The Role of IRBs in Ensuring Ethical Conduct of QI Activities

1. The Role of IRBs in Ensuring Ethical Conduct of QI Activities Mary Ann Baily, PhD Columbia IRB Conference April 1, 2011

2. Question for IRB:Is this activity research with human subjects?

3. Federal Definitions RESEARCH: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. HUMAN SUBJECT: A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

4. Is this activity (clinical and/or managerial) practice?

5. What is QI? Systematic data-guided activities designed to bring about immediate improvements in health care delivery in particular settings through a wide variety of methods. (Go to www. ihi.com for examples.)

6. QI vs. Clinical & Managerial Practice • Clinical & managerial practice includes innovation and adaptation. • QI is DATA-GUIDED C & M innovation and adaptation. • QI is an integral part of normal health care operations, carried out by people in the local setting.

7. QI vs. Research • QI is closely linked to the implementation of change in the setting in which it occurs, whereas research is a distinct enterprise. • Participation in research is optional, whereas participation in QI is not completely optional.

8. Ethical Requirements for QI See table of requirements in: MA Baily, M Bottrell, et al. “The Ethics of Using QI Methods to Improve Health Care Quality and Safety,” Hastings Center Report Special Report 2006; 36(4):S1-S40. OR in: J Lynn, MA Baily, M Bottrell, etal. "The Ethics of Using Quality Improvement Methods in Health Care," Annals of Internal Medicine 2007;146 (9):666-673.

9. Major Differences between Ethical Requirements for QI and for Research • Informed consent • Independent review

10. Informed Consent for Patient Participants in QI • Background consent to inclusion in minimal risk QI activities as part of consent to treatment • Informed consent to inclusion in specific QI activity that represents more than minimal risk • Patient risk is measured relative to risk in standard health care • Confidentiality is protected

11. Informed Consent for Health Worker Participants in QI • Informed consent to inclusion in specific QI activity that represents more than minimal risk to worker BUT • Worker risk is measured relative to risk in usual work situation and DOES NOT INCLUDE risk that QI will show the worker to be incompetent or unnecessary

12. Independent Review There must be accountability for the ethical conduct of QI, but the IRB process is not the right approach.

13. Problems with IRB Review of QI • IRB process has high transactions costs. • IRB process does not fit the structure of many QI activities. • Ethical principles must be interpreted in the light of both the activity’s characteristics and the environment in which it is carried out. • Requiring IRB review creates a disincentive for systematic monitoring and evaluation of change.

14. Conclusion NO: Export QI to IRB-based system for protection of human subjects of research. YES: Import protection of human participants in QI into a transformed accountability system for clinical care.

15. What would the transformed clinical accountability system have? • Guidance on ethical requirements • Flexible accountability structure -Internal (within orgs) -External (across orgs)

16. Tough Questions • What ethical oversight is appropriate for activities that are BOTH QI and human subject research? • How do we determine which activities fall into this overlap category?

17. Current Answers • According to the regulations, an activity that has any elements of human subject research should be treated as human subject research. • IRBs must interpret the federal definitions of research and human subject in the light of limited OHRP guidance to decide if a QI activity is in the overlap category. If it is, the 11 OHRP decision charts must be used to determine if the activity is exempt, requires informed consent, qualifies for expedited review, and so on.

18. Alternative Answers • Overlap activities shouldn’t automatically be treated as human subject research. The regulations should exempt overlap activities and appropriate safeguards for human subjects of overlap activities should be included in the clinical accountability system for the ethical conduct of QI. • The exact boundary between QI and overlap activities is less important when a robust clinical accountability system covers all of them.

19. The Big Picture Data-based management, health services research, outcomes research using clinically generated data, and similar activities are valuable tools in the pursuit of a better , cheaper, more effective health care system. We should develop policies that make it easier to use these tools but do not expose patients and workers to undue risks.

20. More Information The Special Report referenced in Slide 8, The Ethics of Using QI Methods to Improve Health Care Quality and Safety, can be downloaded for free from the Hastings Center website at: http://www.thehastingscenter.org/Publications/SpecialReports/Detail.aspx?id=1342 Or from the IHI website at: http://www.ihi.org/IHI/Topics/Improvement/ImprovementMethods/Literature/EthicsQIMethodsImproveQualitySafety.htm For questions, contact MA Baily at 845-265-4669 or bailym09@gmail.com