Ethics in International Research: Navigating International Policies
Concerning Human Subjects and
Bioprospecting
Cassandra L. Quave, PhD
Emory University, Center for the Study of Human Health
January 29th, 2013
Program for Scholarly Integrity
Learning Objectives
• Upon completion of this workshop, students should be
able to:
• Explain the importance of informed consent and ethics in
international research with human subjects
• Differentiate between bioprospecting and biopiracy
• Discuss the role of international policy (i.e. Convention on
Biological Diversity and Codes of Ethics for Ethnobiological
Research) in drug discovery research
Workshop Outline
• Introduction to basic principles:
• Human subjects and PIC
• Bioprospecting versus biopiracy
• IP and traditional knowledge
• Ownership of genetic resources
• International Codes of Ethics – Academic Societies
• Convention on Biological Diversity & the Nagoya Protocol
• Case studies
• Nestle and the case of rooibos robbery
• NIH/NCI cancer and HIV drug bioprospecting
• Small group activity
Who are Human Subjects?
• Anyone who is involved in an experiment and is not a
researcher?
• Anyone who shares personal information with a
researcher?
• Anyone who is asked questions by a researcher?
What is Prior Informed Consent (PIC)?
1. General statement (outline of proposed research)
2. Researcher statement
3. Question (consent request)
Consent that is required for accessing genetic resources or
the associated knowledge held by communities (and
individuals) living in the locality; requires individuals
communities to be informed of all consequence of grant of
such permission.
General Statement
• What the research will involve (surveys, gathering
samples, filming, photography, etc)
• Who the research will involve
• How the results will be:
• Distributed to other researchers
• Distributed to any local governments
• Distributed back to the community of origin
Researcher Statement
• Who you are
• Your personal background
• Explanation of why you are conducting this research
• List of specific expectations of the research project
Consent Question
• This is who I am
• This is what I would like to do
• Please, may I?
• Specifics as to level of consent may also be included here
(such as whether or not they agree to be filmed or
photographed or whether or not they want to be
acknowledged in final products or reports.
Laws and Consent
• Many governments require separate human subjects
approval
• The researcher’s host institution has rules/requirements
for consent (IRB approval)
• Professional organizations have expectations with
regards to consent as do certain scientific journals
• Local communities may also have a special consent
process
What is traditional knowledge?
• Traditional knowledge (TK) is the information that people
in a given community, based on experience and
adaptation to a local culture and environment, have
developed over time, and continue to develop.
• This knowledge is used to sustain the community and its
culture and to maintain the genetic resources necessary
for the continued survival of the community.
Where is TK found?
• Farming
• Gardening
• Animal breeding and care
• Food and nutrition
• Health Care and reproductive health
• Water resource use
• Community records
• Spiritual and religious activities
• Folklore, songs, poetry, theater
What are intellectual property rights?
• Intellectual property rights (IPRs) are the legal protections
given to persons over their creative endeavors and
usually give the creator an exclusive right over the use of
his/her creation or discovery for a certain period of time.
• Intellectual property protections may include patents,
copyrights, trademarks, and trade secrets. Intellectual
property is codified at an international level through a
series of legally binding treaties.
What are traditional resource rights?
• Traditional resources include plants, animals, and other
material objects that may have sacred, ceremonial, heritage, or
aesthetic significance.
• For indigenous peoples and local communities, the term
‘property’ often has an intangible, spiritual meaning. Although
worthy of protection, it can belong to no human being.
• The change in terminology from IPR to TRR reflects an attempt
to build on the concept of IPR protection and compensation,
while recognizing that traditional resources—both tangible and
intangible—are also covered under a significant number of
international agreements that can be used to form the basis for
a sui generis system.
What is bioprospecting?
• The collection and screening of plant and other biological
materials for potential commercial purposes, such as the
development of new drugs
What is biopiracy?
• Biopiracy can be defined as the manipulation of intellectual
property rights laws by corporations intent on gaining exclusive
control over national genetic resources without giving adequate
recognition or remuneration to the original possessors of those
resources.
• Example: Traditional Indian spices such as cumin and turmeric
have been patented via this process (and the patents were
later revoked).
Access & Benefit Sharing
• Access refers to granting permission to enter an area for the
purpose of sampling, collecting, and removing genetic or
other resources.
• Benefit sharing refers to all forms of compensation for the
use of genetic resources, whether monetary or non-
monetary. This might also include participation in scientific
research and development of genetic resources, and sharing
the findings of any potential benefits resulting from this work.
Important!!! Once any knowledge is released to the public,
either with consent or in any other way, the
creators and holders of that knowledge are no
longer able to pursue intellectual property
protections.
But….
Since the knowledge is already public, it can’t
be patented any more either!
International Human Rights
Instruments Addressing Intellectual
Property
• Universal Declaration of Human Rights (UDHR) (1948)
Article 27:
1. Everyone has the right freely to participate in the
cultural life of the community, to enjoy the arts and to
share in scientific advancement and its benefits.
2. Everyone has the right to the protection of the moral
and material interests resulting from any scientific, literary
or artistic production of which he is the author.
International Covenant on Economic,
Social and Cultural Rights (ICESCR)
Article 15:
• 1. The States Parties to the present Covenant recognize
the right of everyone:
(a) To take part in cultural life;
(b) To enjoy the benefits of scientific progress and its
applications;
(c) To benefit from the protection of the moral and material
interests resulting from any scientific, literary or artistic
production of which he is the author.
Convention on Biological Diversity
(CBD) Article 8(j):
• Subject to its national legislation, respect, preserve
and maintain knowledge, innovations and practices of
indigenous and local communities embodying traditional
lifestyles relevant for the conservation and sustainable
use of biological diversity and promote their wider
application with the approval and involvement of the
holders of such knowledge, innovations and practices and
encourage the equitable sharing of the benefits arising
from the utilization of such knowledge, innovations and
practices
Draft Declaration on Indigenous Rights
Article 29:
• Indigenous peoples are entitled to the recognition of the
full ownership, control and protection of their cultural
and intellectual property. They have the right to special
measures to control, develop and protect their sciences,
technologies and cultural manifestations, including human
and other genetic resources, seeds, medicines,
knowledge of the properties of fauna and flora, oral
traditions, literatures, designs and visual and performing
arts.
Patents
• As the strongest form of IPR, patents are awarded subject
to a thorough examination procedure. They confer a very
high level of exclusive rights over an invention for a period
of 20 years from the date of the application. Any use of
the patented matter, except strictly private use, requires
permission (license) from the owner. To receive a patent,
an invention must fulfill three main criteria: novelty, non-
obviousness (inventive step) and industrial
applicability (usefulness). A detailed description of the
invention must be submitted, which becomes public after
the grant of the patent.
Declarations and Statements on
Implementing TRR Indigenous Peoples
Statements
• The Draft Declaration on the Rights of Indigenous Peoples
• Statement from the International Workshop on Indigenous Peoples and Development (Ollantaytambo, 21-26 April 1997)
• The Suva Statement (April 1995 - South Pacific UNDP Consultation on Indigenous Peoples' Knowledge and Intellectual Property Rights)
• The Sabah Statement (February 1995 - Asian UNDP Consultation on Indigenous Peoples' Knowledge and Intellectual Property Rights)
• The COICA Statement (September 1994 - South American UNDP Consultation on Indigenous Peoples' Knowledge and Intellectual Property Rights)
• The Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples (June 1993 - 1st International Conference on Cultural and Intellectual Property Rights of Indigenous Peoples)
• Inuit Tapirisat of Canada Principles for Negotiating Research Relationships in the North
Other Declarations • The Nairobi Statement from the ACTS/UNEP International Conference on Trade
Related Aspects of Intellectual Property Rights and the Convention on Biological Diversity (6-7 February 1999
• Report on the Institute for Sustainable Development/ Biological Society of Ethiopia National Workshop: "Have We Valued Our Biodiversity?" (3-5 February 1999)
• Statement and Recommendations from RIS/Kalpavriksh/IUCN Workshop on Biodiversity Conservation and Intellectual Property Rights (29-31 January 1999)
• Joint Statement from the Indian Institute of Public Administration / Kalpavriksh Consultation on Wildlfe Conservation and People's Livelihood Rights: Building Bridges (10-12 April 1997)
• In Safe Hands: Communities Safeguard Biodiversity for Food Security (June 1996, Leipzig, Germany)
• The Bellagio Declaration (March 1993 - Conference on Cultural Ageny/Cultural Authority)
• The Manila Declaration Concerning the Ethical Utilisation of Asian Biological Resources (February, 1992 - 7th Asian Symposium on Medicinal Plants, Spices, and Other Natural Products)
• The Chang Mai Declaration (March 1988 - WHO/IUCN/WWF International Consultation on Conservation of Medicinal Plants)
• The Declaration of Belem (1988 - 1st International Congress of Ethnobiology)
Codes of Ethics and Guidelines for
Ethical Conduct
• Ethical Guidelines for Good Research Practice (Association of Social Anthropologists of the Commonwealth)
• Code of Ethics (final version - Nov. 1998) (International Society of Ethnobiology)
• Green College Summary and Conclusions (June 1995 - Workshop on Indigenous Peoples and Traditional Resource Rights)
• Suggested Ethical Guidelines for Accessing and Exploring Biodiversity (by Prof. Anil K. Gupta) Guidelines for Equitable Partnerships in New Natural Product Development: Recommendations for a Code of Practice (by Dr. Anthony B. Cunningham)
• The Covenant on Intellectual, Cultural, and Scientific Resources (1993 -Global Coalition on Biological and Cultural Diversity)
• Professional Ethics in Economic Botany: A Preliminary Draft (Society for Economic Botany)
• Code of Ethics for Foreign Collectors of Biological Samples (April 1992 revised - Botany 2000 Herbarium Curation Workshop)
• National Institutes of Health/National Cancer Institute Conclusions (March 1991 - Workshop on Drug Development, Biological Diversity and Economic Growth
The Nagoya Protocol on Access and
Benefit-sharing http://www.cbd.int/abs/
• The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.
• It was adopted by the Conference of the Parties to the Convention on Biological Diversity at its tenth meeting on 29 October 2010 in Nagoya, Japan.
• The fair and equitable sharing of the benefits arising out of the utilization of genetic resources is one of the three objectives of the Convention on Biological Diversity.
Case Study: Nestle Vs. The San
• Nestle filed patents on Honeybush and Rooibos
• No ABS agreements with TK stakeholders
• Violation of International Convention on Biological
Diversity
• Suit filed on behalf of San by Natural Justice
• http://www.youtube.com/watch?v=GH5JF-n-
rnA&feature=share&list=FL5BLrcEp1kF7lHGeXJgC2oQ
NIH/NCI and Cancer/HIV Screening
• Gordon M. Cragg, Flora Katz, David J. Newman and
Joshua Rosenthal (2012) The impact of the United
Nations Convention on Biological Diversity on natural
products research. Nat. Prod. Rep. 29, 1407