1. Right of Way: Does your project need ethics review? Lori d’Agincourt-Canning, PhD, Ethicist, C&W Ethics Service Geoff Schierbeck, Quality Leader, BCPSQC

2. Objectives At the end of this session, participants will be able to:  Identify similarities and differences between quality improvement studies and research  Understand ethical requirements that QI studies should meet  Demonstrate knowledge about why/when a project warrant REB review  Have a practical opportunity to assess project risk using the ARECCI tool

3. What is quality improvement (QI)?  Covers a broad range of activities whose goal is to monitor, evaluate or improve the quality of health care delivered  Uses an array of methods and can look like practical problem solving, an evidence-based management style, or an application of a theory-driven science of system change  QI projects often encourage health care workers to use their experience, along with insights from others, to identify promising improvements, implement changes on a small scale, monitor and interpret effects, and decide about additional changes and wider implementation (Bailey, 2008)

4. Examples  Quality assurance  Program evaluation  Cost containment  Health services research  Outcomes monitoring research (Baily, 2008)

5. What is research? (UBC Policy #89)  Research involving human subjects is defined as any systemic investigation (including pilot studies, exploratory studies, and course based assignments) to establish facts, principles or generalizable knowledge  Research may involve living subjects through their physical participation and/or through collection or use of personal health information, tissue (including foetal and "waste" tissue), biological fluids, embryos, foetuses, human remains and cadavers

6. Research and QI Similarities  Systematic  Guided by data  Varying degrees of complexity and methodological rigor  Produces ‘generalizable’ knowledge (?)

7. Research and QI differences Research  Distinct & separate from care delivery  Participation is voluntary  Independent ethics review QI  Implemented in care delivery context in which it is carried out  Expected part of health care  Participation is not completely optional  No formal process for ethics review

8. Gray zones  Designed to be generalized  Risk of harm to be participants  Intent to publish  Evaluation research (vs. program evaluation); secondary analysis of data

9. There is considerable overlap Researchers at Johns Hopkins University coordinated a quality-improvement research project aimed at reducing catheter-related infections in 103 ICUs at 67 Michigan hospitals. The study evaluated a protocol designed to routinely implement five evidence-based procedures: having clinicians wash their hands, using full-barrier precautions during insertion of central venous catheters, using chlorhexidine for skin cleansing before catheter insertion, minimizing the use of the femoral site for catheter insertion, and removing unnecessary catheters. In addition to the training of clinicians in such standard infection-control procedures, the project involved the use of a checklist to ensure adherence to the protocol The result was a dramatic decrease in catheter-related infections: at baseline, the participating hospitals had a median of 2.7 infections per 1000 catheter- days; after 3 months, the median had dropped to 0, and it remained there for 18 months

10. Overlap Publication of the results, however, triggered an investigation by the OHRP The REB at Johns Hopkins had judged that this quality-improvement program was exempt from federal regulations governing human-subjects research; the published report noted that "informed consent was waived because the study was considered exempt from review. The OHRP judged that the project was not exempt since it prospectively implemented a protocol of infection-control interventions and tested hypotheses regarding its effectiveness. Publication of study results suggests that a goal was to produce generalizable knowledge and therefore the researchers should have obtained informed consent. (Miller and Emanuel, 2008 )

11. Underlying principle Protecting people in quality and improvement projects is just as important as protecting people in research studies

12. Ethics considerations: QI & evaluation studies 1. How will the knowledge gained from this project be useful? 2. How will the described method or approach generate the desired knowledge? 3. How will you ensure that the participant (or data) selection process is fair and appropriate? 4. What have you done to identify and minimize risks? Are the remaining risks justified? (What are the risks of not doing the project?) 5. How are the rights of individuals, communities, and populations respected in this project? 6. Is informed consent needed in this project?

13. Key ethical issues  Respect for persons  Risk-benefit ratios  Confidentiality  Data stewardship  Patient protection  Staff protection  Consent

14. Alberta Research Community Consensus Initiative (ARECCI)  Goal:  To develop a simple screening tool that would allow evaluators to determine if a project is research and needs REB review  Focuses on determining level of risk  Assigning guidelines to have appropriate review based on level of risk

15. Goal of ethics screening tools  To implement and facilitate consistency of ethics review in any project involving people or their information

17. ARECCI Ethics Screening Tool

18. ARECCI Ethics Screening Tool: Step 1

19. ARECCI Ethics Screening Tool: Step 2

20. Applying the QI Risk Filter

21. Time to Google ARECCI screening tool

22. Scenario

23. Goal of ethics screening tools  To implement and facilitate consistency of ethics review in any project involving people or their information

24. When to use? For any project involving people or their information When developing or drafting a project to ensure that ethics is integrated When it is unclear whether the project, QI or both and what degree of ethics review is needed When unsure of the level or risk involved in a project (D. Lake, 2008)

25. Recognizing Risks & Benefits  There is always risk  Most risk when you don’t review or look for it!  Always ask:  Who might be at risk?  The category of risk?  How to minimize or mitigate that risk?  What about benefits?

26. Difficulties in recognizing risk  Unfamiliar or too familiar  Pressure (time, resources, vendors, individual health service providers, etc.)  Projects change over time (people, focus, lead, scope)

27. In Summary  QI projects are integral to improving health and human service quality  Ethical issues exist in QI projects and should be considered at all stages  Ethics screening is quick using the ARECCI Ethics Screening Tool  Higher categories of risk require greater levels of ethical scrutiny  ARECCI tools support the decision-making process

28. Where to access ARECCI tool  Alberta Heritage Foundation for Medical Research http://www.ahfmr.ab.ca/arecci/guidelines  ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects

29. References ARECCI website: Baily, MA Taking Stock: Strengths, Issues, Gaps in the Ethical Oversight of Health Projects. Protecting People While Increasing Knowledge: Ethics in Health Research Conference, Calgary, Alberta, CA, May 5, 2008. Lake, D. Online tool for evaluating the primary purpose of knowledge generating activities. Protecting People While Increasing Knowledge: Ethics in Health Research Conference, Calgary, Alberta, CA, May 5, 2008 Lynn, Baily, Bottrell et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146:666-673 Miller, P. & Emanuel, E. Quality-Improvement Research and Informed Consent. NEJM 2008; 358 (8):765-767 Taylor, H. Pronovost P, Sugarman J. Ethics, oversight and quality improvement initiatives. Qual Saf Health Care 2010;19:271e274.

30. Does Your Project Need Ethics Review? Questions or comments…