The Right to Withdraw Consent to Research on Biobank Samples

Abstract

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right.

Trends in ethical and legal frameworks for the use of human biobanks

“…Several features of biobanks have generated debate about consent applicability, its limits, modalities and the conditions for waiving consent. This makes it the most controversial issue in the domain of biobanking [9,37,38,[41][42][43][44][45]. A number of studies have been carried out to examine the opinions and attitudes of research participants on the matter of consent and issues in the context of biobanking [46][47][48][49][50], which showed a variety of patterns, with more concern focusing on confidentiality issues rather than the consent itself.…”

The Italian Twin Register: New Cohorts and Tools, Current Projects and Future Perspectives of a Developing Resource

“…It is our opinion that broad consent together with the requirement for future consent are still ethically sound as the original meaning of informed consent is not violated. Autonomy of individuals and respect for human dignity are guaranteed, provided that: participants risks are not very high, personal information are handled safely, withdrawal from the study as well as from biobank is guaranteed (Helgesson & Johnsson, 2005) and each new step (i.e., new hypotheses to be proved) is approved by the local ethical board.…”

Withdrawing from Research: A Rethink in the Context of Research Biobanks

“…Finally the US 'Common Rule' requires consent procedures to include: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (CFR45 §46.116.…”

“…(CFR45 §46.116. 8) Many more examples could be given, but these ought to suffice. From these sources we can gather that the right to withdraw can be characterised by 5 components.…”