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

Abstract

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.