1. International Forum - Quality & Safety in Healthcare 2014 1 |1 | An overview of the Guidance points Ethical issues in Patient Safety Research An overview of the Guidance points Ethical issues in Patient Safety Research 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 International Forum on Quality and Safety in Health Care Paris 2014

2. International Forum - Quality & Safety in Healthcare 2014 2 |2 | Declaration of Interests: NONE

3. International Forum - Quality & Safety in Healthcare 2014 3 |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. International Forum - Quality & Safety in Healthcare 2014 4 |4 | Patient Safety Activities Audits Health facility evaluations

5. International Forum - Quality & Safety in Healthcare 2014 5 |5 | Issues in Patient Safety Research

6. International Forum - Quality & Safety in Healthcare 2014 6 |6 | All Patient Safety research must undergo review by an Ethics Review Committee

7. International Forum - Quality & Safety in Healthcare 2014 7 |7 |

8. 8 |8 | Risks in Patient Safety Research Clinical Social Economic Psychological 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 From interviewing From observing From collecting information from Patient Records

9. International Forum - Quality & Safety in Healthcare 2014 9 |9 | Defining the Research participants Patients? Patient families? Health care Providers?

10. International Forum - Quality & Safety in Healthcare 2014 10 | Waivers of informed consent Physicians 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. 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 Strong case for Disclosure

11. International Forum - Quality & Safety in Healthcare 2014 11 | Privacy & Confidentiality Research participants may be patients or health care providers!

12. International Forum - Quality & Safety in Healthcare 2014 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. International Forum - Quality & Safety in Healthcare 2014 13 | Be mindful of privacy, and confidentiality Consider how to deal with negligence or non-professional behaviour

14. International Forum - Quality & Safety in Healthcare 2014 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

15. International Forum - Quality & Safety in Healthcare 2014 15 |