International Forum - Quality & Safety in Healthcare 2014 1 |1 | An overview of the Guidance points...

International Forum - Quality & Safety in Healthcare 20141 |

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 CareParis 2014


Declaration of Interests: NONE


Patient Safety ResearchPatient 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 ActivitiesPatient Safety Activities

Audits

Health facility evaluations


Issues in Patient Safety Research Issues in Patient Safety Research


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


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


Defining the Research participantsDefining the Research participants

Patients?

Patient families?

Health care Providers?


Waivers of informed consent 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


Privacy & ConfidentialityPrivacy & Confidentiality

Research participants may be patients or health care providers!


Duty to interveneDuty 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;


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


Withholding InformationWithholding 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

International Forum - Quality & Safety in Healthcare 2014 1 |1 | An overview of the Guidance points...

Documents

Transcript of International Forum - Quality & Safety in Healthcare 2014 1 |1 | An overview of the Guidance points...