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In any research, regardless of whether it is conducted by an individual researcher, clinician or collaborative research team, it is imperative to determine the nature of the consent obtained from a patient for the secondary use of their data. This assessment should consider the risks and the potential for psychological, social, economic and legal harm that may arise from data collection, utilisation or any potential breaches.
In Australia, a ‘waiver of consent’ as per National Health and Medical Research Council (NHMRC) guidelines can be applied to secondary use of health data26 (box 1). Some ethics committees may request an ‘opt-out’ model, necessitating the consideration of options for patients who wish to decline to participate.26 27 Through the deidentification methods employed by OMOP-CDM, the risks related to data breaches, such as the reidentification of individuals, are significantly reduced. This is achieved by exclusively using aggregated results from OMOP-CDM and by refraining from reporting small cell sizes. Reidentification is further minimised by ensuring only aggregated outputs from OMOP-CDM are used and that small cell sizes are not reported.
Consent
If an ethics committee deems a research project or a healthcare evaluation to be of minimal risk to the individual, an exception to obtaining the legislated requirement for patient consent can be managed using a ‘waiver of consent.’ A ‘waiver of consent’ can be applied based on a duty of ‘easy rescue,’ where the potential benefits of data access are considered significant, and the harm associated with the risk of a loss of privacy are considered minimal.30 It is also hypothesised a ‘waiver of consent’ avoids the consequence of consent bias where individuals who provide informed consent to participate in a study differ in important ways from those who do not consent or choose not to participate.30 Numerous research and evaluation initiatives have employed a ‘waiver of consent’ approach, allowing for the secondary utilisation of electronic medical record (EMR) data.31–34
Arguments against a ‘waiver of consent’ considers the societal costs and potential patient harm, against the benefits of patient data utilisation. Costs include privacy breaches per se and the use of data for nefarious purposes, both of which contribute to a heightened risk of eroding trust.35 This includes potential for a loss of informational privacy where an individual’s personal or sensitive information is exposed, shared or accessed by others without their consent, or in a manner that violates their expectations of privacy.35 Additional rational against the application of a ‘waiver of consent’ stems from the primary rationale for an individual’s involvement in research lies in the process of duty of care to obtain, ‘informed consent’. This justification is grounded in the idea that depending solely on research and evaluation might not adequately protect the values and interests of those participating. Further to this, informed consent is regarded as a means of building trust, not only in the research and evaluation process itself but in the researcher/clinician understanding of health data use.35
Notwithstanding ethics committee considerations for patient consent, there should also be considerable social engagement across a breadth of stakeholders on research that uses health data, even if it is deidentified. This engagement provides options for the provision of ‘social permission’ and ‘social licence’ for consent, where the determination of consent is cocreated by patients and therefore morally legitimised—beyond the limits of law and outside of what is acceptable by an ethics committee—to preserve societal trust.36
Patient and community acceptability of the use of data within their EMR for research and healthcare evaluation indicates, for social licence to be assumed, a breadth of patient and public values, needs and interests should be incorporated into governance frameworks.37
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