This document discusses the different levels of review by an Institutional Review Board (IRB). It outlines that IRBs are responsible for protecting the rights and welfare of research subjects. There are three levels of IRB review: exempt, expedited, and full-board. Exempt review involves minimal risk studies that fit defined categories. Expedited review also involves minimal risk but fits categories allowing for a streamlined review process. Full-board review is required for studies involving more than minimal risk.

1. Levels of IRB Review
Weam M. Banjar; DDS., MS
July 14, 2019

2. OUTLINE
• What is the IRB?
• Responsibilities
• Levels of IRB review

3. What is an IRB?
• Institutional Review Board
• An American term
• Equivalent for Research Ethics Committee and Ethical Review
Board in other countries
• A committee whose primary responsibility is to protect the rights
and welfare of research subjects

4. Reviewers Worksheet
• Introduction, specific aims and background:
• Are the specific aims clearly specified?
• Are there adequate preliminary data to justify the research?
• Is there appropriate justification for this research protocol?
• Scientific design:
• Is the scientific design adequate to answer the question?
• Are the objectives likely to be achievable within a given time
period?
• is the study design described and adequately justified?

5. Reviewers Worksheet
• Eligibility criteria:
• Are eligibility criteria clearly specified and appropriate?
• If vulnerable population were included or excluded, is this
justified?
• Data management and statistical analysis:
• Is the rationale for the proposed sample size reasonable?
• Are the plan for data management and statistical analysis defined
and justified, including the use of stopping rules and end points?
• Are there adequate provision for monitoring data (Data safety
monitoring board (DSMB))

6. Reviewers Worksheet
• Potential risks, discomforts, and benefits for subjects:
• Are the risks and benefits are adequately identified, evaluated
and described?
• Are potential risk minimized and likelihood benefits maximized?
• Is the risk/benefit ration acceptable for proceeding with the
research?
• If children are involved, which regulatory category of benefit does
the protocol fall within, and are all criteria within the category
adequately addressed?

7. Reviewers Worksheet
• compensation, and costs for subjects:
• Is the amount or type compensation or reimbursement
reasonable?
• Are there adequate provision to avoid out-of-pocket expenses by
research subjects or is there sufficient justification to allow
subjects to pay?
• If children or adolescents are involved, who receives the
compensation, and is this appropriate?

8. Reviewers Worksheet
• Privacy and confidentiality:
• Are there adequate provisions to protect the privacy and ensure
the confidentiality of the research subjects?
• Are there adequate plans to store and code the data?
• Is the used of identifies or links to identifies necessary and how is
this information protected?
• Informed consent/ assent:
• Are all elements of informed consent contained in the consent
document?
• Is the process of obtaining consent adequately described?
• Is assent required?
• Is waiver or modification of consent possible?

9. Reviewers Worksheet
• Other issues:
• Are adequate references provided?
• When should the next review occur? If frequent reviews are
necessary, how should the interval be determined?

10. Levels of IRB Review
• Exempt Review:
• Studies involve less than “minimal risk”
• Fits one of six categories defined by federal regulations (45CFR-46)
1. Education research
2. Surveys, interviews, educational tests,
public observations (that do not involve children)
3. Benign behavioral interventions
4. Analysis of previously-collected, identifiable info/specimens
5. Federal research/demonstration projects
6. Taste and food evaluation studies

11. Levels of IRB Review
• Expedited Review:
• Not greater than “minimal risk”
• Fits one of nine categories defined by federal regulations (45CFR-46)
• Clinical studies of drugs and medical devices only when certain conditions are met
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in
certain populations and within certain amounts
• Prospective collection of biological specimens for research purposes by noninvasive
means
• Collection of data through noninvasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding procedures involving x-rays
or microwaves.
• Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for non-research purposes
• Collection of data from voice, video, digital, or image recordings made for research
purposes
• Research on individual or group characteristics or behavior or research employing
survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies

12. Levels of IRB Review
• Full-board Review:
• Studies involve more than “minimal risk”
• Not covered under other revision categories
• Example: interventions involving physical or emotional
discomfort, studies involve sensitive data