Title: The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm
1The 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
- Lea Malia Kanehe
- Indigenous Peoples Council
- on Biocolonialism
2Patent Pending
3Overview
- 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
4Native 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
5Purposes 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.
6Indigenous 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
7Principle 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
8Principle 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
9Principle of Inalienability
- recognizes the inalienable rights of
Tribes/Nation in relation to their traditional
territories, cultural property and natural
resources, and associated knowledge
10Principle of Traditional Guardianship
- This principle recognizes the obligation and
responsibility of Tribe/Nations role as
traditional guardians to preserve and protect
their traditional territories, cultural and
natural resources, and associated traditional
indigenous knowledge.
11Principle 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.
12Free 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.
13Free 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.
14Principle 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.
15Principle 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).
16Principle 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.
17Principle 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.
18Other Principles
- Principle of Communication
- Principle of Empowerment
- Principle of Equity
- Principle of Mutual Respect
19IRPAs Special Regulations for Biological Samples
20Cultural 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.
21DNA 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
22Cultural 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
23Section 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.
24No 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
25Storage 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.
26Miscellaneous
- 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.
27Patents 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
28Elements of a Model Research Agreement
- Responsibilities of the researcher
- Responsibilities of the Tribe/Nation
- Terms of agreement
- Timeline
- Liabilities
- Ownership
- Non-commercialization
- Termination
29Resources
- Indigenous Research Protection Act - www.ipcb.org
- Debra Harry Lea 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_at_ipcb.org