Consent and the ethical duty to participate in health data research

Abstract

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.

Deep learning workflow in radiology: a primer

“…If a project relies on second use of imaging data, approval by institutional review boards must comply with regional regulations such as Health Insurance Portability and Accountability Act in the USA [29], the General Data Protection Regulation in Europe [30], and the Ethical Conduct for Research Involving Humans in Canada [31]. Institutional review boards must enforce the respect of patient autonomy (free, informed and ongoing consent) or waive the need for patient consent (discussed below) and find a balance between risks (e.g., preventing large-scale data breach and unintended disclosure) and benefits (e.g., improving diagnosis and improving treatment selection) [32]. If a study requires tissue biobanking as the reference standard, registration in an online repository such as the Texas Cancer Research Biobank (USA) [33], Manchester Cancer Research Centre (UK) [34], or Cancer Research Network (Canada) [35] may be required.…”

Ethical Considerations for Movement Mapping to Identify Disease Transmission Hotspots

“…Even if such surveillance is not intended as research, a public health program should involve the appropriate ethics committee. The ethics committee can assess the protocol for collecting mobility data and the informed consent tool, as well as the proposed project’s public engagement and transparency plans to determine its benefit to the public ( 31 ). …”

Taxonomy of justifications for consent waivers: When and why are public views relevant?

“…A third justification, as we argued in the original paper, is that patients have an obligation to participate in socially valuable health research, and sharing data is an easy, low-risk way to meet this obligation 9. We proposed that this ethical obligation was sufficient to ground consent waivers.…”

“…We discuss three different justifications for consent waivers; of which ‘the obligation to contribute to research’ (the focus of our earlier paper) is only one 9. The specific role and relevance of public views will depend on which justification is employed.…”