IRB – Levels of Review

Levels of Review

The IRB recognizes three types of research applications: 1) Exempt Review, 2) Expedited Review, and 3) Full Review. The table below details the approximate time required for complete applications to be reviewed and a decision reached.   

 
Once a New Protocol Application is submitted, the IRB reviews and categorizes each project according to the following guidelines:

1. Exempt Review:
     This level of review involves minimal risk studies only. Research activities involving human subjects must qualify under one or more of the following six exempt categories:

1. The research is conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on the effectiveness of among instructional techniques, curricula, or classroom management methods).
2. The research involves 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 subjects can be identified, directly or through identifiers linked to the subjects; AND (2) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. In other words, anonymity is required for exemption ONLY if disclosure outside the research “could reasonably place the subjects at risk.” Conversely, in this context, anonymity satisfies the criterion for exemption even if disclosure outside the research could reasonably place the subjects at risk.
3. The research involves public officials, either elected or appointed, or candidates for public office, using survey procedures, interview procedures or observation of public behavior. This includes research that is not anonymous and that involves sensitive questions.
4. The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available OR the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, either directly, or through identifiers linked to the subject).
5. The research (including demonstration projects) is conducted by, or subject to, the approval of department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
6. The research involves taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives that are consumed, or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

Note: Research on vulnerable populations including pregnant women, children, prisoners, and others not in a position to give informed consent, may not be exempt.

2. Expedited Review:
     This level of review is for research involving no more than minimal risk. It may also be used for minor changes in previously approved research during the period for which approval is authorized. One or more IRB members will review the application in lieu of the full board. The research must involve only procedures listed in one or more of the following 5 categories:

1. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
2. Collection of data from voice, video, digital, or image recordings made for research purposes.
3. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
4. Continuing review of research previously approved by the convened IRB as follows:
   1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
   2. where no subjects have been enrolled and no additional risks have been identified; or
   3. where the remaining research activities are limited to data analysis.
5. Continuing review of research where categories one (1) through four (4) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

3. Full Review:
     Any protocol that MAY be greater than minimal risk must be reviewed by the full board. This level of review is used for greater than minimal risk projects or those projects that do not meet the exempt or expedited categories. The IRB discusses the risks vs. benefits of the research and assures that the protocol is compliant with federal regulations.

Research which meets any of the following criteria may need Full Review:

1. Any research in which IRB reviewers (a) conclude that a full review is required or (b) conclude that the research should not be approved.
2. The research involves individuals under the age of 18.
3. The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subjects’ financial standing, employability, insurability, or reputation.
4. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior) AND the confidentiality of a participant’s responses cannot be assured (e.g., audio or videotaped interviews, or a “key” which would allow someone to match a set of responses with a particular participant).
5. The research involves prisoners, fetuses, pregnant women, and the seriously ill, or mentally or cognitively compromised adults as subjects.

What is minimal risk?

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR 46.102)