Consent and Consultation in Genetic Research on American Indians and Alaska Natives

by Brett Lee Shelton, J.D.

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There are many reasons why a person might choose not to participate in as a subject in scientific research.Å It may take too much time, make the person uncomfortable, or infringe on privacy in a way that makes it undesirable to participate. There may be other reasons, as well, such as religious qualms with the research or certain aspects of it, or a dislike for the researcher.Å Whatever the reason, most civil societies deem it important that a person generally not be required to participate in any research in which they do not want to take part.Å There are many laws and ethical canons that address this requirement that subjects ÒconsentÓ to being studied before research is allowable.

Moreover, it is not enough to merely get consent from a potential study participant‚the person must be informed of what their participation will entail in order for their consent to be considered valid.Å While there is some debate about just how much information a potential subject must be given in order for consent to be considered Òinformed consent,Ó it is generally agreed that the participant must be fairly well-informed in order for their consent to be valid.Å Otherwise, the potential subjects are not aware of that to which they are consenting. The consent is not real.Å

In the United States, the only real legal protection for informed consent is in the Federal Policy for the Protection of Human Subjects (ÒFederal PolicyÓ).Å The Federal Policy covers only research funded or conducted by the federal government, and it requires consent by requiring that research be approved by Institutional Review Boards (IRBs).Å The IRBs in turn, must require that informed consent be a part of the design of all research that they approve. See 45 C.F.R. Part 46.Å

Consent Among Individual American Indians in Genetic Research

Among American Indians, there may be many culturally-based reasons why an individual might choose not to participate in genetic studies.Å In addition to the reasons any person might decline to participate in genetic research, an American Indian might have other reasons.Å Their particular tribal background, and the degree to which that particular tribal culture affects their values and beliefs, will determine on whether they have such objections.Å

There are many different American Indian cultures in the United States, and these cultures can differ from those of the mainstream culture in many, sometimes unexpected, ways.Å It would be virtually impossible for any researcher to anticipate all the factors that an individual American Indian would deem important in deciding whether to participate in a particular study.Å That is why it is important that American Indians be educated as much as possible about a study before they are asked to participate. In the field of genetics, the necessary education includes information about how samples are handled before, during, and after the research, and what the final product of the research is likely to be, in addition to education about the particular study.Å

This education does not take place very often before consent for genetic research is sought from American Indians.Å American Indian people are frequently shocked and disappointed to hear that they may have been the source of biological samples being used in ways they never understood to be a possibility.Å Further, many of the scientific journal reports on genetic research show evidence of a lack of any consent to the use of samples.Å By using biological samples from American Indian people without their fully informed consent, researchers are violating the human rights of those individuals. By supporting the research through funding, the agencies involved are complicit in the human rights violations.

The federal agencies funding genetic research need to make at least two changes in order to correct the current systemic flaws that violate the human rights of American Indians.Å First, education of American Indian people about genetics and its procedures is necessary on a large scale, so that potential study participants are informed about what they might participate in, and so that they may bring their own cultural values to bear on the decision of whether to participate or not.Å Second, a system requiring specific consent for each secondary use of biological samples must be implemented and enforced.Å Each secondary use is a new study, and neither consent for the primary use nor blanket consent by an under-informed sample source legitimately establishes the informed consent necessary for the protection of the subject American IndianÔs human rights.

Consultation Protects Individuals and Group Rights

American Indians, if they are members of tribes that have been officially recognized by the United States government, have another potential governmental safeguard for their interests--Å in the form of their tribal governments. In theory, tribal governments can help protect the rights of their members.Å

Through all the years since the first contact with non-Indians, tribes have retained their sovereign authority to act for the benefit of their members.Å This sovereign authority is frequently recognized by the United States and thereby made a part of federal law as well.Å Further, sometimes the federal government grants additional authority to tribal governments that it would have otherwise claimed itself.Å However, tribal governments must have sufficient power to make their protective actions effective.Å

In addition to their ability to protect the rights of individual members, tribal governments also serve to protect the collectively-held rights of the tribe as a whole.Å The notion of group rights, particularly those that may be paramount to individual rights, is sometimes very foreign to those living in the mainstream culture, which usually assumes that rights and property are to be held by individuals and that all property can be alienable.Å However, American Indians, and many cultures worldwide, continue to recognize certain areas in which the concerns of the group are paramount to those of any individual.Å

Tribal governments must frequently act in the interest of the tribe as a whole, and thereby protect group rights.Å In cases where group rights of the tribe and individual rights of tribal members are in potential conflict, the people of the tribe are uniquely able to strike the culturally appropriate balance. Most frequently, the people of the tribe are able to strike this balance most effectively by acting through the governing body of the tribe, the tribal government.

Recognizing (1) the often inherent imbalance in power between itself and tribal governments, (2) the important function that tribal governments play in protecting the rights of tribal members and the tribe as a whole, and (3) the appropriateness of tribal determination of issues involving tribal values, the federal government has chosen a policy that encourages the development of tribal governments and vests as much authority as possible in tribal governments whenever possible.Å In terms of policy development and administration of the executive branch, this policy is manifest in a mandate that that agencies consult with Indian tribal governments whenever a federal action will affect Indian people.Å

Executive Policy Requires Tribal Consultation on Research

Executive Orders and Executive Memoranda are two official documents that the President of the United States uses to direct internal management of the agencies in the executive branch of the federal government.Å At least twice, the President has directed all federal agencies to consult with Indian tribes whenever they take actions that will affect tribes.Å In the Executive Memorandum on Government-to-Government Relations with Native American Tribal Governments (April 29, 1994), the President directed that:

[e]ach executive department and agency shall consult, to the greatest extent practicable and the extend permitted by law, with tribal governments prior to taking actions that affect federally recognized tribal governments.Å All such consultations are to be open and candid so that all interested parties evaluate for themselves the potential impact of relevant proposals.

Four years later, the President augmented this sentiment in the Executive Order on Consultation and Coordination with Indian Tribal Governments (May 14, 1998).Å The Executive Order states that:

[e]ach agency shall have an effective process to permit elected officials and other representatives of Indian tribal governments to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.

Research projects that focus on Native American tribes and their members Òsignificantly or uniquely affectÓ tribes by their very nature -- without the targeted tribe(s), the study would not exist in the same form. Therefore, according to the executive documents on consultation, federal agencies have an obligation to consult with targeted tribes prior to funding research that targets the tribes or their members.

The Trust Responsibility Requires Consultation

The United States has unique power in Indian affairs, stemming from the power to make treaties and the reservation to the federal government of the Constitutional power to Òregulate commerce with the Indian tribes,Ó (or the ÒIndian Commerce ClauseÓ of the U.S. Constitution).Å Along with this authority, courts have routinely held, comes a special responsibility‚the trust responsibility of the United States towards American Indian people and tribes.

The trust responsibility applies to all agencies with programs concerning Indians, and it may not be subordinated to other public interests unless specifically authorized by Congress (see Nevada v. United States, U.S. Sup. Ct. 1983).Å Because research involving American Indian people as subjects, particularly involving them because they are American Indians, concerns Indian people and tribes, participation in the research by the federal government creates a trust responsibility on the part of the governmental agencies involved.Å Is this trust relationship not being violated if the human rights of the subjects of the research are violated?Å The current processes whereby federal funding decisions are made repeatedly result in such violations.

WHAT MUST BE DONE

In order to protect the rights of individual American Indians whose participation might be sought in genetic (and other) research, several steps must be taken at the federal level. Without better education on the basics of genetic research at the grassroots community level, the possibility of truly informed consent is negligible. Therefore, if the federal government desires to spend money on research involving American Indians, it must first make sure that the potential subjects are sufficiently informed to be able to validly consent to participating.Å Spending for education is a necessary precursor to valid spending for actual research.

Tribal consultation, as a method for obtaining tribal consent, is also necessary for every proposed research project involving a tribe. The federal mandate to consult with tribal governments must be honored, in order to ensure good policy and decisions, and to help protect against human rights violations of individuals and violations of tribal group rights.

Finally, effective controls must be put in place to prevent secondary uses of biological samples and information when specific informed consent for those uses has not been obtained. Each new study is a new use, and informed consent should be required. Each participantÔs right to decide whether they will participate should be honored. This right should not be compromised by a lack of information, or by empty general ÒblanketÓ consent, as is the current norm.

All of these changes will be best implemented at the federal level, by the agencies controlling and supporting the research. The agencies need to develop an implement policies restricting secondary sample use. The agencies also need to consult with tribes prior to funding research that targets tribes, or at least require that research proposals show valid evidence of tribal approval prior to funding.

Tribes can advocate for these changes at the federal level. In the meantime, it will also be useful for tribes to pass tribal legislation that will protect them and their members locally, relying on their own sovereign authorities.Å

Only when such protective measures are enacted will American Indian participation in genetic research be able to proceed, if at all, on valid grounds. Until such measures are enacted, the long list of human rights and tribal rights violations that is being stacked up by the actions of federal agencies funding research on American Indians will only continue to get longer. And the possibility for embarrassing human rights violations and concomitant lawsuits will only continue to grow as well.