Beyond Informed Consent: A Model of Collective Guardianship for Ethical Genetic Research

Beyond Informed Consent: A Model of Collective Guardianship for Ethical Genetic Research

Leonardo de Castro (National University of Singapore, Singapore) and Chin Leong Teoh (National University of Singapore, Singapore)
DOI: 10.4018/978-1-61692-883-4.ch007
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This chapter affirms the continuing relevance of requiring informed consent for health research in a context consisting of evolving genetic research methodologies and non-paradigmatic ways by which human beings become subjects of genetic research. The chapter also recognizes the special status of genetic materials and genetic data as subjects of research, as well as the different ways in which genetic materials and genetic data may be “owned.” Different senses of ownership necessitate variable ways of implementing informed consent and these have to be clarified and carefully matched. Taking into account the specific interests expressed by human participants in human tissue research,the authors can see that these can be best promoted by a kind of oversight function delegated to ethics committees. The idea of a “one-time” or absolute consent given at the time of recruitment sounds appealing in that it minimizes inconveniences to many stakeholders, including researchers and human subjects. However, there remain valid reasons to be wary lest the system allow some types of research (or use of human research materials) that subjects would disapprove of unless sufficient pertinent information could be provided at the moment of recruitment. Thus the authors present an option for something close to “one-time” or absolute consent with safety nets in the form of oversight functions “delegated” to oversight ethics committees. The exercise of oversight function should involve flexibility to negotiate specific instructions given by the subject(s), such as those that may have something to do with uses that could have a particular religious or cultural significance.
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One of the reasons why informed consent for genetic research is especially problematic is that there are a number of ways by which humans could become research subjects. Not all of these ways are recognized as involving research, especially when we consider the initial starting point when an individual’s genetic materials or information become candidates for use in a particular study. When we consider the opportunities for sharing of research resources among various laboratories, we realize how difficult it is even merely to determine the specific point when consent for the use of genetic materials for a specific study could and should have been secured.

In general, to become a research subject is to have oneself–or one’s bodily parts or information–become the subject of investigation or examination that could yield generalizable information, where “generalizable” means that which could be inferred to be true also of others in a similar situation, or that which could be inferred to apply on a broader scale, e.g., to an individual at other times in his or her life. Thus, there are a number of possible entry points for someone (or something) becoming a research subject, including the following:

  • 1.

    Having tissues/samples taken for diagnostic examination

  • 2.

    Having one’s records filed in a health care institution

  • 3.

    Participating in non-genetic research that requires tissues to be drawn and stored

  • 4.

    Submitting oneself for genetic testing

  • 5.

    Having a genetic relative participate in research in any of the above ways

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