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Human Subject Research: FAQs

Institutional Review Board (IRB) FAQs 

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What is an IRB and what is its purpose?
A multidisciplinary board that reviews human-subjects research for participant protection and regulatory compliance. See CFR Title 45, Part 46; Title 21, Parts 50 & 56.
When is an IRB required?
Whenever your activity meets the definitions of “research” and “human subjects.” When in doubt, contact your local IRB.
Where can I learn more about IRBs?
Many institutions require CITI training. See:
How do I find an IRB?
Most universities/medical centers have IRBs. Search the OHRP database of registered IRBs.
Are there commercial IRBs?
Yes. See CIRCARE or search OHRP.
Should my clinic set up its own IRB?
Usually not cost-effective; requires federal registration (FWA), qualified staff, and ongoing compliance education.
Publishing without IRB approval?
If human subjects were involved, reputable journals typically require IRB approval and informed consent documentation (see ICMJE guidelines).
What information will the IRB require?
Comprehensive protocol (title, purpose, duration, recruitment, site, methods), risk/benefit assessment, data protection, and informed consent materials. See NIH’s IRB Criteria.
What is a Letter of Informed Consent?
A document participants sign acknowledging understanding of study purpose, risks, benefits, confidentiality, injury care, and participation requirements/withdrawal. See NIH consent guidance.
Will my protocol be denied?
Revisions are common. Most O&P research is “no greater than minimal risk.” Collaborating with experienced IRB institutions improves success; data security/privacy are key concerns.
How long does IRB approval take?
A few weeks to a couple of months; complete applications and communication with staff help avoid delays.
When may I begin data collection?
Only after written IRB approval—no recruitment, collection, or analysis before approval.
Can IRB approval be retroactive?
No—federal regulations do not allow retroactive approval.
Is FDA approval required before IRB?
Rare in O&P. Most devices are Class I (exempt); cranial remolding orthoses are Class II. If devices claim to prevent/diagnose/treat/cure, FDA oversight may apply. Consult your IRB if unsure.
Do surveys require IRB review?
Yes, if it meets the definition of human-subjects research. When in doubt, consult your IRB.
I want to test new devices I’ve developed—IRB needed?
Likely—consider invasiveness, non-standard procedures, publication intent, privacy risks, vulnerable populations, and potential harm/costs. If any “yes,” consult an IRB.

Outcome Measures-Related FAQs

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Why should I use outcome measures in my practice?
Outcome measures help evaluate, document, and demonstrate the benefits of orthotic/prosthetic services relative to goals, and can support continued services and component selection.
How do I decide which measure to use?
Start with your clinical question and desired data. Set goals, baseline, and collect consistently. Objective measures quantify plans/progress.
Clinical vs. patient-reported outcomes?
Clinical: objective tests (e.g., 10MWT, TUG). PROs: patient perspective (ADLs, satisfaction). Use both; compare to published data.
Validated vs. non-validated—does it matter?
Yes—validated tools measure what they claim in the target population, enabling better decisions and comparisons.
Where can I find validated measures?
See JPO 2006 and rehabmeasures.org. The Academy’s OLC has courses on outcome measures.
Best approach to choose a measure?
Define the question; learn each tool’s method; standardize collection & charting; use repeated measures to track change. See “Outcome Measurements and Daily Clinical Life—Can They Co-Exist.”
Interpreting collected data?
Compare to population norms where available (e.g., rehabmeasures.org) and analyze trends over time; schools can support stats.
Do I need consent for outcome data?
Routine-care measures are usually covered by treatment consent/HIPAA. For dissemination beyond care, IRB review may be required—see IRB/Human Subjects.

HIPAA-Related FAQs

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Using patient file data in research—what to consider?
PHI includes any identifiable health info. Researchers typically need authorization; state law may be stricter. Consult IRB/Privacy Board before using PHI.
Can I use PHI in my research?
Usually requires subject authorization. “Preparatory to research” access may allow feasibility checks without removing PHI. For research use, obtain IRB/Privacy Board waiver.
What if I can’t get authorization?
Seek a waiver from an IRB or Privacy Board; disclose minimum necessary PHI and document the disclosure.
What is a Privacy Board?
A body meeting HIPAA 164.512(i) that can grant waivers/alterations of authorization; includes at least one unaffiliated member. See NIH guidance.
What’s a “limited data set”?
Only city, state, ZIP, and dates retained; requires a data use agreement (no authorization/waiver needed).