The Three Types of IRB Review
This page is intended to provide general guidelines as to the three types of IRB Reviews.
1. EXEMPT REVIEW
If the proposed research involves any of the following, it may qualify for exempt status.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices such as research on, or comparison among, instructional strategies, curricula or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if the data are recorded so that subjects cannot be identified either by use of names or any special coded identifiers.
- Research involving surveys, interviews, or observations of public behavior except where all of the following conditions exist. If subjects can be identified directly through an identification code, an exemption is allowable only if the subject’s responses (should they become public) will not place the subject at risk of criminal or civil liability, or be damaging to the subject’s financial standing or employability AND the subject’s responses do not deal with sensitive aspects of personal behavior, for example, illegal conduct, drug use, sexual behavior, alcohol abuse, cheating, etc.
- Research involving the collection and 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 investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects
- Research using survey or interview procedures when the respondents are elected or appointed officials or candidates for public office.
2. EXPEDITED REVIEW
If the proposed research presents no more than minimal risk and involves any of the following, it may qualify for expedited review.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- 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.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as for medical treatment or diagnosis).
- Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving X-rays or microwaves.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) research on medical devices for which (i) an investigational device exemption application (21CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Minor changes to research previously approved by the SCCC’s IRB may also qualify for expedited review.
3. FULL REVIEW
If the proposed research does not qualify for Exempt or Expedited Review as defined above, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to full review.
- Pregnant women
- Seriously ill people
- Decisionally impaired people
- Procedures that might cause physical harm.
- Procedures that might cause significant psychological/emotional distress.
- Collection of information about highly sensitive topics.
- Collection of information about illegal behavior.
- Collection of information that could seriously harm the participant legally, socially, financially etc. if other people could identify them.
- Children under the age of 18
To assist in making a decision about which type of review is appropriate, contact Dr. Michael Roggow, Chair of the IRB, prior to submitting a proposal.