Quality Improvement Vs. Research

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If the activity involves patient, employees, and/or lab specimens (from human subjects), and the answer is yes/unsure to any of the following, project should be submitted for IRB review.

Yes/Unsure

No

1.  Does it assign people or lab specimens to groups for simultaneous comparisons?

Yes/Unsure

No

2.  Is it being conducted in hopes of contributing  to general  knowledge in the area of study (and not for the sole purpose of improving Banner processes)?

Yes/Unsure

No

3.  Is the initial intent to publish the research results?  (Inquire also with the publishing entity for guidance on IRB review.)

Yes/Unsure

No

4.  Does it involve patient/subjects undergoing procedures that normally would not be done for their disease/problem (i.e. beyond routine care for patients or outside of routine for employees-their work day)?

Yes/Unsure

No

5.  Does it involve increased risk or burden to the participants (e.g. additional blood draws, fatigue, embarrassment, or giving personal information)?

Yes/Unsure

No

6.  Does it involve interactions or observations that do not routinely occur in patient care (for patients) or everyday life?

Yes/Unsure

No

7.  Does it involve releasing data, protected health information (PHI) or personal information to individuals/entities other than for regulatory/accreditation purposes?

Yes/Unsure

No

*This tool is revised with permission from Kimberly Woods-McCormick, PVHS IRB Manager and Poudre Valley Health System (12/15/08) and is for general guidance use only. If your project involves any of the activities above, contact your research director for further discussion and advisement.

For additional information please also read and review the following:

       
  • Department of Health and Human Services (HHS) regulations at 45CFR46.103(a) require that each institution "engaged" in human subjects research provide OPRR with a satisfactory Assurance to comply with the regulations, unless the research is exempt under 45CFR46.101(b). An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d), (f)]. An institution is automatically considered to be "engaged" in human subjects research whenever it receives a direct HHS award to support such research.
  • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50
  • FDA definition of clinical investigation (21 CFR 50 & 56)
  • Office of Civil Rights (HIPAA)
  • http://privacyruleandresearch.nih.gov/
  •    
  • Boundaries Between Practice and Research - Belmont Report
  • Other federal guidance
  • State law
  • Professional guidance (journals, AAMC, ICMJE)
  • Policies & Procedures of Institution
  • Court decisions