Elsevier

Social Science & Medicine

Volume 70, Issue 2, January 2010, Pages 217-220
Social Science & Medicine

Short report
“Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose

https://doi.org/10.1016/j.socscimed.2009.10.004Get rights and content

Abstract

An important ethical issue regarding biological samples stored in biobanks is unforeseen future sample use, when no or limited subject consent is obtained. Biobanks of biological samples have significant future research potential, but may cause conflicts of interest regarding the consent obtained. Indeed, ethics, deontology, and jurisprudence generally advise that consent must be specific and circumstantiated. However, it is not possible to foresee all of the future circumstances in which the samples might be useful, nor is it possible to re-contact all subjects in order to gain consent for a new use. The main arguments for the use of “broad” consent are presented with a brief discussion of the conditions where it may be legitimate not to obtain consent. Particular attention is given to the expressed positions of national and international bioethics bodies.

Introduction

An important ethical issue regarding biological samples stored in biobanks is unforeseen future sample use, when no or limited subject consent is obtained (Giroux, 2007, Greely, 1999). Informed consent is ethically important to protect patients' interests, protect the confidentiality of personal information, ensure subject autonomy, define research and social interests in the general advancement of knowledge, and maintain public trust in researchers and institutions. Broad informed consent expands informed consent by allowing sample use in unforeseen future studies. Although there are several authoritative reviews of the peer reviewed literature regarding informed consent (Dupont, 2008, Elger et al., 2008, Weir and Olick, 2004), there has been no formal analysis of the impact on the breadth of informed consent made by the published opinions of national bioethics committees of European and other nations (Petrini (in press) lists relevant opinions). This paper will review problems that arise when using samples for unforeseen purposes, describe ethical guidelines published by national bioethics committees that favor a broad interpretation of consent for sample use, and discuss exceptions to the need for consent. The author's proposals for ethically consistent broad consent will be compared to the published opinions of national bioethics committees. Finally, recommendations will be proposed for conditions in which broad interpretation of subject consent are acceptable.

Section snippets

The problem of using samples for initially unforeseen studies

Many samples stored in biobanks are collected in non-standard situations, where an awareness of the need to meticulously handle information and obtain consent is lacking. The issue of the permissibility of sample use therefore arises when the samples have been stored without the consent of the subject or with very broad consent for future uses (Greely, 1999). The problem for the potential use of the samples is widely noted and confronted in differently. Knoppers (2005) states “legal comparisons

Examples of institutions and laws favoring broad consent

“Broad” (“open”, “blanket” or “generic”) consent has been proposed authoritatively. The World Health Organization (1998, p. 13) considers it “the most efficient and economical approach”. The Human Genome Organisation ethics committee (2002), the Commission of European Communities (2004), and the national bioethics committees of various countries, including the Danish Council of Ethics (1996), the French National Consultative Ethics Committee for Health and Life Sciences (2003), and the German

Exceptions to consent

Generic consent permitting any research at all is considered unacceptable, not only by this author, but by bioethicists and bioethics committees throughout the world. Informed consent, a “prima facie” duty, is linked directly to the principle of autonomy. Ross (1939) defined “prima facie” duties as binding in all circumstances unless they conflict with duties of equal importance in a given concrete situation. In such a scenario, one should look to the “actual” duties to be fulfilled, which are

Conclusions

In circumstances, such as large-scale sample collections involving hundreds of thousands to millions of samples and associated data, it is impossible to contact each subject prior to each new data use. Further, additional contact with the subjects might disturb or cause unjustified concerns. The UK Human Genetics Commission (2000), for example, found many patients explicitly do not wish to be re-contacted for such consent. Contacting subjects for every new project also limits the usefulness of

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      There is strong support for broad consent in developed countries as it is occasionally difficult to re-consent participants (Petrini, 2010; Ruiz-Canela et al., 2009). Some presume that it is ethical to store samples and re-use them for future studies, since the specimens were donated and society will eventually benefit; thus, there is no need for controls on what research is conducted (Petrini, 2010). Others have considered the broad consent as pragmatic, but not an acceptable ethical solution (Ploug and Holm, 2020; Steinsbekk et al., 2013).

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