Beyond Helsinki: a vision for global health ethics
BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7289.747 (Published 31 March 2001) Cite this as: BMJ 2001;322:747All rapid responses
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Now that the harassment in Canada of heamatologist Nancy Olivieri and
psychiatrist David Healy by the university of Toronto and by two
affiliated teaching-hospitals has been made public (the appaling story of
these two honest whistle-blowers is available free of charge on the
website of the Journal of Medical Ethics [1]), Peter Singer's statement
that "Canada has tremendous potential for leadership in global health
ethics" [2] sounds almost like a joke.
References:
[1] www.jmedethics.com (left-hand menu 'NEW FEATURE: Advanced
Publications', and scroll down to find "The Mini Olivieri Symposium")
[2]http://bmj.bmjjournals.com/cgi/eletters/322/7289/747#14047
Competing interests:
None declared
Competing interests: No competing interests
Canada has tremendous potential for leadership in global health
ethics.
The work on ethical challenges in medical education cited by Wilson
actually demonstrates this, although Wilson erroneously draws the opposite
conclusion. These problems probably exist probably in every medical
school in the world. The issue is whether and how the challenges are
confronted and addressed. With the publication of the recent study by
BMJ, Canada, the University of Toronto, and especially the remarkable
medical student-authors have provided international leadership on the
ethics of medical education.
No research ethics system is perfect, as Wilson rightly points out.
It is not clear that any country is doing better than Canada in research
ethics. Canada has a good set of guidelines on research ethics, the Tri-
Council Policy Statement. The Canadian Institutes for Health Research has
made ethics a top priority: most Institute Advisory Boards have ethics
members, there is a peer review grant panel dedicated to ethics, and there
is currently a search for a Director of Ethics, a person who will be on
par with Institute Directors and could assist CIHR to provide
international leadership in ethics. Canada also has a strong system of
Universities and Hospital Research Institutes to regulate research ethics.
Improving the research ethics system in Canada is not inconsistent
with also providing international leadership. Moreover, our vision of
global health ethics addresses not only research ethics but many other
potential areas of international leadership in ethics including genomics,
priority setting, end of life care, and others.
Most fundamentally though Canada could play a leadership role in
global health ethics because of its long history of important
contributions to foreign affairs. The legacy of Lester Pearson, Canada's
contributions to peacekeeping, and its recent promotion of the concept of
human security at the UN Security Council are only a few examples of
Canada's international role. Moreover, Canada has the resources to lead.
The annual budget of the Canadian International Development Agency is
about CAN $ 1.6 billion; this is more than enough to underwrite all or
part of our global health ethics vision, which we estimate might cost US $
100 million over 10 years.
Whether Canada, in partnership with other countries, will provide
this leadership is still an open question. But its ability to do so
should not be in doubt.
Competing interests: No competing interests
While it is important that countries share knowledge, lessons
learned, and expertise in research ethics, it is not clear why Canada
would play the kind of international leadership role that Peter Singer
suggests. The Canadian system,including training for research ethics
committee members, is in its infancy and needs considerable development.
No accreditation system exists in Canada and what training exists is
limited. There have been workshops across the country on research ethics
and a handbook of case studies has recently been produced. But more work
needs to be done in developing education and training materials in record
keeping, informed consent practices, assessing adverse events, and
effectively monitoring clinical trials. Also, private-for-profit-research
ethics boards, which are increasingly being used by drugs companies, do
not fall under the Tri-Council Policy Statement guidelines which apply
solely to federally sponsored research. Concerns about the system are
reflected in a passage from a letter to Health Canada from the President
of the National Council on Ethics of Human Research, NCEHR, in Nov. 1999.
"A Report published last year by the Office of the Inspector General
in the U.S. Department of Health concluded that the system of REBs was in
jeopardy. REBs are reviewing more and more research with insufficient
resources; they conduct minimal continuing review of the research they
approved; they face conflicts that threaten their independence; and they
are offered insufficient training. A study published by NCEHR in 1995, as
well as the information gathered through our program of site visits and
other interactions with REBs across the country,lead us to conclude that
our system suffers from similar problems." (1)
A system in "jeopardy", "conflicts that threaten "independence", and
"insufficient training" suggests that we Canadians have our work cut out
in research ethics.
Subsequent reports have also raised concerns about informed consent
practices and the need for greater REB oversight.(2) The oversight issue
was raised in Canada six years ago and remains a concern.(3)(4) And in the
light of medical students feeling pressured to act unethically or
witnessing their teachers (role models) acting unethically, the issue of
leadership in teaching schools also requires attention, especially for
doctors being trained to do research. (5) Better to focus on building a
foundation for our own regulatory system (and teaching) and then offering
help to our neighbors abroad, should it be requested.
Conflict of Interests: None
References
1. Letter to Health Canada from the President of the National Council
on Ethics in Human Research, NCEHR.
2. OIG Office of the Inspector General, Department of Health and
Human Services). 2000d. Recruiting Human Subjects: Pressures in Industry
Sponsored Clinical Research.
OEI-01- 97-00195. Washington, DC: DHHS.
3. Weijer C, Shapiro S, Fuks A, Glass K, Skrutkowska M. Monitoring
clinical research: an obligation unfulfilled. CMAJ 1995;152:1973-1980.
4. Weijer C. Continuing review of research approved by Canadian
research ethics boards. CMAJ 2001;164(9) (in press)
5. Hicks LK, Lin Y, Robertson DW, Robinson DL, Woodrow SI.
Understanding the clinical dilemmas that shape medical students'ethical
development: questionnaire survey and focus group study. BMJ 2001;322:709-
710.
Competing interests: No competing interests
I fully agree with Prof. Justo's views on the importance of teaching
bioethics. Bioethics teaching is among the services the trainees from our
vision of global health ethics would provide.
For one approach, see our recent article on teaching bioethics in the
clinical setting published recently in the Canadian Medical Association
Journal (available full text online at http://www.cma.ca/cmaj/vol-
164/issue-8/1163.asp).
This approach needs to be analyzed from the standpoint of developing
countries and possibly adapted for use in that context. My preliminary
observations based on a workshop about teaching bioethics I conducted in
Thailand is that the focus on clinical performance inherent in our
approach is as relevant for developing countries as it is for developed
ones.
Competing interests: No competing interests
Research ethics is a priority, and so is biotechnology, but poor
countries have several priorities going on at the same time. Bioethics
teaching to medicine students is one of them, since it is a good way to
arouse physicians awareness of research and many other ethical troubles.
Introducing bioethics on the curriculum gives us a welcome opportunity to
work with the clinical teachers, since we try to avoid hidden curriculum
troubles.
Poor countries priorities in countries with a transitional epidemiologic
pattern are, as Volnei Garrafa (1) puts it, both "persistent" (resource
allocation, justice, etc), and "emergent" (genomics, biotechnology, etc).
One way to start tackling those problems is by trying to have new medical
graduates with a solid ethics training. So I hope that many of the Fogarty
trainees will return to our countries and improve bioethics teaching,
which is not so glamorous but could be rewarding on the long run.
(1) Garrafa V. Hard Bioethics. Presented in the Jornadas de la Asociación
Argentina de Bioetica, Mar del Plata, 1999.
Competing interests: No competing interests
Our vision of global health ethics is not limited to research ethics.
As we noted in our editorial, "If this vision of capacity strengthening
proved effective in research ethics the model could be extended to other
issues in global health ethics such as genomics and biotechnology,
priority setting in health systems, women's health, end of life care, and
others, as well as to sectors other than health."
The developing country trainees we envision would possess, among
them, expertise on all these topics. They could also chair clinical
ethics committees (although I would rather Schuklenk advocate for clinical
ethics more generally since I am unaware of evidence that ethics
committees are more effective than other methods of introducing ethics
into health care organizations).
As for the issue of priorities, Schuklenk should not see our proposal
in such either/or terms. This is not a zero sum game. The key to
understanding our vision is that it is focussed on people, and people can
do research ethics and clinical ethics at the same time. Moreover, $100 m
over 10 years for ethics is only a tiny fraction of global spending on
health research. Surely ethics is a fundamental component of health
research and ought to be supported accordingly.
Competing interests: No competing interests
Editor
We fully support Singer and Benatar1 for their a vision for a global
health ethics. We propose few other areas to be included in the agenda for
the global health ethics. They are, ethical standards for publication of
research from the developing world, authorship issues, international
collaborations and commercial exploitation.
Patel and Sumathipala2 examined the relative contribution between Euro-
American countries and the “Rest of the World” (RoW) to publications in 6
leading psychiatric journals over 3 years. Only 6% of the literature was
published from RoW, which account for over 90% of global population. Less
than 1% of published articles described mental health interventions in the
RoW. Acceptance rates were significantly lower for articles submitted from
the RoW.
It is possible to assign contemporary positions in bio-ethics to the
classical Hellenistic period of western philosophy3. The issues dominating
ethics in medical literature reflect the ethnocentric western
philosophical and scientific tradition in which they are grounded. This
philosophical and epistemological tradition is neither universal nor of
overriding importance and that moral “ rights” and “wrongs” are not
absolute but may vary with the culture in which we live4. The vision for
global alliance for health ethics also should consider this fact.
Therefore, not only the visiting researchers but donor agencies also need
a deeper understanding of social, economic and political context of
research in developing countries. However due to historical reasons the
knowledge, skills, expertise, and funds are available in the west and
there is no doubt about the role of the developed world. Any North–South
initiative should be mutually respectful partnerships rather than attempts
to impose western models. Expatriates having active links in both worlds
will have a significant role to play in this regard.
In the draft guidelines of the National Twin Registry (NTR) of Sri Lanka5,
we attempted to bridge the existing divide between North-South bio-ethical
philosophies. Our position is that no collaboration in research should be
entertained solely for economically cheap and easy research in the
developing world. Exclusive rights should not be demanded nor agreed to
the donors or collaborators. Eventual economic gains should be ethically
shared. With regard to freely given informed consent, it should be
obtained by a designated non-clinical member (of the NTR) and not by a
member of the investigator’s team. Involving an independent person is a
way of eliminating untoward compliance arising because of the
authoritative position held by the clinicians in the developing world.
Athula Sumathipala
spjuats@iop.kcl.ac.uk
Sisira Siribaddana
ssiribaddana@hotmail.com
National Twin Registry of Sri Lanka
References
1. Singer P, Benatar SR . Beyond Helsinki: a vision for global health
ethics. BMJ 2001;322: 747-8
2. Patel V, Sumathipala A. International representation in psychiatric
journals; a survey of six leading journals. In press (BJ Pych 2001 May)
3. Lovat T. Main streams of bio ethical thought. In W. Walters (Ed) Human
reproduction current and future ethical issues. London; Bailliere
Tindall,1991.
4. Engle-Heardt HT. The foundations of bio ethics (2nd Edition) NewYork;
Oxford University Press, 1995.
5. Sumathipala A, Fernando DJS, Siribaddana SH, Abe
ysingha MRN, Jayasekare
RW, Dissanayake VHW, De Silva N. Establishing a twin register in Sri
Lanka. Twin research 2000; 3: 202-4
Competing interests: No competing interests
It is worth noting that Singer and Benatar failed as yet to reply adequately to the charge that the money they would like to see spent on research ethics training could be spent more beneficially on other health needs in developing countries. They suggest, rather vaguely, that there is some great benefit to be attained by this exercise. One example of an alternative area to spend money on (if one believes it should be spent on ethics training at all!) would be to train clinical ethics committee members. Such committees are badly needed. They are non-existent in most hospitals. Proper work undertaken by competent clinical ethics committee members would undoubtedly benefit more patients than a similar number of research ethics specialists. Reason being that there are many more patients who suffer as a consequence of unethical conduct in hospitals then there are research subjects in developing countries.
Furthermore, there are already excellent week-long research ethics training programs run by WHO (under the leadership of Ruth Macklin and David Griffin). I think it would be good if a few million could be made available to support their 'research ethics training on a shoestring' program, but I am not convinced by anything Singer and Benatar have written so far that 100 million US$ are required. I am pleased to hear that they are not actually asking that this money, if it became available, should be spent on expensive scholarships for training of thousands of research ethics specialists in developed countries. There is plenty of teaching/traing capacity both in South Africa but also in other developing countries to train people. It is unnecessary to resort to these people criss-crossing the planet in search of ethical enlightenment in a developed world bioethics institution.
Competing interests: No competing interests
The backyard is a very good place to do things. Research involving
persons and not respecting ethical standards, for one. Nevertheless
underdeveloped countries have long been considered as backyards by some
people in developed ones, so perhaps it's all the same thing.
I think the Fogarty initiative should command some respect as an attempt
to give back our countries some portion of the heavy toll paid by poor
countries by putting people's lives in the hands of foreign researchers,
often (I must acknowledge) with inside supporters.
3.600, or any number of honest and well trained scientists, may have a
very positive side-effect on our health and science environment, so I
support it wholly.
Competing interests: No competing interests
Re: Canadian Leadership
The President of the Canadian Medical Association has recently
questioned a CMAJ editorial (1) that raises concerns about professional
self-regulation and a possible erosion of public confidence in Canadian
physicians. Dr Schumacher criticizes the editorial for making a case that
draws heavily on troubling events and alleged shortcomings in UK medical
governance. Implicit in his criticism is the view that it is best to stick
to what is known about Canadian governance in order to have informed
discussion and debate and to avoid unnecessary alarmism. This is sound and
responsible public policy advice.
The editorial could have strengthened its case had it set its sights
on leadership in governace on the Canadian research regulatory terrain.
Concerns about the self-regulating character of research ethics boards
(REBs) and public confidence in physicians as researchers were key issues
in a report on national research governance arrangements. (2) The report
has been described in another CMAJ editorial as an expression of Canada
playing a leading role in research ethics on the international stage. (3)
REBs are charged to protect the rights and welfare of research subjects as
independent ethics watchdogs. The report assessed the effectiveness and
integrity of governance arrangements and called for reform. Dr. Bisby of
the Canadian Institute of Health Research noted in a recent presentation
at an annual conference that concerns raised in the report about REBs
remain active. (4)
There are longstanding accountability concerns about REBs. They
include: REBs dominated by physicians who are often research colleagues
employed by an institution hosting an REB; a secretive regulatory culture;
token public representation; an absence of REB accreditation; conflict of
interest of a professional, institutional and commercial nature that
threaten REB independence. REBs often report to the office in a research
centre that promotes research. And this occurs in a very competitive,
commercial and entrepreneurial research climate where researchers,
hospitals and universities are taking out patents and testing their own
medical devices and drugs for the market place.
There have been calls for greater REB transparency (5) and public
representation in research governance (6) to help offset concerns about
conflict of interest and to promote public trust and confidence in
regulatory affairs. But they have yet to be heeded. These calls have been
heightened by insider reports of troubling REB practices at leading
research centres. (7) The U.S. Office of Health Research Protection
recently reproached a Canadian REB at a leading research university for
serious informed consent violations in a multi-centered clinical trial.
(8) Health Canada recognizes the need for reform and a robust system of
protection in light of ethics violations and different kinds of conflict
of interest that may exist between researchers, REBs, and research
institutions. (9)
Against this backdrop, concerns raised in the CMAJ editorial are not
as alarmist as Dr. Schumacher suggests. But to have been more on target
and forceful, the editorial could have focused on the Canadian research
regulatory terrain. The challenge that now looms large on that regulatory
horizon is who is going to exercise the political and moral leadership to
tackle long standing accountability issues - issues that have been
approached too long at the speed of a slow drip.
References
1. Can physicians regulate themselves? [editorial] The Can Med
Assoc J 2005;172(6):717.
http://www.cmaj.ca/cgi/content/full/172/6/717
See A. Schumacher’s rapid response to this editorial.
2. Law Commission of Canada. The governance of health research
involving human subjects. Ottawa: The Commission; 2000.
3. Dismantling the Helsinki accord [editorial]. Can Med Assoc J
2003;169:997.
4 National Council Ethics Human Research nation conference, Ottawa,
March 5, 2005.
5. Freedman B, Lemmens T. Ethics Review for Sale? Conflict of
Interest and Commercial Research Review Boards. Milbank
Quarterly (2000) 78.
6 Weijer C. Placebo trials and tribulations [editorial]. Can Med
Assoc J 2002;166:6034.
Waring D, Lemmens T. Integrating Values in Risk Analysis of
Biomedical Research: The Case for Regulatory and Law Reform.
University of Toronto Law Journal 54.3 (2004) 249-290.
7. Corman C, Blajchman M, Knight A. Placebo tribulations. Can Med
Assoc J 2002;167:4456.
8. Office of Health Research Protection.
http://www.hhs.gov/ohrp/detrm_letrs/YR03/jul03z.pdf
9. Health Canada. A Canadian system of oversight for the governance
of research involving human subjects. www.hc-sc.gc.ca/sab-
ccs/feb2002_governance_subject_e.pdf
Competing interests:
None declared
Competing interests: No competing interests