The purpose of this chapter is to assist nurse educators, service providers, and researchers in understanding Native American culturally relevant, but diverse, perceptions of research, technology, and genetics related to healthcare diagnostics and therapeutics. The chapter provides a brief background of why many Native American communities are resistant to participating in classical research methodology and how Native communities prefer contemporary research to be conducted (i.e., community-based participatory research). The chapter provides references for additional information about genetic issues in Native American communities and issues related to clinical trials. This chapter will focus on successful strategies to implement contemporary research studies that allow certain tribal communities access to new diagnostic and therapeutic technologies.

Many of the genetic issues for Native communities have been raised prior to (1995-1997) and during “Genetic Education for Native Americans” (GENA: NHGRI Grant R25 HG01866) workshops (1998-2004) (Dignan, Burhansstipanov, and Bemis 2005). GENA was funded by the Ethical, Legal, and Social Implications (ELSI) program of the National Human Genome Research Institute (NHGRI) to provide a unique genetics education program for Native American college and university students. The decision to focus on students was based on recommendations from intertribal leaders on how to effectively integrate genetic education into Native American communities (Burhansstipanov, Bemis, and Dignan 2001).

Based upon multiple intertribal focus groups with tribal elders, the initial priority target population of GENA was Native college students. Tribal elders believed that these students would be able to return to their respective communities to help them understand genetic research requests from academic and clinical research settings. Ultimately, it was hoped that this instruction would help to improve informed decision-making about genetics and genetics research in Native American communities and to encourage students to seek genetic science career opportunities. GENA was implemented in geographically diverse settings throughout the United States, primarily in conjunction with regional and national scientific conferences that included substantial numbers of Native American attendees. The working null hypothesis was that there would be no difference in knowledge or attitudes of individuals who participated in specified education objectives (customized workshops) as compared to individuals who participated in those same objectives within the comprehensive 16-hour workshop. The pretest scores for the customized (three-to-five-hour workshops) workshops ranged from 0.3 to 4.8 and averaged 2.16. For the post-tests, the mean was 4.78 and scores ranged from a low of 3.0 to a high of 7.3. Over all customized workshops, there was a 55% increase in mean score from pretest to posttest (p<.05). For the comprehensive 16-hour workshops, the mean pretest score was 19.9 compared with to a mean post-test score of 27.5, a 38% increase (p<.05). Thus, both formats were effective ways to increase participants’ knowledge and we failed to reject the null hypothesis.

Since GENA officially ended in 2003, GENA has presented 15 workshops, all of which continue to include ELSI and cultural issues. This included a total of 384 participants. The average pretest scores were 33.3% and the average posttest scores were 69.7% for an average increase of 35.2%. When pre- and post-test items are matched the p. value is .001.

There are many reasons why Native communities are resistant to taking part in research studies. These include, but are not limited to (Burhansstipanov, Christopher, and Schumacher 2005; Burhansstipanov 1999):

There is also a history of Natives being lied to and included in studies without informed consent; this is the Native’s equivalent to African Americans’ Tuskegee Study. The most recent example is the forced sterilization of American Indian women in the 1970s (Staats 1976; Rodriguez-Trias 1980; American Indian Policy Review Commission 1977; Carpio 1995; Dillingham 1977; Hunter, Linn, and Stein 1984; Jarrell 1992; Larson 1977; Trombley 1988).

In addition, for the majority of Indian Health Service, Tribal, and Urban Indian healthcare programs (referred to as I/T/U programs), the physician turnover averages 18 months (i.e., loan payoff programs). Thus, there is limited trust between the patient and physician in such clinical settings. This turnover is not observed for nurses and therefore, nurses are frequently more trusted than are physicians in I/T/U programs. If a nurse is working in one of these I/T/U programs that experiences the high turnover of physicians and subsequently has low trust of those providers, one can imagine how the community feels if this same provider comes into the I/T/U programs with new technology. It is unclear whether the distrust is of the provider or the technology. Such technology needs to be explained to the Native leadership within the I/T/U programs.

In the early 1990s researchers at Stanford University proposed a project called the Human Genome Diversity Project (HGDP) (Morrison Institute 1999). This was to be a genetic catalogue of populations from around the globe. Native communities, indeed indigenous peoples from around the world, opposed the HGDP, and some communities called for an immediate halt to the project until indigenous communities had a thorough understanding of the project (the Mataatua Declaration, June
1993). Eventually components of the project went forward with a new understanding of the ethical issues related to working with these communities but not to the level of community-based participatory research (CBPR) expected by most North American Native communities. Much of the opposition to the HGDP came from the issues outlined above such as access to the information, talking down to the community, and absence of concern for cultural issues of collection, storage, and use. Another issue raised about genetic catalog projects was that the money spent on cataloging a small community could be better spent to help the community.

Largely because of the HGDP, Tribal Nations have become actively involved in meetings addressing genetic issues since 1993 (Burhansstipanov, Bemis, Kaur, and Bemis 2005). The meetings were convened in response to Native concerns about genetic patenting, genetic research, and several other issues. Studies such as the HGDP added to concerns about tribal participation and risk to both individuals and communities. Both scientifically accurate and inaccurate information was disseminated at these early meetings as well as more recent meetings (e.g., the existence of an “American Indian gene”). Such misinformation has led to assorted fears, such as the potential annihilation of American Indians and Alaska Natives as a race. Likewise, politicians who want excuses to take over American Indian casinos have attempted to mandate that all enrolled tribal members have a blood test to prove that they are American Indian. Since there is no American Indian gene, the tests will come back negative and the Native community may lose all tribal benefits specified by both the state and the federal government.

Such misinformation contributes to great distrust by Tribal Nations of research in general, but specifically of genetic studies. Nevertheless, not all tribes are opposed to genetic research. Almost all of the tribes that the authors have worked with agree that there has been insufficient effort by scientists to understand and learn how local communities perceive genetic research.

Meetings and workshops on or related to GENA indicate that the most common genetic issues among Native communities are:

The subjection of Native communities to years of research without the benefit of study findings or perceived benefits has continued. Indeed, the communities perceive research as solely benefiting the researcher, with little or no regard for the impact on the community. Thus, for this and many other reasons the tribes who do wish to take part in research typically desire or mandate community-based participatory research (CBPR) methodology. Many scientists continue to misinterpret this methodology, yet examples of successful CBPR are well documented (Romero, Bemis, Burhansstipanov, and Dignan 2001; Orians, Erb, Kenyon, Lantz, Liebow, Joe, et al. 2004; Burhansstipanov 1998; Segal-Matsunaga, Enos, Gotay, Banner, DeCambra, Hammond, et al. 1996; Davis and Reid 1999; Israel, Schulz, Parker, and Becker 1998; Macaulay, Delormier, McComber, Cross, Potvin, Paradis, et al. 1998; Metzler, Higgins, Beeker, Freudenberg, Lantz, Senturia, et al. 2003; Minkler and Wallerstein 2003; Minkler, Blackwell, Thompson, and Tamir 2003; Cornwall and Jewkes 1995; Wallerstein and Bernstein 1994; Israel, Lichtenstein, Lantz, McGranaghan, Allen, Guzman, et al. 2001; Lantz, Viruell-Fuentes, Israel, Softley, and Guzman 2001; Israel, Schulz, Parker, and Becker 2001). Among the more common erroneous interpretations is that if Natives are study participants, then the study is a CBPR project; this can be a false conclusion. CBPR requires that the community be equal partners in all the proposed study stages (e.g., the development, refinement, implementation,
assessment, interpretation, and dissemination of findings). CBPR requires for each study phase that community members and researchers have equal decision-making responsibilities. It also means that the study budget is divided equitably among all partners. This budgetary allocation is a way to begin to determine whether a study is really a partnership or CBPR.

An effective CBPR relationship among researchers and tribal leaders should exist prior to the release of the RFA. The scientists and tribal leadership typically need a few years to develop trust, agree on priorities, and establish a working relationship among the regulating entities (e.g., Tribal Review Boards and Institutional Review Boards). The following are some of the lessons learned from CBPR:

In the early 1990s, because of repeated requests for genetic specimens with insufficient informed consent, the Alaska Native Medical Center (ANMC) took the lead in drafting Institutional Review Board (IRB) guidelines for Native communities. Dr. Bill Freeman, who at that time was with the Indian Health Service (IHS), shared the ANMC model with other communities. The Navajo Nation immediately modified the guidelines to reflect their local cultural concerns. Dr. Freeman began to offer IRB training programs to IHS Area offices and Native programs within those regions (Indian Health Service 2007). As a result there are two federally recognized Native IRBs, 12 IHS Area IRBs, and the National IHS IRB. In addition, most I/T/U programs have a research committee that must approve the project before it goes to the IHS Area IRB. IHS Area IRB approval is mandated if the research study is implemented in any clinical setting that receives IHS monies. Thus, if an urban program does not receive IHS funding, they can use the local research or academic
IRB. But any research must be approved by an IRB and the research team cannot just decide they don’t need it. This includes NIH-supported research conducted in Indian Country. Still, in many I/T/U programs IRB approval has not been obtained prior to attempts to collect specimens from Natives. For example, in 2003 during a Native science conference, an individual collected specimens from high school and college students without any informed consent process. No I/T/U program had approved collection of these specimens.