Abstract
It is generally assumed in research ethics that research participants have an unconditional right to withdraw from research without any detriment or reprisal. This paper analyses this right in the context of biobank research and argues that the traditional shape of the right in clinical research can be modified in biobank research without incurring significant ethical cost. The paper falls in three parts. The first part is a brief explication of the philosophical justification of the right to withdraw. The second part presents a number of extant criticisms of the right. And the third and final part argues that although a right to withdraw is crucial in relation to biobank research, such a right has to be specified in a different way to the similar right in relation to clinical research.
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Notes
World Medical Association Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, Italy, October 1983, 41st WMA General Assembly, Hong Kong, September 1989, 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002.
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
If there is a moral duty to participate in research as many have argued [5, 7] there may also be a moral duty not to withdraw from research without good reason. Such a duty would potentially conflict with unconditionality, since we normally find it acceptable to ask people to explain or justify their prima facie breaches of moral duties. I will not pursue this line of argument here although I believe it has some merit.
Apart from in the justification of the right to withdrawal, this power imbalance plays a major role in the rule that rejecting participation in research should not affect the patient’s access to standard treatment, for instance in paragraph 31 of the Helsinki Declaration: “31. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship”.
I will leave out discussion of whether it is preferable that biobanks are public, private or constituted along fiduciary or charitable trust lines [17], as well as discussion about benefit sharing arrangements. Although the mode of constitution has some linkage with ethics I can see no reason to believe that one of these forms of constitution is necessarily better. They will for instance all be subject to economic incentives, simply in order to generate the amount of finance necessary to sustain the functioning of the bank.
Specifying what is ‘adequate’ ethical oversight is not a simple matter, but it will at least include consideration of each specific use of material and data including consideration of whether that specific use is ethically justifiable in light of the original consent and the interests of the research participants.
I have previously written about the use of biobanks where materials were originally entered without consent and will not further analyse these issues here but see [1].
Biobanks with material obtained from children following proxy consent also raise specific issues that I will not analyse here but see [9].
A person withdrawing could try to avoid the free rider problem by joining another biobank, but given the irreversible loss to the first biobank, and the initial costs to be borne by the second biobank he will still impose costs on others, even though this will only be in the short term.
If there is complete anonymisation it will no longer be possible to link to information outside of the biobank, or to collect new information about the person who has now withdrawn.
Many statistical methods will allow for the analysis of incomplete datasets which may further add to the continued usefulness of incomplete records.
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Holm, S. Withdrawing from Research: A Rethink in the Context of Research Biobanks. Health Care Anal 19, 269–281 (2011). https://doi.org/10.1007/s10728-011-0194-8
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DOI: https://doi.org/10.1007/s10728-011-0194-8