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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)

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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



Patient safety research
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


Patient safety activities
Patient Safety Activities

  • Audits

  • Health facility evaluations




Risks in Patient Safety Research Review Committee

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


Defining the research participants
Defining the Research participants Review Committee

  • Patients?

  • Patient families?

  • Health care Providers?


Waivers of informed consent
Waivers of informed consent Review Committee

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


Privacy confidentiality
Privacy & Confidentiality Review Committee

Research participants may be patients or health care providers!


Duty to intervene
Duty to intervene Review Committee

  • 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;


Be mindful of privacy, and confidentiality Review Committee

Consider how to deal with negligence or non-professional behaviour


Withholding information
Withholding Information Review Committee

  • 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


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