Categories of Research Eligible for Expedited IRB Review
This guidance outlines the categories of research that may be reviewed by Institutional Review Boards (IRBs) through an expedited review procedure. It applies to research activities that present no more than minimal risk to human subjects and involve only procedures listed in the specified categories. The guidance aims to streamline the IRB review process for qualifying research while maintaining appropriate human subject protections.
What You Need to Know? 👇
What is the expedited review procedure for IRBs and when can it be used?
The expedited review procedure allows IRB chairpersons or designated experienced reviewers to review certain minimal risk research activities instead of requiring full board review. It can be used for nine specific categories of research involving no more than minimal risk to human subjects.
Does expedited IRB review eliminate the need for informed consent in medical device studies?
No, expedited review and informed consent are completely separate requirements. All research, regardless of review type, must conform to applicable informed consent requirements unless specific waiver conditions are met under federal regulations.
What blood collection procedures qualify for expedited IRB review?
Blood collection by finger stick, heel stick, ear stick, or venipuncture qualifies when amounts don’t exceed 550ml in 8 weeks for healthy adults (≥110 pounds) or 50ml/3ml per kg for others, with maximum frequency of twice weekly.
Can medical device studies using cleared/approved devices undergo expedited review?
Yes, if the device is FDA cleared/approved and used according to its labeling, or if no IDE is required. However, studies evaluating safety/effectiveness of devices or using devices for new indications generally require full board review.
What types of biological specimen collection are eligible for expedited review?
Noninvasive collection methods including hair/nail clippings, saliva, excreta, buccal swabs, dental plaque (routine scaling only), and specimens obtained during routine medical care like placenta or amniotic fluid at delivery.
When can continuing review of previously approved research use expedited procedures?
When research is closed to new enrollment with only long-term follow-up remaining, when no subjects have been enrolled, or when only data analysis activities remain, provided the research involves minimal risk.
What You Need to Do 👇
Recommended Actions
- Establish clear procedures to determine if research qualifies for expedited review based on risk level and categories
- Implement a screening process to verify research meets all applicability criteria before expedited review
- Document rationale for using expedited review procedures for each qualifying protocol
- Ensure appropriate protections for subject privacy and confidentiality are in place
- Maintain standard informed consent processes regardless of review type
- Create checklists to verify research meets specific category requirements
- Establish process for continuing review of previously approved research
- Train IRB members on proper application of expedited review procedures
- Develop documentation templates specific to expedited review process
- Implement monitoring system to ensure ongoing compliance with expedited review requirements
Key Considerations
Clinical testing
- Clinical studies of drugs and medical devices only when:
- Research on drugs not requiring an IND application
- Research on medical devices not requiring an IDE or cleared/approved devices used according to labeling
Non-clinical testing
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture with specific volume limits
- Collection of biological specimens by noninvasive means
- Collection of data through noninvasive procedures routinely used in clinical practice
- Research involving materials collected for non-research purposes
Human Factors
- Research on individual or group characteristics/behavior including:
- Perception, cognition, motivation studies
- Language and communication research
- Cultural beliefs/practices studies
- Social behavior research
- Human factors evaluation
Safety
- Research must present no more than minimal risk to subjects
- Cannot be used for classified research
- Must consider risks related to privacy and confidentiality
- Must protect subjects from potential criminal/civil liability risks
Other considerations
- Standard informed consent requirements apply regardless of review type
- Continuing review of previously approved research under specific conditions
- Age of subjects does not affect applicability except where noted
- Must protect subjects’ financial standing, employability, insurability and reputation
Relevant Guidances 🔗
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Written Procedures for Institutional Review Boards (IRBs): Content and Organization
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
Related references and norms 📂
- 21 CFR Part 312: Investigational New Drug Application
- 21 CFR Part 812: Investigational Device Exemption
- 45 CFR 46.110: Expedited review procedures for certain kinds of research
- 21 CFR 56.110: Expedited review procedures for certain kinds of research