1. Ethics in Quality Improvement Quality Academy Cohort 6 Melanie Rathgeber MERGE Consulting

2. 1. Understand key differences that distinguish research projects from QI projects 2. Be familiar with theory and work of experts in outlining ethical considerations for QI 3. Know where to go for further investigation on ethical considerations for your QI work Objectives

3. Mythbusters:

4. Research Ethics Board (REB) Do you have experience in applying to a REB for a research or quality improvement project?

5. Checklist from UBC Research Ethics Board (REB) Distinguishes between –Research projects –Projects that are solely for Quality Assurance Research Ethics Boards only review projects that have a research element

6. Checklist from UBC Research Ethics Board (REB)

7. Why might we want to have an ethical review or discussion for QI work?

8. - Formerly Alberta Research Ethics Community Consensus Initiative

9. Ethics in QI – Hasting Centre guidelines Lynn et al. The ethics of using Quality Improvement methods in Health Care, Annals of Internal Medicine. 2007; 146: 666-73.  QI = any systematic data guided activities designed to bring about immediate improvement in a health care setting  IRB (Institutional Research Board) is not the right process

10. Ethics in QI: Hastings Centre Report (www.thehastingscenter.org) Seven Ethical Considerations as they relate to QI: 1.Social or scientific value –Gains justify risk (can include any extra visits, paper work, surveys) –Gains justify expense 2.Scientific validity – Is it properly structured to achieve its goal? –Consider context and how to make something happen in local context

11. Seven Ethical Considerations as they relate to QI: 3.Fair subject selection -Consider other QI programs going on in your organization -Consider vulnerable populations 4.Favorable risk-benefit ratio –Focus particularly on individual

12. Seven Ethical Considerations as they relate to QI: 5.Respect for potential and enrolled participants: -Includes respect for privacy and confidentiality -Only that health information that is necessary for the QI activity -Same confidentiality obligations as for health care providers 6. Informed Consent –Not required unless poses more than minimum risk

13. Access to personal health information QI is considered an essential part of normal health care, therefore, consent for QI is assumed in consent to receive health care (within reasonable limits and no more than minimal additional risk) QI staff/teams can use health information in the same way staff use it to provide care A person who does not normally have access to participant records for clinical care and whose use of records is for a secondary purpose – constitutes need for an ethical review at the organizational level. Hastings Centre: Alberta (ARECCI): Alberta (ARECCI):

14. Access to personal health information VCH

15. Seven Ethical Considerations as they relate to QI: 7. Independent Review -If conditions exist that justify a need for a review – should be an external review body – but not a REB -Should be internal to the organization -In general, ongoing monitoring of ethical principles in QI activities should become part of the clinical care or management structure

16. ARECCI Ethics Guidelines for QI and Evaluation Projects Decision Support Tools http://www.aihealthsolutions.ca/arecci/areccitools.php 1. GUIDELINES TOOL -> probing questions – identification of ethical considerations for your project 2. SCREENING TOOL -> guidance on what level of review to consider “Together, these two decision-support guides can assist you in evaluating your projects to ensure that ethics considerations are included and that you have done due diligence to protect people and their health information”

17. ARECCI Guideline Tool:

18. Screening Tool: Should go to an Second Review Process if there is more than minimal risk

19. Practice with Screening Tool: http://www.aihealthsolutions.ca/arecci/areccitools.php

20. Mythbusters:

21. Key Resources Ethics Board if your QI project has a research component – usually if your findings can be generalized outside of your local setting ARECCI Ethics Guidelines for QI –Guideline Tool to help you apply and consider ethical principles –Screening Tool to determine level of review needed Ask your Quality Department about policies or guidelines SQUIRE guidelines for publishing QI http://qualitysafety.bmj.com/content/17/Suppl_1/i3.full.pdf+html?sid=f86520 69-7e90-4721-a40a-1aba380c3194 http://squire-statement.org/