Institutional Review Board: Types of Review

Typically, NHSR determinations do not require review by a member or board review, therefore such reviews are made by IRB staff. Timeline: Three to five days.

A nonhuman subjects determination form should be completed and submitted to the IRB for an official determination and letter if: (i) you are uncertain whether you will be conducting human subjects research; or (ii) you believe you will not be conducting human subjects research but your sponsor or a publication requires certification. Err on the side of caution and consult the IRB if you’re uncertain whether the study is human subjects research.

Read more about how to determine if a study involves human subjects

Download the nonhuman subjects research determination form

The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. At Children’s, only the IRB has authority to determine that a study is exempt from federal regulations and from IRB review and approval.

When the IRB notifies a principal investigator (PI) that a research project is exempt, it also notifies the PI that the research is approved for initiation or continuation. Exempt studies don’t require annual re-review. Timeline: Five to ten days.

In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption, and it cannot place subjects at greater than minimal risk. If the research involves prisoners, it does not qualify for exemption from federal regulations and IRB review.

If a research study qualifies for exemption, then it is exempt from the requirements set forth in Regulations for the Protection of Human Subjects (Title 45 Part 46 of the Code of Federal Regulations), such as the requirement for a written informed consent document.

• If a research study does not qualify for exemption, then the research activity is not exempt from laws and the research must conform to the canon of sound research ethics.
• If you are considering changes to an exempt study that could make it nonexempt, then consult with the IRB as to whether planned changes might make that study nonexempt human subjects research.

Read the HHS policy for protection of human research subjects

The Office for Human Research Protections (OHRP) provides more information about exempt review categories in its decision charts:

• Chart 2: Is the Human Subjects Research Eligible for Exemption?
• Chart 3: Does Exemption 45 CFR 46.104(d)(1) for Educational Practices Apply?
• Chart 4: Does Exemption 45 CFR 46.104(d)(2) for Educational Tests, Surveys, Interviews or Observation of Public Behavior Apply?
• Chart 5: Does Exemption 45 CFR 46.104(d)(3) for Benign Behavioral Interventions Apply?
• Chart 6: Does Exemption 45 CFR 46.104(d)(4) for Secondary Research that Does Not Require Consent Apply?
• Chart 7: Does Exemption 45 CFR 46.104(d)(5) for Public Benefit or Service Programs Apply?
• Chart 8: Does Exemption 45 CFR 46.104(d)(6) for Food Taste and Acceptance Studies Apply?

Under an expedited review procedure, the IRB Chair—or one or more experienced reviewers designated by the Chair from among the IRB members—reviews the research protocol. Timeline: One to two weeks.

Expedited review doesn’t require convening a meeting of the IRB. The term "expedited" is misleading: This type of review isn’t faster or less detailed, it just requires fewer reviewers for approval.

IRB reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. A research activity may be disapproved only after review by the convened IRB.

In general, research may be considered for expedited review if it:

• Involves no more than minimal risk
• Doesn’t include intentional deception
• Doesn’t use sensitive populations or topics
• Includes appropriate consent procedures

Expedited review may also be used for amendments or modifications when minor changes have been made to a previously approved research project.

Studies that qualify for expedited review still require a full application form and an informed consent statement. As with all research, researchers must engage in practices that minimize risk, maximize benefit and ensure confidentiality.

The current list of research categories that qualify for an expedited review process was set by the Federal Government in 1998; neither Children’s nor the IRB is able to make changes to—or extrapolate from—this list. For example, an expedited review procedure cannot be used for the initial review of research that involves minimal risk but doesn’t appear in the Federal Register’s categories of published research or research that involves greater than minimal risk.

Learn more about OHRP expedited review categories

Human subjects research that isn’t classified as exempt or expedited requires review by the full IRB at a convened meeting, which takes place once a month. A full board meeting may be canceled or rescheduled for various reasons, such as an insufficient number of applications requiring full board review, a holiday designated by Children’s or an inability to secure a quorum.

Before a project can be submitted for full board review, the project must pass the IRB staff screening that checks for completeness of forms, Collaborative Institutional Training Initiative (CITI) Program certification, required materials, adherence to policies and regulations, and more.

All protocols submitted for full board review are assigned to one or more primary (or secondary) reviewers who will present the protocol to the full IRB for discussion. These reviewers will review the protocol, the proposed informed consent documents and any recruitment materials, including advertisements intended to be seen or heard by potential subjects. Timeline: Six to eight weeks.