Consent and the ethical duty to participate in health data research

• Published in: Journal of medical ethics Vol. 44; no. 6; pp. 392 - 396
• Main Authors: Ballantyne, Angela, Schaefer, G Owen
• Format: Journal Article
• Language: English
• Published: England BMJ 01.06.2018; BMJ Publishing Group Ltd; BMJ Publishing Group LTD
• Subjects: Bioethics; Biomedical research; Biomedical Research - ethics; Community Participation; Councils; Data Collection - ethics; Ethical aspects; Ethics; Ethics Committees, Research; Ethics, Research; Health surveillance; Humans; Informed consent; Informed consent (Medical law); Informed Consent - ethics; International organizations; Medical research; Medical research volunteers; Medicine, Experimental; Moral Obligations; Participation; Patients; Personal health; Public good; Public health; Public sector; Research ethics; Research Subjects; Researchers; Waivers; informed consent; research ethics; distributive justice
• ISSN: 0306-6800; 1473-4257; 1473-4257
• DOI: 10.1136/medethics-2017-104550

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency.