Turning residual human biological materials into research collections: playing with consent

Abstract

This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human biological materials, which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use.

La Heterogeneidad del Alfabetismo en Salud y el Consentimiento Informado en Chile

“…However, the complex ethical challenges raised by modern biomedicine like genetic and genomic research (Simon, Shinkunas, Brandt & Williams, 2012) or the use of residual biological material (Gefenas, Dranseika, Serepkaite, Cekanauskaite, Caenazzo, Gordijn & Yuko, 2012) are just beginning to be defined and they need to be thoroughly addressed locally in developing countries like Chile, where clinical trials and research have traditionally been carried out in disadvantaged communities.…”

Biobanks and human health research: Balancing progress and protections

“…These include re-consent, tiered consent and multi-layered consent with secondary use statements. [1,4,11] However, these could result in consent exhaustion on the part of the participant and increase the financial costs and administrative burdens of the research. Therefore, we advocate obtaining broad consent from participants and assuring them that there would be REC oversight and approval for future research using their samples and data as the most appropriate way forward.…”

“…[12] Depending on the category of the biobank, differing degrees of broad consent could be obtained and range from consent to conducting research in a specific sphere in health, or on a specific disease, to unrestricted consent for future health research use as in population biobank studies. [11] International organisations, for example, the Organisation for Economic Cooperation and Development (OECD) advocate this type of broad consent for biobank research. [13] The Draft World Medical Association (WMA) Declaration on Ethical Considerations Regarding Health Databases and Biobanks [14] which has been out for open consultation since March this year, states that individuals must be given the choice to decide whether or not their biological materials will be included in a biobank.…”

Croatian National Centre for Biobanking – a new perspective in biobanks governance?

“…Different countries in Europe have different types of biobanks, and the material is collected in different ways for different purposes (2-7) (Table 1). For example, there are different approaches to obtain informed consent depending on the type and the use of the collected tissue samples and whether the material is irreversibly anonymized or not.…”