Types of IRB Review

Institutional Review Board at the Minnesota Department of Health

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Preliminary review
Exempt research
Expedited review
Full board review
Continuing review

Some research that involves human subjects is exempt from the regulations requiring IRB review, because it poses little to no risk to participants. The IRB administrator and IRB chair determine whether research is exempt. Studies that involve surveys or interviews on non-sensitive topics or rely on existing data are commonly deemed exempt.

• Related: 45 CFR 46: Exemptions (2018 Requirements) (US Department of Health and Human Services)

The IRB will use an expedited review process for research that involves no more than minimal risk, and for which the human subjects' involvement falls into one of the categories identified by the U.S. Department of Health and Human Services. The IRB administrator and IRB chair determine whether research is eligible for expedited review, and if so, the administrator will ask an IRB member to conduct the review.

• Related: Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) (US Department of Health and Human Services)

A full board review is one in which the study must be discussed and approved by majority vote at a meeting of the board. The board will review proposals at regularly scheduled IRB meetings. At the board meeting, the board will assign one of the following status types to the study:

1. Approval
2. Approval pending stipulations
3. Deferral
4. Disapproval

A majority vote determines the proposal's status. Investigators will receive written notification of the study’s status within one week after the meeting. If applicable, the notice will include a detailed description of stipulations that must be met before the IRB will grant approval. "Approval" status can be granted only after receipt and approval of the investigator’s written response to each stipulation. The IRB will then notify the Principal Investigator (PI) that the study has received final approval. Researchers may not begin data collection until the IRB administrator and primary reviewer have reviewed and approved all stipulations and other requested materials.

In addition to formal stipulations, which must be met before data collection begins, the IRB may also make "suggestions" and "comments" when reviewing applications and study materials, defined as follows:

Stipulations: Approval with conditions that are mandatory (must be met) before final IRB approval and the beginning of research. The IRB will state any stipulations in its letter to the principal investigator.

Suggestions: These are recommendations to the researcher. Responding to these suggestions is encouraged but not mandatory for final IRB approval. The IRB will state any suggestions in the letter to the principal investigator.

Comments: The IRB may include comments in the letter, especially if they relate to a stipulation or suggestion. The PI is encouraged but not required to respond to these comments for final IRB approval.

The IRB must review a research project until the PI notifies the IRB that the study is complete or no longer active. Studies that have completed collecting data or are collecting only routine follow-up medical care data are considered complete. IRB approval for a research project is valid for no more than one year. The federal regulations require IRBs to conduct continuing reviews of research at intervals appropriate to the degree of risk, but not less than once a year.

Studies that required full IRB review initially and are still active require full IRB review for continuation. The review must take place at a convened meeting of the IRB and action on a study must be approved by a majority of the members present. The researcher must meet the IRB's stipulations, if any, before approval for continuation is granted.

IRB applications that were reviewed initially using the expedited process may be re-reviewed using the expedited process as long as the degree of risk associated with the study has not increased. Research deemed exempt from IRB review does not require continuing review. 

The IRB reviews research related to public health, which typically carries a lower level of risk to human subjects than clinical trials or drug and medical device studies. Therefore, an annual re-review is sufficient unless, at the IRB’s discretion, there are adverse events or other evidence to warrant more frequent or closer scrutiny. The IRB has the authority to observe or have a third party observe the consent process and the research. In full board reviews, the board will determine whether the risk is sufficient to require monitoring and what is needed to address the risk. The IRB will implement a monitoring plan when one is warranted.