Purpose of an Institutional Review Board
An institutional review board (IRB) is a formally designated committee that reviews and monitors research involving human subjects to ensure the rights and welfare of participants are protected. RHIA candidates should understand IRB composition requirements, review categories, and the criteria boards use to approve research, since IRB oversight frequently intersects with HIM's role in managing research data access.
IRB Membership Requirements
- At least five members with varying backgrounds to promote complete and adequate review
- At least one member whose primary concerns are scientific
- At least one member whose primary concerns are nonscientific, such as an ethicist or clergy member
- At least one member who is not affiliated with the institution and has no immediate family member affiliated with it
Categories of IRB Review
Research proposals are assigned to one of three review categories based on the level of risk involved. Exempt research involves minimal risk and meets specific regulatory categories, such as certain educational testing or analysis of existing, publicly available, or de-identified data. Expedited review applies to minimal-risk research that does not qualify for exemption but involves procedures on a recognized expedited category list, allowing review by a single designated reviewer rather than the full board. Full board review is required for research presenting more than minimal risk, requiring convened board discussion and majority vote.
Approval Criteria
To approve research, an IRB must determine that risks to subjects are minimized and reasonable in relation to anticipated benefits, that selection of subjects is equitable, that informed consent will be sought and appropriately documented, and that adequate provisions exist to protect subject privacy and maintain confidentiality of data, an area where HIM expertise is particularly valuable during protocol review.
Continuing Review and Adverse Events
IRBs must conduct continuing review of approved research at intervals appropriate to the degree of risk, but not less than annually, and must have procedures for promptly reporting unanticipated problems involving risks to subjects. HIM professionals may support this process by helping investigators track and document data-related incidents affecting research participants.
Exam Tips
Expect questions asking you to classify a described research scenario into exempt, expedited, or full board review. Also expect questions on minimum IRB composition requirements, since the unaffiliated member and nonscientific member requirements are commonly tested details.
Key takeaway: IRB structure and review categories protect research subjects, and RHIA candidates should be able to classify scenarios correctly within the Compliance domain.