Emory University IRB Expedited Review Applicability Criteria and Approval Categories
The Emory IRB uses the following guide to assist members in determining which studies may be reviewed using the expedited procedure. This guidance is derived from the list of categories published in the Federal Register. Federal regulations regarding Expedited review can be found in 45 CFR 46.110. The Department of Health and Human Services (DHHS) lists the expedited categories on their website alongside additional information on the review process.
Studies must meet all of the following applicability criteria:
- The current and future research procedures present no more than minimal risk to participants. Does not apply to category (8)(b)
- The identification of the participants or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Does not apply to category (8)(b)
- The research is not classified.
AND fit into one of the following categories:
Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
Research on medical devices where:
- An investigational device exemption application (21 CFR Part 812) is not required; OR
- 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, ear stick, or venipuncture from healthy, non-pregnant adults where:
- The participants weigh at least 110 pounds; AND
- The amounts drawn will not exceed 550 ml in an 8-week period; AND
- Collection does not occur more frequently than 2 times per week.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from other adults and children considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected where:
- The amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period; AND
- Collection will not occur more frequently than 2 times per week.
Category (3): Prospective collection of biological specimens for research purposes by noninvasive means.
Category (4): Collection of data through noninvasive procedures routinely employed in clinical practice where:
- The procedures do not involve general anesthesia or sedation; AND
- The procedures do not involve x-rays or microwaves; AND
- If medical devices are employed, they are cleared/approved for marketing.
- Research involving materials (data, documents, records, or specimens) that have been collected; OR
- Research involving materials (data, documents, records, or specimens) that 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.
- 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:
- The research is permanently closed to the enrollment of new participants; AND
- All participants have completed all research-related interventions; AND
- The research remains active only for long-term follow-up of participants.
- No participants have been enrolled; AND
- No additional risks have been identified.
- The remaining research activities are limited to data analysis.
- 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