Elsevier

The Lancet Oncology

Volume 7, Issue 3, March 2006, Pages 266-269
The Lancet Oncology

Essay
Should donors be allowed to give broad consent to future biobank research?

https://doi.org/10.1016/S1470-2045(06)70618-0Get rights and content

Summary

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.

Introduction

Local and national research for genetic risk factors for cancer frequently lack statistical power, and specific traits might be identified when their prevalence in a population or in specific families is merely a confounding factor. Validation of the biological importance of genes thought to be associated with cancer and the identification of previously unknown causes of cancer need analyses of large numbers of familial cases and controls—preferably from multiple populations. International collaboration is needed, but regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress in cancer research (figure 1).1, 2, 3 Establishment of common ground for review of the ethics of biobank research is essential. Here, we argue that broad consent to multiple purposes of biomedical research and future consent to as yet unspecified biomedical research by donors for use of human blood and tissue samples in future biobank-based research is legitimate.

Section snippets

The conceptual issue

Arguments against allowing broad consent and future consent state that consent should be based on information relevant to an assessment of benefits and risks associated with participation in a research project. Vilhjalmur Arnason argues that “the more general the consent is, the less informed it becomes. It is misleading to use the notion of informed consent for participation in research that is unforeseen and has not been specified in a research protocol”.4 However, this claim raises the

Respect for donors

A further argument against broad consent and future consent states that the practice of giving specific information and asking for specific consent shows respect for patients and donors. This argument would indeed be true if the process of obtaining specific consent did not jeopardise the amount and quality of research that can be done. Since the response for collection of data (eg, sending out questionnaires or asking for renewed consent to use biobank samples obtained previously) from any

The informed and voluntary assumption of risk

An argument against broad consent and future consent is risk exposure. The basic idea of informed consent, emanating from the Nuremberg trials, is that any risk associated with a research protocol must be accepted on a voluntary basis. The need for an informed and voluntary assumption of risk seems to preclude broad consent and future consent. However, if the risk of harm from future biomedical research is low and sufficiently well controlled, if the participant voluntarily accepts this level

Broad consent for future biobank research

Strong arguments for allowing broad consent and future consent include the importance of biobank-related research, respect for the autonomy of donors, and consistency with current practice.

Acknowledgment of the view of actual donors and potential donors

Few studies have investigated the perceptions of actual donors and potential donors regarding the use of broad consent or specific consent to biobank research.19 Interviews20 of 1038 members of a so-called people's panel by the UK human genetics commission suggested that most panel members (ie, four in five) wanted specific consent for every new project on existing samples. In a study21 of 100 healthy volunteers, 35% reported that they wanted to be consulted if their tissue samples were to be

Broad consent and future consent: a scale from specified to blanket consent

Although we argue for broad consent and future consent, we do not suggest a policy where anything goes. If respect for autonomy was the only argument for the need for informed consent, blanket consent permitting any use of a sample would be a logical solution. Our argument against blanket consent is the societal importance of biobank-related biomedical research: blanket consent could lead to the consumption of important samples, potentially allowing commercial, purely technical or political

Withdrawal of consent

We suggest that consent should be regarded as valid until further notice. There should be a realistic opportunity for withdrawal of consent for those who have donated identifiable samples and data, which can be an issue with biobank-based research that can last for many decades (eg, contact information to the biobank might have changed, and donors are unlikely to save contact information for decades).

The Swedish national biobanking programme has established regional biobank registries that act

Broad consent: not broad permissions from ethics-review boards

The option of broad consent and future consent does not imply once-and-for-all permission for broad research proposals by ethics-review boards. For an ethics-review board to assess the risk–benefit relation for a donor, it must review the coding measures, information security, and other potential risks for the donor that might arise from, for example, changes in legal status, principal investigators, or organisation of the original biobank.

Conclusion

Broad consent and consent to future research studies are valid ethically and should be recommended for biobank research, provided that personal information related to the research is handled safely, that donors of biological samples are granted the right to withdraw consent, and that every new study is approved by the ethics-review board; all three criteria must be fulfilled. Giving donors the option of broad consent and future consent facilitates important research and shows respect for the

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