Environmental Biomonitoring - ACS Publications - American Chemical

Chapter 22

Ethical and Legal Aspects of Human Tissue Banking 1

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Downloaded by UNIV MASSACHUSETTS AMHERST on October 1, 2012 | http://pubs.acs.org Publication Date: May 5, 1997 | doi: 10.1021/bk-1997-0654.ch022

E.-H. W. Kluge and K. S. Subramanian 1

University of Victoria, Victoria, British Columbia V8W 3P4, Canada Environmental Health Directorate, Postal Locator 0800B3, Health Canada, Tunney's Pasture, Ottawa, Ontario K1A 0L2, Canada 2

The collection and banking of human fluids and tissues is an integral part of biomonitoring on a global scale. However, this presents unique problems on the interface between ethics and law that are unlike those which are encountered in other contexts. They include issues of collection, disposition, ownership, access and use. Moreover, different jurisdictions have different laws that deal with these issues. This makes coordination and standardization difficult to achieve on an international scale. This chapter identifies the major ethical and legal issues involved and proposes a model for dealing with the problems based on analogous developments in medical informatics, but independent of juridical and legal variations.

Environmental degradation has become a matter of international concern, and concerted efforts are being made to ameliorate the situation. However, while protection of the environment is acknowledged to be of significance - especially when its degradation has a deleterious effect on its ability to support sustainable commercial usage and exploitation - it is the impact that environmental degradation has on human health that carries social significance. Biomonitoring of animal and plant models has proved itself to be a useful tool in this regard, and different countries have undertaken, or are currently undertaking, indicator studies with varying degrees of intensity and success. The assumption that underlies these monitoring efforts has been that the environmental effects that are evident in animal and plant models sooner or later translate into analogous effects on human beings. As a working hypothesis this is fine. However, it is difficult to persuade policy makers to allocate the funds required for conducting biomonitoring programs unless it can be shown that environmental degradation does in fact have negative effects on human populations. This, in turn, can only be achieved by establishing, on the basis of scientifically sound data, that the indicators which can be found in animal and

© 1997 American Chemical Society

In Environmental Biomonitoring; Subramanian, K., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1997.


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plant models are also present in human populations; and, further, that the effects that can be documented for animals and plants are indicative of effects that can be documented for human populations. To this end, the collection and banking of human fluids and tissues is a sine qua non. Several jurisdictions have, or plan to have, human tissue banks which facilitate the long-term collection and storage of human tissues and fluids (7). However, without exception, these banks are rather specialized, concentrating on only a few types of tissues or fluids. Further, there is a growing realization that environmental degradation is not a limited phenomenon that respects national boundaries. The total global environment, in which humanity as whole is embedded, is implicated. Consequently the ultimate aim of biomonitoring, even when it is driven by national concerns, can be achieved only by biomonitoring on a global scale. This suggests that human tissue banks should be established on a national as well as international basis. Tissue banks also are useful tools for the planning of national health care agendas. Current approaches to such planning typically involve identifying patterns in previous health care expenditures in order to determine what form future health care expenditures should take. Such an approach is liable to miss trends at the cellular level that have not as yet expressed themselves in overt disease processes but will ultimately manifest themselves in this fashion. As opposed to this, the materials collected by tissue banks would provide baseline snap-shots of the health status of the relevant populations at the organic, fluid and cellular levels. When compared with tissues and fluids that are collected at regular intervals and under controlled conditions, this would permit the scientific identification and evaluation of whether something has an impact on human health, what sort of impact it has, its extent, and under what conditions.

In summary, specimen banks for human tissues and fluids, therefore, are appropriate and cost-effective tools. Thus, they allow health care planners to avoid the pitfalls inherent in a purely expenditure-based approach; they satisfy the scientific needs of the environmental health community; they provide appropriate standardized materials for bio-scientific research and development; and they allow the development of strategies to deal with environmental changes that impact on human beings from the local to the global level. Current Rules and Regulations The collection, storage and use of human tissues has generally proceeded independently of legal guidelines, except for the national equivalents of the Human Tissue Gift Acts that exist in Canada and the United States. Although these national acts (and their equivalents) are good initial attempts at providing a juridical framework, they fail to deal with many of the issues that have emerged since the drafting of the relevant laws themselves. The problematic that is here involved includes, but is not exhausted by, issues of collection, disposition, ownership, privacy, access, use etc. These are issues whose full import was not appreciated at the time the original legislation was passed because the scientific, social and political considerations that are now important did not obtain at that



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time. Therefore the acts and their equivalents are insufficient in nature and scope even at the national level for dealing with the issues that have since emerged. The fact that these rudimentary guidelines are national in scope also limits their usefulness in an international setting. In addition to the legal problems, there is the ethical dilemma which centres on the relationship between the individual person and the human species, and of the rights of the human species as a whole. Implicated here are such issues as: (I) does the individual person have a property right in the tissue and in the components of her or his tissues, fluids and cells?; (ii) can ownership be claimed for the tissues and fluids themselves, but not to their structural features and to the structural features of their components - specifically, for the structural features of such components as chromosomal and mitochondrial DNA?; (iii) does the fact that all human beings have a shared biological heritage entail that all human beings the same right to claim ownership to the relevant structures?; and (iv) does the fact of a common heritage entail that the dignity of the human species as a whole is implicated in alterations and/or modifications of shared features? These and similar questions are independent of any appeal to the rights of the individual person as these may be legally enshrined in a framework of laws that is unique to a particular jurisdiction. In other words, these problems cannot be resolved by the mere enactment of national laws. Instead, they concern the ethical status and rights of individual persons as members of the human species, as well as the ethical claims (if any) that humanity as a species may raise in its own regard. Arguably, therefore, the time has come to realize that the establishment of tissue banks and the development of collection processes demand more than merely the passage of enabling laws and the inception of standardized procedures within particular jurisdictions. Some efforts must be made to develop an international and integrated approach that is independent of variations in legal traditions, and whose results will be ethically acceptable irrespective of individual traditions. A Canadian Model In this connection, it may be useful to consider the reasoning that underlies a current Canadian effort to establish a national bank. A basic premise underlying the Canadian approach is that the issues which arise in this connection are essentially ethical in nature, and that therefore a juridical approach, based as it would be on purely legal considerations, would fail to address the problems in an appropriate fashion. The approach that has been adopted involves several stages: (I) identification of the relevant ethical parameters; (ii) examination of their nature and implications; (iii) consideration of how the matter could best be dealt within from a purely ethical perspective; and (iv) and integration of the results of these considerations into a process leading to appropriate legislation. The issues that have so far been identified include the following: collection and storage; ownership and disposition; use; access; and privacy. The list is not all-inclusive,


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but may give some indication of the complexity of the ethical paradigm. Each of the issues is discussed below. Issues of Collection and Storage. Under this rubric, the following major issues have emerged as ethically significant: (I) disclosure of the existence, location, nature and purpose of the bank in which the tissues and/or fluids will be stored; (ii) informed consent by the biological originator of the relevant biota (or their duly empowered proxy decision-makers) to the collection of the relevant fluids and tissues; (iii) informed consent to the ultimate disposition of the banked fluids and/or tissues collected; and (iv) the establishment of nationally enforced controls over any aspect of collection and storage. Issues of Ownership and Disposition. The issues that have been identified under the rubric of ownership and disposition centre in questions such as the following: (I) is the current law prohibiting the sale of human tissue ethically defensible? In light of recent developments in biotechnology, should the law be changed so as to give the immediate biological originator of human tissue property rights over the tissues and fluids?; (ii) if property rights are recognized, should these rights be of the same nature and extent as those recognized for items that are otherwise produced by an individual in a non-biological fashion, inclusive of the whole panoply ofrightsto commercial transaction?; (iii) ifrightsto commercial transaction are recognized, should tissue that is functionally structured into organs be treated differently from tissue of essentially cellular nature?; (iv) if property rights are recognized for tissues at the cellular or organ level, should these rights extend merely to the material components of the tissues or should they extend to the structural features of the tissues and their various components, inclusive of nuclear and mitochondrial DNA?; (iv) if property rights are not recognized, should there be a recognition of the biological originator's right of disposition, inclusive of the right of usufructuary benefit deriving from use, modification etc. of the relevant tissues and their component structures?; and (v) should the benefits, if any, that derive or are derivable from the use, modification, or manipulation of human tissue be shared by society and any agent or agency that might have been involved causally and materially in bringing about these interests or considerations? Issues of Use. The rubric of what constitutes ethically allowable use includes the following considerations: (I) to what use may human tissue ethically be put in terms of experimentation and research, commercial venture, health care or any other purposes?; (ii) what are the ethically allowable limits, if any, concerning the manipulation, modification, use, alteration, etc., of human tissues?; and (iii) how are such limits to be determined, and by whom? It may also be of interest to note that the evolving perspective in these matters holds that because of its unique nature, and for any manner of use: (I) human tissue should be accorded a dignity-status that is qualitatively distinct from, and greater than, the status that is accorded non-human tissue; (ii) the interests of relevant third-party who might be affected by the use of the tissue


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should be explored prior to any use; and (iii) these third-party interests include information-associated interests, and that therefore privacy and confidentiality may play an important role in this regard. Issues of Access. Issues of use are distinct from issues of access. Therefore the following have emerged as considerations worthy of separate mention: (I) should there be special categories of access to the tissues and fluids banked in a tissue bank?; (ii) should access be controlled by nationally promulgated and enforced guidelines, or should other means of control of access be instituted?; (iii) should access to tissue be on the basis of prior and ethically validated protocols detailing use or should this matter be left open?; and (iv) in case prior ethically validated protocols are required, should these protocols be vetted (and adherence to them be supervised) by an appropriate national body having ethical, legal as well as scientific expertise, or should some other mechanism be instituted? Issues of Privacy. In the Canadian context, as in many other jurisdictions, the individual person is protected by a series of concentric and increasingly stringent legal hurdles that safeguard the individual from unwanted and untoward external scrutiny. The existence of these hurdles is premised on the general presumption that everyone has a fundamental right to security of the person which may be overruled only for reasons that are demonstrably necessary to safeguard the equal and competing rights of others. As recent developments in forensic DNA analysis and similar undertakings have shown, this sphere of privacy can easily be breached on the basis of information that is derivable from the tissues and fluids originating in the body of the individual person. Consequently, the concern has arisen that the establishment of tissue banks may open the way to an otherwise unwarranted invasion of individual privacy. These consideration have been focused in proposals like the following: (I) the collection, storage, access to and use of human tissue should be subject to appropriately structured laws, guidelines and regulations that meet all otherwise legitimate privacy concerns of the individual person; and (ii) the laws, guidelines and regulations governing such privacy concerns should be enforceable in a uniform and standard manner. General Considerations In exploring these and other ethically based issues, Canada is proceeding on the assumption that human tissue has a special ethical status which is distinct from that of other species and consequently that it would be inappropriate to deal with human tissue on a property model. Canada inclines to the position that considerations which centre in the dignity of the human species must find appropriate reflection in any relevant legislation. Canada is also proceeding on the general assumption that there are certain basis ethical principles that govern the behaviour of human societies, and that these principles mandate the ascription of rights and demand the imposition of duties even if neither these rights nor these duties find explicit expression in legal tradition or in the laws as


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they are currently structured. This perspective finds support in the Nuremberg Code and the International Declaration of Human Rights, as well as in the condemnation of terrorism, oppressive regimes, etc. If this Canadian perspective is correct, then it is arguable that there lies an universal obligation to ensure that the establishment of tissue banks will be governed by appropriately structured but ethically grounded rules and regulations. However, the mere adherence to this requirement would be insufficient. Different jurisdictions have different legal traditions and perspectives. To allow regulation to progress independently for each nation thereby run the risk of resulting in an international patchwork of regulations that are mutually incompatible and impossible to enforce. Therefore what is needed is some international mechanisms that reflects the above-mentioned ethical concerns. Several mechanisms suggest themselves. Three in particular deserve mention: Conventions Under the Auspices of the UN. This mechanism has already been explored in U N Conventions concerning human rights. The advantage of such conventions is that they provide a global framework. Their disadvantage is that individual countries frequently do not consider them binding; and that in any case, they are not readily enforceable. Professional Codes of Ethics. The various professional groups that are involved in the collection, storage and use of human tissue could incorporate the relevant ethical clauses into their respective codes of ethics. Although not specific to the issue at hand, the Code of Ethics of the World Medical Association could be seen as a model in this regard, as likewise the international professional agreements restricting the use of recombinant DNA techniques. The advantage of this approach is that adoption of the relevant clauses would be independent of national laws and would govern scientific conduct, which in turn would be enforceable through the adoption of ethically based policies that restrict publication in scientific journals. The ethical guidelines adopted by journals such as Nature and The New England Journal of Medicine clearly demonstrate that such a combined mechanism may work quite well. On the other hand, the disadvantage of such an approach is that it would be ineffective in cases of commercial exploitation where publication and professional behaviour is not an issue. International Treaties that Incorporate the Ethically-based Concerns Indicated Above. The most promising model is a treaty model. The treaties that bind the various members of the European Economic Community provide a usable parallel. Particularly implicated here are the treaties that regulate the collection, use, storage and disposition of medical records. The relevant clauses anent this matter are grounded in the recognition that every person has a fundamental right to privacy, that this an ethically grounded right and not the creature of legislative accident, and that it should therefore be recognized irrespective of the juridical


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traditions of the respective jurisdictions. The clauses that detail the treatment of medical records are enforceable by the same mechanisms that enforce adherence to the other treaties that bind the European Economic Community. Arguably, similar provisions regarding tissue banks could be made within the framework of the international trade agreements that are currently being developed for the Asia-Pacific Rim region. Analogous measures could also be incorporated into international trade agreements on a global scale. Conclusions The preceding discussion has explored some of the ethical implications that surround the establishment of human tissue banks. No doubt, there are sound social, scientific and pragmatic reasons for establishing such banks. However, care should be taken to address the ethical concerns that arise in this connection. A preliminary effort has been made here to identify some of these ethical concerns. Literature Cited (1)

Subramanian, K. S. Sci. Total Environ. 1993, 139/140, 109-121.


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