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

Ethics is about relationships and as relationships involve consideration of power, there is an intimate link between ethics and power.

Bioethics, power and injustice

“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 collaboration-mutually 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

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

Why should we be concerned about research ethics ?

SO LETS BE PRO-ACTIVE THAN REACTIVE

2005 Annual Health Bulletin

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 FernandoHon. Senior Lecturer in Mental HealthEuropean Centre for Study of Migration & Social Care (MASC)University of Kent Visiting ProfessorDepartment of Applied Social SciencesLondon Metropolitan UniversityLondon

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]

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

Consent under duress

Reservations were expressed about current

informed consent processes

The theme that repeatedly appeared during the survey was 'conflict of interests' in international collaborations

A qualitative study on international collaborative research

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.

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.

New issues and problems demand new solutions

"...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..."