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
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
All Patient Safety research must undergo review by an Ethics Review Committee
Risks in Patient Safety Research Review Committee
Consider context – anonymize individuals and organizations
Identify and recruit support mechanisms for participants.
Establish support mechanisms for researchers – The Safety Committee
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
Research participants may be patients or health care providers!
Be mindful of privacy, and confidentiality Review Committee
Consider how to deal with negligence or non-professional behaviour