Council for Responsible Genetics

In 2005 the National Geographic Society and IBM launched the Genographic Project, a five-year effort “to understand the human journey — where we came from and how we got to where we live today.” The Project has fired the imagination of supporters, but has also has ignited criticism from representatives of indigenous peoples from whom blood samples are sought. For example, to the Indigenous Peoples Council on Biocolonialism (IPCB), the Project merely is a “renewed attempt to further the goals of the defunct Human Genome Diversity Project,” which foundered on accusations of exploitation of indigenous populations. The IPCB has criticized the Genographic Project’s advocacy of gene-based theories of human origins that may contradict indigenous peoples’ oral traditions; lack of voluntary, competent, informed, and understanding consent from research subjects; biopiracy and the commercialization of human genes; inadequate respect for cultural relics, including sampling of bone and hair from exhumed ancestors; and the prospects for further stigmatization and discrimination against indigenous peoples qua “scientific curiosities.” In May 2006, representatives of Indigenous peoples presented a statement to the United Nations Permanent Forum on Indigenous Issues protesting the project. In their words:

“The Genographic Project is exploitative and unethical because it will use Indigenous peoples as subjects of scientific curiosity in research that provides no benefit to Indigenous peoples, yet subjects them to significant risks. Researchers will take blood or other bodily tissue samples for their own use in order to further their own speculative theories of human history.”

In response, the United Nations Permanent Forum on Indigenous Issues adopted the following recommendation, that:

“WHO [World Health Organization] and the Human Rights Council conduct an investigation of the objectives of the Genographic Projects…that the Genographic Project should be immediately suspended and that they report to indigenous peoples in all communities where activities are conducted and planned.”

Because the Genographic Project was conceived and has been initiated without appropriate consultation with or regard for the risks to its subjects, the Indigenous peoples, the Council for Responsible Genetics concludes that the Indigenous peoples’ representatives are correct and that the Project should be immediately suspended.

The Genographic Project is led by population geneticist Spencer Wells. The project relies on the identification of genetic markers – occasional mutations to DNA that are passed on through generations – “to chart new knowledge about the migratory history of the human species and answer age-old questions surrounding the genetic diversity of humanity.” Different populations carry distinct markers. According to the researchers, following these markers through the generations reveals a “genetic tree” on which “today's many diverse branches may be followed ever backward to their common African root.” The Genographic Project aims to collect blood and DNA samples from indigenous populations, before modern globalization further erodes the cultural groupings that could provide the geographical and historical context for interpreting the diverse genetic patterns.

There are three areas of focus for the Genographic Project. The Project’s field research – the collection of genetic material from indigenous peoples – is overseen by Dr. Wells. A separate “public participation and awareness campaign” aims to involve the general public, by offering genetic marker analysis kits for sale to consumers via the National Geographic website. Proceeds from sales fund a third area of focus, a “legacy project” which purports to support educational and cultural preservation programs among participating indigenous groups.

All indigenous peoples have the right to manage their own biological resources, to preserve their traditional knowledge, and to protect these from expropriation and biopiracy by scientific, corporate or government interests.
All people have the right to genetic privacy, including the right to prevent the taking or storing of bodily samples for genetic information without their voluntary informed consent.
All people have the right to be free from genetic discrimination.

Based on the CRG’s review of the Genographic Project’s consent form for the collection and analysis of DNA from indigenous people in North America, and a corresponding Technical Summary, we believe the Project’s field research inadequately safeguards indigenous peoples’ rights. (CRG takes no position here on the Project’s website-mediated collection and analysis of genetic information from consumers.) With representatives of indigenous groups expressing their serious concerns, we would have expected the Genographic Project’s North American informed consent document to be ethically sound and impeccably drafted. It is not. With proper attention, the Project’s field research inadequacies could be substantially reduced, and the Project’s ethics substantially improved. But thus far, CRG has seen no sign that the Genographic Project has adequately addressed the following key questions.

1. Will researchers describe the Project as “research?” Researchers must inform prospective subjects that the study involves research. The word “research” is generally omitted from the Genographic Project’s consent document. Instead, the form repeatedly references the “project” – for example, “this project is a major international effort” and “[y]our participation in the project will take no more than 20 minutes.” Moreover, the Project’s Technical Summary emphasizes an intent to “reassure the participants that they are true collaborators in the scientific process and not merely ‘study subjects.’” This view has been echoed by principal investigator Spencer Wells: “We do not see the indigenous peoples as ‘subjects’ of the research, but as collaborators. The project has celebrating cultures and diversity at its core; it is not genetic research, but an anthropological study that simply uses genetic tools.” Genographic Project scientists seem to be purposely obscuring the basic research nature of their project, and this is not ethically acceptable.

2. Will consent be ethically defensible? To meet widely-accepted ethical standards, research subjects must give voluntary, competent, informed, and understanding consent to participate. Obtaining ethically defensible consent from research subjects in developing countries for research done primarily to benefit rich countries, like the U.S., always poses significant challenges and therefore warrants heightened ethical scrutiny. The Project’s researchers must consider the difficulty of adequately informing research subjects from these populations; cultural nuances in valuing autonomy and locating decisional authority; the appropriateness and utility of written consent documentation; and even the prospects for ethically defensible consent from vulnerable populations.

Blood collection poses special challenges. “It is axiomatic in anthropology that blood is never ‘just’ blood,” anthropologist (and IPCB board member) Jonathan Marks has noted. “Blood is invariably powerfully vested with magic and surrounded by taboos. Consequently, it’s not too easy to talk other people out of their blood, so you need to be very persuasive.” The ethical challenge for the Genographic Project researchers – being persuasive and respecting indigenous peoples’ rights to manage their own biological resources – is daunting. The Project’s consent document indicates that it will take only about 20 minutes to explain the research, obtain consent, and draw blood. More likely, they will encounter people who, like the Maoris, believe the “collection of DNA through blood samples goes against our view of the body as tapu, or sacred.” CRG is persuaded that the Project has not devoted adequate resources, or paid adequate attention, to the challenges of obtaining ethically defensible consent.

3. Will the prospective subjects be informed of the risks? Project researchers have an ethical obligation to provide prospective subjects with a description of reasonably foreseeable risks. Based on CRG’s review of the Project’s North American consent form, we believe the researchers have been cavalier about (or have purposefully avoided discussing) at least four areas of risk posed to research subjects: (a) psychological risks; (b) breach of confidentiality and informational risks; (c) the risk of enhanced discrimination and political persecution; and (d) unforeseen future risks.

It is naïve of the Project to think that indigenous peoples automatically want to learn more about their genetic roots from outsiders. In this respect, Dr. Wells’ description of the goal of the project is overtly paternalistic: “Our goal is to enable indigenous communities rather than to take from them…Our goal is to empower the indigenous peoples to tell their stories, to help revitalize their cultures, and to raise awareness about issues facing them.” (Wells, Deep Ancestry). The Project needs to acknowledge that Indigenous peoples may have their own views on these issues.

Despite widespread excitement over the prospects of “knowing” the migratory routes and genetic origins of our ancestors, the Genographic Project has not adequately considered that other cultures may not wish to “know” this information – at least, not in ways that purport to automatically subrogate cultural traditions, myths and legends. The Project must disclose potential psychosocial and psychological risks to prospective subjects.

Confidentiality. Project researchers are obligated to describing how the confidentiality of records identifying research subjects will be maintained. The Genographic Project’s consent document details confidentiality and data security procedures, but the provisions are inconsistent and difficult to understand. The Project’s regional centers will retain a link, or key, to match individual subjects to the data and their genetic ancestry results. According to the Project, this link will be destroyed only after the subject retrieves (via the Internet) or requests a mailed copy of the results. But the Technical Summary states that “no key or linking code will be in existence.” Does this only hold for the National Geographic Society and its Genographic Project database? The project describes mailing the key to research subjects who do not have Internet access. How will this work in areas plagued by civil unrest and persistent ethnic discrimination? Are genetic results to be mailed in unmarked envelopes? Moreover, the Project will collect and store consent forms and descriptions of ethnicity provided by the subjects in its ten autonomously-run field offices. Especially in areas subject to political turmoil, this information may be at risk of unauthorized access and misuse.

News accounts in December 2006 suggest that even in comparatively tranquil areas, local ethics review committees continue to be concerned with the Project’s confidentiality and data security measures. Attempts to collect DNA samples from indigenous peoples in Alaska by the Project have been rebuffed by the Alaska Area Institutional Review Board, which has demanded that “the consent form all volunteers must sign…should contain greater detail about the risks, including the fact that the DNA would be stored in a database linked to tribal information.” This development underlines the gross inadequacy of the original review that the Project underwent at the University of Pennsylvania before a review board that had no representative of any Indigenous peoples on it and was unqualified to review research on Indigenous populations. (Annas, Anthropology)

Risk of Enhanced Discrimination and Political Persecution. According to the Genographic Project, “the [genetic] markers [the project is] examining will not categorize participants as members of a particular race or ethnicity, and will only be used to discern ancestral migratory relationships to other populations.” Even so, the researchers will ask subjects “basic questions about their ancestry and duration of residence in the region,” including their (and their parents’ and grandparents’), names, ethnicities, and places of birth, and these self-descriptions will be stored in the regional center offices. The identity of study subjects, but not the results, will be recorded on written consent forms and retained in the regional offices. Subjects will be in possession of a “Genographic Participant Identification number, or GPID,” which subjects can use to retrieve their genetic ancestry results. For an unspecified period, the regional centers will retain a link, or key, to match individual subjects to the data and their genetic ancestry results. According to the Project, this link will be destroyed once the subject retrieves (via the Internet) or receives a mailed copy of the results. Debra Harry, executive director of the IPCB, asks, “How can they control that these findings will not be used against indigenous peoples?”

Optimistically, the Genographic Project believes that information derived from the study will be used to alleviate discrimination and political persecution, by revealing our common, distant ancestry. “In today’s fractious world,” the Technical Summary predicts, “knowledge of the genetic ties that bind us together in one large, extended family may help us to mitigate some of the prejudice and hatred that have defined human relations for thousands of years.” But as Jonathan Marks points out, “the greatest hatreds are between the peoples who are biologically the most similar: Hutu and Tutsi, Bosnian and Serbian, Israeli and Palestinian, Huron and Iroquois, German and Jew, English and Irish.” There is little in human history to suggest that scientific understanding will alleviate persecution. The potential for political risk and increased discrimination, persecution or conflict are not disclosed to potential research subjects.

Unforeseen Risks and Blanket Consent. According to the consent documents, “[g]enerations of researchers will be able to make use of these resources [the biobank of genetic samples from indigenous populations,] perhaps applying research methods that we cannot envision at the present time.” These stored samples “may be used for further study to better understand human origins and the histories of your people.” This form of blanket (open-ended) consent does not satisfy informed consent norms.

4. Will the Prospective Subjects Understand the Purposes of the Research? The Genographic Project has not addressed culturally-based difficulties in understanding the purposes of the research and the benefits and risks to research subjects. It is hard to imagine how understanding consent will be obtained in a twenty-minute process. Indeed, the Genographic Project researchers seem to have ignored helpful guidance from, e.g., the International Ethical Guidelines for Biomedical Research Involving Human Subjects (the CIOMS Guidelines) and the former National Bioethics Advisory Commission’s report on Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, both of which discuss measures to enhance and confirm understanding when research is conducted in developing countries and/or with indigenous peoples.

It is late – but better late than never – for the Genographic Project to address the concerns articulated by its critics. Until they are adequately addressed, however, the Project should be suspended. Public curiosity and perceived support for the Project cannot and should not excuse under-attention to the serious ethical missteps identified by CRG, IPCB and other groups. There still is a chance for responsible genographics – but only if the Project’s sponsors pay attention, ethically, “to where we came from and how we got to where we [are] today.”

Spencer Wells, Deep Ancestry: Inside the Genographic Project, National Geographic, Washington, D.C., 2006.

Committee on Human Genetic Diversity, National Research Council, Evaluating Human Genetic Diversity, Washington, D.C., National Academies Press, 1997.

George J. Annas, Anthropology, IRBs, and Human Rights, American Ethnologist, 33: 541-44 (2006).

Amy Harmon, DNA Gatherers Hit Snag: Tribes Don’t Trust Them, New York Times, December 10, 2006, Al.

Jonathan Marks, The Human Genome Diversity Project, Anthropology Newsletter, Nov. 1995.

Jonathan Marks, Heredity and Genetics after the Holocaust, in Michael A. Signer, ed., Humanity at the Limit: The Impact of the Holocaust Experience on Jews and Christians, Indianapolis: Indiana University Press, 2000, p.242, 246.

Jenny Reardon, Race to the Finish: Identity and Governance inan Age of Genomics, Princeton U. Press, 2005.