The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm 9th Global Forum on Bioethics in Research Auckland, Aotearoa (December 3-5, 2008) Presented by: Le`a Malia Kanehe Indigenous Peoples Council on Biocolonialism

Patent Pending From the GE Series by Theresa Reihana. This painting shows how life is being patented, named and labelled and given numbers, ready for sale.

Overview Necessity for Indigenous peoples to regulate research on their own terms in the exercise of their right of self-determination Indigenous Research Protection Act (IRPA)- a model tribal code to assist Native American Tribes with recognized jurisdiction to assert sovereignty throughout the research process by establishing the legal basis under tribal statutory law to protect their rights, citizens and resources

Native American Tribal Sovereignty The Tribe/Nation reserves its right, through its inherent sovereign authority and its police power, to exclude individuals from tribal jurisdiction and to deny permission and access for any research activities whatsoever. 500+ federally-recognized Tribes & Alaska Villages

Purposes of the IRPA to protect the Tribe/Nation/Nation, culture and natural resources of the Tribe/Nation and the Tribe/Nation's future generations from unauthorized scientific research; and to reduce the adverse effects of research and related activities on the Tribal community; and to ensure that researchers recognize Tribal control of research activities and that the Tribe/Nation owns all data and information generated or produced by such research; and to establish and provide a statutory basis for a process to review, govern, and control any research, collection, database, or publication undertaken within tribal jurisdiction or that impacts the Tribe/Nation.

Indigenous Research Protection Act Definitions Establish Research Review Committee Sets Guiding Principles Research Proposals Requirements Review Process Research Agreements Permits/agreement Reservations and Termination Prohibits Certain Conduct Penalties Jurisdiction

Principle of Inherent and Prior Rights “recognizes that the Tribe/Nation has inherent and prior proprietary rights and interests over all forms of their cultural and natural resources within their territories together with all cultural property and cultural property rights associated with such properties and their use”

Principle of Self-Determination “recognizes that the Tribe/Nation have a right of self-determination and exercise tribal sovereignty over their affairs, and that researchers and persons will acknowledge and respect such rights”

Principle of Inalienability “recognizes the inalienable rights of Tribes/Nation in relation to their traditional territories, cultural property and natural resources, and associated knowledge”

Principle of Traditional Guardianship This principle recognizes the obligation and responsibility of Tribe/Nation’s role as traditional guardians to preserve and protect their traditional territories, cultural and natural resources, and associated traditional indigenous knowledge.

Principle of Free Prior Informed Consent (1) This principle recognizes that individuals have a right to give their free prior and informed written consent before participating in any research. Informed consent is a process in which information is provided to enable individuals to make fully informed choices about their participation in a specific research. The principle of free, prior informed consent also applies to groups, such as Tribes, when the research or other proposed activity potentially impacts the collective group.

Free Prior Informed Consent (2) Potential research participants must be provided all information regarding the potential risks and benefits of the research, provisions to protect their privacy, available alternatives, and the right to choose not to participate and to withdraw from the project at any time. Information must be provided in a language and terms that the research participant can understand. This process should be free of any coercion or any fear of repercussion for refusing to participate.

Free Prior Informed Consent (3) In no case should consent be presumed or implied, and new consent must be sought for uses other than that for which the original consent was granted.

Principle of Benefits to the Tribal Community This principle recognizes that research should be of immediate benefit to the Tribe/Nation, and the risks associated with the research should be less significant than the benefits to be gained. Benefits must outweigh the risks, otherwise the research should be considered unethical. The Tribe/Nation should be informed of any potential legal, financial, social, physical, or psychological risk to members of the community, and any deleterious impact on the cultural, social, economic or political well-being of the community or the environment.

Principle of Full Disclosure This principle recognizes that research should not be conducted until there has been full disclosure with all potentially affected Tribal communities and individuals. Full disclosure includes but is not limited to: the full range of potential benefits and harms of the research, all relevant affiliations of the person(s) or organization(s) seeking to undertake the research, and all sponsors of the researcher(s).

Principle of Confidentiality This principle recognizes that the Tribe/Nation and local communities, at their sole discretion, have the right to exclude from publication and/or to have kept confidential any information concerning their tribal identification, tribal members, families, clans, bands, culture, traditions, mythologies, or spiritual beliefs. Furthermore, researchers and other potential users shall undertake all necessary steps to guarantee such confidentiality.

Principle of Respect “recognizes the necessity for researchers to respect culture, traditions, and relationships of tribes and tribal members, and to avoid the imposition of external concepts and standards.”

Other Principles Principle of Communication Principle of Empowerment Principle of Equity Principle of Mutual Respect

IRPA’s Special Regulations for Biological Samples

Cultural Property means the traditional Indigenous knowledge, cultural information, uses, and practices unique to the Tribe/Nation's ways of life maintained and established over tribal homelands and aboriginal areas since time immemorial. This knowledge is based upon millennia of observation, habitation, and experience, and is a communal right held by the Tribe/Nation, and in some instances by individuals. Cultural Property in a traditional Indigenous knowledge system context includes both tangible and intangible, historic and/or contemporary, which derives from unique historic or collective experience of the Tribe, or is otherwise held collectively by the Tribe.

DNA included as “Cultural Property” 3.8j. tissues, cells, biological molecules including DNA, RNA, and proteins, and all other substances originating in the bodies of Tribal members, in addition to genetic and other information derived therefrom;

“Cultural Property Right” the traditional right of the Tribe and individual members as consistent with tribal customs, laws and practice to determine access to, and use of cultural property. Use of cultural property requires prior informed consent of the Tribe

Section 11 - Regulating Biological Samples 11.2 The Tribe/Nation may, at any time, decide to withdraw from the research project or any portion thereof, and request the return of all biological samples. The researcher, and any other parties, must comply. 11.3 Upon completion of the research project, or termination or cancellation of the project at any time prior to completion, the biological samples must be completely and fully returned to the possession of the Tribe/Nation. A Tribe/Nation designate must be present and sign/witness any chain of custody, destruction or release of biological samples.

No secondary uses w/out PIC 11.4 No biological samples from this study may be released to, or used by, any other researcher(s), research institution, or any other entity, whether public or private, without the prior and fully-informed written approval of the Tribe/Nation. Unauthorized secondary uses include but not limited to: stored biological materials that include identifiers, testing, growing, or storing of any genetic material not explicitly mentioned in the original proposal, contacting tribal members in the future following their permit deadlines, trying to obtain tribal member medical information, using genetic material from the placenta or umbilical cord, obtaining genetic material through surgery or biopsy for the benefit of a an unauthorized researcher agenda, sharing or selling genetic material to a laboratory not explicitly stated in the original proposal even if the researcher is doing the same research at a different laboratory

Storage of Biological Samples Off-Reservation 11.5 If the Tribe/Nation permits any biological samples to be stored in any other locations, the researcher shall maintain at all times a complete list thereof. The list shall include a description of the sample or data, source, specific use or purpose of each item, responsible person(s) at the location, and where the item is housed (e.g., in a "gene bank" or on a specific computer), and any relevant time lines with regard to use of, disposition, return, or destruction of the samples or data. The researcher shall provide an updated copy of the list to the Tribe/Nation whenever changes are made. The updated list shall include identification of changes made since the last copy of the list was provided to the Tribe/Nation. The researcher will provide proof that the storage facility is physically guarded against unauthorized or inappropriate access.

Miscellaneous 11.6 Any situation where biological samples will leave the possession or control of the researcher will require a separate agreement between the Tribe/Nation and the external party in accordance with this Act. 11.8 Any research that involves genetic tests will require pre-test counseling to tribal members. 11.9 In the event a tribal participant dies after a research proposal has begun and/or completed the Tribe/Nation maintains the authority to request that genetic material returned immediately.

Patents & commercialization prohibited 11.7 No entity may seek to patent or commercialize any biological materials obtained from the Tribe/Nation, from the Tribe/Nation's jurisdiction, or under the authority of the Tribe/Nation. This includes genetic samples, any copies of the original genetic samples, any cell lines containing copies of the original genetic samples, and data derived from these samples. Commercialization only with FPIC of the Tribe & a second written agreement

Elements of a Model Research Agreement Responsibilities of the researcher Responsibilities of the Tribe/Nation Terms of agreement Timeline Liabilities Ownership Non-commercialization Termination

Resources Indigenous Research Protection Act - www.ipcb.org Debra Harry & Le`a Malia Kanehe, Asserting Sovereignty Over Cultural Property: Moving Towards Protection of Genetic Materials and Indigenous Knowledge, Seattle Journal for Social Justice, Fall/Winter 2006. Email: lkanehe@ipcb.org