An IRB must have a minimum of 5 members, including a member with scientific expertise, a member whose area of expertise is nonscientific, and a member who is unaffiliated with the institution. IRB members must be qualified by expertise and experience and represent different races, genders, and cultural backgrounds (45 CFR §46). For any IRB action, the presence of a quorum and the recusal of any member with a conflict of interest are required. The IRB must be independent in its decision-making. While a protocol approved by an IRB may also be reviewed by institutional officials who can disapprove the protocol, institutional officials cannot approve a protocol that was not approved by the IRB.

There are a number of options regarding which IRB will review a given research project. While most research and academic institutions have their own IRBs, they may also use an external IRB, which may include a freestanding independent IRB or an IRB at another institution. Since 2016, the use of external IRBs has increased owing to the issuance of an NIH policy requiring the use of a single IRB (sIRB) for NIH-funded multisite research (NIH 2016) and for cooperative research as set forth in the revised Common Rule (45 CFR §46).

Use of an external IRB requires a formal reliance agreement between the institution doing the research and the IRB itself. The IRB completing the review is called the “reviewing IRB,” and the institution relying on the external IRB is called the “relying institution.”

The use of an external IRB or sIRB is discussed in Section 4 of this chapter, Working With an External IRB.

OHRP is an office within the US Department of Health and Human Services that oversees the implementation of the Common Rule. The OHRP website includes decision charts to help researchers determine when IRB review is required under the Common Rule. Note that FDA regulations have a different definition of activities subject to oversight, referred to as “clinical investigations” rather than “research,” and they do not follow the OHRP decision charts (21 CFR §50 and §56). Therefore, even if an activity does not meet the 4 OHRP criteria listed below, if the activity is FDA-regulated, evaluating an investigational drug, biologic, or device, it may still need IRB review.

See Section 5 of this chapter, FDA Regulations and the IRB, for more information about FDA regulations.

If the activity meets the following 4 criteria, the activity requires IRB review.

1. The activity is research, defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
2. The activity involves human subjects, defined as “a living individual about whom an investigator (whether professional or student) conducting research:
   1. “Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
   2. “Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
3. The activity is supported or conducted by a relevant federal agency. As noted above, in most institutions, even if the answer to this question is no, the institution will still require IRB review.
4. The activity is not in an exempt category.

There are several categories of research that are exempt from review under the federal regulations. In general, the categories include the following:

• Some educational procedures
• Many surveys and interviews
• Benign behavioral interventions in adults only
• Secondary research using existing data and biospecimens
• Taste and food quality studies

Note, however, that there are detailed conditions regarding privacy and confidentiality that must be met before research meets an exemption category. The best advice is to consult with the responsible IRB for specific advice.