The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

Purpose: To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS).

Data sources: The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015.

Study selection: The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict.

Data extraction: A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective.

Results of data synthesis: A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care.

Conclusion: The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.