Retrospective access to data: the ENGAGE consent experience

Abstract

The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium.

Biobank research: Time for discussion and debate

“…Solutions include broad/blanket consent; multilayered consent with secondary use statements; recontact/reconsent mechanisms; presumed consent/opting out; and waived consent. [7] Biobank research entails a balanced choice between autonomy and the public good as the benefits of this type of research involve broader societal concerns of scientific advancements for diagnosis, prevention and treatment of disease, and increasing knowledge.…”

Children, biobanks and the scope of parental consent

“…The information sheets of the remaining 17 did not mention genetic research per se but only biological research. 23 The seminal UK biobank states in its consent form:…”

Personal privacy, public benefits, and biobanks: a conjoint analysis of policy priorities and public perceptions

“…The problem is a lack of international consensus on appropriate regulatory standards and governance structures for biobanks. [7][8][9][10][11][12] This regulatory impasse is perplexing in light of the fact that broad international consensus has been achieved for guidelines related to clinical research in which the risks of direct physical harm to participating individuals are generally much higher than is the case with research on biobanked samples. However, although clinical research guidelines are designed to limit identifiable harms to individual research subjects, research using biobanked specimens is generally directed at populations.…”