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Abstract
Although sociologists, anthropologists, and behavioral scientists have been grappling for the past few decades with the process of researching entire societies and groups, community research is relatively new to biomedical researchers. Recent advances in genetics, which seeks to identify shared characteristics among family members and larger groups, are increasing the focus on groups and communities. In the United States, recent years have also seen the development of National Institutes of Health (NIH) policies necessitating a broader definition of community, such as that requiring the inclusion of women and minorities as subjects in clinical research (amended in October 9, 2001) and that on reporting race and ethnicity data (released August 8, 2001).
| Most genetic variation occurs within ethnic and racial groups. |
Data from the Human Genome Project has confirmed that, as scientists have long suspected, there is far more genetic similarity (99.9 percent) than difference between individuals and that most of the variation (200,000 sites among the 3 billion bases of human DNA) occurs within, not between, ethnic and racial groups. Hence, genetic research involving participants from groups with a higher frequency of a particular disease may provide insights into the genetic variants associated with a disease. Already, scientists are seeing the potential of community research with diseases such as cystic fibrosis, diabetes, Tay-Sachs, and colon cancer.
While a population is the pool from which the research participants are drawn, the community consists of the broader ethnic, racial or geographic group that may be impacted by the research. There are therefore some concerns about the harm that could result from genetic research on particular communities, such as discrimination and loss of privacy. For some people, moreover, such research can raise the specter of some of history's darker chapters, when supposed racial characteristics have been used to stigmatize particular groups.
| Genetic research within groups may promote stereotypes. |
"Native Americans might be especially wary of research that highlights the incidence of alcoholism in their communities, given the prevailing stereotype of the 'drunken Indian'," noted Dena S. Davis in an article in the November-December 2000 Hastings Center Report. "Jews, targeted during the Holocaust for destruction as a 'cancer' that would 'infect' and destroy the otherwise healthy Aryan 'race,' might well be uneasy about research that suggests to the popular mind that they are inbred or particularly prone to genetic disease." [1]
In addition, communities may be difficult to define, as may be the potential benefits and risks of the research for these communities and their members. Among the questions that may confront researchers are: When is community involvement necessary, what is the community, how does one contact its members, and how does one deal with disagreements within the community? Different communities and members may also have different needs and interests and may want to participate in the proposed research in a variety of ways.
NIGMS Meeting
| NIGMS invited community representatives to express their concerns. |
Because of these concerns, it is important to have community consultation in addition to the individual consent process required by current regulations guiding human subjects research. The process may be a difficult one. To provide a forum for discussing concerns and addressing modes of community involvement among diverse groups, NIH's National Institute of General Medical Sciences (NIGMS) convened the First Community Consultation on the Responsible Collection and Use of Samples for Genetic Research from September 25 to 26, 2000. [2] The meeting gave members of identified populations in the United States an opportunity to exchange views formally and informally with research administrators, and represented a variety of disciplines and roles, including educators, social scientists, biologists, lawyers, ethicists, clergy, doctors, nurses, and community leaders.
During the discussions, several overriding themes for NIH-supported genetic research involving populations and communities emerged:
The meeting also convened breakout groups to develop recommendations in these areas. Ten major recommendations for genetic research involving populations and communities were, in brief:
Other Developments
| Native American communities have extra legal requirements. |
After the meeting, in February 2001 the NIGMS and the National Human Genome Research Institute (NHGRI) cosponsored the American-Indian and Alaskan-Native Genetics Research Policy Formulation Meeting. This roundtable meeting brought together 25 Native Americans, geneticists, and physicians who are Native American, work with Indian populations (Indian Health Service), or are in some other way associated with Native American communities to discuss ways to distribute knowledge about genetics research to the communities. Because Native American tribes are sovereign nations, there are legal requirements that the tribal leadership give consent for the tribe's members to participate in research, making education about genetics more necessary than ever. The outcome of the meeting has been the decision to develop several primers. One will be for researchers, to help them understand the issues involved in this kind of research and to give them some guidance in approaching tribes. Another will target lay people and tribal members to explain the research process. A third will be directed at members of institutional review boards and research funding agencies.
"We plan additional follow up to the Comunity Consultation meeting," said Judith Greenberg, director of the Division of Genetics and Developmental Biology, NIGMS, NIH, and the First Community Consultation Meeting organizer. "In general, we are hoping that a variety of ethnic groups will get together as communities and apply for funding to hold meetings to discuss the issues that they consider to be most important to them. We also hope to raise awareness among researchers about the concerns of communities.
| Pharmacogenetics is ripe for community research. |
Community research also has implications for emerging fields, such as pharmacogenetics, the study of how genes affect people's responses to different medicines. At the first annual meeting of the NIGMS's Pharmacogenetics Research Network in April, a panel was specifically devoted to the topic of community consultation.
A Workable Model
Greenberg referred to one of the studies being conducted under the Pharmacogenetics Research Network as a successful model for the community consultation process. Julio Licinio of the University of California at Los Angeles had proposed to collect blood samples from Mexican-Americans to deposit in a cell repository for use by investigators in the Pharmacogenetics network. Licinio's group wanted to consult the community before undertaking the sample collection.
| Don't underestimate community interest. |
Initially, the researchers were unsure whether members of the community would be interested in attending a forum to discuss their research, and whether a presentation on genetics and the purpose of cell repositories would be clearly understood by the audience. Before holding the forum, Licinio's team of researchers met with community leaders from many different Mexican-American organizations to gain an understanding of key issues and potential ethical problems that would be of concern to the community. As a result of those meetings, they also decided to hold the first forum on a Saturday morning at a housing development, where they were able to enlist the help of the a social worker to generate attendance. At the forum, the presentation slides were in English and Spanish, and an English-Spanish interpreter was on hand to provide additional language assistance. The turnout for the first meeting was 50 people,but attendance for the second meeting was more than doubled (to 120 people) because of word of mouth from the attendees of the first forum.
"It was marvelous," comments Greenberg. Through a sincere attempt to involve the community in the research and consent process, the researchers gained credibility.
| The second forum generated more significant questions. |
Interestingly, the second forum solicited more significant questions. While the first forum generated questions such as "Can they use my cells to create a clone?", the second generated questions about immigration status.
"This is another reason why community consultation is important. Each community has its own concerns. It's also a good reason to have follow-up meetings so these kinds of things can simmer and get asked at a second meeting," Greenberg says.
A major outcome of the meeting was the creation of a community-liaison advisory group with representatives from the Mexican-American community. A bilingual hotline has also been set up to answer questions from the community.
Sanyin Siang works on a variety of issues at the intersection of science, ethics, and law at the Directorate for Science Policy Programs of the American Association for the Advancement of Science.
Matt Morrow is a freelance illustrator from Omaha, Nebraska.
Human Genome Diversity Project - a proposed project to collect DNA from many of the world's indigenous populations. Links to a summary of the project, frequently asked questions, and a model ethical protocol for collecting DNA under the HGDP.
The Challenges and Impact of Human Genome Research for Minority Communities - proceedings from the second in a series of conference presented by Zeta Phi Beta Sorority National Educational Foundation, July 7-8, 2000, Philadelphia, Pennsylvania.
Genetics Privacy and Legislation - discusses current and future policies in the U.S. From Ethical, Legal, and Social Issues of the Human Genome Project.
Genetics Scandal Inflames Iceland and Iceland's Public Supports Database, But Scientists Object - discuss the controversies surrounding the Icelandic Health Sector Database. From Wired and The Scientist, respectively.
Bioethics.net - offers an extensive library of articles, as well as current news, general resources, educational tools, and basic cloning and genetics information. From the Center for Bioethics at the University of Pennsylvania.
National Reference Center for BioEthics Literature - contains the world's largest collection of biomedical ethics literature. From the Georgetown University Kennedy Institute of Ethics.
Bioethics Resources on the Web - contains a broad collage of annotated Web links. From the National Institutes of Health.
PharmGKB - offers a shared data library and resources for pharmacogenetics researchers.
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