What you need to know about the Saint Leo IRB review process

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Information available online IRB procedures and bylaws IRB FAQs Definition of research Link to the CITI ethics training Application form Instructions to fill out the application form Chart of the review process Templates for various types of consent Explanation of the various types of consent

What is the purpose of the IRB? To ensure compliance with the Federal Policy for the Protection of Human Subjects (45 CFR Part 46: “Common Rule”) To ensure observance of policies of Saint Leo University regarding the protection of human subjects in any and all research conducted by faculty, students, or staff at Saint Leo University.

Please note Any research on human subjects that is conducted by Saint Leo students, staff, or faculty needs to be approved by the Saint Leo IRB before data collection begins.

What is a human subject? A physical person or any data or tissue pertaining to a physical person

What is research? “…a project or study is research if it is conducted with the intention of drawing conclusions that have some general applicability and uses a commonly accepted scientific method. The random collection of information about individuals that has no general applicability is not research” (Steneck 2007:39). Steneck, Nicholas H ORI Introduction to the Responsible Conduct of Research. Washington,DC: U.S. Government Printing Office. Retrieved November 6, 2010 (

Class activities are excluded if they meet all the following criteria: Part of a course requirement Supervised by faculty Not shared outside of class No contribution to generalizable knowledge No risk to participants No sensitive population Complete anonymity No generation of new knowledge

How to apply for IRB approval 1 Fill out every single item of IRB application form, part 1 2 If any * is checked, fill out part 2 3 For student research, obtain signature from faculty advisor 4 Attach any instrument(s) used in the research 5 Attach consent form(s) as applicable 6 Attach permission from outside agency if applicable 7 Attach proof of ethics certification for PI and faculty advisor if PI is a student 8 complete application to

The review process Exemption Expedited review Full review

Exemption No risk greater than daily life No sensitive population Review by one IRB member Decision within 10 days of receipt –For student research, faculty advisors are cced on all communication

Expedited review Sensitive population and/or Some risk Review by 3 IRB members Decision within 15 days of receipt –For student research, faculty advisors are cced on all communication

Full review Highly sensitive research Review by the full IRB at the next IRB meeting –The IRB meeting every third week of every 8- week term –For student research, faculty advisors are cced on all communication

Types of IRB decisions Not approved Revise and resubmit Minor revisions required Approved

Not approved The proposed research is unethical Examples: –Risk too high compared to benefits –Sharing of data for disciplinary purposes –PI lacks expertise to address risk The PI CANNOT proceed with the research

Revise and resubmit The application presents serious flaws, but is not unethical Examples: –Inconsistencies in procedures described –Unclear answers –Insufficient measures to ensure confidentiality –Pronounced deficiencies in writing of consent forms and/or data collection instruments The PI needs to rework the proposal according to IRB feedback and resubmit it for a new review

Minor revisions required The application presents minor flaws Examples: –A minor inconsistency in the application form –Minor clarification needed –Minor grammatical issues in the consent form or instrument The PI forwards the required revisions and may then proceed with the research

Approved No modifications required The PI may proceed with the research