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

Intellectual Property Rights

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