ATSU, AZ IRB: Exempt Reviews

Begin using new Exempt Review Study Template immediately (v 25Aug2021).

Exempt human subjects research studies are identified in 45 CFR 46.104(d)(1)-(8):  https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1104.  The main categories of Exempt research are subcategories, 1-4:  educational settings, educational tests and surveys, benign behavioral interventions, and secondary research uses of identifiable private information or identifiable biospecimens.

When PI thinks his/her study could be eligible for Exemption, he/she may submit a request for IRB Exemption (link to the Exemption form is in the box to the right).

• All research forms should be submitted with the Exemption Request form.  This includes data collection forms, recruitment flyers, study tools, etc. (In some cases, an informed consent form or assent form.)
• Don't know if your study is Exempt?  Open the Is my Study Exempt? PDF form.
• Certificates documenting compliance with ATSU RGIS research training requirements (Human Subjects Protection and Financial Conflict of Interest) should be submitted to RGIS.

Most chart review studies can be considered Exempt. Though probably Exempt, these studies must incorporate procedures that ensure confidentiality of research subjects' data such as Protected Health Information (PHI). 

For more examples and information on "Exemptions," see: 

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#exemptions

For access to ATSU General Order COI/FCOI policies, go to: 

https://docs.google.com/document/d/1CM1qrWwIDSTA_KpLFMqTFs2G7sWLjjZpjnI405XGlfo/edit  

Quality Assurance and Quality Improvement (QA/QI):

QA/QI studies should also be submitted using the Exempt form.  QA/QI activities lack a systematic investigation and/or applicable generalizable knowledge outside of the specific location being assessed.  Findings are only expected to directly affect site-specific individuals, institutional practices, and/or will only help improve agency outcomes or processes. 

Evaluation vs. Research (shared from Mathison, 2007):

• Evaluation particularizes, research generalizes.
• Evaluation is designed to improve something, while research is designed to prove something.
• Evaluation – so what?   Research – what’s so?
• Evaluation – how well it works?   Research – how it works?
• Evaluation is about what is valuable; research is about what is.
• Evaluation provides the basis for decision-making; research provides the basis for drawing conclusions.

Research vs. Evaluation (Blome, 2009 – Office of Program Analysis and Evaluation, National Institute of General Medical Sciences):

Research

• Produces generalizable knowledge
• Scientific inquiry based on intellectual curiosity
• Advances broad knowledge and theory
• Controlled setting

Evaluation

• Judges merit or worth
• Policy & program interests of stakeholders paramount
• Provides information for decision-making on specific program
• Conducted within setting of changing actors, priorities, resources, & timelines

Program evaluation activities are not considered human subject research when (shared from Chen 2013, Stanford):

• They do not involve experimental or non-standard interventions;
• Their intent is only to provide information for and about the setting in which they are conducted;
• They are conducted as part of the standard operating procedures of the setting; and
• They are (usually) not subject to peer review.

The IRB is NOT required to monitor all ongoing human subject research.  Research using existing data or conducted in educational settings or collecting data anonymously must receive a limited initial IRB review.

STUDENTS NOTE:  If your academic program requires submitting a complete IRB application (protocol), you should not complete the Exemption request letter.  Your study methods may be Exempt (e.g., an anonymous survey), but you will still need to complete the Initial IRB Non-Exempt Application under the "Applications and Forms" tab for academic credit.