Belmont Report and the Common Rule.  Note that research conducted in countries outside the United States by U.S.-based Principal Investigators is not affected by this potential modification.  Researchers should review the section covering international research for further information and always consult with their institution’s IRB.