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Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data.
Ruth Faden1, Nancy Kass, Danielle Whicher
1Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA. rfaden@jhu.edu
Medical Care
|June 25, 2013
Summary
Prospective comparative effectiveness research using electronic clinical data (ECD) may not require explicit patient consent if minimal risk is involved and patients are informed about research integration. Certain pragmatic trials also meet these ethical standards under specific conditions.
Area of Science:
- Health Services Research
- Bioethics
- Clinical Informatics
Background:
- Electronic clinical data (ECD) is a growing resource for comparative effectiveness research (CER).
- Prospective CER utilizing ECD presents ethical challenges, particularly regarding informed consent.
- Existing research primarily uses ECD for retrospective studies.
Purpose of the Study:
- To identify ethical considerations for prospective CER using ECD.
- To analyze consent issues within observational and pragmatic randomized trials.
- To apply an ethics framework for learning health care systems.
Main Methods:
- Examined two case studies: an observational study and a pragmatic randomized trial.
- Focused on ethical questions of informed consent.
- Assumed prior ethics review and oversight for all research.
Main Results:
- Observational CER-ECD studies with minimal patient risk/burden can proceed without express consent if patients are informed about research integration and patient rights are protected.
- Some pragmatic randomized trials with minimal risk/burden may also forgo express consent under specific conditions.
Conclusions:
- Ethical conduct of prospective CER-ECD studies hinges on transparency and patient protections.
- Conditions for waiving express consent in pragmatic trials include maintaining clinical outcomes, physician autonomy, and respecting patient values.
- Integration of research and practice in health care requires careful ethical navigation.
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