An overview of the Guidance points Ethical issues in Patient Safety Research

1. An overview of the Guidance points Ethical issues in Patient Safety Research International Forum on Quality and Safety in Health Care Paris 2014 Dr Abha Saxena (MD) , Coordinator, Global Health Ethics (GHE) Secretary, Research Ethics Review Committee (ERC) Department of Knowledge Ethics and Research (KER) Cluster of Health Systems and Innovation (HIS) World Health Organization

2. Declaration of Interests: NONE

3. Patient Safety Research • Also includes Quality Improvement Research • Testing different ways of implementing evidence based interventions, observation of practices, evaluating prescription practices from medical records… • Evaluation of health care providers practices, assessment of care systems or practices. • Health care facilities or units of care may be randomized. • Often no new drug or interventions tested • Outcomes are often tested as patient outcomes

4. Patient Safety Activities • Audits • Health facility evaluations

5. Issues in Patient Safety Research

6. All Patient Safety research must undergo review by an Ethics Review Committee

8. Risks in Patient Safety Research Minimizing Risks No-blame approach Consider context – anonymize individuals and organizations Anticipate Risks Identify and recruit support mechanisms for participants. Establish support mechanisms for researchers – The Safety Committee • Clinical • Social • Economic • Psychological • From interviewing • From observing • From collecting information from Patient Records

9. Defining the Research participants • Patients? • Patient families? • Health care Providers?

10. Waivers of informed consent Physicians Patients The research does not directly inform or alter the individual patients’ therapeutic or medical treatment plans; and Risks posed to patients by the research are minimal; and The research could not practically be carried out if individual informed consent were required; and The privacy and confidentiality or anonymity of individual patients are assured • The research does not directly inform or alter individual patients’ therapeutic or medical treatment plans; and • Risks to the provider are minimal; and • The research could not practicably be carried out with the consent of providers. Strong case for Disclosure

11. Privacy & Confidentiality Research participants may be patients or health care providers!

12. Duty to intervene • Observing physician practices (Error) • Abstracting information from patient records (Incident) • they are highly suspicious that an error is imminent or an incident has occurred and there is no evidence to suspect that an intervention has already occurred in response to the (potential) incident ; • they believe it is highly likely that the error will result in direct, severe or irreversible harm or that the consequences of the incident are of direct, severe or irreversible harm; • their immediate action or intervention will prevent or reverse some of the negative effects of the error;

13. Be mindful of privacy, and confidentiality Consider how to deal with negligence or non-professional behaviour

14. Withholding Information • Conditions under which information can be withheld from research participants • Obligations of researchers when information is withheld • Duty of the Ethics Review Committee, when information is withheld