Grappling with Groups: Protecting Collective Interests in Biomedical Research

Abstract

Strategies for protecting historically disadvantaged groups have been extensively debated in the context of genetic variation research, making this a useful starting point in examining the protection of social groups from harm resulting from biomedical research. We analyze research practices developed in response to concerns about the involvement of indigenous communities in studies of genetic variation and consider their potential application in other contexts. We highlight several conceptual ambiguities and practical challenges associated with the protection of group interests and argue that protectionist strategies developed in the context of genetic research will not be easily adapted to other types of research in which social groups are placed at risk. We suggest that it is this set of conceptual and practical issues that philosophers, ethicists, and others should focus on in their efforts to protect identifiable social groups from harm resulting from biomedical research.

Keywords:

• ethics
• biomedical research
• group harm
• genetics
• race
• ethnicity
• culture

ACKNOWLEDGMENTS

This publication was made possible by research grants from the National Institutes of Health: HG003042 (RS), HG03083 (RS), HG002498 (MF, RS), and ES11174 (MF). We thank Laurence McCullough, Jennifer Hamilton, and two anonymous reviewers for their thoughtful comments on an earlier draft. The contents are solely the responsibility of the authors.

Notes

1. Examples include: Greely (1997); Foster, Bernsten, & Carter (1998); Foster, Sharp, Freeman, Chino, Bernsten, & Carter (1999); Greenberg (2000); Annas (2001); and Gollust, Apse, Fuller, Miller, & Biesecker (2005). A discussion of normative arguments supporting special ethical protections for community interests can be found in Weijer (1999).

2. Examples include: Juengst (1998a, 1998b, 2000, 2003); Reilly (1998); and Reilly & Page (1998).

3. Our analysis of guidelines on the participation of indigenous communities in genetic variation research is adapted from an expanded treatment in Sharp & Foster (2002b). Examples of pertinent guidelines can be found in: North American Regional Committee of the Human Genome Diversity Project (1997), National Research Council (1997), Canadian Tri-Council (1998), and American Indian Law Center (1999).

4. We are grateful to Daniel Hausman for helping us to appreciate this important point.

5. For a defense of this approach and its consistency with existing federal regulations on the conduct of research with human subjects, see Sharp & Foster (2002a).

6. For a contrasting perspective, see Reilly (1998).

7. Even in the absence of explicit disagreement among affected parties, it may be unclear how investigators should respond to information learned through community consultation. If some members of an affected community find aspects of a research study morally objectionable, for example, are investigators required to respond in some way?