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Using human tissue: when do we need consent?
  1. Lisa Parker
  1. Correspondence to Dr Lisa Parker, School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales 2052 Australia; lisa.parker{at}unsw.edu.au

Abstract

Identifiable excess surgical tissue is an important resource for medical research but we have become overly restrictive about consent requirements. I suggest we devolve consent to ethics committees for ordinary research projects involving human tissue, retaining the requirement for explicit consent only for those sensitive research situations where there is significant risk of harm to individual interests in privacy.

  • Allocation of organs/tissues
  • informed consent
  • education for health care professionals
  • history of health ethics/bioethics
  • informed consent

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Introduction

Human tissue is widely used in medical research and has contributed greatly to many important medical discoveries. Human tissue removed at surgery and excess to diagnostic requirements is a particularly important source of research material. Recent controversy about well publicised uses of human tissue involving the Bristol Royal Infirmary and Alder Hey Hospital1 2 resulted in changes to UK legislation which is now overly constraining in its requirement for explicit consent for the research use of all identifiable tissue collected after 2004.3 There is concern that medical research will be hampered and the great advances in medical practices that have resulted from human tissue research will be a thing of the past.4–7 I suggest there is ethical support for relaxation of the current approach to consent requirements.

Deciding upon consent: a new model

The Human Tissue Act of 2004 focuses on identifiability of human tissue as being the main detail of importance with regard to the need for consent. That is, assuming normal approval for the research project has been obtained, the Act allows for the waiving of explicit, individual consent only when non-identifiable tissue is used. I suggest that this is unnecessarily limiting and propose a new way of assessing the consent requirements that acknowledges links between the tissue type and the research proposal, thus taking into account both tissue and research variables. As well as providing a useful framework to assist with research proposal design and review, it allows for the waiving of consent where ‘ordinary’ human tissue is used in ‘ordinary’ research projects. Ethical review of this model shows that such changes to the consent requirements for use of human tissue would contribute greatly to the public interest and would not constitute serious risk of harm to individual interests.

Two of the important ethical issues in the use of human tissue in medical research are (a) the type of tissue that is being used, and (b) the use to which the tissue is being put. Both of these can be visualised as a spectrum from ordinary to sensitive. Reference to figure 1 will be of assistance to the reader here.

Figure 1

Relationship between tissue sensitivity and research sensitivity. (Unshaded quadrant represents a combination that I suggest does not require explicit consent for tissue use.)

Human tissue variables

‘Human tissue’ comes in many guises and there are a number of significant variables affecting its potential sensitivity; these include tissue type, the life status of the person from whom it was taken and the identifiability of the tissue. For the purposes of my model I note that the majority of excess surgical tissue can be classified as ‘ordinary’ but undoubtedly there are certain tissue types that belong in the ‘sensitive’ category, and here I include large organs, particularly the heart, brain and reproductive organs; large body parts such as the head and limbs8; gametes; aborted fetal tissue and genetic tissue. I will also include any cadaveric tissue9–11 but will not automatically include identifiable tissue, for reasons that I discuss later. Importantly, the classification of tissue along the ordinary to sensitive spectrum is likely to vary between cultures12 13 and perhaps with time. Any attempt at prescriptive and binding delineation of the two tissue categories is therefore undesirable and potentially unworkable. Instead, it will be a matter for continual ethics committee review.

Research project variables

‘Research use’ is also a conglomerate term with many variables contributing to its classification along the ordinary to sensitive spectrum. Research includes projects of varying degree of scientific value and ethical acceptance and may or may not involve the pursuit of financial profit. Some types of research, which I call ‘ordinary’, are unlikely to be objected to, and this includes investigation into the treatment or prevention of major diseases such as cancer and immunological disorders. Other types of tissue use, which are less widely accepted or commonly believed to be objectionable, I call ‘sensitive’ use and this includes research into human cloning; interspecies reproduction; research for profit; prolonged storage of tissue without any likelihood of scientifically beneficial use; research that involves, or is likely to result in, embryo destruction or fetal abortion; and research that is likely to result in further oppression of minority groups.14 Again, the classification of such research will be the responsibility of the ethics committee, and this will be an extension of its existing duty to review the overall ethical acceptability of research proposals.

Figure 1 shows the relationship between research use and tissue classification. According to this diagram, the phrase ‘ordinary medical research involving ordinary human tissue’ will apply only when both ‘ordinary use’ and ‘ordinary tissue’ categories are satisfied—that is, the top left quadrant of the diagram. Disqualifiers include sensitive research using ordinary tissue (eg, creating a commercially marketed therapeutic product from excess surgical bone); ordinary research using sensitive tissue (eg, using cadaveric cerebral tissue in brain tumour research) and sensitive research using sensitive tissue (eg, the prolonged storage without benefit of cadaveric paediatric hearts). The ethics committee is responsible for assessing the tissue/use nexus. My suggestions widen the scope of its actions, giving it the ability to approve the use of identified tissue without explicit consent, depending upon tissue variables and the research proposal.

Ethical justification

The ethical justification for the above approach relies upon a close examination of the interests of both the individual and the public in the use of human tissue in medical research. Current debate indicates that there are strong individual interests in the use of human tissue in medical research, and these must be weighed up against the public interest. It has been suggested that while individual interests should generally be regarded as being more important, such is the strength of the public interest in medical research that we should tolerate some (minor) risk of harm to the individual interest.15 16 This view is echoed in the current Australian National Health and Medical Research Council guidelines, which suggest that low risk of harm to individual interests is acceptable in order to pursue the public interest in medical research.17

Individual interests in human tissue

Individual interests in human tissue rest upon a number of well-established ethical values, including respect for privacy, persons and personal value systems; principles of justice; and respect for religious and spiritual freedom. It is beyond the scope of this paper to discuss each of these in detail; since it is the privacy interest that is most relevant to the use of identifiable tissue, this is the topic I will concentrate on.

The individual has a clear privacy interest in her own tissue since the tissue contains information of direct relevance to her past, present and future health. Note that the public also has an interest in identifiable tissue since specific (and therefore potentially identifying) information such as age, and place of residence might be an important part of a research project, without which the full benefits of the project would be unable to be realised. What we need to consider is whether or not the use of such tissue constitutes a significant harm to individual privacy interests, and I will argue that, in the main, it does not. My argument concerns both the risk of breach of privacy, and the risk of harm arising from that breach.

The risk of personal information becoming public is low if researchers are bound by the same high standards of confidentiality and respect for personal privacy as clinical health professionals. That is, those involved in research that uses identifiable human tissue must not share such information with the general public and extreme care should be taken when sharing information to researchers outside of the main team. This may involve specific training for those not already working in the health profession but should not be a difficult standard of care to achieve.18

My second point concerns the risk of harm arising from any breach of privacy and despite my conclusion above that the likelihood of breach is low, there is still unacceptable risk of harm if the consequences of that breach would be significantly detrimental for the individual/s involved. Such research might include the use of sensitive tissues such as products of conception, which, if in the public domain, automatically releases information about a failed or aborted pregnancy; or HIV-positive tissue, which clearly declares the infectious status of the individual. The type of research might also be relevant, and here I am thinking particularly of genetic research, as public knowledge of individual genetic data might have a serious negative impact upon insurance applications, job opportunities and social attitudes towards the individual. In these situations then, where sensitive tissue is being used and/or sensitive research is being undertaken, there is a significant risk of harm to individual privacy interests, and thus the use of tissues without explicit consent is unacceptable.

However, in the ordinary research use of ordinary tissue the likelihood of harm from accidental disclosure of information would seem to be low enough such that, when combined with a low probability of breach, the risk of harm to privacy interests is minimal. I base this assumption on a number of important observations. There is a high degree of public acceptance of the use of surplus surgical tissue in medical research19–21 together with a lack of voiced concern about privacy issues among both the public and academic community outside of the sensitive areas of research/tissue types that I have already acknowledged.4 22 23 In addition there are many parallels between this type of tissue research and medical research using identifiable (paper) patient data. The recent creation of the ethics and confidentiality committee, a committee with the power to approve the research use of identifiable patient data without explicit consent, indicates formal, national recognition of a subset of research projects where the use of identifiable patient data carries a low risk of harm to privacy interests such that consent can be acceptably devolved from the individual to a separate body.

According to the Declaration of Helsinki24 consent should normally be obtained for the research use of all identifiable human tissue, (my italics) but given the low risks involved in the ordinary research use of ordinary tissue, as discussed above, and in line with comments by O'Neill on the practical limits of informed consent,5 I suggest that this need not always be explicit, individual consent but instead is well served by devolving consent to the ethics committee, with the back-up of an opt-out policy for individuals who do not wish their ordinary tissues to be available for ordinary research in the manner suggested here.

Conclusion

I conclude that explicit consent is unnecessary for the use of human tissue in the ordinary situation and I make this conclusion not because I am indifferent to the harm that this causes to individual interests, but rather because I do not believe, for those situations that I identify, that individual interests are significantly at risk. Where there is significant potential for harm to individual interests, as I have outlined here, explicit consent must be obtained before research can begin.

This approach gives a substantial increase in responsibility to the research ethics committee, which will be required to examine the research proposal with specific reference to the planned research use and the tissue type variables in order to determine whether or not the consent process can be waived. The benefits stemming from this increased responsibility and workload are in line with the public interest in having ready access to human tissue for interests in human medical research and will not result in significant harm to individual interests.

Acknowledgments

Thanks to Linda Barclay, Justin Oakley (Monash University) and Wendy Lipworth (UNSW) for their comments on early drafts.

References

Footnotes

  • The author is a lecturer in medical and public health ethics at the University of New South Wales and has clinical experience in anatomical pathology and hospital medicine. This paper is based upon work completed as part of a Master of Bioethics through Monash University, Australia.

  • Funding Self-funded.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.