The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm - PowerPoint PPT Presentation

1 / 29
About This Presentation
Title:

The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm

Description:

The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm 9th Global Forum on Bioethics in Research Auckland, Aotearoa – PowerPoint PPT presentation

Number of Views:110
Avg rating:3.0/5.0
Slides: 30
Provided by: LeaKane
Category:

less

Transcript and Presenter's Notes

Title: The Indigenous Research Protection Act: A Model Tribal Code to Change the Research Paradigm


1
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
  • Lea Malia Kanehe
  • Indigenous Peoples Council
  • on Biocolonialism

2
Patent Pending
3
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

4
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

5
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.

6
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

7
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

8
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

9
Principle of Inalienability
  • recognizes the inalienable rights of
    Tribes/Nation in relation to their traditional
    territories, cultural property and natural
    resources, and associated knowledge

10
Principle 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.

11
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.

12
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.

13
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.

14
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.

15
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).

16
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.

17
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.

18
Other Principles
  • Principle of Communication
  • Principle of Empowerment
  • Principle of Equity
  • Principle of Mutual Respect

19
IRPAs Special Regulations for Biological Samples
20
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.

21
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

22
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

23
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.

24
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

25
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.

26
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.

27
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

28
Elements of a Model Research Agreement
  • Responsibilities of the researcher
  • Responsibilities of the Tribe/Nation
  • Terms of agreement
  • Timeline
  • Liabilities
  • Ownership
  • Non-commercialization
  • Termination

29
Resources
  • 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
Write a Comment
User Comments (0)
About PowerShow.com