ETHICS, RESEARCH &...

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CONFERENCE PROCEEDINGSBrussels, 14-15 May 2007

ETHICS, RESEARCH & GLOBALISATION

Europe and its partners building capacity in research ethics

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Directorate L — Science, Economy and Society

Unit L.3 — Governance and Ethics

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EUROPEAN COMMISSION

ETHICS, RESEARCH & GLOBALISATION

Europe and its partners building

capacity in research ethics

CONFERENCE PROCEEDINGSBrussels, 14-15 May 2007

Edited by: Professor James A Houghton

National University of Ireland, Galway – Ireland

Directorate-General for Research

2007 Science, Economy and Society EUR 22960

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3

Table of contents

Conference programme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Global governance of research ethics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Building capacity in research ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Socio-economical and environmental factors in research ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Double standards in research ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Intellectual property rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Identifi cation of strategic needs in research ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Future objectives and policy priorities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

4

CONFERENCE PROGRAMME

MONDAY 14 MAY 2007

PLENARY SESSION 1CHAIR

Jean-Michel Baer

Directorate Science, Economy and Society, DG RTD

Ethics and the global governance of scientifi c research

Opening speech Jean-Michel Baer

Directorate Science, Economy and Society, DG RTD

The role of Europe Philippe Busquin

Member of the European Parliament

The role of developing countries Fernand Guédou

Ministry of Health, Benin

The role of international institutions Pierre Sané (presented by Shamila Nair-Bedouelle)

UNESCO

Marie-Charlotte Bouësseau

World Health Organisation

Alexander Capron

University of Southern California, USA

Laurence Lwoff

Bioethics Department, Council of Europe

5

Capacity-building in research ethics

Socio-political aspects Reidar Lie

National Institutes of Health (NIH), USA

University of Bergen, Norway

Cláudio Lorenzo

National Health Council, Brazil

Carel IJsselmuiden

Council on Health Research for Development (COHRED)

Shamila Nair-Bedouelle

UNESCO

The European Commission as a partner Julian Kinderlerer

European Group on Ethics in Science and New Technologies

(EGE)/ Sheffi eld School of Law, UK

Peteris Zilgalvis

Unit Governance and Ethics, DG RTD

Breakout sessions

Socio-economical and environmental aspects of research ethicsMODERATOR

Catherine Hankins

UNAIDS

RAPPORTEUR

Carrie Marias

UNESCO-Africa, Senegal

PANELLISTS

Hannah Akuffo

Karolinska Institute, Sweden

Alioune Dieye

Institut Pasteur, Senegal

6

Henning Mikkelsen

Unit Human Development, Social Cohesion and

Employment, DG DEV

Philippe Guérin

Epicentre, France

Melody Lin

Offi ce for Human Research Protections, USA

Double standards in research ethicsMODERATOR

Doug Wassenaar

South African Research Ethics Training Initiative (SARETI),

South Africa

RAPPORTEUR

Raffaella Ravinetto

Institute of Tropical Medicine, Belgium

PANELLISTS

Clement Adebamowo

Centre of Ethics, West Africa, Nigeria

Jean-Claude Ameisen

INSERM/Comité Consultatif d’Ethique, France

Tumani Corrah

Medical Research Council, Gambia

Patrick Lozes

Independent Consultant, France

Barbara Sina

National Institutes of Health (NIH), USA

John Williams

World Medical Association

Intellectual property rightsMODERATOR

Emilio Mordini

Centre for Science, Society and Citizenship, Italy

RAPPORTEUR

Hervé Chneiweiss

INSERM, France

7

PANELLISTS

Pamela Andanda

University of Witwatersrand, South Africa

David Bennett

European Federation of Biotechnology, The Netherlands

Adeyinka Falusi

University of Ibadan/Nigerian Bioethics Initiative, Nigeria

DaeYoung Park

Korea Environmental Council in Europe, Belgium

Anthony Taubman

World Intellectual Property Organisation

TUESDAY 15 MAY 2007

PLENARY SESSION 2CO-CHAIRS

Hanna Nohynek

National Public Health Institute (KTL), Finland

Maurizio Salvi

Bureau of European Policy Advisors (BEPA)

Results from the breakout sessions

Socio-economical and environmental aspects of research ethicsMODERATOR

Catherine Hankins

RAPPORTEUR

Carrie Marias

8

Double standards in research ethicsMODERATOR

Doug Wassenaar

RAPPORTEUR

Raffaella Ravinetto

Intellectual property rightsMODERATOR

Emilio Mordini

RAPPORTEUR

Hervé Chneiweiss

“Candid eyes”: sociological and philosophical refl ections Mylène Botbol-Baum

Université Catholique de Louvain, Belgium

Lazare Poamé

Université de Bouaké, Ivory Coast

Major needs in research ethics Vasantha Muthuswamy

Council of Medical Research, India

Wen Kilama

African Malaria Network Trust, Tanzania

Ethics networks at european and national level François Chapuis

European Network of Research Ethics Committees (EUREC)

Eero Vuorio

National Advisory Board on Research Ethics, Finland

9

TUESDAY 15 MAY 2007

PLENARY SESSION 3CHAIR

Maria da Graça Carvalho


Global perspective on further priorities and actions to improve capacity-building in research ethics

European Union Maria da Graça Carvalho


Partners Kanikaram Satyanarayana

Council of Medical Research, India

Ariel Henry

Member of the Cabinet of the Minister of Public Health

and Population, Haiti

Charles Kondi Agba

Minister of Health, Togo

Albert Ondo Ossa

Minister of Education and Research, Gabon

Closure of the conference Europe, ethics, globalisation and research Janez Potocnik

EU Commissioner for Science and Research

10

INTRODUCTION

In his melancholic poem “Dover Beach”1, the great

19th century English poet, Matthew Arnold2 rumi-

nated on the profound religious and philosophical

turmoil of the times. This, he believed, was mainly

brought about by the upheaval caused by scientifi c

progress: particularly the seismic tremors of Dar-

winism. He concluded:

“And we are here as on a darkling plain Swept with

confused alarms of struggle and flight, Where

ignorant armies clash by night.”

In our own age, we live in a time of unprecedented

scientifi c and technological advancement. Each

day, our moral and philosophical preconceptions

about the world in which we live are challenged by

new discoveries and innovations. We still hold fast

to many of our basic principles of humanity and

probity whilst, at the same time, we are compelled

to adapt some of our traditional concepts in the

face of the new and changing times in which we

fi nd ourselves.

The exciting technological developments that are

taking place through innovative research programmes

confer upon us new, and undreamed of, powers.

However, as Jean-Michel Baer, Director of “Science,

Economy and Society Directorate”, Directorate-

General for Research, European Commission3, so

succinctly stated in his introduction to this Conference,

these powers bring a totally new responsibility

which demands consideration of the “far-reaching

consequences of decisions and actions that go beyond

present generations and beyond the possibility of

reparation”.

Mr Baer asserted that an ethic of responsibility is a

prerequisite for the governance of European research

and that the European Commission is committed to

strengthening the international dialogue generated

in FP6 on ethics in an increasingly globalised

scientifi c research environment.

As a contribution to this commitment, the European

Commission organised this International Conference

on “Ethics, Research and Globalisation”. By bringing

together key decision makers in ethics, science,

healthcare, research policy and governance, the

Conference was intended to enable the European

Union to establish its responsibilities towards its

partners. Only through informed dialogue can the

international community face the challenges and

opportunities posed by modern science and technol-

ogy and together ensure a responsible and balanced 10

1 http://www.victorianweb.org/authors/arnold/writings/doverbeach.html2 http://www.victorianweb.org/authors/arnold/arnoldov.html3 http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=781&CFID=9393960&CFTOKEN=97950904

11

approach to the governance of research ethics

around the globe.

In his presentation, Mr Baer discussed methods of

increasing the societal and ethical impact of inter-

national scientifi c cooperation. Using examples

from biomedicine, nanotechnology and biodiver-

sity, he decisively demonstrated that research is

developing “in a context of interaction and inter-

dependence on an international scale”. In order to

ensure that partner countries will benefi t from this

research and share equitably in the scientifi c prog-

ress that is achieved, he asserted that the European

community has established common ethical prin-

ciples. European research programmes, including

those involving partner countries, must be conducted

in accordance with the Charter of Fundamental

Rights of the European Union4 and the European

Group on Ethics5 has confi rmed this in Opinion 176.

Furthermore, human research is regulated in ac-

cordance with shared ethical principles, which

range from the Nuremburg Code7 of 1947 to the

Helsinki Declaration8 revised in 2000. However, he

warned, whilst research is subject to control and

Good Clinical Practice (GCP) procedures in developed

countries, this is often lacking in developing econ-

omies. He offered a solution that was echoed many

times by other speakers throughout the Conference.

It is imperative that the developed nations help

poorer neighbours in capacity building in research

ethics. Ethics Committees need to be established

and adequately funded. The members of these

committees must receive adequate training and

ongoing education. Furthermore, it is essential that

these committees do not work in isolation. There

must be interaction between them and the scientifi c,

industrial and general communities of the region.

International networks must also be established

and supported so as to ensure that there is regu-

lated oversight, monitoring and updating. The aim

must be that the globalisation of research requires

the establishment of a body of ethical norms which

are acceptable internationally but which are sensitive

to cultural diversity.

Through supportive interaction, the developing

countries will fi nd their own voice and ensure that

“rich countries do not monopolize this debate or

become the sole decision makers”.

There is no doubt that the European community

has an essential role to play in this process. It has

considerable experience in the ethical supervision

of research and intends to promote a strict ethical 11

4 http://www.europarl.europa.eu/charter/pdf/text_en.pdf5 European Group on Ethics in Science and New Technologies > http://ec.europa.eu/european_group_ethics/index_en.htm 6 Ethical aspects of clinical research in developing countries > http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf7 http://ohsr.od.nih.gov/guidelines/nuremberg.html8 http://www.wma.net/e/policy/b3.htm

The globalisation of research requires the establishment of a body of ethical norms which are acceptable internationally but which are sensitive to cultural diversity.

12

model for research conducted in Europe and

throughout the world. In particular, through the

programmes of the European Commission, this

community has the opportunity to assist partner

countries to implement their own ethical frame-

works and organize their own ethical reviews.

Capacity building will enable these poorer countries

to participate more effectively in international

research, compete equally for funding and establish

their own strategic priorities.

Jean-Michel Baer reiterated that the European

Commission is committed to actively contributing

to the global governance of research ethics and

assisting the developing economies. He concluded,

“New capacities should help these countries to

reconcile the different parameters of governance

of research, namely, the sustainable use of bio-

logical resources, economic effi ciency, dialogue

and social acceptability”.

The European Commission wants a genuine global

dialogue on the governance of research: through

dialogue comes mutual understanding and

respect. This Conference on “Ethics, Research and

Globalisation” is a notable statement in this

conversation.

13

GLOBAL GOVERNANCE OF RESEARCH ETHICS

Research in science and technology is the power-

house of future development and sustainable

growth. Present advances in the fi eld of biomedical

research will determine the health and welfare of

humanity for decades to come. Increasingly, research

cooperation crosses geographical borders and cultural

boundaries and has become internationalised. The

challenge is to achieve a credible balance between

the progress of science and the protection of the

rights of individuals and sensitivity to their cultural

values. The global governance of research ethics

is a provocative topic and was the subject of the

fi rst Plenary Session of this Conference.

The European Commission is committed to fostering,

in cooperation with other international institutions,

responsible governance of research. In the Plenary

Session, representatives of the European Parlia-

ment9, developing countries and international

organisations such as WHO10, UNESCO11 and the

Council of Europe12 offered their perspectives on

ethics, governance and international scientifi c

research.

The positive role that Europe is ready to play was

forcefully outlined by Philippe Busquin, Member

of the European Parliament (MEP). He explained

that he is President of the Scientifi c Technology

Options Assessment Committee (STOA)13, which is

an offi cial organ designed to enlighten MEPs on

science and technological issues. He acknow ledged

that startling advances in research were taking

place and that these demanded that MEPs made

informed, democratic choices on ethical issues. He

cited, as an example, the controversy over embryonic

stem cell research and the dilemma that can arise

when modern science comes face-to-face with cultural

values that have developed over centuries.

When looking at research governance throughout

the world, explained Mr Busquin, it was necessary

to be sensitive to interdependencies. Not only must

advanced countries participate in the debate but

they must also make every effort to include devel-

oping countries and the international agencies so

that eventually everyone realises that they are taking

part in a truly democratic discussion and, through

this, consensus can emerge.

Mr Busquin also spoke of the problem of intellectual

property rights and their importance to the European

Parliament. He expressed the view that intellectual

property “is an engine of research and development

but it is also a brake on the accessibility and dis-

tribution of the products which may result from this

9 http://www.europarl.europa.eu10 http://www.who.int 11 http://portal.unesco.org12 http://www.coe.int 13 http://www.europarl.europa.eu/stoa/default_en.htm

14

research”. The contradictions raised by patenting

must be resolved if world trade is to run smoothly.

A variety of different opinions on research ethics

abound throughout Europe, concluded Mr Busquin.

Nevertheless, he was proud of the democratic dialogue

that was a cornerstone of the European Union and he

hoped that a similar informed discussion on the

governance of research would develop throughout

the world. “Our main common objective is to protect

the planet for future generations”.

A very clear perspective on the role of developing

countries in the global governance of research ethics

was provided by Fernand Guédou, Ministry of

Health, Benin14. He believed that research in devel-

oping countries is an essential contributor to their

sustained development. However, he argued,

inadequacies in the management of research are

inhibiting its potential contribution. Ineffective

policies for the promotion of research impede the

mobilisation of adequate fi nancing and there is

often a discrepancy between the investigative

themes that are pursued and the actual needs and

priorities of the country. This is compounded by a

lack of dialogue between researchers and decision-

makers resulting in the poor exploitation of the

fruits of the technology. What is really needed is

research which will assist sustainable development

but which is rooted in the cultural heart of the

communities.

Mr Guédou acknowledged that there was a growing

internationalisation of research. However, this

trend has not always been benefi cial for the devel-

oping countries. As an example, he cited confl icts

of values: Northern countries do not take the socio-

cultural realities of the developing countries into

account. He insisted that developing countries

must encourage research that contributes to local

development and “where basic ethical principles

will be truly respected through practices based on

local values”. As a contribution to global governance,

he argued that developing countries should adapt

regulatory texts and legal provisions to take local

cultural values into account. They should also identify

regional needs and aim to strengthen their capacity

for the promotion of research that was acceptable

strategically, scientifi cally and, most importantly,

ethically. Fernand Guédou insisted that developing

countries should “have no qualms in expressing

and defending local demands for research that is

truly at the service of regional development and

work towards the reinforcement of capacities

based on real needs”. He had no doubts that this

would demand political initiative and commitment

from the developing countries but would result in

a new type of partnership with Northern countries.

14 http://www.gouv.bj/en/ministeres/msp/index.php

15

A partnership characterised by a spirit of equality

and mutual respect, which would then gain genuine

acceptance at the local level.

The role of the international institutions in the

global governance of research was discussed by

Pierre Sané, UNESCO15 (whose paper was presented

by Shamila Nair-Bedouelle); Marie-Charlotte

Bouësseau, WHO16; Alexander Capron, of the Uni-

versity Of Southern California, USA17 and Laurence

Lwoff, Council of Europe18.

Pierre Sané emphasised that the social, human and

cultural dimensions of development and globalisation

are at the core of the work of UNESCO. Its universal

mission is bolstered by its capacity to initiate actions

that take into account, and respect, the diversity

of its Member States. Education is a powerful lever

for the “promotion of welfare, for civic and social

advancement, for the progress of democracy and

respect for human rights”. Scientifi c research is a

vital component of educational advancement

and the creation of sustainable development

and economic b enefi t. UNESCO’s International

Sciences Programmes aim to strengthen regional

and international cooperation. The programmes

enhance scientifi c capacity in national priority areas

by working through a network of national, regional

and international centres of research excellence.

Participation in high quality, international research

programmes will enable developing countries to

play an equitable role in global science and techno-

logy. Because of the work of UNESCO as “an intel-

lectual clearinghouse and knowledge broker”,

asserted Mr Sané, it has a unique capacity to facilitate

international cooperation in scientifi c endeavour.

He insisted that there could be no doubt about

UNESCO’s steadfast commitment to the rigorous

ethical conduct of research and he cited the Universal

Declaration on the Human Genome and Human

Rights (1997)19; the International Declaration on

Human Genetics Data (2005)20 and the Universal

Declaration on Bioethics and Human Rights (2005)21

as testimony to this conviction. This commitment

of UNESCO is compounded by its support of three

Statutory Committees: World Commission on the

Ethics of Scientifi c Knowledge and Technology

(COMEST)22, International Bioethics Committee

(IBC)23 and the Intergovernmental Bioethics

15 http://portal.unesco.org/en/ev.php-URL_ID=29008&URL_DO=DO_TOPIC&URL_SECTION=201.html16 http://www.who.int17 http://www.usc.edu18 http://www.coe.int20 http://portal.unesco.org/shs/en/ev.php-URL_ID=1881&URL_DO=DO_TOPIC&URL_SECTION=201.html21 http://portal.unesco.org/shs/en/ev.php-URL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html 22 http://portal.unesco.org/shs/en/ev.php-URL_ID=6193&URL_DO=DO_TOPIC&URL_SECTION=201.html 23 http://portal.unesco.org/shs/en/ev.php-URL_ID=1879&URL_DO=DO_TOPIC&URL_SECTION=201.html

The lack of dialogue between researchers and decision-makers results in the poor exploitation of the fruit of technology.

16

Committee (IGBC)24. These committees are charged

with fostering international cooperative dialogue

and policy orientation in the ethical governance of

scientifi c research.

Pierre Sané made it very clear that UNESCO takes

its responsibilities for capacity building in research

ethics very seriously. For example, it assists Member

States to set up Ethics Committees; it supports

ethics teaching, the evaluation of ongoing scientifi c

research and the identifi cation of new and emerging

ethical issues. UNESCO is a pre-eminent instrument

for international cooperation. Accepting UNESCO’s

responsibilities, he concluded, “It is imperative

that, within the dynamics of globalisation, the impor-

tance of science as a cultural value is maximised”.

In a similar vein, the signifi cant contribution of

WHO25 to the ethical conduct of global research was

highlighted by Marie-Charlotte Bouësseau and

Alexander Capron. Part of the mission of the De-

partment of Ethics, Trade, Human Rights and Health

Law of WHO is “To advance human dignity, justice

and security in health” and this includes health

research. WHO’s aims are to strengthen local capac-

ities and harmonise regulations whilst, at the same

time, respecting local cultural sensitivities. WHO

strives to maximise synergies between national and

international, governmental and non-governmental

institutions to ensure that ethical standards and

analysis are included in all health research policies.

Some examples of the activities of WHO in the fi eld

of research ethics were summarised. These included

extensive capacity building exercises, for example

through participation in TREE (Training and Resources

in Research Ethics Evaluation for Africa)26, NEBRA

(Networking for Ethics on Biomedical Research in

Africa)27 and several other collaborative networks.

WHO also plays an active part in international debate;

for example, it was a co-founder of the Global Forum

on Bioethics in Research28 in 1999 and has hosted

meetings in Bangkok (2000) and Brasilia (2002).

At a very practical level, WHO has been involved in

the support of research Ethics Committees and the

publication of guidelines for their operation. WHO

continues to actively contribute to the global gover-

nance of ethically responsible research. Nevertheless,

as Alexander Capron concluded, many important

international ethical issues remain unresolved but,

he declared, WHO is steadfastly committed to

working towards their solution.

24 http://portal.unesco.org/shs/en/ev.php-URL_ID=1878&URL_DO=DO_TOPIC&URL_SECTION=201.html25 http://www.who.int/ethics/research/en/26 http://trree.org/site27 http://trree.org/site/nebra.phtml28 http://www.gfbronline.com

17

The fi nal contribution to this discussion on the role

of the international institutions was by Laurence

Lwoff, who is Deputy Head of the Bioethics Depart-

ment of the Council of Europe29. She eloquently

explained that in a modern society, research and

ethics must go hand in hand: it is an essential element

in the pact between society and researchers. Finding

the correct balance between scientifi c progress and

the protection of the individual is an objective of

the Council of Europe: an intergovernmental

organisation created in 1949 to defend human rights

and democracy. It now includes 47 Member States.

Convinced that ethics is an asset to credible research,

the Council of Europe has developed several dif-

ferent activities in this fi eld. As Ms Lwoff explained

“The Council of Europe has developed a legal corpus

which is unique at an international level”. One of

its towering achievements in this fi eld must be re-

garded as The Convention on Human Rights and

Bio medicine30, originally signed in 1997 with an

additional Protocol added in 2005. This legally

binding instrument aims to standardise ethical and

legal norms in the area of biomedical research and

to ensure the same level of minimum protection

for citizens throughout Europe. Amongst its many

provisions, for example, is the specifi cation of the

conditions in which research can be undertaken on

individuals who are not in a position to give their

own informed consent and it provides rules for re-

search in emergency circumstances. The Protocol,

which comes into effect in September 2007, high-

lights the essential role of independent Ethics Com-

mittees in the assessment of research projects so

as to protect the dignity, rights and safety of par-

ticipants. In addition to the Convention and the

additional Protocol, Rec (2006) 4 of the Council of

Europe31 deals with research on biological of hu-

man origin and biobanking.

It was the view of Ms Lwoff that, whilst this normative

corpus represented a European consensus, it is

also relevant to issues that arise beyond European

borders. There is a fear, she explained, that research

which might be considered unethical might be

carried out by European researchers in countries

where the protection of participants is not so well

embedded. As a “pilot project”, the DEBRA32 pro-

gramme, launched in partnership with the European

Commission, is intended to facilitate and monitor

the establishment of Ethics Committees in Central

and Eastern Europe. A greater awareness has

emerged of the diversity of opinions on ethical

issues in these different socio-economic and

cultural communities. Other initiatives by the

29 http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/Contacts/contacts_Secretariat.asp 30 http://conventions.coe.int/treaty/en/treaties/html/164.htm31 https://wcd.coe.int/ViewDoc.jsp?id=977859&BackColorInternet=9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC7532 http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/activities/biomedical_research/2Intro_DEBRA.asp

A greater awareness has emerged of the diversity of opinions on ethical issues in different socio-economic and cultural communities.

18

Council of Europe include the development of

teaching tools. In particular, a set of data sheets

specifi cally aimed at biomedical research and the

role of ethical assessment will be launched in 2007.

Laurence Lwoff concluded that the increasing

internationalisation of research creates new

responsibilities, particularly regarding research

carried out in developing countries under the scientifi c

and fi nancial control of developed nations. Euro-

pean institutions such as the Council of Europe

should work with other international organisations

like UNESCO and WHO to develop sound ethical

principles and facilitate their implementation globally.

This, she declared, “would contribute to the devel-

opment of research of quality, that respects the

fundamental rights of each individual and is a

source of progress for the health and welfare of

everyone across the globe”.

19

BUILDING CAPACITY IN RESEARCH ETHICS

Research investment is accelerating in the devel-

oping countries and the emerging economies. Not

only is research being generated indigenously, but

also external research organisations and commercial

enterprises are using these locations as a base for

research into poverty- and geographically-related

diseases. However, there is also a justifi able fear

that some of these investigations, particularly clinical

trials, may be motivated by the availability of a large,

accessible but vulnerable population of research

subjects. It is essential that this research adheres

to the highest international standards and that there

is no danger of exploitation of the participants.

Capacity building in research ethics must be con-

sidered as vital. Effective procedures need to be

developed and successful interactions established

between the industrialised partners and the develop-

ing countries for the careful monitoring of research

programmes to ensure that they meet global

standards. However, ethics review procedures vary

from country to country and it is important that

well-considered decisions are made about the systems

that should be adopted and how they should be

modifi ed to local contexts.

The differences between industrialised and devel-

oping countries and the vulnerability of the latter to

exploitation were highlighted by Julian Kinderlerer,

a member of EGE33. This group was established by

the European Commission to deliver advice on

ethical questions relating to science and new

techno logies. Opinion 1734 of the EGE dealt with

the ethics of clinical research in developing countries.

It acknowledged the signifi cant differences, socially,

culturally and economically that exist between the

developing and industrialised nations and identifi ed

the different values that may be held by different

cultures. The dilemma is to ensure that the external

sponsor neither assumes a paternalistic approach

to the host country, nor tolerates ethical standards

that would be considered unacceptable in industri-

alised nations. The risk of accepting double standards

may involve issues of informed consent, privacy

and the protection of personal data and the rights

of the individual compared to the needs of the family

or local community. In discussing Opinion 17, Julian

Kindererler emphasised that the protocols used in

research, and particularly clinical trials, cannot ignore

the local context. Participation in a trial may offer

patients their only opportunity for access to health-

care. He argued that research carried out in developing

countries should actively contribute to reducing the

33 European Group on Ethics in Science and New Technologies > http://ec.europa.eu/european_group_ethics/index_en.htm34 Ethical aspects of clinical research in developing countries > http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf

20

differences in accessibility to health care between

rich and poor nations and concluded that researchers

“have a moral duty to make a concrete contribution to

overcome inequalities”.

Cláudio Lorenzo of the National Health Council,

Brazil, offered a Latin American perspective on

ethical regulation. The degree of social exclusion

in Latin America and the way in which this exclusion

may interact with international research means

that there is social vulnerability. This is a major

preoccupation for research centres in these countries.

Social disparities in Latin America are among the

greatest on the planet with nearly 44% of the popu-

lation under the poverty line with about 19% being

destitute. The social vulnerability fi gures reveal

that, in the four countries studied, signifi cant pro-

portions of the poorer sections of the community

have no access to medical care. These are poor

people who cannot afford medication but who have

most to benefi t from its availability. The direct con-

sequence of this is that there is a social group in

these countries that is clearly vulnerable to medical

exploitation. The data indicate that the lower the

research capacity of a country, the greater the socio-

economic inequalities, the lower the education

level, the greater the degree of rural dwelling and

ethnic diversity: then, inevitably, the greater the

degree of social vulnerability. Dr Lorenzo argued

that research should not be carried out with these

vulnerable populations unless the benefi ts are

directly linked to the health problems of that com-

munity and to the individuals participating.

In spite of these concerns, the countries of Latin

America are, obviously, very attractive to commercial

organizations for research studies and clinical trials.

This is because of the existence in large cities of

trained specialists and equipped healthcare insti-

tutions. There is easy and rapid subject recruitment

and a large concentration of naïve patients in public

hospitals. Research expenses are also much lower

in Latin America. Furthermore, he contended that

an attractive incentive was the lower surveillance

and the reduced severity of the regulation of ethics

issues.

Because of this more benign regulatory system,

the population are vulnerable to abuse and are not

effectively protected. In 2004, only 13 of the 20 Latin

American countries had Ethics Committees and

only 8 have national normative documents. Further-

more, there is considerable variation in the ethical

regulation of different types of research and clinical

trials.

Although Ethics Committees have been established

in some countries, there are signifi cant problems

in their functioning. There is often inadequate training

of the committee members and a lack of logistical

support for the work. A source of concern is a lack

of recognition of the legitimacy of the committees

21

by the research community and an absence of

accreditation systems to supervise their quality.

Cláudio Lorenzo offered some worthwhile recom-

mendations to improve regulation and ethical control.

These included the interchange of experiences and,

following debate in the region, the joint formulation

of new documents for the ethical standardisation of

biomedical research. He further recommended

the creation of a smaller number of high capacity

committees, accredited by international, non-

governmental, organisations. What was also

needed, he argued, was social as well as political

action to reinforce the ethics regulation systems.

The increase in research on poverty–related disease

such as HIV/AIDS and malaria and the consequent

outsourcing of clinical drug development was high-

lighted by Reidar Lie of the University of Bergen,

Norway35 and the Department of Clinical Bioethics,

NIH, USA36. A growing awareness of the necessity

for regulatory requirements and adherence to strict

ethical principles had led to the establishment of

training programmes for capacity building in ethics

such as those provided by, for example, EDCTP37,

the Fogarty International Centre, NIH38. Reidar Lie

affi rmed that there had been a dramatic increase

in capacity building in recent years and indicated

that the emphasis has been on short training

courses with a focus on Africa. His personal recom-

mendation was that these short courses and train-

ing programmes should be continued but that they

should be better targeted and focused. The aim

should be to develop a high level of expertise with

the possibility of a career path for specialists. He

also insisted that increased attention must be paid

to Asia.

UNESCO39 also plays a role in the building and

strategic implementation of capacity in ethics; par-

ticularly through COMEST40. Shamila Nair-Bedouelle,

working in the Division of Ethics of Science and

Technology, UNESCO, Paris, explained that COMEST

was created in 1998 as a forum for the exchange of

ideas and as an early warning system of risk situ-

ations that may arise in science and technology.

Among its activities is the development of Global

Ethics Observatory Database41 and an Ethics Education

35 http://www.uib.no/info/english/36 http://www.bioethics.nih.gov37 European and Developing Countries Clinical Trials Partnership > http://ec.europa.eu/research/info/conferences/edctp/edctp_en.html38 Fogarty International Centre, NIH, USA > http://www.fi c.nih.gov39 United Nations Educational, Scientifi c and Cultural Organization > http://www.unesco.org40 World Commission on the Ethics of Scientifi c Knowledge and Technology >

http://portal.unesco.org/shs/en/ev.php-URL_ID=6193&URL_DO=DO_TOPIC&URL_SECTION=201.html41 http://portal.unesco.org/shs/en/ev.php-URL_ID=6200&URL_DO=DO_TOPIC&URL_SECTION=201.html

22

Programme (EEP)42. The function of EEP is to identify

ethics experts, monitor training programmes, develop

educational resources and facilitate teacher-training

courses. Rotating conferences, of which there have

been 18 since 2004, facilitate the dissemination of

information on ethics and assist opportunities for

effective networking.

A global contributor to capacity building was

described by Carel IJsselmuiden of COHRED43. Having

illustrated the problems faced by concerned

researchers and ethics committees; he outlined

the role of the Global Forum on Bioethics in Research

(GFBR)44. It serves as a global platform for debate

on emerging ethical issues in international collab-

orative health research between developing and

developed countries. Its annual meetings bring

together ethicists, researchers, and policy makers

from developing and developed countries. Their

aims include strengthening the protection of human

participants in international research and building

the capacity for ethical review of research. The work

of GFBR will also be enhanced by the operation of

a fellowship scheme. GFBR receives funding support

from the EU Research Framework Programme (FP)45.

Other important activities of the European Com-

mission to ensure that international research

funded by the Community complies with stringent

ethical principles were summarised by Peteris

Zilgalvis, Head of Governance and Ethics Unit,

Directorate-General for Research, European Com-

mission46. He described how the Governance and

Ethics Unit supports capacity building in research

ethics in partner countries and emphasized that

several collaborative projects were financed

through FP6.

These include, in particular EULABOR47, the fi rst

European and Latin American network on ethics

regulation, BIONET48 a 21-partner European-Chinese

collaboration and EDCEP49 (European and Developing

Countries Ethics Partnership). This aims to develop

capacity in the ethics review of research projects

in developing countries and emerging economies

by co-fi nancing capacity building workshops and

providing researchers in key countries with ethics

expertise. NEBRA50 (Networking for Ethics on Bio-

medical Research in Africa) has conducted a survey

under the guidance of both African and European

supervisors to identify the existing and required

42 http://portal.unesco.org/shs/en/ev.php-URL_ID=6199&URL_DO=DO_TOPIC&URL_SECTION=201.html43 Council on Health Research for Development > http://cohred.org44 Global Forum on Bioethics in Research > http://www.scidev.net/events/index.cfm?fuseaction=readevents&itemid=783&language=145 http://cordis.europa.eu/fp7/home_en.html46 http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=2247 http://www.eulabor.org48 http://www.bionet-china.org 49 http://www.bioethics.it/pdf/pc_4/edcep_pagina_introduttiva.pdf.

ethics review capacity in 15 African countries. NEBRA

intends to build a sustainable network of ethics

committees in Africa. It is hoped that it will have

signifi cant impact because of the involvement of a

broad range of countries and stakeholders, the

networking and the identifi cation of locally relevant

best practice.

Peteris Zilgalvis concluded that through these EU

co-funded-initiatives in capacity building and by

sharing knowledge and best practices, effective

ethics procedures would be developed between

the partner countries themselves. This, he affi rmed,

will enable these countries to play an active role in

international research relevant to their own needs

and, he said, “to actively participate in the inter-

national debate on research ethics as our equal

partners”.

23

Countries will be enabled to actively participate in the international debate on research ethics as our equal partners.

50 http://www.trree.org/site/nebra.phtml

24

SOCIO-ECONOMICAL AND ENVIRONMENTAL FACTORS IN RESEARCH ETHICS

A thought-provoking and exciting element of this

Conference on the globalisation of research ethics

was the inclusion in the Programme of three “Break-

out Sessions”. These Sessions, which involved stim-

ulating audience interaction, were on the topics of:

1 Socio-economical and environmental aspects

of research ethics

2 Double standards in research ethics

3 Intellectual property rights.

Each of these Sessions involved a Chair, a Rapporteur

whose function was to summarise the fi ndings of the

debate and a Panel of distinguished speakers.

The summary of each Breakout Session was

presented by its Rapporteur in a Plenary Session,

co-Chaired by Maurizio Salvi, Bureau of European

Policy Advisers (BEPA)51 and Hanna Nohynek,

National Public Health Institute (KTL), Finland52.

Opening the Plenary session, Maurizio Salvi explained

that the Bureau of European Policy Advisers was a

“sort of think-tank for the President of the European

Commission”. Mr Salvi’s responsibility is related to

ethics, including some co-ordination of Commission

services and activities in this area. He is also Head

of the Secretariat of the European Group on Ethics

in Science and New Technologies (EGE)53. This is

an Advisory Board with external experts to inform

the Commission about the ethics of research and

development. He emphasised to the audience that

with regard to the globalisation of ethics and

research in developed and developing countries,

there is now a “political momentum to endorse

these activities, at least from the European Union,

in a serious and consistent way”. He acknow ledged

that some times political momentum does not ma-

terialise into concrete action but remains a missed

opportunity. However, in this case, it is not just

political agreement but also concrete instruments

with two different branches. One arm is the Frame-

work Programme (FP7)54; the other is made up of

the bilateral and multilateral agreements for re-

search and technology through the European

Union. Mr Salvi asserted that in both these axes it

will be possible to have research ethics included

or, at least as part of one of the activities to take

on board. However, he exhorted the audience “You

are the people working directly on the fl oor, on the

frontline of research ethics. You must not take a

passive role, you must be proactive and you need

to propose ideas!”

51 http://ec.europa.eu/dgs/policy_advisers/index_en.htm52 http://www.ktl.fi /portal/english/53 http://ec.europa.eu/european_group_ethics/index_en.htm54 http://cordis.europa.eu/fp7/home_en.html

25

The other co-Chair, Hanna Nohynek, caused great

amusement for the audience when introducing

herself. She explained that she was from Helsinki

and that, because of the Declaration55, every

conference on ethics was obliged to have at least

one participant from Helsinki!

Breakout Session 1, on the socio-economical and

environmental factors in research ethics, was

chaired by Catherine Hankins, Chief Scientific

Advisor and Associate Director of Policy, Evidence

and Partnerships Department, UNAIDS56, Geneva.

The Rapporteur was Carrie Marias, UNESCO-Africa57,

Dakar, Senegal.

The primary concern of this session was that whilst

it is readily acknowledged that research will impact

upon the social, economical, environmental and

cultural fabric of the host developing country, this

is not quantifi ed nor often taken into account when

formulating the research agenda. This is singularly

challenging because it is often diffi cult to monitor

the effects of a research project on social or eco-

nomical benefi t or on environmental improvement

and it is rarely possible to tease apart the different

elements in this complex network of cause and

effect. Two case studies were chosen to serve as

guides or reference material: Chagas disease and

HIV/AIDS. However, these were used to illustrate

points of principle and were not intended to limit

the horizons of the discussion.

At the start of the Session, the Chair emphasised

that the aim of the discussion was to identify the

challenges, the needs and the priorities of the

effects of research on the welfare of host com-

munities. Presentations were made by: Hannah

Akuffo, Karolinska Institute58; Alioune Dieye, Institute

Pasteur59 and University of Cheikh Anta Diop,

Senegal60; Henning Mikkelsen, DG DEV61; Philippe

Guérin, Epicentre62, France and Melody Lin, Offi ce

for Human Resource Protections63, USA. Following

these presentations and contributions from the au-

dience, a report was produced which summarised

the main issues.

One of the primary challenges that was recognised by

the speakers was the potential dilemma in balancing

the different best interests of the host developing

country. It was argued that it might be diffi cult to

undertake research programmes that are in line

with national priorities, maintain a constructive

international scientifi c and fi nancial relationship

whilst, at the same time, maintaining an independent

position on research ethics. As Hannah Akuffo

questioned “Are well-meaning collaborating

55 http://www.wma.net/e/policy/b3.htm56 http://www.unaids.org57 http://www.dakar.unesco.org58 http://ki.se/ki/jsp/polopoly.jsp?d=130&l=en59 http://www.pasteur.fr/english.html60 http://www.ucad.sn61 http://ec.europa.eu/development/AboutGen_en.cfm62 http://www.epicentre.msf.org63 http://www.hhs.gov/ohrp/

You are the people working directly on the frontline of research ethics!

26

researchers from high income countries working

in developing countries truly open to the agenda

for the research to be defi ned by their collabora-

tors from low income countries?” It was acknowl-

edged that it is problematic to incorporate cultural

sensitivity and social relevance into the ethical

framework of a research programme and to recognise

the socio-economic and welfare needs of the local

population and, in particular, vulnerable indigenous

groups.

Other signifi cant challenges that were identifi ed

included the absence or weakness of independent

ethical review structures in situations were clinical

trials is being sponsored in poorer countries. Hannah

Akuffo clearly articulated “Well designed, ethically

evaluated clinical trials must be done even in the

wake of diffi cult to treat conditions in vulnerable

individuals. It must take the time it takes to be able

to obtain the right information”. It was regarded as

important to ensure that clinical trials are designed

to help to improve the health situation in the host

country and not to exploit a vulnerable population.

The trials must be conducted with ethical rigour and

there should be access to the products or therapies

resulting from successful trials. Ms Akuffo warned,

“Even well meaning doctors should not be above

following these norms”.

For an informed and effective relationship to develop,

the communities in the host countries need to become

ethically aware and research literate so that they

can actively participate, as equal partners, in the

design and conduct of the research studies and

clinical trials.

A major priority in ensuring equitable treatment of

research participants was access to drugs and

therapies. It was agreed that patients in vulnerable

or poorer communities with life-threatening diseases,

who would not otherwise survive, should be given

access to drugs which are undergoing clinical trial.

Melody Lin demanded that it is a priority to “Ensure

that participants and communities receive benefi ts

from the results of research”. She argued that not

only must research be benefi cent but it must also

demonstrate justice. The selection of subjects must

be equitable, vulnerable subjects must be protected.

However, there is also a professional imperative to

“Ensure scientifi c validity by selecting appropriate

subject population”.

Another requirement must be to help vulnerable,

poorer countries develop their own well-managed,

ethically sensitive research. To achieve this end,

policies and infrastructure need to be put into

place that would facilitate the development of in-

digenous scientifi c research underpinned by higher

levels of state funding. The Universities must be

supported so that they can effectively apply for

27

competitive research grants and thereby develop

their own research capacity and independence.

Few would argue with Hannah Akuffo’s assertion

that “The investigator controlling the funds remains

the one with the power to have the last word!”

To ensure that any research, be it local or interna-

tional, fully complies with ethical sensitivities, ethical

committees must be established. However, this alone

is not suffi cient. The conduct, independence from

interference and effectiveness of these committees

must be rigorously monitored and opportunities

provided for the sharing of experience of research

ethics both within the home country and interna-

tionally. Melody Lin was insistent that ethical review

must be subject to accountability and must be able

to demonstrated transparency, independence and

competence and ensure adequate protection of

“human subjects in socio-economic and environ-

mentally challenged research sites”. Alioune Dieye

summarized this requirement by the trenchant phrase

“From the ethics of technology towards an ethics of

knowledge policy and knowledge assessment”.

The key to ensuring ethical sensitivity and respect for

cultural values in a community is always education

and in the Breakout Session it was agreed that this

is a vital priority. This education in research ethics

must extend across the board and include not only

members of ethics committees and the health care

professions, but also the general population. In

this way, it should be possible to encourage the

informed participation by the whole community in

acceptable research programmes and clinical trials.

The need for cooperation and understanding was

also emphasised in this session. Equal and open dia-

logue must occur at several interface points: between

local researchers, policy makers and the general

community and also with the international research

partners and the sponsors of the studies. It was

also agreed that to strengthen capacity building, dia-

logue and cooperation on ethics issues must extend

far beyond national boundaries. It was recommended

that there should be twinning between Research

Institutes and Universities in Europe and the develop-

ing countries and the establishment of ethics networks.

There must also be continued support for networks

that are already performing successfully such as

the European and Developing Countries Clinical

Trials Partnership Programme (EDCTP)64, which was

established to enable ethically acceptable clinical

trials for drugs and vaccines against HIV/AIDS,

tuberculosis and malaria. Other successful net-

working initiatives that, it was proposed, merited

continued support included NEBRA65 and the Bio-

ethics Network for West and Central Africa66.

64 http://ec.europa.eu/research/info/conferences/edctp/edctp_en.html and http://www.edctp.org65 Networking for Ethics in Biomedical research in Africa > http://trree.org/site/nebra.phtml66 http://www.westafricanbioethics.net

Trials must be conducted with ethical rigour and there should be access to the products or therapies resulting from the successful trials.

28

To conclude, the Breakout Session vigorously con-

fi rmed the frequently stated commitment to open

and wide discussion. Citing Opinion 1767 of the

EGE68, it was generally agreed that debate must

continue to ensure that cultural diversity, participation

and the education of the local population on ethical

issues must always be taken into account when

international research collaborations are established

between developing and developed countries. Only

by appropriate sensitivity can acceptable socio-

economic and environmental impact of research

be achieved.

67 Ethical aspects of clinical research in developing countries > http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf68 European Group on Ethics in Science and New Technologies > http://ec.europa.eu/european_group_ethics/index_en.htm

29

DOUBLE STANDARDS IN RESEARCH ETHICS

With a single incisive question, John R. Williams of the

University of Ottawa69 threw into sharp perspective

the discussion of double standards in research ethics:

“When, if ever, should research that is considered

unethical in developed countries be conducted in

developing countries?”

In order to prevent exploitation and the applica-

tion of double standards in vulnerable resource-

poor countries, it is generally accepted that there

is a need for universally applicable ethical stan-

dards for research on human subjects. A variety

of guidelines and regulations have been published

to achieve this aim (e.g. Declaration of Helsinki70;

European Group on Ethics in Science and New

Technologies71; National Bioethics Advisory Com-

mittee, USA72; Nuffi eld Council on Bioethics, UK73;

CIOMS74; etc). However, as John Williams pointed

out, these documents have not been in full agree-

ment on the issue of double standards. For example,

the guidelines do not fully concur as to whether a

placebo or no treatment arm should be included in

clinical trials when effective treatment is not gen-

erally available in the country in which the research

is conducted. In the subsequent discussion, it was

recommended that the EU should fund further

consensus-seeking forums to defi ne the accept-

able standards for the inclusion of a placebo arm

in research studies in developing countries.

Clement A. Adebamowo, Professor of Surgery,

Lecturer in Bioethics and Nutrition Epidemiology,

Chairman, NHREC75 and Director of Programmes,

West African Centre for Bioethics76, highlighted the

increasing volume of international research that is

underway in the developing countries. Whilst there

is an increased awareness of the need to apply

sound ethical principles to the conduct of research

throughout the world, it is also true that there is a

move towards the outsourcing of research to de-

veloping countries to take advantage of lax regula-

tory environment and lower costs. Professor Ade-

bamowo contended that this leads to an “increased

69 http://www.cihr-irsc.gc.ca70 http://www.wma.net/e/policy/b3.htm71 Ethical aspects of clinical research in developing countries > http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf72 Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries >

http://www.georgetown.edu/research/nrcbl/nbac/pubs.html73 The Ethics of Research Related to Healthcare in Developing Countries >

http://www.nuffi eldbioethics.org/go/ourwork/developingcountries/introduction74 Council for International Organizations of Medical Sciences International Ethical Guidelines for

Biomedical Research Involving Human Subjects > http://www.cioms.ch/frame_guidelines_nov_2002.htm75 National Health Research Ethics Committee of Nigeria > http://www.nhrec.net/nhrec/76 http://www.westafricanbioethics.net

30

risk of exploitation of citizens of low-resource

countries”. This has resulted, he argued, in a higher

prevalence of research misconduct in the developing

countries. Several factors were responsible; including

socioeconomic disparity between researchers and

participants, high levels of illiteracy, ethnic and

religious diversity, colonial experience, gender issues,

corruption etc. However, the loss of research by

industrialized countries in developing countries

would not be without its harmful consequences.

Using Africa as an example, he suggested that as

global capacity for solving health problems increases,

the capacity of Africa will reduce and it will be denied

the benefi ts of health research and its resulting

benefi cial outcomes.

During the Breakout Session, chaired by Doug

Wassenaar, SARETI77, with Raffaella Ravinetto,

Institute of Tropical Medicine, Belgium78 as Rap-

porteur, presentations were also made by Jean-

Claude Ameisen, INSERM79/Comité Consultatif

National d’Ethique (CCNE), France80; Tumani Corrah,

Medical Research Council, Gambia81; Patrick Lozes,

Independent Consultant, France and Barbara Sina,

National Institutes of Health (NIH), USA82. It was

pointed out that double standards might also exist

in developed or “Northern” countries. Northern

cultures may have hidden or covert forms of

oppression. Vulnerable groups may face exclusion,

based on medical history, social status and

national health priorities. The Panel was reminded

that diversity is not only between Africa and Europe;

there is also diversity within Africa, within Europe,

and within the USA. It was suggested that developed

countries should address such double standards

fi rst, before trying to eliminate double standards

in the developing world. It was argued that they

would be “more likely to be consistent in their

attitudes if there are no double standards at

home”. It was emphasized that ethics cannot be

isolated from context: ethical principles are universal

but plurality and respect for cultural differences is

also of value. The challenge for researchers and policy-

makers is to fi nd an ethically acceptable balance

between a principled approach and a pragmatic one.

There is a need to contextualize the procedures

and tools, in light of the cultural tradition, values

and national laws without weakening the universal

ethical principles and standards.

77 South African Research Ethics Training Initiatives, South Africa > http://www.up.ac.za/sareti/index.html78 http://www.itg.be79 http://www.inserm.fr/en/home.html80 http://www.ccne-ethique.fr81 http://www.mrc.gm82 http://www.nih.gov

31

In order to focus the debate, the issue of double

standards in the requirement for informed consent

was highlighted. It was argued that rather than

“informed consent”, a more appropriate term might

be “informed free choice” which more precisely

implies the concept of genuine consent.

In the resulting discussion, several contributors

pointed out that in seeking consent, communication

is the key factor. If the information is given clearly,

correctly and, most importantly, appropriately then

communities both North and South can understand

the situation. Failure to understand the nature of

the required consent is because of inappropriate

communication procedures. The important factor in

avoiding double standards in the process of informed

free choice is to realize that the process is a

continuous and interactive one, not simply requiring

a signature on a document. There is a need to

establish good practice guidelines on the delivery

of the information to the volunteer and this process

should involve patients’ organizations and com-

munity groups.

Speakers emphasized that informed consent pro-

cedures must be designed to protect the patient,

rather than the researcher or the industrial sponsor.

It was emphasised that all documentation must be

written in a lay-friendly language and must be

designed to protect vulnerable and poorly educated

patients. It was argued that representatives of the

concerned study population should validate the

material.

Speakers pointed out that the person who informs

the potential volunteer must be fully free and

independent. If the informer is primarily interested

in recruiting patients, rather than ensuring what is

best for the volunteer, then the process will be

fl awed and probably fail to maintain adequate ethical

standards.

There is clearly a need for ongoing dialogue between

sponsors, researchers, hosts, ethics experts, Ethics

Committee members and patient groups, to enhance

the quality of the informed consent. It was pointed

out that research sponsoring bodies should always

obtain ethical clearance from their own institution

and their own country, in addition to the ethical

clearance in the host country were the research is

to be carried out. This “double ethical clearance” is

an effective way to help to reduce double standard.

In the discussion on this issue, there was general

agreement that, in the developing countries, informed

consent must be contextualized. Local tradition and

cultural values must be respected and integrated

into the process. This must be through dialogue

and not by imposition.

Ethical principles are universal but plurality and respect for cultural differences is also of value.

32

Integrating regional cultural values should not

weaken the basic principles of the rights of an indi-

vidual to be personally and fully informed. However,

in some circumstances, a regional population may

prefer a community approach, which may lead to

tension between the relevance of opinion of the

Chief of the community and the individual consent.

It was suggested that in these circumstances, a

two-step process should be adopted. Initially, the

opinion of the Chief should be sought, in order to

gain access to the community. However, it must be

made clear, from the beginning, that personal con-

sultation and consent is mandatory.

In the discussion, concern was expressed that it is

not always possible to ensure that consent is really

given freely and assessment of the procedure is

advisable. The responsibility for the process is a

shared one, involving sponsors, investigators,

subjects etc. Tumani Corrah, Medical Research

Council, Gambia83, suggested that Ethics Committee

members and principal Investigators should make

ad hoc fi eld visits to check the implementation of

the Informed Consent process: this must be patient-

centred and based on dialogue.

In conclusion, it was proposed that the EU should fund

the study of best practices to promote the enhance-

ment of understanding in consent procedures.

Another major theme in the discussion of double

standards was that of access to health by participants

in clinical research in developing economies.

A consensus view appeared to be that a responsible

attitude to health research demanded that the par-

ticipants receive the best medical care. Integrating

traditional cultural values does not mean, “fatalis-

tically accepting the status quo”. It was agreed that

it is always ethical to provide treatment during a

research study. Conversely, it must be argued that

is unethical to require participation in a research

programme in order to gain access to a life-saving

therapy. If this is the case, then the consent is a

“biased” consent, it is fl awed and there is a double

standard operating.

The audience in the Session concluded that the

ethical priority must always be to ensure sustained

access to appropriate, not minimum, health care

for all. Once access to health care has been

achieved, then research on improving that care can

then be started.

The relevance of the research to the regional pop-

ulation was also discussed. It was concluded that,

in order to avoid double standards, the research must

be of benefi t and/or relevance to the participants and

they must have full access to its benefi cial outcomes.

The general view was that there should be open

access to the scientifi c fi ndings of all research. 83 http://www.mrc.gm

33

However, it was noted that, in addition to research

initiated by international organizations and commer-

cial enterprises, an increasing amount of research

in developing countries is being carried out by

investigator-initiated, locally funded small-scale

studies. These small projects cannot ensure access

to benefi ts. It was questioned whether there was

a double standard operating, if benefi ts are only

obligatory for large well-funded, usually interna-

tional, studies.

It was recommended that funding mechanisms

should be put into place for the ethical analysis of

these problems and procedures proposed to ensure

better access to the beneficial outcomes from

research: particularly in countries where access to

public health care is poor.

There was general agreement that one of the most

important elements in monitoring the risk of double

standards in developing countries is the role of local

Ethical Committees. The evidence indicates that

these are generally resource-poor. To be effective,

fi nancial resources are needed for research studies

to identify the best practices for dealing with the

placebo issue; to fund capacity building based on

need assessment; to determine optimal procedures

to monitor the protection of research participants

and to put mechanisms in place to ensure compliance

with appropriate protocols. It was agreed that it is

essential that local Ethical Committees be provided

with adequate core funding and ongoing educa-

tional materials.

The diligent training of Ethics Committee members

was considered essential. A study of the effectiveness

of current training approaches, often involving only

short-term courses, is needed. It was regarded as

vital that a sustained system should be put in place

to ensure collaborative research training and a

continuous education process to embed expertise

in bio-ethics. The goal must be the development of

Centres of Excellence in research ethics in resource-

limited countries.

If the risk of exploitation of developing countries and

the application of double standards is to be avoided,

it was concluded that the weapons of defence

must be funding, research, training and, most

importantly, sensitivity and responsibility.

The ethical priority must always be to ensure sustained access to appropriate, not minimum, health care for all.

34

INTELLECTUAL PROPERTY RIGHTS

It has been argued that one of the major problems

surrounding our understanding of the risks and

benefi ts of intellectual property protection and its

relationship to research ethics is a profound lack of

knowledge. There is almost no evidence available

that proves the economic effectiveness of increased

patent protection, nor any that demonstrates that

decreased protection is benefi cial to research in-

centive. In Opinion 2184 of the European Group in

Ethics in Science and New Technologies85, which

dealt with ethical aspects of nanomedicine, section

4.4.3.3 was concerned with Intellectual Property

Rights (IPR). The Opinion explained that patenting

of biological materials for medical use has become

a serious issue of ethical concern. This is because

patent protection may limit the availability of medical

treatments to needy patients because they are

rendered prohibitively expensive. European patent

law does not permit patenting of “methods for

treatment of the human or animal body by surgery

or therapy” and it attempts to balance the protection

of IPR by researchers and commercial companies who

wish to profi t from their investment while, at the same

time, protecting the best interests of patients.

This possible confl ict between intellectual property

rights, patenting and research ethics was the subject

of Breakout Session 3.

This Session was Chaired by Emilio Mordini, Centre

for Science, Society and Citizenship, Italy86 and the

Rapporteur was Hervé Chneiweiss, INSERM,

France87. The panellists were Pamela Andanda,

University of Witwatersrand, South Africa88; David

Bennett, European Federation of Biotechnology,

The Netherlands89; Adeyinka Falusi, University of

Ibadan/Nigerian Bioethics Initiative, Nigeria90;

DaeYoung Park, Korea Environmental Council in

Europe, Belgium91 and Anthony Taubman, World

Intellectual Property Organisation92.

In the introduction to this session, it was argued

that, in recent years, a number of controversies

have surrounded the use of IP in science-based

economy. One of these issues is the over-liberal

granting of patents. This can result in an increase

84 http://ec.europa.eu/european_group_ethics/activities/index_en.htm85 http://ec.europa.eu/european_group_ethics/index_en.htm86 http://www.bioethics.it/87 http://www.inserm.fr/en/home.html88 http://web.wits.ac.za/89 http://www.efbweb.org/activities/links.htm90 http://www.ui.edu.ng/91 http://www.kece.eu/92 http://www.wipo.int/portal/index.html.en

35

in litigation and complex systems of cross-licensing

and patent trading. Another problem concerns the

new database laws. In some cases, this can effec-

tively provide a single corporation with rights over

important factual information. This can have the

harmful effect of restricting well-meaning, basic

research by introducing prohibitive costs. A recently

emerging problem in IP is the increase of so-called

“business method” patents in information technology.

These give broad rights to corporations who carry

out established processes but using the latest

computer technology. This type of “over zealous

expansionism” in IP may present particular problems

to nanotechnology because it involves the exploita-

tion of novel properties of well-known materials.

In a thought-provoking presentation, the Rapporteur,

Hervé Chneiweiss, summarised the Session. He

emphasised that a rich debate had taken place

involving a mixture of cultures and specialisations.

Participants from Africa, India, other Asian countries

and Europe had exchanged their views and he was

particularly gratifi ed that legal experts had engaged

with basic research scientists.

“Intellectual Property (IP) is an additional weapon

in a technical world”, he asserted. Many ethical

issues could be avoided if the potential IP problems

were anticipated prior to the commencement of a

research investigation. It is essential, he sum-

marised, that researchers condition themselves

“to almost unconsciously integrate the potential

IP issues into their thinking in order to foresee future

hazards”.

Mr Chneiweiss laughingly remarked that the

expression “two hands” was repeatedly used in

the Session: “on the one hand there is something,

on the other hand there is something else!” For

example, on the one hand there is disclosure, on

the other hand secrecy; the rights of taxpayers today

versus those of future generations; patients versus

healthcare insurers etc. This confl ict of interests

often arises in the IP fi eld and, as was frequently

emphasised by participants in the Session, re-

searchers need training in order to deal with these

IP dilemmas. Specifi cally designed training courses on

IP matters need to be made available for researchers,

not only in the developing, but also the developed

countries.

The Rapporteur noted that a paradox had been appar-

ent in the discussions. There is a desire to construct

effective infrastructural support for the resolution of

IP issues. However, the fi nancing of this infrastructure

is often achieved by using competitive grants. “It

is” he argued, “an aberration to establish long term

infrastructure using short term grant funding”.

A clear consensus view had emerged from the Session

that IP must not be regarded simply as a matter of

income stream. It is essential to be sensitive to the

Intellectual Property is an additional weapon in a technical world.

36

culture of the country and the justifi able concerns

that may arise. “With IP, you don’t have the same

view of the world, depending on whether you are a

shareholder or a stakeholder” said Mr Chneiweiss.

The best interests of the shareholder depend on

good practice and this includes safety and ethics

as well as profi ts. The stakeholder, on the other

hand, needs access: access to the local population

as a human resource, access to the infrastructure

and access to the local biological and environmental

resources. It is not feasible for companies to restrict

themselves simply to a system of good practice; it

is also necessary to guarantee accessibility to valu-

able resources and the ability to transfer these

resources beyond the immediate locality. The transfer

of resources also poses serious ethical diffi culties.

These include the provision of clear, fully informed

consent and also such issues as biosafety. These

important issues demand serious debate and

effective resolution.

The Rapporteur also reviewed the debate that had

taken place on biobanking. Biobanks are rightly

regarded as an invaluable resource treasure.

A harmonised international charter should regulate

them. These biobanks are such an important research

resource that vital questions must be answered.

These questions include who may have access to

the biobanks and, importantly, to what extent can

IP result from work using these collections? Further-

more, who should be included among the benefi -

ciaries of any IP resulting from these studies using

banked material?

Hervé Chneiweiss explained that the Breakout

Session also discussed patents and patentability

and the present state of uncertainty in this complex

fi eld. Speakers in the Session had demonstrated

that the role of the patent is changing and is

increasingly open to abuse. A major priority must

be the development of new forms of protection for

IP. He argued that the European Union should be

more proactive and should play an important role

in focussing and expediting this debate. Further-

more, it was proposed that the EU should engage

more in the establishment of infrastructure in the

developing countries and not abrogate this respon-

sibility to the private sector.

The review of this Breakout Session provoked

a lively debate from the audience.

Maurizio Salvi elaborated on the suggestion of a

proactive role for the European Union in the devel-

opment of regulatory frameworks. He argued that

Europe is multifactorial “and does not always

speak with only one voice”. For example, in discus-

sions on informed consent and clinical trials, the

EU was able to promote a general methodology

rather than a specifi c topology. This general struc-

ture involved a framework for ethics review of the

trial but did not specify the details of how this was

37

to be accomplished in each individual country. “It

is for the member states to determine the fi ne

detail. In other words, subsidiarity needs to be

accomplished”.

Maurizio Salvi also discussed the IP issues and

emphasised that a variety of different international

organisations are working to regularise the situation.

The EU is participating in this development and

attempting to establish a new system of copyright

and IP protection. He emphasised that compared

with the past, the EU no longer attempts to impose

a particular viewpoint but rather wishes to promote

open discussion and dialogue and to develop syner-

gies with the major stakeholders. He concluded

that while proactivity is necessary, it should be

used to facilitate open global debate.

Julian Kinderlerer, speaking from the audience,

stressed that the Breakout Session spent a great

deal of time discussing the important issue of in-

formed consent preceding the commercialisation

of products that arise from human tissues. The

group had debated the ethical issues in this context

and the procedures by which informed consent

should be obtained in developing countries, “bearing

in mind that it is often diffi cult to obtain it, in real

terms, in developed countries”.

Other speakers in the audience took up this

issue of informed consent for tissue donation

and subsequent ownership of IP. It was empha-

sised that it should be the responsibility of the

research ethics committee to monitor the informed

consent process and its relationship to IP protection.

However, it was highlighted that this could impose

a serious additional burden on ethics committees.

The members of ethics committees, particularly in

developing countries, are often very busy providing

a service to their institutions in addition to carrying

out all their other duties. If their responsibilities

are to be increased, then it is necessary to consider

how this might realistically be achieved. The solution

may be direct funding. This could support training

for members. However, pivotal to the effi cient

operation of the committees is the position of the

administrator and their contribution is often

neglected. As one speaker remarked “the

administrator either makes or breaks the review

process for the rest of the members”. It was

concluded that if additional duties concerning IP

and patenting are to become the remit of research

ethics committees, then well-trained and well-

qualifi ed ethics analysts need to be appointed as

administrators who would expedite the work of the

rest of the membership.

The audience also discussed the ownership of tissue

transferred out of the country of origin into biobanks.

In the informed consent process it is important for

donors to understand clearly whether the material

will be anonymised or not, how long it will be

There is a valuable role for lay members of ethics committees.

38

retained, to what future use may the tissue be put

and, most importantly, what are the implications

for IP and possible commercialisation. Pamela

Andanda was praised for having spotlighted this

issue and the distinction between the ethical

framework and the strictly legal procedures. If a

patent is taken out using banked material, how far

back do the ethical responsibilities extend? Should

the provenance of material and the ethical context

infl uence the way a patent is exercised? It was

pointed out that the International Bioethics Com-

mittee of UNESCO93 is presently working on this

topic and is hoping to develop an issues paper that

will set out the whole range of interactions between

IP and bioethics. This should stimulate relevant

debate. It was also argued that European organisa-

tions needed to develop mechanisms for arbitration

between communities in underdeveloped countries

and Northern industries. These communities are

increasingly the victims of biopiracy and there is

no proper framework in place for them to develop

their patents or reap fi nancial reward. A similar

point was made concerning traditional medicine.

Increasingly, researchers from a modern medicine

background are exploiting knowledge of traditional

medicine without appropriate protection or reward

for the practitioners.

This lively Session concluded by returning to the

central issue of the important role of ethics com-

mittees in the whole IP and patenting process. It

was reiterated that for research ethics committees

to effectively deal with these issues and handle

them properly, then additional specialist members

needed to be recruited. A clear warning was

sounded “in Europe, things do not always work if

you just keep adding new things on to people’s

work load without looking at the structures that

are in place: do not overload the boat!”

In closing the Plenary Session, the Co-Chair Hanna

Nohynek commented that participants, Chairs,

Rapporteurs and the audiences of the three indi-

vidual Breakout Sessions had carried out sterling

work and that the deliberations had yielded a very

fruitful harvest. She was convinced that the Euro-

pean Commission, the national and international

organisations, the scientifi c investigators and the

general community would find “plenty of food

for thought to improve and embellish our ethical

conduct of scientific research throughout the

world”.

93 http://portal.unesco.org/shs/en/ev.php-URL_ID=1879&URL_DO=DO_TOPIC&URL_SECTION=201.html

39

IDENTIFICATION OF STRATEGIC NEEDS IN RESEARCH ETHICS

Responsible global governance of research ethics

demands that policy-makers in international insti-

tutions and partner countries defi ne the policy

strategies that need to be initiated and must

establish priorities in their implementation.

In order to provide perspective on this strategic

planning process and to highlight the importance

of network creation in effective ethics review, the

situation in two European countries, France and

Finland was described.

François Chapuis of EUREC94 set out to illustrate the

importance of ethical review of research in Europe

and the need for sustained training. The European

population is over 500 million. There are over

2,000 Research Ethics Committees, each with

about 10-40 members giving a total of 50,000: 1

for every 10,000 people. Most of these committees

are renewed every few years and, as such, there is

a real need for a reservoir of trained personnel to

monitor the ethics of research. Furthermore, members

of ethics committees require continuing education and

the upgrading of their expertise and skills. They

need to maintain a fundamental understanding of

ethical principles and the ability to balance the

contradiction between the precautionary stance:

“if you don’t know the potential outcome of a

research study, then you stop the work” and the

research principle: “if you don’t know the outcome

of a project, then you go ahead and pursue it!”

However, in addition to philosophical, scientifi c

and moral understanding, ethical committee mem-

bers need to develop other, more practical, skills: in

administration, management and cultural sensitivity.

François Chapuis pointed out that the constraints

on continuing education involved both the lack of

committed funding for training courses and available

time from the overworked, busy committee members.

The ultimate goal, to ensure an adequate supply

of up-to-date, well-trained members of ethics

committees would be University diplomas and

postgraduate degrees in ethics with specifi c modules

on research. However, he cautioned, that it was

also important to protect naivety. To be represen-

tative and to be sensitive to the opinions and norms

of the local population, it is necessary to avoid too

many “professionals”. A University degree in ethics

should not be a pre-requisite; there is, he maintained,

a valuable role for lay members of ethics com-

mittees.

The establishment of a national forum of committees

that would meet regularly and maintain networking

contacts was also considered by Dr Chapuis to be

94 European Network of Research Ethics Committees > http://www.eurecnet.org

40

an important mechanism for the updating of skills.

This theme was also endorsed by Eero Vuorio,

Chair of the National Advisory Board on Research

Ethics in Finland (TENK)95.

In Finland, there is a well-developed mechanism in

place for ethical review to ensure the responsible

conduct of research and this involves a high degree

of networking. The Government appoints members

of the scientifi c community, as well as other stake-

holders, to serve on national and local ethics review

boards and provides these boards with suffi cient

secretarial and legal personnel. The boards work

independently, but in close co-operation with each

other and in accordance with a range of European

and Finnish decrees and guidelines: for example,

ETENE96 and TUKIJA97. TENK, the National Advisory

Board on Research Ethics in Finland, makes pro-

posals and issues statements to governmental

authorities concerning research ethics in all fi elds

of science. It acts as an expert body working towards

the resolution of ethical issues relating to research

and promotes good scientifi c practice and the respon-

sible conduct of research. Importantly, it is charged

with monitoring international developments. It is also

involved in training and, as recommended by

Dr Chapuis from his experience of EUREC, net-

working is an important mechanism for skill updating.

In Finland, the chairs and secretary-generals of all

ethics boards meet frequently to co-ordinate activi-

ties and to discuss topical issues. As a result of

these effective networking procedures, joint training

programmes have been developed in all fi elds of

research ethics, with a focus on the PhD level.

Eero Vuorio also explained that the opportunity is

taken to inform members of ethical boards about

national and international developments and to

decide on representation in international organisa-

tions, conferences and networks. Networking at

the European level was also discussed by François

Chapuis. The EUREC98 network is essentially a “net-

work of networks” and will soon include all European

countries, with 2-3 members per country.

EUREC is intended to enable communication between

national forums, accurately collect and correlate

national texts and data and facilitate collaborative

ethics research and education between European

countries and international bodies. François

Chapuis emphasized that effective networking

requires elaborate organization. At the present

time, research ethics committees tend to be NGOs

(Non-Government Organizations) and they often

95 http://www.tenk.fi 96 National Advisory Board on Health Care Ethics > http://www.etene.org97 Sub Committee on Medical Research Ethics > http://www.etene.org/e/tukija/98 European Network of Research Ethics Committees > http://www.eurecnet.org

41

have diffi culty fi nding time and resources to imple-

ment their networking requirements. The solution,

he humorously concluded was that there is also

“a need for GONGOs – Government Organized Non-

Government Organizations!”

With these European experiences in mind, the

requirements of developing countries could be

more clearly focussed.

Dr Vasantha Muthuswamy, Senior Deputy Director

General, Indian Council of Medical Research99,

described the challenges in health research in

developing countries and the identifi cation of the

major needs in research ethics. Reviewing the

Global Forum for Health Research report on the

10/90 gap100, she summarized the fi nding that 90%

of the world’s healthcare funds are used for tackling

the health problems of only 10% of the population.

Furthermore, only 10% of funds are available for

the remaining 90% who face the maximum health

problems. Clearly the impetus must be to change

that equation to 50/50. However, developing countries

must be vigilant if they are to avoid exploitation.

The vulnerability of Southern countries to exploitation

was also described by Wen L. Kilama, Managing

Trustee, AMANET101, Tanzania. He ascribed this risk

of exploitation to such factors as low incomes and

high illiteracy rates together with a lack of awareness

of human rights. He suggested that local customs

and beliefs may contradict health principles and this

is compounded by ignorance of modern concepts

of health, medicine, science and research. The local

population often has high disease rates together

with poorly developed health care facilities and

medical research institutions.

Using India as a model, Dr Muthuswamy emphasized

that developing countries must work on a priority

setting exercise, identifying the particular priorities

within their own communities. To avoid the risk of

exploitation, they must seek out appropriate part-

nerships that would assist them to develop their

own local capacity in research. “It is essential”,

argued Dr Muthuswamy, “that each community is

respectful of its own cultural and moral values and

establish meaningful dialogue with its community

members on the health implications of its cultural

practices”.

It is a well-worn cliché to state that the dramatic

advances that are taking place in biomedical

research pose unprecedented ethical questions

99 http://mohfw.nic.in/kk/95/ib/95ib0r01.htm100 http://www.globalforumhealth.org/Site/002__What%20we%20do/005__Publications/001__10%2090%20reports.php101 African Malaria Network Trust > http://www.amanet-trust.org

Developing countries must work on a priority setting exercise, identifying the particular priorities within their own communities.

42

and it is essential that appropriate monitoring

mechanisms be put into place. To cope with these

increasing demands for ethical vigilance, education

is essential and long-term strategies for increasing

knowledge of the principles and policies of research

ethics need to be prioritised.

Vasantha Muthuswamy proposed that the teaching

of ethics at University level must place: in general

streams as well as in the medical curriculum. Work-

shops, training programmes etc should be conducted

and the publication of ethics articles in journals and

non-specialist magazines should be encouraged.

Wen Kilama also supported this view and argued

that targeted ethics courses should be included in

all undergraduate degrees. Furthermore, he sug-

gested that bioethics postgraduate research and

training programmes should be developed and that

bioethics training should be mandatory for all biology

and health/medical postgraduate trainees. This

should help to build career paths in bioethics.

Further more, with local staff trained and qualifi ed in

bioethics, he argued that it would not be unreason-

able to demand ethics certifi cates from all foreign

researchers working in developing countries.

Dr Muthuswamy was able to confi rm that a range of

training programmes in bioethics is now available

in India. Indian guideline documents have also

been published, for example, Ethical Guidelines

for Biomedical Research on Human Subjects102.

Similarly, training facilities are improving in Africa.

AMANET103 has provided training programmes and

also provides a free web-based bioethics course104.

Support for capacity building has also been provided

through the Bill and Melinda Gates Foundation105.

It was apparent that ethical priorities in India are

centred on such issues of autonomy, privacy, and

confi dentiality and the need to obtain fully in-

formed consent when studying large populations.

Furthermore, there was an ethical imperative to

protect privacy and maintain confi dentiality when

data are included in public health registries and

databases. An important aspect of these ethical

concerns is to prevent group stigmatization and

discrimination and to transfer the benefi cial results

of research into the public domain.

Turning to international research collaborations,

Vasantha Muthuswamy itemised the ethical issues

of concern in India. These included the need for

102 http://www.icmr.nic.in/ethical.pdf 103 African Malaria Network Trust > http://www.amanet-trust.org104 http://www.amanet-trust.org105 http://www.gatesfoundation.org

43

research capacity building, community participation

and with it, the protection of vulnerable individuals.

She insisted that there should be the careful planning

of clinical trials that should be associated with the

availability of the best possible national care. Wen

Kilama was concerned that research funding from

developed countries focused mainly on vaccine

and drug trials whilst other, locally important, areas

such as epidemiology and health care systems

were neglected. He contended, “Industry has little

interest in the diseases of poverty”. Whilst new

products are tested on poor rural populations, the

benefi ciaries are mainly the urban rich and short-

term travelers: “The local population bears the

burden of clinical trials, but they have little acces-

sibility to the fi nal products”. There was agreement

that in international collaborations, the overarching

principle must be an equal respect for the rules

and regulations of both countries and sensitivity

to the health needs of the host.

In the light of the information available from Europe

and other developed countries and his own experi-

ence of the developing economies, Dr Muthuswamy

summarised her views on the strategic implemen-

tation of the globalisation of research ethics. She

offered a thorough and detailed list of her ethical

priorities in the developing economies. The foremost

of these was ensuring global justice and narrowing

the gap between the developed and the developing

countries. She insisted that vulnerable groups

must be given adequate care and protection and

there should be no discriminatory practices.

Based on the experience of developed countries,

she argued that proven therapeutic interventions

should be made widely available to developing

countries and measures implemented to prevent

the exploitation of research participants. Ideally,

research ethics should be an integral part of every

biomedical research project and be embedded in

the thinking of every stakeholder. There must be

strict adherence to ethical guidelines and appropriate

legislation must be enacted to ensure this. However,

legal sanctions are not, in themselves, suffi cient

there has to be meaningful engagement between

the research population and general community.

Community involvement should take place at all

stages of research and facilitate the creation of

opinion-leaders with representation from different

diverse groups. The experience of Europe and the

developing countries has highlighted the impor-

tant need for the training of researchers and lay

people in ethical principles. Vasantha Muthuswamy

argued in favour of University courses and appro-

priate funding for promoting ethics education.

However, this should not proceed without careful

monitoring and evaluation and she proposed the

need for qualitative research to evaluate the effi cacy

of research ethics education. This should aim to en-

sure uniform consistency of teaching programmes

across Universities and, hopefully, guarantee quality

Community involvement should take place at all stages of research and facilitate the creation of opinion-leaders.

44

assurance in health education and its ethical stan-

dards. Mechanisms are needed for the continuous

evaluation of a professional code of conduct and,

in light of the European experience, networking

between researchers and ethical review commit-

tees should be regarded as essential.

In the modern world, academic researchers and

industrial sponsors must communicate effectively

and so signifi cant effort must be made to improve the

industry-academia interface. Finally, she asserted,

the developed and developing countries must

strive for mutual understanding and so a vital

strategic need must be, she declared “meaningful

international collaboration”.

45

FUTURE OBJECTIVES AND POLICY PRIORITIES

In the course of this Conference, opportunity was

taken to review the current state of the global gov-

ernance of research ethics and, through the Break-

out Sessions, to make recommendations on the

future direction of such contentious issues as dou-

ble standards, informed consent and intellectual

property rights. The fi nal Plenary Session was de-

signed to identify major objectives and priorities

and to propose policy strategy so that decision-

makers; from Europe, the international institutions

and the partner countries; may promote the respon-

sible governance of ethically conducted research.

Maria da Graça Carvalho, Bureau of European Pol-

icy Advisers of the European Commission (BEPA)106

offered a European viewpoint. She reminded the

audience that we are celebrating the 50th anniver-

sary of European integration: a period of shared

responsibility for prosperity, security, justice, soli-

darity and tolerance. These concepts are essential

elements of European policy: including research

and development. Because of the global nature of

modern science, it is an embedded policy of the

European Commission to promote capacity building

in research ethics at an international level. She

provided detailed fi gures to demonstrate that

epidemics, such as SARS, Asian fl u, HIV/AIDS etc,

remain the key issue for global public health. She

emphasised that the battle against such epidemics

cannot be country-dependent or region-dependent

but must be intrinsically international. A global

strategy is essential and Europe must play its role

in policy design. Responding to this need, the Com-

mission has actively supported scientifi c cooperation

with developing countries and has introduced R &

D as an integral component of its relationships with

African states. It is intended to support research

into poverty-related diseases through the 7th

Framework Programme (FP7). Other initiatives

include the clinical trials partnership between the

EU and developing countries and joint studies on

vaccine development.

Responding to the sometimes-expressed opinion

that Europe should focus on its own needs, she

trenchantly justifi ed the promotion of a global

strategy on research by the European Union. She

supported the view that research can become a

vehicle for social stability, economic growth and

the encouragement of international trade. Recent

discussions have emphasised that research must

be fully integrated into EU economic growth and

development strategy; particularly when considering

other regions of the world, both less-favoured and

emerging economies.

106 http://ec.europa.eu/dgs/policy_advisers/

46

Research ethics must play a central role in Com-

munity considerations. Ethical conduct is a legal

requirement. For example, the EU regulatory frame-

work demands that clinical trials and research,

wherever conducted, be approved by local Ethics

Committees. However, she emphasised, that the

strict adherence to ethical principles in research is not

merely a legalistic consideration; it is a fundamental

cornerstone of EU belief and policy. To illustrate this

commitment, Maria da Graça Carvalho emphasised

that the current Framework Programme requires the

integration of ethics into all EU-funded research.

“The European Commission has”, she said, “taken

a pro-active role to facilitate both the embedding

of ethics in research policies and has promoted

research ethics within and beyond the European

Union”.

She emphatically concluded that through its

governance policies, “Europe not only strives

to promote prosperity and economic welfare inside

its own borders but to strongly intervene to eradicate

those factors: disease, hunger and poverty, which

affect the lives of less-favoured regions of the globe”.

Kanikaram Satyanarayana, Council of Medical Re-

search, India107, Ariel Henry, Member of the Cabinet

of the Minister of Public Health and Population,

Haiti, Charles Kondi Agba, Minister of Health, Togo

and Albert Ondo Ossa, Minister of Education and

Research, Gabon presented the views of partner

countries on the priorities for capacity building in

research ethics and emphasised the need for sup-

port from developed nations.

Kanikaram Satyanarayana provided a detailed

overview on research ethics in India. The mandate

of the Indian Council of Medical Research is to sup-

port research in the fi eld of national public health

importance using appropriate technology: including

modern molecular biology. It was clear from Kani-

karam Satyanarayana that ethics plays an important

role in the research policy in India. Many ethical

guidelines have been published, covering, for example,

animal and human experimentation, assisted repro-

duction, stem cell research, intellectual property

rights and the authorship of scholarly publications.

Furthermore, a variety of legislative regulations

have been enacted covering human and animal

experimentation. Nevertheless, India has some

very serious concerns about certain aspects of re-

search ethics, for example intellectual property

rights, globalisation and clinical trials. Focussing

on clinical trials, he declared that this is a huge

emerging problem. The global market for these trials

amounts to over US$ 30 billion and conducting

them in developing countries is on the increase.

India is becoming a global hub for clinical trials with

more than 150 trials underway in major hospitals.

Furthermore, the market is expected to grow 15%

107 http://www.icmr.nic.in

47

per year from the current US$ 150 million to US$ 1.5

billion by 2010. The driving force, and the concern,

is the cost factor. The cost is 40-60% lower in India

than in the USA. Much of this research is not re-

corded or monitored and there are serious, and

justifi able, fears that it may not conform to ethical

guidelines and that vulnerable individuals may be

exposed to exploitation. Rigorous monitoring,

capacity building and the harmonisation of ethical

guidelines are a priority. A key element will also

be partnership with global agencies such as

WHO108 and WTO109. He believes that the way ahead

is to put focus on effective North-South partnerships.

However, it is also of paramount importance to

facilitate and encourage meaningful South-

South dialogue.

A Caribbean perspective on research ethics was

offered by Ariel Henry from Haiti. He emphasised

that an essential element in the conduct of ethically

acceptable research was careful monitoring by national

Ethics Committees. However, there is a shortage of

informed members and to strengthen the capacity

of these Committees there must be necessary

resources put into training. “This does not just

mean organising seminars” he said “but also pro-

moting training programmes”. These would not only

be for researchers but also responsible ethicists

and, most importantly, decision-makers and legis-

lators. Capacity building in research ethics also

depends upon educating society to recognise the

importance of the work of Ethics Committees.

Interaction with developed countries is essential

to maintain international standards. However, he

warned, there must be mutual respect: not the

imposition of a Northern viewpoint on the South.

The solution is regular dialogue and exchange of

views. Cooperation should also go beyond ethics

to include the socio-economic problems faced by

the developing countries. He concluded, “ethics is

a global challenge and it needs to be treated as

such if cooperation is to be fruitful in both the short

and long term”.

The increasing awareness of the importance of

ethics in Togo was highlighted by the Minister of

Health, Kondi Charles Agba. He was pleased to report

that recently a rotating conference of UNESCO,

“Ethics of Science and Technology”110 was held in

Lomé. This represented a new experience for Togo

and has acted as a catalyst for the formation of a

Consultative National Committee of Bioethics and

a public conference on ethics. This is a timely

development as this year is the 10th anniversary

of the fi rst Togolese test-tube baby. This has lead

to heated public debate about such controversial

108 http://www.who.int109 http://www.wto.org110 http://portal.unesco.org/shs/en/ev.phpURL_ID=10569&URL_DO=DO_TOPIC&URL_SECTION=201.html

Ethics is a global challenge and it needs to be treated as such if cooperation is to be fruitful in both the short and long term.

48

issues as abortion, assisted reproduction and frozen

embryos. “Debate on medical ethics has now gone

on to the streets and is no longer the exclusive

concern of academics”, declared Mr Agba. The

Togolese government is going to take all appropriate

legislative, educative and administrative measures

to give effect to international principles of bioethics.

He requested the support of the European Com-

mission “to accompany us in our efforts to show

proper respect to the human person”.

Albert Ondo Ossa also emphasised that the Govern-

ment of Gabon puts a high priority on multilateral

contacts in research ethics. Gabon is very aware of

the modern trend towards the globalisation of

research and is anxious to apply international ethical

standards to work carried out there. Thanks to its

links with a FP6 project111, Gabon has been able to

determine the ethical needs of research on humans

and to develop and appropriate strategy and

strengthen the necessary structures. Recently, a

Higher Education Ministry has been created which

covers all aspects of research and a National Ethics

Committee has been established. A legislative

framework now needs to be put in place to govern

the conduct of national and local Ethics Committees.

Mr Ossa made the point that in developing coun-

tries, such as Gabon, adequate funding is always

a major concern. Very little money can be allocated

by the State for scientifi c research. In most labora-

tories, equipment is very outdated and the budget

is so low that it is not possible to focus research in

line with national priorities. Poor funding also

means that African researchers are vulnerable to

temptation by external fi nancing enterprises and

may be induced to carry out work that would not

be considered to be ethically acceptable. A carefully

considered national research strategy will facilitate

an effective interface with developing economies and

attract international funding which is also sensitive

to African needs and priorities.

Using Gabon’s forests and biodiversity as examples,

Mr Ossa emphasised the importance of indigenous

knowledge in research and the respect that should

be accorded, for example, to traditional medicine.

He also warned against the dangers of the exploi-

tation of local, vulnerable communities and the

need to maintain the autonomy of local Ethical

Committees when faced with research projects that

are fi nanced with large amounts of funding from

outside. It will be the responsibility of the National

Ethics Committee to protect the heritage of the

Gabonese people and defend their human rights

and dignity. It must also give an opinion on draft

projects: particularly those that are multi-centre,

multi-national and multi-disciplinary.

The members of the national and the local Ethics

Committees need to be well trained if they are to

111 http://trree.org/site/en_nebra.phtml

49

execute their tasks effectively. This poses a problem

for Gabon because, as Mr Ossa explained, it does

not have the fi nancial resources or competencies

to carry out this training. He expressed his sincere

gratitude to the European Union for having made

a financial contribution towards training pro-

grammes. However, there is still a great deal more

that needs to be done. Gabon has many prob-

lems with over population and disease; it also

has resources that are not being fully or responsibly

utilised. Universities need to be more generously

funded so that they can carry out research that is

relevant to the needs of society and to share the results

of these studies in a fair and equitable manner.

Albert Ondo Ossa is convinced that supporting

well-trained and funded Ethics Committees is the

only way to guarantee that there is a moral dimen-

sion to progress in science and technology. He

concluded, “That a major priority must be an inter-

national partnership which is, in fact, facing the

actual needs of the country in question”.

This Conference was organised and supported by

the European Commission and so it was wholly ap-

propriate that the fi nal presentation, on Europe,

ethics, globalisation and research was given by

Janez Potocnik, EU Commissioner for Science and

Research112. He emphasised from the start that there

are no ready-made answers to ethics in research;

rather there must be effective dialogue and we

must all learn from each other. The globalisation

of research demands better implementation of

inter national ethics guidelines. Partner countries,

he said, should become “more involved in the elab-

oration, dissemination and implementation of ethics

guidelines which should be adapted to their spe-

cifi c context”. In Europe, the ethical framework is

based on scientifi c and political responsibility and,

at its heart, is respect for the diversity of opinion.

The framework must strive to achieve a balance of

all these divergent interests. The Community is

deeply committed to ensuring that any of its funded

research, wherever it is carried out, rigorously com-

plies with fundamental ethical principles. The key

weapon is the stringent ethical review of all funded

research projects by panels of international ex-

perts. Furthermore, research cannot be undertaken

against the objections of local the Ethics Committee

of the host country. To support this contention, he

explained that in 2006, 10% of the FP6 proposals

that underwent ethics review raised serious ethical

and social issues. These objections were sometimes

linked to the specifi c context of the host country.

Mr Potocnik acknowledged the particular ethical

problems that can be raised by clinical trials and

agreed that the number being carried out in partner

countries has increased signifi cantly in recent

112 http://ec.europa.eu/research/

A major priority must be an international partnership which is, in fact, facing the actual needs of the country in question.

50

years. Protection of participants requires careful

consideration and, he asserted, the EU Directive on

Good Clinical Practice113 is an excellent benchmark.

He also recognised the ethical challenges linked

to benefi t-sharing and data protection and he hoped

that the recent initiative by the EU to develop and

action plan or a “code of conduct” for the responsible

development and use of nanotechnology114 would

promote international debate.

However, although dialogue and cooperation are

vitally important, they alone are not suffi cient,

declared Mr Potocnik . Increased investment in

supporting the establishment of research ethics is

essential if partner countries are to fully participate

in international research and compete for funding.

Europe will not be slow in playing its part. The Com-

munity, through FP7, will fund projects that can

contribute directly to capacity building in research

ethics. FP7 will also contribute to reinforcing knowl-

edge networks and particular regional networks:

this will include complementary activities to those

of international organisations such as UNESCO115,

the Council of Europe116 and WHO117. International

mobility will also continue to be supported in FP7

through the Marie Curie schemes118. As Mr Potocnik

explained, these fellowships will attract excellent

foreign students to Europe who, on their return home,

“will strengthen relations between the scientifi c

communities in their country and Europe”. Consider-

able progress has been achieved but the commitment

must be ongoing.

Commissioner Potocnik concluded his presentation

on Europe’s contribution to global research ethics

with the rousing clarion call: “This is the end of our

Conference, but not the end of our work!”

113 http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:091:0013:0019:EN:PDF114 http://cordis.europa.eu/nanotechnology/src/intldialogue.htm115 http://portal.unesco.org/en/ev.phpURL_ID=29008&URL_DO=DO_TOPIC&URL_SECTION=201.html116 http://www.coe.int117 http://www.who.int118 http://ec.europa.eu/research/fp6/mariecurie-actions/

European Commission

EUR 22960 – ETHICS, RESEARCH & GLOBALISATION

Luxembourg: Offi ce for Offi cial Publications of the European Communities

2007 – 50 pp. – 21.0 x 29.7 cm

ISBN 978-92-79-06384-8

How to obtain EU publications

Our priced publications are available from EU Bookshop (http://bookshop.europa.eu/), where you can place an order

with the sales agent of your choice.

The Publications Offi ce has a worldwide network of sales agents. You can obtain their contact details by sending a fax to

(352) 29 29-42758.

KI-

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N-C

On 14 and 15 May 2007 the European Commission hosted an international

conference in Brussels on capacity building in research ethics. The confer-

ence addressed in particular policy makers, opinion leaders, academics and

researchers. The main goal was to bring together stakeholders from developed

countries, emerging economies and developing countries, in an effort to identify

policy options together and to encourage the development of support actions

under FP7 in the European Research Area and world-wide. The overall ambition

of the conference was to contribute to fostering a responsible governance of

research in a sector that is becoming always more globalised.

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