IRB Assessment and Management of QI Projects

1. IRB Assessment and Management of QI Projects H. Edward Davidson, PharmD, MPH Assistant Professor, Clinical Internal Medicine Glennan Center for Geriatrics and Gerontology Eastern Virginia Medical School Partner, Insight Therapeutics, LLC

2. Objectives • Review relevant terminology regarding quality improvement (QI) project review • Describe how to categorize a QI project for IRB submission • Present a case study • Explore current controversies surrounding this topic

3. Definitions • Research: A systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge (45 CFR 46.102) • Quality improvement:A systematic, data-guided activity designed to bring about immediate improvement in health care delivery in a local setting. Lynn J et al. Ann Intern Med 2007;146:666-73.

4. Definition of “Human Subject” • A living individual about whom an investigator … conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 45 CFR 46.102(f)

5. Institutional Review Board Administrative bodies established to protect the rights and welfare of human research participants Have the authority for all research activities to: Approve or disapprove Require modifications Assess violations Investigate subject complaints Conduct continuing reviews 5

6. Research & QI Part of the continuum of change in healthcare • Quality Improvement • Systematic experiential learning • Operational context • Rapid feedback of trends that shape changes • Clinical Research • Distinct from clinical care • Designed to contribute to scientific knowledge • Clinical Practice • Adaptation, innovation • At the individual patient level

7. There is a Grey Area Quality Improvement Research

8. Research Vs. Quality Improvement Beyea SC. AORN J 1998.

9. Research Vs. Quality Improvement (cont.) Beyea SC. AORN J 1998.

10. The Basics of IRB Review for a QI Project

11. Level of Risk Determines Level of IRB Review More than Minimal Risk Full IRB Committee Review Expedited Review Minimal Risk Exempt from Review

12. Definition of Minimal Risk in Subpart A of Code of Federal Regulations • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life* or during the performance of routine physical or psychological examinations or tests *Daily lives of the subjects of the research, not healthy individuals 45 CFR 46.1029(i)

13. Which is greater? • Risk of harm or discomfort anticipated in the research OR • Risk of harm or discomfort ordinarily encountered in daily life

14. Scope of IRB Review • All research that uses • Human subjects • Tissues/specimens from humans • Data/records from human subjects • Quality assurance, quality improvement, and program evaluations have the potential to involve human subjects and therefore are subject to IRB oversight

15. Four Levels of IRB Evaluation • Evaluation for involvement of human subjects • Exempt from regulations addressing IRB review • Expedited IRB review • Full board (convened) review

16. Evaluation for Involvement of Human Subjects • IRB has oversight authority to determine if a study can be classified as “Not Human Subjects Research” • These projects may be: • “research” by definition, however they do not involve human subjects, or • Other projects such as quality assurance or program evaluation that do not meet the definition of “research”

17. Human Subject Regulations Decision Charts

18. Research that Qualifies for Exempt Status • Research in educational settings involving normal education practices • Educational tests, survey procedures, interview procedures, or observing public behavior unless subjects can be identified and disclosure places subjects at risk of criminal and civil liability • Educational tests, survey procedures, interview procedures, or observing public behavior unless subjects are elected/appointed or candidates for public office and federal statue requires maintenance of confidentiality

19. Exempt Status (cont.) • Collection/study of existing data, documents, records, pathological/diagnostic specimens if these sources are publically available or if the information is recorded in such a way that subjects cannot be identified • Federal department/agency research and demonstration projects evaluating public benefit programs • Taste and food quality evaluation and consumer acceptance studies

20. Research that Qualifies for Expedited Status • Clinical studies of drug or devices when an IND or IDE are not required • Collection of blood samples • Prospective collection of biological specimens for research purposes by non-invasive means • Collection of data through noninvasive procedures routinely employed in clinical practice (excluding x-rays or microwaves)

21. Expedited Status (cont.) • Research involving material that have been collected, or will be collected solely for non-research purposes • Collection of data from voice, video, digital, or image recording made for research purposes • Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation human factors evaluation, or quality assurance methodologies

22. Waivers • Waiver of consent • Waiver for authorization for the use of Protected Health Information (PHI)

23. Exception from Requirement for Informed Consent An IRB may waive consent requirement or alter consent element if it finds and documents that: • Research involves no more than minimal risk; • Rights and welfare of subjects will not be adversely affected; • Research could not be practicably carried out without waiver or alteration; and • When appropriate, the subjects will be provided pertinent information after participation.

24. Waiver of Authorization for the Use of PHI Justification • Provide a brief description of the specific PHI to which you are requesting access • The research could not practically be conducted without access to and use of the PHI • The research could not practicably be conducted without the alteration or waiver

25. Waiver of Authorization for the Use of PHI Justification (cont.) • The use or disclosure of PHI involves no more than minimal risk to the individuals, based on, at least, the presence of the following elements: • An adequate plan to protect the identifiers from improper use/disclosure • An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research • Adequate written assurance that PHI will not be reused/disclosed to any other person or entity, except as required by law, for authorized oversight of the research project

26. Items to Exclude for De-identification ● Names ● E-mail address ● Addresses ● SS# ● Zip codes ● Medical Record # ● Dates except years ● Health plan beneficiary #s ● Telephone #s ● Account #’s ● Fax #s ● Certificate/license #s ● VIN #’s ● Device ID & serial #’s ● URLs ●Full face photo images ● biometric identifiers ● internet protocol address #s ● any other unique identifying #, characteristic or code 45 CFR 64.514(b)(2)

27. Institutional Assurance • Institutional Assurances of Protection for Human Subjects • Institution’s “contract” with the Department of Health and Human Services • Institution stipulates it will abide by 21CFR56 • Federal Wide Assurance (FWA)

28. Case Study in QI Research

29. Study Design • A prospective cohort study of 5 evidence-based procedures recommended by the CDC and identified as having the greatest effect on the rate of catheter-related blood stream infections and the lowest barriers to implementation.

30. Ethical Review “…The study was approved by the institutional review board of Johns Hopkins University School of Medicine. Informed consent was waived because the study was considered exempt from review.”

31. OHRP Actions/Findings • An anonymous complaint was made to OHRP after the publication of the article • Project was suspended (only the submission of data from Michigan hospitals to JHU) • OHRP ruled project not exempt • Participating hospitals in Michigan did not have FWA • JHU and MHA revised procedures/policies and project re-reviewed by JHU – was approved as expedited with waiver of consent • Data transmission allowed to be re-instated

32. Disagreement on IRB Role • “I think it is very maddening. The OHRP has created an impossible situation. Why in heavens name would the OHRP want to tie QI researchers up in knots?” • “It comes down to evaluating the level of risk to patients…And there needs to be someone, somewhere in the process evaluating the risk to patients of each intervention.”

33. Controversies

34. Publication – ICMJE Requirements http://www.icmje.org/index.html#publish

35. Rigor in QI Methods Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies Qual Saf Health Care 2003;12:47-52 “The methods of evaluating change and improvement strategies are not well described. The general principle under-lying the choice of evaluative design is, however, simple—those conducting such evaluations should use the most robust design possible to minimize bias and maximize generalizability.” Speroff T, O’Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care 2004;13:17-32. “Improving the rigor of the quality improvement literature will build a stronger foundation and more convincing justification for the study and practice of quality improvement in health care.”

37. Policy Options • Establish separate committee to review QI projects • Usually a subcommittee of the IRB • Follow usual IRB guidelines and submission process for all projects

38. Suggested Reading • Lynn J et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007;146:666-73. • Klepser ME et al. Ethical issues related to clinical, translational, and health system research. Pharmacotherapy 2008;28:229-43. • Neff MJ. Institutional review board consideration of chart reviews, case reports, and observational studies. Respir Care 2008;53:1350-53.