TYPES OF IRB REVIEW
There are three possible IRB review procedures: limited review, expedited review or convened committee review. The type of review is determined per the federal guidelines presented in 45 CRF 46 and by the UMES IRB.
The following definitions, per 45 CFR 46.102, are provided to assist investigators with the preparation of their application to the IRB.
- Minimal risk is defined to be 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.
- Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.
- A human subject is a living individual about whom an investigator conducts research.
- Children are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research.
Limited IRB Review
Limited IRB review is provided for exempt, minimal risk research. Research that is exempt falls into eight categories (45 CFR 46.104). At, UMES, exempt status is designated by the IRB. These eight categories are exempt from the other provisions of the regulations at 45 CFR 46. The eight exempt categories are summarized in the following statements.
- Research conducted in established or commonly accepted educational settings.
Category 2: Research that only includes interactions involving education tests.
Category 3: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses.
Category 4: Secondary research for which consent is not required.
Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency.
Category 6: Taste and food quality evaluation and consumer acceptance studies.
Category 7: Storage or maintenance for secondary research for which broad consent is required.
Category 8: Secondary research for which broad consent is required.
Expedited Review
Research activities that present no more than minimal risk to human subjects may be reviewed through the expedited review procedure (45 CFR 46.110 and 21 CFR 56.110). An expedited review procedure consists of a review of the research by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. There are nine categories of research that are eligible for an expedited review. The following is a summary of each category (HHS OHRP Expedited Review Category (1998); https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html#footnote1).
Category 1: Clinical studies of drugs and medical devices only when: (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 (21 CFR Part 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.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.
Category 4: Collection of data through noninvasive procedures.
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7: 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.
Category 8: Continuing review of research previously approved by the convened IRB as follows:
Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) 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.
Convened Committee Review
A convened review is required when the research presents greater than minimal risk research.
