Institutional Review Board

Almost all research involving human subjects requires IRB review. Truly exempt research is rare and limited to: (1) research using de-identified existing data (no identifiers, no way to link data back to individuals); (2) research using publicly available information without identifiers; (3) some quality improvement activities (but not if findings will be published or contribute to scholarly knowledge—then it is research requiring review). If unsure, contact your institution's IRB office—they can advise. Do not assume your research is exempt without explicit confirmation from IRB; proceeding with research that should have been reviewed can invalidate data and result in institutional sanctions. When in doubt, submit for review; IRB can quickly determine exemption status.

Timeline depends on review type: EXEMPT DETERMINATION: 1–2 weeks; EXPEDITED REVIEW: 2–4 weeks; FULL BOARD REVIEW: 1–3 months (depends on IRB agenda, protocol complexity, revisions needed). Some institutions allow longer waits during high-volume periods. Do NOT begin subject enrollment before receiving written IRB approval. Any data collected before approval may not be usable, and your institution risks regulatory sanctions. Plan accordingly: submit protocol to IRB well in advance of intended study start date (typically 2–3 months buffer). If research is urgent (e.g., pandemic response), some IRBs can expedite review; contact IRB office to discuss options.

ANY material change to an approved protocol requires IRB approval before implementation. Material changes include: (1) changes to study procedures (adding a procedure, changing dose, altering duration); (2) changes to study population (e.g., lowering age limit, adding prisoner population); (3) changes to informed consent (revising risk descriptions, adding new risks, changing compensation); (4) changes to data handling (longer retention, secondary use, sharing with outside researchers). Minor administrative changes (e.g., correcting typo in protocol, updating researcher address) may not require approval; contact IRB office for clarification. Submit protocol amendment to IRB describing change and justification. IRB reviews amendment (typically expedited process, 1–2 weeks) and either approves change, approves with conditions, or requests modifications. You may not implement change until IRB approves.

Submit a complete protocol addressing all IRB review criteria: (1) RESEARCH QUESTION: Clear, specific statement of what you are studying and why (purpose and significance). (2) STUDY DESIGN: Detailed description of what subjects will do—procedures in chronological order, time commitment, frequency of visits. (3) SUBJECT POPULATION: Size (sample size with justification), age range, inclusion/exclusion criteria. (4) RISKS AND BENEFITS: Describe all foreseeable risks (physical, psychological, privacy, economic, social); for each risk, describe mitigation strategies. Describe benefits (if any) to subjects and potential benefits to science/medicine. (5) INFORMED CONSENT: Attach draft consent form addressing all required elements (purpose, procedures, risks, benefits, confidentiality, withdrawal rights, researcher contact, IRB contact). Describe consent process (will you discuss in person? How will you assess understanding?) (6) CONFIDENTIALITY: How will identifiable data be handled? Who has access? How long retained? Will data be de-identified? How will biological samples be stored? (7) RESEARCHER QUALIFICATIONS: Your CV demonstrating research experience; for studies of vulnerable populations, describe any special training. (8) IRB CHECKLIST: Complete IRB's own submission form/checklist. Do not leave items blank; if not applicable, state 'N/A' with brief explanation. Contact IRB staff before submission for guidance or to discuss complex issues. Submit all attachments and forms together; incomplete submissions delay review.

Depends on specific characteristics. Minimal-risk OBSERVATIONAL research with NO identifiable information (you do not collect/record identifiers, cannot link observations to individuals) and involving only observation of publicly observable behavior is often exempt from review. Example: sitting in a mall and observing crowd flow patterns without recording faces or identifying individuals. However, if you collect ANY identifying information (recording faces, asking names, noting which individuals you observed), or if you ask questions (not mere observation), IRB review is required. If unsure, submit description to IRB office; they can quickly determine exemption status. Do not assume observation without identifying data is automatically exempt—context matters.