Transcript What makes research ethical? 6. Informed consent cont’d • Researchers can promote participants’ freedom by: – Adequate assessment of the specific vulnerability factors, and offsetting.

What makes research ethical?
6. Informed consent cont’d
• Researchers can promote participants’ freedom
by:
– Adequate assessment of the specific
vulnerability factors, and offsetting these.
E.g., education to offset lack of familiarity
with research; avoiding undue incentives to
offset impoverishment.
– Providing participants with ways to voice
concerns and monitor the impact of
participation (e.g., CABs; trial site
counsellors).
– Reminding participants of the right to
withdraw.
What makes research ethical?
6. Informed consent cont’d
• Participation of minors: Current MRC
guidelines (2002) provide strict conditions for
the participation of minors: Minors can only
participate in non-therapeutic research if:
– They will be exposed to no or negligible risk of
harm (commensurate with daily life in a stable
society or routine psych or medical exams).
– The same research could not be done equally well
on adults, and the results will be valuable for
minors.
– Consent of the parent or legal guardian and assent
of the minor child is obtained.
– Assent of the child.
– But in SA parents cannot consent to research
which is more than minimal risk!
What makes research ethical?
6. Informed consent cont’d
• 4 Formal explicit consent
• Participants must indicate their consent in an
explicit manner through signing a written
consent form
• Complexities: Indemnity driven consent forms
may be long / unwieldy; written consent form
sometimes seen as substitute for the
bidirectional process.
• The essential obligation is for researchers to
empower participants to make decisions and
create the conditions where participants can
make decisions in their best interests.
Debate: Informed consent & culture
• Argument: In communitarian cultures it is
inappropriate to secure first person consent
(‘imperialism”); legitimate parties such as
husbands/ traditional leaders can give proxy
consent for women.
• Counterargument: First person informed consent
is best safeguard against potential exploitation
therefore substantive principle must apply.
• However, respect for multi-person involvement
can be demonstrated in procedural
implementation of consent (e.g., endorsement of
community leader to enter community; respect
participants’ choice to involve significant others).
What makes research ethical?
7. Respect for dignity
• Once enrolled, researchers should respect the
dignity of participants in an ongoing manner by:
– Respecting their right to withdraw at any time
(“revocable”)
– Monitoring their welfare throughout the
research (ongoing social harm monitoring /
“social impact analysis”; Data Safety and
Monitoring Boards)
– Informing volunteers of research results
– Respecting confidentiality of freely
volunteered data
Respect for dignity: Confidentiality
• Confidentiality: The proper treatment of
data that has been volunteered by the
participant.
• Participants must consent to the ways in
which confidentiality will be maintained
(e.g., using codes instead of identifiers,
restricted access to data), how the results
will be published, and any limits to
confidentiality where these apply.
• Confidentiality minimizes risk of harm (e.g.,
stigma if HIV testing is involved) and
respects participants’ rights to choose to
whom and what personal information is
disclosed.
Our work in bio ethics
in pursuit of local & global
justice & fair play
Bioethics, power and injustice
Ethics is about relationships and as
relationships involve consideration of
power, there is an intimate link
between ethics and power.
“Despite spectacular progress in science and
technology during the twentieth century, as we
enter the 21st the world is more inequitable than it
was 50 years ago. Disparities in wealth and health
within and between nations are widening
inexorably, and the rapidly expanding global
economy has failed to reduce poverty and improve
health for all. This is evident in both in terms of
access to health care for individuals, and in relation
to the health of the whole populations. Billions of
people live in degrading poverty with little if any
access to health care, and the Universal Declaration
of Human Rights remains an unrealized aspiration
for the majority of the world's people.”
Solomon Benatar.
President of World d Association of Bioethics.
89% of annual global expenditure
on health is on 16% of the world
population that bears 7% of the
global disease burden.
(Iglehart J. American Health Service:
expenditure. New England J of Medicine 1999;
340:70-76)
Although more than 90% of the world’s
potential years of life loss belong to the
developing world, an estimated 10% of
global research funds (out of 70 billion US
dollars) are devoted to studying the
developing world’s health problems.”…
(WHO. Investing in health research and
development. Report of the ad hoc committee
on health research relating to future
intervention options. Geneva WHO 1996.)
A survey was conducted by us in BMJ, The
Lancet, NEJM, Annals of Internal Medicine &
JAMA 2001.
countries were categorised into four regions:
1. UK,
2. USA,
3. Other Euro-American countries and
Australia, New Zealand and Canada.
4. all other countries.
BMC Medical Ethics 2004, 5:5.
The average contribution of the all
the other countries to the research
literature in five journals is 6.5%. In the
two British journals 7.6% of the articles
were from the these countries and in
the three American journals 4.8% were
from these countries
BMC Medical Ethics 2004, 5:5.
Genomic divide
In harnessing genetic technologies, it is
critical to ensure that these advances do
not increase the 10/90 divide
India, Brazil, Indonesia and Korea have
even biotechnology industries capable of
producing new and high quality, low cost
generic drugs. Vietnam, South Africa,
China, Cuba and Brazil are endeavoring
to develop their own essential vaccines,
although they are doing so in the face of
competition from multinationals. (BMJ
28th April 2001)
1. Accurate, rapid and affordable diagnostic tests for
infectious diseases (molecular diagnostics)
2. Using genetic engineering to develop safer, more
effective vaccines (recombinant vaccines)
3. Better ways of introducing drugs and vaccines into the
body (Vaccine and drug delivery)
4. Using genetic engineering to improve nutrition
(enriched GM crops)
5. Using innate protein-making ability of organisms to
mass produce more affordable drugs (recombinant
drugs)
6. Female controlled protection against STD
7. Harnessing the power of nature for environmental
cleanup (Bioremediation)
Global Forum on Health Research
Established in 1998
Objective was to help correct 10/90 gap
Work as a catalyst
Highlights the role of governments, civil
organisations, media, research institutions,
private sector, women’s organisations…….
Importance of research on neglected diseases
• International collaborationmutually beneficial agenda
by developed world
• Capacity building in South
• Third party to monitor
informed consent
• Protect national ownership
from undue commercial
ownership
• Statutory framework robust
enough to protect and
balanced enough to foster
new developments
• Training
programme
undertaken by us
• WHO collaboration
• Funded by
Wellcome Trust
• 30 advertised 150
applied
• Learner profiling
with time– new
curriculum
assessment tool
Why should we be concerned
about research ethics ?
1. Bio-medical ethics is still in its early stage of
development, relatively there are a few
experts and interested academics in the
filed of bioethics in Sri Lanka
Simpson, B.Ethical regulation and the new reproductive
technologies in Sri Lanka: perspectives of the ethics
committee members. Ceylon Medical Journal 2001, 46:54-57.
2. Lack of an overarching research culture in
Sri Lanka
2005 Annual Health Bulletin
SO LETS BE PRO-ACTIVE THAN REACTIVE
Research in the aftermath of Tsunami
Parachute Research
I have heard that (for example) in Kosovo
researchers whose main aim was to get data for
their doctoral theses (regardless of anything else)
descended on many villages with PTSD
questionnaires etc. The pressure for people to do
research is such that I can well understand this
happening.
Suman Fernando
Hon. Senior Lecturer in Mental Health
European Centre for Study of Migration & Social Care (MASC)
University of Kent
Visiting Professor
Department of Applied Social Sciences
London Metropolitan University
London
Example (pre Tsunami)
Two novel FUT3 alleles responsible for Lewisnull
phenotypes in Sri Lanka
Blood samples from 54 Sinhalese persons in Sri Lanka
were collected from volunteer donors, according to a
protocol that was approved by the ethics committee of
Kurume University School of Medicine.
Mikiko Soejima, Hiroshi Kimura, Yoshiro Koda,
Department of Forensic Medicine and Human Genetics
Kurume University School of Medicine Kurume, Fukuoka,
Japan
TRANSFUSION Volume 44, October 2004 pages 1534-1537
Informed Consent
Consent is taken to be ‘informed’ when it is
given by a person who understand the
purpose and the nature, what participating
in the study require the person to do and to
risk, and what benefits are intended to
result from the study
Informed consent in vulnerable
populations
Informed consent alone is not protective
enough, because of the asymmetry in
knowledge and authority between researchers
and participants
The weaker the personal competence of a
research subject, the most stringent must be the
procedural considerations [Syse 2000]
Consent under duress
In Helsinki Declaration 10th clause of the 12
basic principles states that, " when obtaining
informed consent for a research project, the
physician should be particularly cautious if the
subject is in a dependent relationship to him or
her or may consent under duress. In that case a
physician who is not engaged in the
investigation and who is completely
independent of this official relationship should
obtain the informed consent" [World Medical
association 1997].
Undue inducement for participation
A qualitative study on international
collaborative research
Reservations were expressed about current
informed consent processes
The theme that repeatedly appeared during
the survey was 'conflict of interests' in
international collaborations
The American Journal of Bioethics 2004; 4(3): 1-7.
Potential 'conflict of interests'
Researchers from the developed countries may
bring about conflicts of interests, who may work
on strict deadlines. While respecting the ethics of
the developed countries, especially in the
protocols, the researchers in the developing
countries tend to overlook these ethics in their
research for several reasons:
(a) Researchers in the developing countries are
actually not aware of these issues or just ignore
them.
(b) The quality control bodies are not active
enough, so these issues are not picked up
The American Journal of Bioethics 2004; 4(3): 1-7.
Types of 'conflict of interests'
(a) The very same societal and cultural
dynamics of some areas do not believe that
informed consent should be rigorously
followed and this is tacitly accepted among
the actors and players.
(b) Informed consent issues are usually paid
attention to in the protocol but in practice
very little are done.
The American Journal of Bioethics 2004; 4(3): 1-7.
New issues and problems
demand new solutions
We may even have to think beyond
informed consent
The role for a third party actually witnessing
informed consent process ???
continued monitoring of ethical concerns such
as adhering to standards approved by the ethics
review board, and investigating complaints and
malpractices.
"...John Rawls, perhaps the leading moral philosopher
of our time, has argued that all human beings are
endowed with moral capacities. He is right to insist on
this, but the deployment of those capacities are
severely constrained by the epistemic difficulty in
grasping what exactly is happening and how things
could be actually different. The lessons of the tsunami
and the global response it has generated not only
include the affirmation of the ethical capacity of people
in general, sometimes even at great distance, but also
the critical importance of communication and
understanding. The connection between epistemology
and ethics can be very powerful, and this is part of the
interdependence of the world in which we
live. Ignorance and incomprehension are enemies not
only of science, but also of the practice of ethics..."