Transcript The Indigenous Research Protection Act: A Model Tribal

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
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
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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
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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”
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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.
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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
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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: [email protected]