{"id":3272,"date":"2018-01-25T03:01:25","date_gmt":"2018-01-25T02:01:25","guid":{"rendered":"https:\/\/blogs.bmj.com\/medical-ethics\/?p=3272"},"modified":"2018-02-19T01:42:30","modified_gmt":"2018-02-19T00:42:30","slug":"consent-and-the-ethical-duty-to-participate-in-health-data-research","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/medical-ethics\/2018\/01\/25\/consent-and-the-ethical-duty-to-participate-in-health-data-research\/","title":{"rendered":"Consent and the Ethical Duty to Participate in Health Data Research"},"content":{"rendered":"

Guest Post: Angela Ballantyne and G. Owen Schaefer<\/strong><\/em><\/p>\n

Paper:\u00a0Consent and the ethical duty to participate in health data research<\/a><\/strong><\/em><\/p>\n

Health systems are producing exponentially more data about patients and there is increasing demand to use that data \u2013 for predictive modelling, precision medicine, funding decisions and health system design. One of the features that makes data exciting is it flexibility \u2013 it can be repurposed, combined and recombined, shared across sectors and jurisdictions. Health data can be combined with a wide variety of other data, from both the public and private systems.\u00a0 A traditional health research model conceives of research data as something that sits within a research study framework \u2013 to be collected, analysed, stored and then destroyed. But in modern research, the data sits outside the confines of a specific project and has a life-cycle of its own. \u00a0Data may be initially collected for clinical purposes but can and is easily adapted for administrative or research purposes. \u00a0Examples of systematic gathering of clinical data for administrative and research purposes include the Scottish Primary Care Information Resource (SPIRE)[1]<\/a> and, more controversially, NHS England\u2019s Care.data system that was shuttered in 2016 after public outcry.[2]<\/a><\/p>\n

All of this innovation poses challenges for consent models concerning the use of patients\u2019 health information (de-identified or otherwise). How<\/em> to make consent work in the age of data, and when<\/em> consent requirements may be waived, are vexing ethical and policy questions.<\/p>\n

<\/p>\n

A traditional research ethics paradigm defines the use of potentially identifiable patient data as observational research that prima facie requires individual consent. Many jurisdictions adopt this view, but allow Institutional Review Boards (IRBs) or Research Ethics Committees (RECs) to waive the consent requirement, typically on the grounds that consent would be impossible or impractical (in terms of numbers, time or cost) and\/or would impede the scientific validity of the study (in research where the entire dataset is required). These waivers suggest that patient autonomy and consent are not absolute, and that the interests of patients can be overridden when risks are low and there is a compelling public interest in the research.<\/p>\n

In this paper we consider recent literature that proposes that citizens have an ethical obligation to participate in research, specifically that citizens have an ethical duty to share their health information for research purposes. We consider three of the most powerful objections put forward in the literature to the proposed obligation to contribute to research, or to the enforceability of such an obligation. Our aim is to show that these objections are not compelling in the case of data <\/em>research. Therefore some who believe that the obligation to participate in research is not enforceable in general<\/em>, could support enforcement in the specific<\/em> case of data research.<\/p>\n

The upshot of this proposal would be to re-orientate IRB\/REC review processes away from requiring consent for data use, towards a more robust review of the proposed public good of the research, opportunities for public engagement and research transparency. \u00a0Some jurisdictions already require that a waiver of consent meet a public good criterion. But we contend that the concept remains under-defined in regulation and under-theorised in the bioethics literature.<\/p>\n

The later part of the paper fleshes out what we mean by public good. We present minimal requirements and factors that should be considered. The minimum requirements are that there be no restrictions on publications; in addition to a lack of patents or other use-restricting copyrights on results.\u00a0\u00a0 Health data is a strategic asset of huge commercial value, and regulatory models need to ensure that public system datasets are carefully governed with a view to promoting public good, not simply private intellectual property.[3]<\/a>\u00a0 In addition there are four factors an IRB\/REC should weigh in their assessment of the potential public good of the research:<\/p>\n