A paper published in the BMJ Journal of Medical Ethics examines the circumstances in which public good outweighs the requirement that researchers receive individual consent to use a person’s data.
Angela Ballantyne, PhD, of the University of Otago in Wellington, New Zealand, and G. Owen Schaefer, PhD, of the Yong Loo Lin School of Medicine in Singapore contend that while issues of privacy, identity, stigma, inequality, and the “right to be forgotten” are important, patients, communities, and the public also have an interest in the efficient use of resources — including health data — to drive innovation and more effective, safer, cheaper healthcare.
While Drs Ballantyne and Schaefer do not dispute the legitimacy of any of these interests, they advocate for a shift in how those interests are weighed. They also argue that citizens have an ethical obligation to participate in health data research, and that this obligation can underpin waivers of informed consent for secondary research using public sector health data, even when acquiring consent would be feasible.
Access to identifiable health data is often necessary to ensure that the data are complete and error-free. The inability to obtain explicit consent often means that data collected for health purposes cannot be used for a secondary purpose such as research.
“The literature identifies 3 potential grounds to support the obligation to participate: beneficence, fairness, and civic responsibility to support public good[s],” wrote Drs Ballantyne and Schaefer. However, they also note that there is a clear distinction between obligatory participation in observational research and interventional research, as the latter may violate participants’ bodily integrity.
The most significant barrier to public obligation to share health information is backlash. “Transparency is especially important in the absence of consent because it facilitates accountability, public trust, and debate about the uses of health data,” the researchers wrote. They propose using several measures to ascertain whether research is in the public good. Minimum requirements would be that sponsors may not censor publication of results, and research results may not be patented or commercialized. Further factors for the Institutional Review Board/Research Ethics Committee to consider are:
- The magnitude of the potential social value of the research relative to its risks and burdens
- Whether the research addresses health inequities or the needs of disenfranchised or vulnerable patient groups
- Whether the research addresses the needs of groups traditionally excluded from clinical research and therefore lacking in robust evidence to guide clinical care
- Whether the research will be made publically available and have open access
- Whether the research has engaged with patient groups in terms of pre-research consultation, ongoing partnership and/or patient involvement with the research governance
The researchers believe that their model will facilitate more research that can improve healthcare delivery while still maintaining a robust review of the ethical issues involved in use of health data.
Ballantyne A, Schaefer GW. Consent and the ethical duty to participate in health data research [published online January 22, 2018]. J Med Ethics. doi:10.1136/medethics.2017-104550