American Indian and Alaska Native Genetics Research Policy Formation Meeting

Location

Rio Rancho, New Mexico

Start Date
End Date

Note: This report is also available in printable PDF format.

Introduction

The American Indian and Alaska Native (AI/AN) Genetics Research Policy Formulation Meeting was held in Rio Rancho, New Mexico from February 7 – 9, 2001. The National Institute of General Medical Sciences and National Human Genome Research Institute jointly funded the meeting. The formulation meeting was attended by Malcolm Bowekaty, Jay Butler, Mei-Ling Chang, Chester Clarke, Laura Commanda, Dena Davis, Thomas Drouhard, William Freeman, Connie Z. Garcia, Roger Gollub, Judith Greenberg, Debra Harry, Jeff Henderson, Marlene Jasperse, William Knowler, Jeff Long, Philip Lowenthal, Jean McEwen, Ben Muneta, Clifton Poodry, Terry J. M. Powell, Lisa Preston, Carolyn M. Robbins, Francine C. Romero, Brett L. Shelton, Paul Spicer, Lisa S. Sterling, and Michael E. Zwick. Participants were invited based largely on their interest and availability. They represent a group of concerned individuals interested in providing a public service.

The purpose of the meeting was to begin the process of creating procedures and documents that could be instructive to both tribal communities and researchers about the conduct of genetics research involving American Indian and Alaska Native people and their communities. The meeting was not organized as a summit of representative genetics research issues, but was intended to be an intense round-table work session with discussion of tribal concerns, tribal expectations, the process of research, existing genetic studies, research codes, and existing genetics policies. No formal presentations were given.

The summary report was written from meeting notes taken separately by Dena Davis, Rae Mae-Ling Chang, and Francine Romero. All meeting participants were given the opportunity to review and to make both editorial and content changes to the summary report. The readers of this document should not assume that all meeting participants agree with or support each idea discussed at the meeting or contained within this summary report. The views presented in this working document reflect the opinions of the meeting participants and should not be interpreted as the view of any tribe, institution, or government organization.

Two weeks before the meeting, participants were sent a binder of background resource materials. A listing of the resource materials is included in Appendix A. Resource materials that were distributed during the meeting are listed in Appendix B. Among the resource materials distributed prior to the meeting was “IHS Guidelines for implementing and complying with IHS Policy on specimens.” The most current draft of this document is included in Appendix C.

Statement of Need

In recent decades, all humanity has witnessed unprecedented changes and advances in genetics research. The sequencing of the human genome, polymerase chain reaction, and automated sequencers are all examples of relatively recent developments that have changed the face of genetics research forever. Not surprisingly, the genetics technology does not necessarily run parallel to the policy surrounding specimen use and storage, human subjects protections, and ethical considerations, especially with regard to research with special populations.

Historically, the experience of American Indians and Alaska Natives (AI/AN) with research in general has contributed to their distrust of genetics research, particularly human migration studies. There are vast, often unrecognized, cultural differences between indigenous and western peoples. Furthermore, there is great cultural diversity among indigenous peoples. Failure to communicate or recognize these differences can result in faulty research, ‘bad blood' between the researchers and tribal communities, and distrust of research by native individuals and tribal communities.

This summary report encapsulates valuable contributions made by the meeting participants regarding genetics research and testifies to the ongoing efforts of individuals to make the field of genetics research accountable to native peoples.

Conference Planning Committee

There was no formal conference planning committee although Drs. Freeman and Poodry provided valuable guidance to Dr. Romero. The conference grant proposal was prepared and submitted by Dr. Francine C. Romero. Once funds were secured, all participants were invited to attend by Dr. Romero. Several criteria guided the invitation process: (1) for Native participants, knowledge of traditional and cultural concerns regarding research; (2) for researchers, experience and expertise in genetics; and (3) for agency representatives, interest and concern regarding genetics research. The size of the meeting was determined by both the structure of the meeting and funding.

Conference Moderators

Moderators led the four main sections of the meeting. The conference moderators included Drs. William Freeman, Jeffrey C. Long, Clifton Poodry, and Francine C. Romero. The moderators were chosen because of their knowledge of genetics and research and because of their ability to handle difficult questions, topics, and discussions.

Conference Site

The Best Western Inn at Rio Rancho in Rio Rancho, New Mexico, was chosen as the conference site because of its proximity to the conference organizer, Shipping, Receiving & Fulfillment Services (SRFS), and to the Rio Grande Pueblos.

Conference Agenda

February 7, 2001–Setting the Research Agenda, the Tribal Perspective.

Moderator: Dr. Francine C. Romero
1:00 p.m. Welcome Prayer, Governor Malcolm Bowekaty (Zuni Pueblo)
1:15 p.m. Introductions, Overview of Meeting Objectives
2:00 p.m. Setting the Research Agenda, the Tribal Perspective
3:15 p.m. Break
3:30 p.m. Discussion of the Tribal Perspective
5:30 p.m. Adjourn for Day 1

February 8, 2001 – Setting the Research Agenda, theResearcherPerspective

Moderator: Dr. Jeffrey C. Long
8:00 a.m. Opening Prayer, Mr. Celestino Romero (Jemez Pueblo)
8:30 a.m. Setting the Research Agenda, the Researcher Perspective
10:00 a.m. Break
10:15 a.m. Discussion of the Researcher Perspective
1:00 p.m. Break

1:15 p.m. Setting the Codes and Policy Agenda, the Review Boards Perspective

Moderator: Dr. William L. Freeman
3:00 p.m. Break
3:15 p.m. Discussion of the Review Boards Perspective
5:30 p.m. Adjourn for Day 2

February 9, 2001 – Formulating the Policy: Education and Capacity Building

Moderator: Dr. William L. Freeman
8:00 a.m. Opening Prayer, Mr. Frank Fragua (Jemez Pueblo)
8:30 a.m. Formulating the Policy: Education and Capacity Building
10:15 a.m. Break
10:30 a.m. Work Groups and Time Frames
1:00 p.m. Meeting Adjourns

Conference Results

The genetics research policy formulation meeting was conducted in four segments. The first segment concentrated on tribal concerns and tribal expectations. The second segment concentrated on the process of research and existing genetics studies. The third segment concentrated on existing research codes and genetics policies. The fourth segment concentrated on the synthesis of the ideas and needs presented at the conference. In this section each segment is presented separately.

During each segment, individuals representing each of the respective areas of tribal perspectives, researcher perspectives, or review board perspectives were provided with opportunity to express their concerns, ideas, or experiences regarding genetics research. There was an ongoing question and answer session as each individual within a given segment spoke. After all the individuals within a segment had spoken, general discussion ensued for the remainder of time within each respective segment.

Although all meeting participants contributed to each segment of the meeting, each individual is not recognized for their comments in the summary report. The exclusion of individuals is in no way to infer that their individual contributions were not worth repeating or important. To the contrary, the contributions of each individual were extremely valuable. If more than one person expressed the same idea, their statement or idea was not repeated but was instead incorporated into the concepts summarized at the end of each segment (without reference to who said the particular statement).

In the following paragraphs, individual contributors are identified by name and affiliation with a narrative of their key ideas and points provided.

Segment One: Tribal Concerns and Expectations Regarding Genetics Research

Governor, Malcolm Bowekaty (Zuni Pueblo)

Governor of Zuni, Malcolm Bowekaty, delivered a comprehensive overview of the conduct of (genetics) research in tribal communities. Governor Bowekaty outlined for the group his tribal expectations of researchers, of the research process, and of his community's role in the research process. The expertise and review system currently present within Governor Bowekaty's community is a result of experience. Similar to other tribal communities, the Zuni are experiencing high rates of disease and limited resources. It is of utmost importance that any research conducted with the Zuni people be conducted respectfully and to the benefit of the tribal members.

Governor Bowekaty said a researcher should have respect for the Zuni people and must also earn the respect of the Zuni people. The Governor said the researcher should have the community learn about his/her background, training, interests, and family. A researcher should first approach the community by way of a letter of intent. The letter should summarize the research objectives, the value of the research, the research hypotheses, the benefits of the outcomes to the tribal people, the background on the research topic, and the outcomes of the previous work. The tribe expects copies of reprints and copies of relevant literature on the research question. A subcommittee within the tribe is formed to conduct an initial review. The subcommittee reviews how the outcomes will be measured, the analyses to be conducted, the benefits to the local community, any community capacity building activities, the requirements for the facilitation of the research (e.g., will a translator be necessary?), and the ethical considerations.

If the subcommittee review goes well, they will request a full proposal from the researcher. The full proposal includes samples of any survey instruments to be used. If the project does not involve the Indian Health Service (IHS), only the tribal health board will review the full proposal. If the project involves the IHS, the investigators must also submit their proposal to the National IHS Institutional Review Board (IRB) for review. In addition to the document, Governor Bowekaty said he requests a site visit by the researchers so that they can tour the local hospital and tribal museum. The researcher is informed of tribal taboos regarding bodily specimens. The site visit is seen as an indication of both the researcher and institution's commitment to the project. In return, the Governor stresses that the Zuni also expect to be able to have access to the sponsoring university, institute, or company for a site visit from the tribe.

In the full review process, the tribe will seek any necessary technical assistance for accurate interpretation of the protocol. The investigators will be asked if they are willing to provide insurance above and beyond what the IHS provides should injuries occur. The reviewers will pay particular attention to sample size, benefits, and interpretation. The instruments and tools are reviewed for their cultural appropriateness and sensitivity. If bodily specimens are to be collected, the review committee expects storage, access, and ownership issues to be clearly defined. The tribe owns the data and is co-author on any publications. The tribe reserves the right to review all manuscripts before publication.

Once approval is given to a particular research project, yearly status updates are required. The project is expected to work with existing tribal programs. The tribal program staff fulfills any translation needs. The ensuing results are evaluated on the basis of benefits to the tribe.

The tribal review process is a forum to answer community questions and to facilitate discussion. The underlying concern of the tribal leadership is the health of their community members. The leadership is looking at the bigger picture of public health and is willing to work with researchers who want to work with them. Governor Bowekaty stressed that a researcher should not try to evade the tribal system.

The Governor and his tribal community recognize that the next phase of research involves genetics. Indeed, this ‘new' approach had already been prophesized by the elders. The Governor recognizes the controversial issues stirred by genetics but also understands that controversial issues can be overcome. He takes very seriously his role of understanding the threats of genetic research while weighing the benefits. He states it is up to him and the tribal council to sift through the issues while giving the community an opportunity to speak. He underscored the power of the collective memory of people and explained how community norms are established.

Governor Bowekaty is looking at the future needs of his community and realizes that the optimal scenario includes his own people as the researchers.

Marla Jasperse (Navajo)

Ms. Jasperse has played an important role in the representation of American Indians at national meetings. Her experience with community-based projects has served as a guide in her discussions of community perceptions regarding genetic research. Ms. Jasperse has learned from elders that the threats of genetics are based on the compromising of the sacred. The elders stress that genetic research is not the same as other types of research because it deals with an individual's body parts. The bodily specimens that are currently used to extract deoxyribonucleic acid (DNA), e.g., blood, hair, and saliva, are very sacred to the Navajo. The respect for the body as a whole and the parts that come from the body have to be dealt with in the most respectful way possible. The elders are skeptical of genetic research because researchers have disrupted existing sacred arenas.

The Navajo Nation is one of the few tribes who have formed their own human subjects review committees. Ms. Jasperse states that the approval process must include an informed consent form that respects the Navajo perspective. The parameters for data collection, data storage, and data disposal must be acceptable. Ms. Jasperse states that the concept of anonymity does not ring true for the Navajo because anonymous samples do not disassociate from the individual. Indeed, among the Navajo, most illness is attributed to the result of the mishandling of body specimens separated from the body.

Ms. Jasperse believes that the community must be involved in the genetic research process. She is adamant that the project goals, objectives, and results be of benefit and be carried out as initially proposed.

Ms. Jasperse reiterates that we need to train our own people to become the researchers. We need to train our own people to both understand the issues involved with genetic research and to remember basic respect for people.

Rae Mei-Ling Chang (Kanaka Maoli)

Ms. Chang has worked closely with families experiencing hereditary disease and has experienced first-hand the promise and perils of genetics research. Because of her work with affected families, Ms. Chang has become knowledgeable in recent years about the laws and principles of ethics regarding genetics research. Although many of the individuals Ms. Chang works with are angry and disappointed, Ms. Chang continues to recognize the value of science and research.

Ms. Chang is an active member of the National IHS IRB. Her knowledge and experience with human subjects protection and principles of ethics will help families and individuals who have been injured by genetics research.

The Kanaka Maoli believe that every piece of an individual's body contains a life force, Mana, which flows through the universe. The disruption of Mana causes disease. The Kanaka Maoli believe an individual is more than the sum of their genes. To see the whole of the Kanaka Maoli, a researcher must look at the whole and understand how everything is related to everything else. The Kanaka Maoli want their culture and all else that is sacred to them to be understood within the context of their cosmology. If a researcher takes any aspect of their culture out of context, the researcher will get something artificial. Moreover, when a researcher fails to respect the Kanaka Maoli worldview, the researcher will cause disruption that may result in illness and injury to the Kanaka Maoli.

Terry Powell (Alaska Native)

Ms. Powell is a community member and co-chair of the Alaska Area IHS IRB. She and her fellow community members, although not formally schooled in scientific research methods, thoroughly review and criticize research proposals, and are often able to recommend changes that will enhance the potential benefit to participants without reducing scientific merit.

Ms. Powell reminds researchers to do their homework when proposing to do research with a tribal community. The recommendation to do background research applies not only to the history and culture of the native group, but also to practical things. For example, Ms. Powell encourages any researcher who is interested in conducting research in Alaska to be cognizant of subsistence hunting and fishing. In Alaska, for example, there will be times of the year when data collection would be nearly impossible because an entire village will be out fishing.

As a rule of thumb, Ms. Powell also encourages researchers to remember the human element. She suggests researchers treat native participants the same way they would treat members of their own families if they were participating in a research project. Ms. Powell strongly advises researchers to ensure that participants are truly informed of the research protocol and to be mindful of translation needs. Be respectful and do not take advantage of people who may not know what they are voluntarily agreeing to participate in. Ms. Powell takes her responsibilities as an IRB member very seriously and will not hesitate to keep researchers in check.

Lisa Preston (Tohono O'odham)

Ms. Preston is an active community member of the National IHS IRB and serves as primary reviewer of informed consent forms for several genetics research protocols. Ms. Preston reiterates to researchers the need to respect people, traditions, cultures, and tribal governments. Ms. Preston briefly outlined the different review process that a researcher would need to go through at Tohono O'odham compared to the processes a researcher encounters at Zuni. Whereas at Zuni, a single tribal council made the decision on whether or not to agree to participate in a research project, the Tohono O'odham have 11 districts, each with a district council. Similar to Zuni, committees make recommendations to the legislative council. These recommendations, however, can be referred to the people who reside in three major localities. Not surprisingly, each of these bodies has different meeting schedules.

Ms. Preston also underlined a couple of key questions a genetics researcher will encounter when proposing a genetics research project to a native community. First, the researcher will be asked to explain why the genetics research is truly necessary within the context of the health and economic priorities of the Tohono O'odham. Second, the researcher will be asked to explain the use of body specimens because among the Tohono O'odham the use of body specimens is not acceptable.

Connie Garcia (Acoma Pueblo)

Ms. Garcia is personally touched by the world of clinical trials, genetic counselors, and genetic tests because she has a granddaughter with holoprosencephaly, a fatal genetic disorder. The challenges of having an affected granddaughter is compounded by the complexities of heredity, of feeling responsible for passing the genes that made her granddaughter sick. Ms. Garcia and her family were not prepared to deal with the issues of genetics, and they know the ramifications of her granddaughter's condition will affect a lot of people.

Ms. Garcia shares many words of wisdom with researchers: integrity, honor, acknowledgement, and understanding. Ms. Garcia stresses to researchers to be true to oneself. No matter what reason a researcher has for going into research or for choosing a particular field of research, he/she should always remember to do no harm. Ms. Garcia instructs researchers to honor native people. Although native people may walk a different path, we are all walking through this life together. Even if our belief systems are different and one person believes in heaven while another believes in the spirit world, our spirits exist. Do not harm the spirits.

Ms. Garcia instructs researchers to acknowledge honesty. If the researcher needs body specimens, be honest about the need for specimens. Do not couch genetic research as anything other than what it is. The tribe, in turn, will be honest in responding with what they are willing to do or not do. Lastly, Ms. Garcia stresses to researchers the need to understand. She acknowledges that it is equally important to understand as to be understood. Ms. Garcia is anxious to share her experiences so that those whom she teaches will go on and teach others. In sharing these words of wisdom, Ms. Garcia is paying tribute and staying true to the teachings of her grandmother.

Ben Muneta (Navajo)

Dr. Muneta stressed the importance of educating scientists on culture and tradition. Specifically, Dr. Muneta expressed concern about researchers not always having respect for those that are deceased. In most native cultures there is reverence for the deceased, and it is sacrilegious to conduct research on the deceased. Dr. Muneta asked researchers to be responsible to people and to be fair in the work they are doing. For example, it is not acceptable to obviate tribal relationships with skeletal remains so that studies can be conducted.

Debra Harry

Ms. Harry underlined the importance of communicating with tribal councils and ensuring that tribes have been consulted and are well informed about the proposed genetics project. Ms. Harry expressed concern about the validity of genetic research in the face of unmet social and medical conditions challenging tribal communities. Ms. Harry also questioned the premise for conducting genetics research on behavioral conditions (for example, alcoholism) or on physical conditions caused by certain behaviors (for example, diabetes resulting from poor diet and heart disease resulting from tobacco use).

Ms. Harry was concerned about who takes responsibility to protect the rights of community members, who gives authorization for research to be conducted, and who has ultimate responsibility to monitor the harms that can result from genetics research. There currently is no line of accountability or liability when genetic research harms groups. There needs to be multiple layers of protection at the tribal, institutional, and federal level, including funding agencies. Ultimately, tribes themselves have the right to control every aspect of genetic research.

Clifton Poodry (Seneca)

Dr. Poodry is a key player in the world of genetics research in native peoples because he is native and a geneticist by training. Dr. Poodry serves as a role model and is a strong proponent of genetics education for native peoples. Dr. Poodry reiterated the diversity among tribes in terms of economic status, empowerment status, government structures, and perceptions of what may be harmful and/or risky in participating in genetic research. The tribe is the ultimate authoritative basis for deciding whether the tribe says yes or no to research. The Seneca are matrilineal, and the clan mothers determine how both tribal politics and any proposed research will play out. If the tribe says no to research, the answer is no.

However, Dr. Poodry pointed out that tribes do have conditions they would like to have studied. For example, Dr. Poodry's tribe may be open to having their prevalence of arthritis studied further. If a researcher is truly interested in benefits to the community, part of the homework could involve finding out the concerns and priorities for that tribal community.

Jeffrey Henderson (Lakota, Cheyenne River Sioux)

Dr. Henderson is very familiar with both the clinical care needs and research needs of native peoples. Dr. Henderson is currently co-investigator for the Strong Heart Study – Dakota Center, funded by the National Heart, Lung, and Blood Institute of NIH. Similar to the Zuni and Navajo, the Cheyenne River Sioux have been extensively exposed to research and have a formal review and approval process for research. A key question for the Cheyenne River Sioux tribe is “How will this research project affect our tribal sovereignty?” A researcher first must first present his/her study to the health committee. The health committee reviews the proposal and, if favorable, makes a recommendation and writes a resolution in support of the project to the tribal council. The researcher then presents his/her study to the full tribal council simultaneously with a review of the proposal by the tribe's legal department to ensure that the tribe's legal interests are well represented.

Dr. Henderson advises researchers that there have been instances when the tribal council has not approved research projects for a variety of reasons. The tribe will weigh heavily the value of the research to the community and the benefits to individuals and families.

Brett Lee Shelton

Mr. Shelton stated that he was not representing any tribe, but rather was speaking from his own experience. He drew a parallel between genetics research and the collection of native artifacts. Similar to how some tribes purposefully sold artifacts to collectors and museums, he adds that there will be tribes who willingly participate in genetic research and others who will be adamantly opposed to it. Mr. Shelton says tribes may not always be totally informed, however, about the potential pitfalls of research such as immortalization of cells and the circulation of samples among colleagues. The immortalization of cells and sharing of samples will make the repatriation of body specimens difficult.

Mr. Shelton highlights the need for education of native community people regarding the dangers and realistic benefits of participating in genetics research. He cautions about various levels of dangers to groups, including stigmatization of a community, of individual families, or of native peoples in general.

Carolyn Robbins (Aleut)

Ms. Robbins stated that tribal diversity needs to be underlined and that researchers should not assume that the priorities of the tribe are similar to their own. When a researcher gets to the community level, the researcher will find many things have already been thought through. Ms. Robbins is a strong proponent of participatory research and knows tribes will come up with ways to answer questions they may have about things not so well understood, as in the case of genetics research.

Summary Segment One

The perspectives represented in the round table discussions underline the dangers of generalization and emphasize the need for greater responsibility by the research community and funding agencies.

  • Researchers should never assume that the tribal concerns, customs, and expectations will be the same from one tribe to another.
  • Researchers should never assume that the tribal concerns, customs, and expectations of a given tribe at one point in time are the same as at another point in time.
  • Researchers should never assume that tribal concerns, customs, and expectations would not be directly affected by the results of the research, irrespective of the findings.
  • Researchers should never assume that tribal concerns and expectations are similar to their own, especially with respect to the use of body specimens.
  • Researchers and institutions have not taken full steps to minimize and repair the disruption of genetics research on individuals, family, and community.
  • Individual researchers and institutions need to consider their agreements with the tribes as contracts, and they must honor, comply with, and fulfill what was agreed with the tribe.
  • Researchers need to recognize the expertise of tribal health boards and the IHS IRBs. Investigators often think of IRBs as another hurdle to get over rather than as a resource.
  • Institutions need to take responsibility for the unethical behavior of their students and faculty.
  • Funding agencies need to be responsive to the needs of non-traditional grantees.

The roundtable also discussed the various responsibilities tribes need to assume if they are participating in genetics research.

  • Tribes need to develop an agenda of what they would like to have studied and have researchers and funding agencies be responsive to that agenda.
  • Tribes need to take responsibility in enforcing contracts and developing minimum damage breech clauses.
  • Tribes need to form partnerships with both the researcher and funding agency, i.e., a three-way triangle.
  • Tribes need to require legally binding contracts with universit
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