Genetic Research: Groups and Potential Harm

Anyone interested in public engagement and community consultation in genetic research will appreciate Daniel Hausman's article "Protecting Groups from Genetic Research" (Bioethics 2008; 22 (3):157-65). Hausman provides a clear, well-written taxonomy of group types and potential harms to these types as a result of genetic research. He identifies three kinds of groups: structured groups – those with corporate interests distinct from the interests of their individual members (for example, indigenous groups with existing or potential corporate property); identifying groups – unstructured groups (Italian Americans or Ashkenazi women, for example); and potentially identifying groups – those that may be identified as a result of genetic research.

Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.

Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.

The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.

The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.

As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.

Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?

While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.

Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]

Biomedical Research Ethics 2.0: MySpace and Pediatrics

Much of the excitement about the future of personalized medicine revolves around the creation of consumer managed, personal health records. To acquire a measure of the anticipation, revisit the blogging blitz inspired the by implicit competition between Microsoft's HealthVault and Google Health (see, for example, David Hamilton's reviews of HealthVault at Venture Beat and Bertalan Meskó's coverage of Google Health at ScienceRoll). Although most are interested in the potential these Web 2.0 developments hold for enhanced, individualized health care, others have speculated that personal health information may become a more common feature of social-networking sites. The big names in social-networking (MySpace and Facebook) already host user-generated groups for individuals with shared health conditions; others, such as iMedix and MyOpenCare (for more examples visit Medicine 2.0) have entered the market with an obvious interest in health 2.0 and shared, personal medical records.

Although many worry about how advertisers might data mine personal information to target potential customers, these networks also offer a new source of information for medical research data and research recruitment. With this in mind, "Research Ethics in the MySpace Era" (Moreno MA, Fost NC, Christakis DA. Pediatrics 2008;121;157-161. PMID:18166570) is a very timely publication. The authors explore the ethical implications of using MySpace profiles as: a source for observational research (potentially exempt from IRB oversight); a tool for research recruitment; and a platform for health intervention studies. Although the authors are particularly interested in the risks and benefits of social-networking sites for pediatric research, the investigation could easily be generalized for research with adult users. The authors, however, do not address the ethical implications of using shared, genetic information. Imagine a day in which users update their profiles and replace zodiac signs with significant genetic biomarkers. How would this "shared" information challenge the ethical framework proposed by Moreno, Fost and Christakis? - J.O.

Barriers to Research and Strategies for Community Engagement: Three Recent Papers

PredictER Blog and the PredictER program have an ongoing interest in encouraging community engagement in genetic and predictive health research. Patrick Barrett introduced this mission in the previous PredictER Blog post (November 19, 2007.) For those with an interest in reading the latest research on this topic, here are brief summaries of three recent papers:

Grand challenges in global health: community engagement in research in developing countries ...
Tindana PO, Sing JA, and et al. provide a short review of community engagement (CE) concepts for research in developing countries and discuss two models in Africa. Although the authors note that community engagement goals "have become prominent in research policy", they point to divergent definitions of CE and the need for evaluation. They caution that "there is a growing recognition that communities, not just individuals, can suffer harm from participation in research. For example, with out adequate protections, population genetics research runs the risk of stigmatizing or discriminating against recognizable communities ....". The authors plan to document CE in developing countries and to develop preliminary guidelines to facilitate CE in research.

Community engagement in epidemiological research ...
Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR outline the CE practices and plan of The National Children's Study (NCS). In introducing the project, they note that CE "can be quite complex, even within a single site due to the difficulty researchers have in defining communities". In addition to the difficulty of defining "community" they add that "finding key community leaders that will best represent [the] multitude of community views and perspectives" can be a challenge.

An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research ...
Robinson JM and Trochim WMK, in a "concept mapping" study of perceived barriers to minority participation in research, demonstrate that the research system (in addition to the often discussed lack of trust in researchers) contributes to lower participation rates. The authors also discuss the discrepancy between how health professionals and community members define these barriers. They conclude with three recommendations for improved minority participation rates in health research: (1) improve relationships between the medical research community and the communities they serve; (2) increase the levels and improve the nature of community involvement in the research process; and (3) efforts must be multi-dimensional, addressing both community interrelations and research process issues.

Citations:

Robinson JM and Trochim WMK. An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethnicity and Health 2007; 12(5):521-39.
DOI: 10.1080/13557850701616987 PredictER CiteULike [abstract]

Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR. Community engagement in epidemiological research. Ambul Pediatr 2007; 7(3): 247-52.
PubMed ID: 17512886 PredictER CiteULike [abstract]

Tindana PO, Singh JA, Tracy CS, Upshur RE, Daar AS, Singer PA, Frohlich J , Lavery JV. Grand challenges in global health: community engagement in research in developing countries. PLoS Med. 2007 Sep 11;4(9):e273
PubMed ID: 1785017 PredictER CiteULike [abstract]