M. C. Bottis and H. T. Tavani
The principle of informed consent is a standard feature in medical research, including international documents, statutes, protocols, guidelines and other “hard” or “soft” law texts. This principle is ethically significant for participants (i.e., human subjects) in research in that provides both: (a) respect for the person, and (b) protection of the person’s autonomy. So, there are good reasons for defending and preserving the principle of informed consent in medical research involving human subjects. However, research in population genomics, which depends on DNA databanks and data mining technology, has introduced some serious challenges for the informed-consent process.
The principle of informed consent originates from a strict, two-part relationship: the physician-patient relationship. Informed consent in the setting of medical research has usually involved patients who are required to take a drug (or placebo). In this context, the subject must know the nature and purpose of the research, as well as its consequences and risks. Consent must be expressed (or explicit), specific, and documented. International documents such as the Oviedo Biomedicine Convention also require that some additional information be given to the research subject – viz., information about:
- any foreseen potential future uses, including commercial uses of the research results, data or biological materials;
- the source of funding of the research project;
- access to the research results in the future.
Undue “influence concerns,” such as misuse of a position of trust, have also led to additional safeguards for human subjects who voluntarily participate in research.
2. DNA Databanks
We argue that the donation of tissue, blood samples, etc. by human subjects to DNA databanks used for population-wide research purposes has introduced some challenges for the informed-consent process. Initially, one might assume that that an individual’s donating some blood or tissue carries no risk of immediate harm to that consenting individual. Indeed, the act of giving a sample of one’s blood, hair, or body tissue for research would seem harmless; in fact, refusing to do so might be interpreted as an “antisocial” act that also violates the principle of “solidarity” underlying DNA research. Consider that without these research “materials,” there can be no DNA research at all.
However, donating one’s blood, etc., for research in a DNA databank presents some new challenges for the informed-consent process because of the special nature of population-wide genomic research projects and because of the kinds of technologies involved (e.g., data mining). For one thing, the familiar two-part relationship involving researcher and patient is seriously threatened in these kinds of projects. It also raises an important question: What is the nature of a “population’s consent”? And this question, in turn, raises two additional questions: (i) What is it that a whole population needs to know before consenting? (ii) How can we ensure “fair consent” from everybody involved? Consider that any harm resulting from “unconsented” and unprincipled research in this area is directed not only against a person, but against an entire population.
Another challenge has to do with the so-called DNA/gene factor; we are not yet sure what it is that we are providing when we donate our DNA for research. For example, is it information about our “entire self” – i.e., our past, present and future? Is it information about who we are now, at the moment of donation, or is it also a “future diary”?
An additional challenge for the consent process in this area of research has to do with Onora O’Neill (2002) calls the “opacity of consent.” The consent process in DNA research involving databanks and data mining is “opaque” or nontransparent because of the secondary uses of that information made possible by data mining. Suppose a person, A, consents to procedure B. Further imagine that B entails C (and that A is unaware of C). Does it follow that A consented to C? This problem arises in DNA research because of the kinds of subsequent uses of information made possible by data-mining technology.
The solutions put forth thus far to the challenges affecting informed consent in population-based genomic research include aspects of three traditional models:
- presumed consent (the researcher takes the tissues, presuming that the person from whom they originate wouldn’t disagree);
- informed consent (documented by signing pre-drafted forms);
- community consent (the ‘leader’ of a community consents for every member and the members consent, also, for themselves).
We argue that these models are inadequate. Our proposed solution examines some alternative schemes, including the “charitable trust” model for informed consent.
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