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L
Analysis of
Ethical Review Committees
for
Medical Institutions
Dr. Mala Ramachandran
Student of Post Graduate Diploma in
Medical Law and Ethics
I.D. No. ML&E 204/2000
(2000-2001 Batch)
i
»
National School of Law
of India University,
. Bangalore
0
Table of Contents
Acknowledgements
2
Introduction
3
Methodology
5
Statement of Purpose
Focus of Research
PART -1
9
Review of Literature
Historical Review
General Principles
Mission Statements of Ethical Review Committees
Ethical Codes
Beneficiaries of ethical review
Objectives and responsibilities of Ethical Review Committees
Ethical Review Procedures
Moral objectives of Ethical Review Committees
Necessary membership of Ethical Review Committees
Should Ethical Committee sit in public or in private?
Reasons for failure of some Ethical Review Committees
A case study
PART - II
Scope of the present study
47
Application of Ethical Review Committee to
Corporation health facilities
Discussion and Conclusion
62
Bibliography
66
1
Acknowledgements
The inspiration to do a theme paper on Ethical Review Committees came mainly
from two sources.
One was the plight of the urban poor, especially women accessing health facilities
who are the victims of the most inhuman unethical practices by the medical fraternity.
The second inspiration came from Dr. C.M. Francis who has spent several
decades trying to uphold medical ethics. Despite all the hurdles he has encountered, he
has persisted in his efforts. His dedication to uphold truth motivated me to enter the field
of medical ethics. He has shared his vast experiences with me during my endeavour to
complete this paper. Words cannot express my gratitude to him.
Professor S.V. Joga Rao responded at every stage of this study and his
suggestions and timely guidance enabled me to complete this project. I express my
sincere thanks to him for his insights.
My son Vikram, whose capacity to work with determination towards his goals
inspired me to work on this project with the same zeal, a very special thanks for
everything. To him and the rest of my family, I owe my gratitude for support and
encouragement. My thanks also to my nephew, Pavan, who patiently worked on the
graphs.
Ms.Radhika and Ms.Sabitha Devi, who devoted a lot of their time to this task, did
the data entry. My thanks are due to them also.
Bangalore
DR. MALA RAMACHANDRAN
April 3, 2001
2
Unfortunately, ethics has not been a focus of study in medical colleges. With the
student to teacher ratio being lop-sided, not much input has been given in areas of ethics
and ethical decision making to a medical student. So we have budding doctors entering
society with very little societal concerns, very highly commercial in their approach and
the medical profession is now seen more as a business than a noble profession it was
meant to be. Recently, the Rajiv Gandhi University of Medical Sciences has introduced
medical ethics in the curriculum. This is in the stages of infancy and needs to be
evaluated in due course.
There is a widespread feeling that there has been a general erosion of ethical
standards in a profession considered noble. This has prompted a soul-searching exercise
amongst concerned sections of society, to understand the problems involved. Such an
exercise would help, since the influence of ethical conduct in positive terms is not
contained or concerned within some exclusive sections and select groups but is relevant
to the entirety of society. The moral basis for the unity and stability of society demands
that ethical restraints must operate not only in respect to individuals but also organized
groups. The intention here is not only to blame any section of the society but to
appreciate the dilemmas that concerned and sensitive people face .
2.
Kannainina Raman, Ethics in Health Care as cited in Report on the XXII annual meet of medico
friend circle 4 (2). Issue in medical ethics, 60-63 (1996)
4
Methodology
Statement of purpose
This researcher has been involved in planning, implementation, monitoring and
evaluation of a series of programmes to provide primary health care for the urban poor,
particularly women and children living in sub-human conditions and abject poverty in the
slums. Despite multi-pronged interventions on a large scale by the government and non
governmental organisations (NGOs), the extent of improvement in living conditions and
standard of living has been limited.
Apart from the biological determinants, sociology and societal determinants play
a great role in women’s health. But what undertones and underlying factors govern her
right to health and quality life is also determined by a number of unethical practices
which are so well-entrenched and subjective on occasion, leave alone a poor woman,
peers in the medical profession cannot pin- point issues.
The woman is denied the right to health from the stages of conception. Sex pre
selection, female foeticide and infanticide all show bias against the female. All health
programmes like immunisation, are generally better utilised for male infants than female
infants.
Several studies have shown that women can be regarded as an “exploitable
population”.
Dr. Sweemar-Ba points out that women are a marginalised group and
therefore subject to exploitation by virtue of social injustice, such as lack of access to
food and water. Among women, it is the pregnant woman who is the most exploited. In
some cultures, women are by custom or by law subordinate to their fathers or husbands
and are manipulated to serve the ends of others3.
3.
W.K. Mariner, Distinguishing “exploitable” from “vulnerable” population, CIOMS, London, cited
in Z. Bankowski and R.J. Levine, ed., Ethics and Research on Human Subjects (1993) at 44
5
Under the circumstances explained above the slum woman, especially when she is
pregnant or in labour is both “vulnerable” and “exploitable” and is the key target for
unethical practices in medical institutions. The pregnant or “in labour” slum woman is in
a situation where she has to either succumb to vested interests in hospitals or lie uncared
for at home where neither society nor peers are supportive.
In its booklet Bangalore Hospitals and the Urban Poor: A Report Card, the
Bangalore-based NGO, the Public Affairs Centre, highlights unethical practices occurring
in government health institutions, which are primarily accessed by the urban poor4.
This study looks into, among other issues, the quality of service, occupancy of
hospitals and corrupt practices in government health facilities in Bangalore. The study
concludes that interventions are required to be made for improved governance.
The researcher having studied such reports and having first hand knowledge of
the corporation hospitals feels the need to establish Ethical Review Committees for these
institutions.
Allowing unethical practices to continue to harm the exploitable and vulnerable ’
populations is in itself unethical.
This paper is a modest attempt at addressing the issue of exploitable and
vulnerable women, through formation of Ethical Review Committees at the local level.
The researcher attempts to study the scope and constituents of existing Ethical Review
Committees and thereafter, to examine the possibility of extending the present scope
from its limited arena to a wider range, so that Ethical Codes can be applied to those who
are amongst the poorest of the poor.
4.
Suresh Balakrishna and Anjana Iyer, Bangalore Hospitals & Urban Poor - Report Card, pp. 1-31
(Bangalore: Communication for development and learning 1998)
6
I’Octi.s of Rcseai ch
The present study will focus on the following aspects:
1)
Review of existing research and information on Ethical Review Committees
2)
Whether women in urban poor slums are entitled to the basic elements of
*
Respect for persons
*
Beneficence or non-maleficience
*
Justice
which are universally valid.
3)
Whether Ethical Review Committees should be constituted for all medical or
group of medical institutions.
4) If so, what criteria may need to be evolved? Ethical requirements for the
objectives to be achieved.
7
PARTI
REVIEW OF LITERATURE
1
•?<
8
Review of Literature
Historical review
The first international statement on the ethics of medical research using human
subjects, namely, the Nuremberg Code was formulated in 1947, which emphasised
consent and voluntariness. The first need for Ethical Review Committees came about
only after the Universal Declaration of Human Rights (1948), which expressed a human
rights concern about human beings subjected to involuntary trials5.
The first International Code of Ethics for Research involving human subjects
the Nuremberg Code
was a response to the atrocities committed by Nazi research
physicians during the Second World War, revealed at the Nuremberg War Crimes trials.
Thus, it was to prevent any repetition by physicians of such attacks on the rights and
welfare of human beings that human research ethics came into being.
The Nuremberg Code, issued in 1947, laid down the standards for carrying out
human experimentation, emphasising the subjects’ voluntary consent. In 1964, the World
Medical Association took an important step further to re-assure society: it adopted the
Declaration of Helsinki, most recently revised in 1989, which lays down ethical
guidelines for research involving human subjects6.
1
5.
Ethical Guidelines for Biomedical Research on Human Subjects, 1-2 (New Delhi: ICMR, 2000).
6.
Z. Bankowski and R.J. Levine, Ethics and Research on Human Subjects: International Guidelines,
vi & vii (Geneva: CIOMS, 1993)
9
In 1966, the United Nations General Assembly adopted the International
Covenant on Civil and Political Rights, specifically which stated “No one shall be
subjected to torture or cruel, inhuman or degrading treatment or punishment.
In
particular, no one shall be subjected to, without his consent, to medical or scientific
treatment7”
In the late 1970s in view of the special circumstances of developing countries in
regard to the applicability of the Nuremberg Code and the Declaration of Helsinki, the
Council for International Organisation of Medical Sciences (CIOMS) and the World
Health Organisation (WHO) undertook a further examination of these matters.
The Indian Council of Medical Research (ICMR), in February 1980, released a
Policy Statement on Ethical Considerations Involved in Research on Human Subjects
prepared by the Ethical Committee under the Chairmanship of Hon’ble Justice H.R.
Khanna. In 1982, the WHO issued Proposed International Guidelines for Biomedical
Research Involving Human Subjects. Subsequently, the CIOMS issued the International
Guidelines for Ethical Review of Epidemiological Studies in 1991 and the International
Ethical Guidelines for Biomedical Research Involving Human Subjects in 1993 .
The purpose of these guidelines was to indicate how the ethical principles that should
guide the conduct of biomedical research involving human subjects, as set forth in the
Declaration of Helsinki could be effectively applied, particularly in developing countries,
given their socio-economic circumstances, laws and regulations and executive and
administrative arrangements9.
7.
Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects,
1 (New Delhi: ICMR, 1997)
8.
Ibid at 1-2.
9.
Supra note 6, at vii
10
In (hcsu circumstances, CIOMS undertook in collaboration with WHO, a revision
of the guidelines, setting up a steering committee to guide the process. The steering
committee decided that in the revision, special attention should be paid to
epidemiological studies, owing to the importance of epidemiology, particularly for public
health, and to the lack of international guidelines for ethical review of such studies. In the
event, it was determined that the need for epidemiological ethical guidelines would be
best met by a separate publication, and the result was the issuing by CIOMS in 1991 of
International Guidelines for Ethical Review of Epidemiological Studies. The preparation
of the epidemiology guidelines contributed materially to the revision of the 1982
guidelines.
After extensive consultation, the first draft of the revised guidelines was prepared
by a group of consultants, reviewed and amended by the steering committee, and
presented to the CIOMS Conference on Ethics and Research on Human Subjects_
International Guidelines, held in Geneva in February 1992.
A Central Ethical Committee on Human Research was constituted by ICMR
under the Chairmanship of Hon’ble Justice M. N. Venkatachaliah to study the ethical
legal and social dimensions of research on humans10.
More recently the scope of Ethical Review Committees extending to other
emerging issues like
(a) Effects of different cultural concepts of ethical principles.
1
(b) Values on the conduct of multinational research.
(c) Challenges to the application of ethical principles, in areas like HIV
infections.
(d) The influence of ethical principles and guidelines on legislation.
(e) Ethics of research into the human genome.
10.
M. N. Venkatachaliah, National Human Rights Commission, New Delhi, December 24, 1997
11
At the CIOMS conference held in Geneva in February 1992, the AssistantDirector General, WHO, Mr. J.R. Jardel made an important remark. “The growing
importance of ethics and human rights in health care in general and in biomedical
research in particular needs to be at the forefront of human rights and ethical dimensions
in the years to come11.”
In the Indian scenario also several hospitals have now instituted hospital ethics
committees, principally for the purpose of checking whether proposals submitted for
research meet established guidelines. Once this is established, the researcher is permitted
to commence his work. This approach makes only a limited use of the committee. The
scope can be increased to improve quality of research and also patient care in
institutions 12 .
General Principles
Ethical Review Committees came into being mainly in all institutions where
research is carried out on human genetics.
The committee members should have
adequate expertise in the field.
Scientific competence of the investigation and sound scientific methodology
should be essential pre-requisites for genetic research. It includes appropriate training,
planning, pilot and field testing of the protocols, containment where necessary and
quality control of laboratory technique13.
11.
Proceedings of the XXVI CIOMS Conference, Geneva, February 1992, cited in Bankowski and
Levine, Ethics and Research on Human Subjects - International Guidelines, 2-3
12.
Sunil K. Pandya, Hospital Ethics Committee, 4 (2), Issues in Medical Ethics, 51-53, (1996).
13.
Supra note 7, at 10.
12
Biomedical ethical issues, guidelines, principles and regulations cut across
national boundaries and often have universal implications. Though peoples and cultures
differ, certain values are common to all. In this context, the most important is respect for
human dignity, and this should not be negotiable. Most developing countries do not have
any mechanism for management of research and very few have national Ethical
Committees or their equivalents14.
Prof. Osuntokum in his paper has said “it is important that every country should
have a dynamic mechanism for dealing with ethical problems as well as for regulating
ethical norms in medical practice and research. Such a mechanism must be responsive to
changes within the country and outside and must take into consideration the views of
majority of the citizens15.
It may involve the establishment of a National Medical Ethics Committee, and
regional, local and institutional ethics committees. The National Medical Ethics
Committee would be responsible for formulating national policies on ethics in medical
practice and research and must also evaluate for approval all research projects that are
externally funded or sponsored; it should have access to law makers and highest policy
makers in the Ministry of Health16.
14.
B.O. Osuntokum, Individual consent: A perspective of developing countries, as cited in Supra
15.
note 6, at 33.
N.E. Davies and L.H. Felder, Applying Brakes to the Runaway American Health Care System,
JAMA, 1990,263: 73-76
16.
B.O. Osuntokum, Supra note 14, at 33.
■-
13
The Central Ethical Committee on Human Research constituted by ICMR
identified five major areas where interventions are required by the Ethical Review
Committees.
(1)
Human genetic research
(2)
Transplantation research including foetal tissue transplantation
(3)
Clinical evaluation of drugs/devices/ vaccines and herbal remedies
(4)
Epidemiological researches
(5)
Assisted reproductive technologies
its technical and ethical issues.
The Annual Meet of Medico Friends Circle, Wardha, met in December 1995,
where most of the deliberations focused on hospital ethics committees. Amar Jesani
provides a global picture on the changing nature of medical ethics. What is understood as
medical ethics today is vastly different from its concept in the 19th century.
The General Medical Council in Great Britain, which was responsible for making
medical practice professional and for regulating practice from within was a major step.
The General Medical Council started penalising those who violated the Hippocratic oath.
Registration with the General Medical Council became mandatory17.
Ethics is an attempt to define what is right and wrong on the basis of certain laws
and involve principles of justice. Morality is a set of rules not necessarily based on
justice, decided by society. Ethics concerns itself with conduct and motive while law
»
takes into account only the act. Intention to hurt is unethical but in the eyes of the law
only when there is actual injury does it become a cognizable act. These complex
dimensions need to be dealt with on a day-to-day basis by medical providers in their
inter-actions with patients.
17.
Amar Jesani, Broad Issues: Ethics in Health Care. 4 (2), Issues in Medical Ethics, at 60-62,
(1996).
14
The Consumer Protection Act is now a Damocles sword hanging over every
practitioner of medicine.
Issues of non-availability of essential medicines, or key personnel are a major
factor in government facilities. Many practitioners who start off practicing in the most
ethical manner eventually get entrapped by the corrupt system or find it difficult to
18
maintain expected standards .
Practicing doctors face ethical dilemmas on a number of issues. Redressal of
ethical problems from both the patient and provider point of view is almost non-existent.
In this backdrop, the constitution of Ethical Review Committees for hospitals
becomes pertinent and mandatory.
Mission Statement of Ethical Review Committees
All Ethical Review Committees whether they are Research Ethical Committees or
Hospital Ethics Committee should have a mission statement. This should be an open
statement on its aims and objectives.
These should be circulated throughout the
institution and feedback sought on how this can be improved. It is necessary to review '
this mission statement periodically and revise it when necessary.
The following may be the heads under which review details could be entered.
Care of the patient in the institution
Research
Education of the staff in biomedical ethics19
18.
Kannamma Raman, Supra note 2
19.
Sunil K. Pandya, Supra note 12, at 51
15
Ethical Codes
Ethical codes of conduct are important for any profession. The codes of conduct
can succeed only if the profession, as a whole, feels responsible for its implementations.
If doctors as members of the profession fail to be responsible and do not take action
against those who do not observe the code, the code becomes in effective.
Ethical code is not a legislation. But, it is equally forceful as it is approved by the
profession. The final court in all action is the conscience.
Purpose of a code of ethics
1)
Self-description: A code helps a group define and redefine itself. Adoption of
this code is belonging. The committee’s code tells its members who and what
they arc. In describing and defining its role, it supplies a vocabulary for intra
professional argument, self-criticism and reform. It not only supplies a vocabulary
but it helps create a community of users.
2)
Descriptions for others: A code declares to others what the group is about. It ‘
states the purposes, values and standards, which others may use to understand it,
form expectations of it, debate with it, assess it and consider any privileges
conferred on it or duties imposed on it.
1
3)
Influence actions: Codes aim to influence the actions of practitioners.
The
contents of the code can make practitioners conscious of the various interests at
play in a particular set of circumstances. It may do so in advance and this fore
knowledge may influence the practitioner’s action when that kind of situation
actually arises. A code may give a person a decisive reason for choosing one
action over the other.
20.
nic:///A/cthics2/html
16
Beneficiaries of ethical review
C de Sweemer Ba, in her article “Informed Consent: Protecting the Vulnerable,”
states that there is cause for dissatisfaction at the state of the art of protecting the
vulnerable both in health education and disease control and in research. There has been
much progress from an individualistic medical deontology to an understanding that both
macro and micro-ethical principles need to be applied and that both individual and
community rights need to recognised. C de Sweemer Ba also states that the ethical
committee seen to be the lone Don Quixote defending the rights of the “vulnerable44 who
are made more vulnerable by the society at large. Our weapons seem strangely
inadequate
largely ritualised normative procedures, which are supposed to result from
consequentiality (one who knows or tries to predict consequences) and thus, contextual
ethics (One who has a basic knowledge of the context that one seeks to extend).
Television journalism and many sociological and anthropological research studies
have cultivated in us an ability to feel better by simply condemning causes of human
misery and inequity, while distancing us from the people concerned21.
First of all to understand the issue of who is vulnerable, one has to understand ‘
what is defined as “vulnerability”. Once a particular situation is understood to render
“vulnerable” a particular society then the Ethical Review Committee can look into
aspects that need to be adopted to render this population less vulnerable.
21.
C de Sweemer Ba, Informed Consent: Protecting the Vulnerable, as cited in Z. Bankowski and
R.J. Levine, ed., Supra note 6, at 36.
17
C de Sweemer Ba in her treatise observes that vulnerability has a mixture of
determinants, all of which connote that the humanity of members of “vulnerable” groups
is diminished or absent and therefore
•
They cannot make decisions for themselves.
•
They have no right to speak in public.
•
They often have no right to demand even the fulfillment of their basic needs (food,
water, medical care, etc.) and often have to scrape by on leftovers.
•
Any community member can order them to work, reprimand them, punish them,
chase them away or shut them up.
•
Often they are given reduced access to survival resources (food, clean water, health
services, and habitat, land or health information)
Beneficence to vulnerable population includes contributing towards making them
conscious of their rights, towards their empowerment and towards awakening of their
dormant faculties.
True progress depends on studying in each specific society who the vulnerable are
and how society maintains and increases individual and group vulnerability. Such a .
study needs to be carried out in each society, because many of the determinants are
economic, cultural, and historical, and opportunities for corrections are even more
diverse.
In its present scope, Ethical Review Committees with its limited jurisdiction,
I
reviews whether trials meet strict ethical criteria, and whether procedures for obtaining
informed consent maximizes the protection of these prospective subjects and their
potential for autonomy.
18
The objectives and responsibilities of Ethical Review Committees
The Ethical Review Committees that function as Hospital Ethics Committees as
part of their primary objective should discuss and explore the different moral values
within the institution. Discussion on specific cases, their reports having been prepared
and circulated in advance, arc likely to yield results. Such cases could be selected with a
view to provoking discussions. On informed consent, the means by which diagnosis is
disclosed to the patient and relatives, expenditure incurred by .patients, the rationale and
justifications of expensive tests or therapies could be discussed.
The hospital-centered committees should initiate review of relevant publications
in medical ethics journals and focus on how to improve hospital standards22.
The Ethical Review Committee is also responsible to ensure that the institution is
providing the best possible medical care. This could be considered under the following
heads:
The art of bedside medicine
Relief of suffering
Cure of disease
Iatrogenic disease
incidence, trend over time
Cost to patient tests, drugs, other costs
can these be lowered?
Prompt attention to the needs of the patient
Care of seriously ill
Dying patients
The dead patient
22.
J. Henry Silverman, Revitalizing a Hospital Ethics Committee, 6, HEC Forum, at 189-222 (1994).
19
The education of the staff within the institution covering all aspects of patient care is
also a responsibility of the Ethical Review Committee.
Silverman also recommends that an Ethics Committee should
Produce guidelines on a broad range of topics. Disclosures of diagnosis,
diagnosis of brain death, requesting permission to harvest organs for
transplantation, truly informed consent, are some examples.
Set up and ensure proper functioning of a forum for redressal of complaints
from patients and families. This forum must receive complaints in writing
and in helping illiterate patients to prepare such documents. Complaints,
proceedings of hearings on them, decisions and action taken must be kept on
record.
Produce a document for the benefit of patients and their families informing
them of services provided by the institution, rights of patients and relatives,
their responsibilities, means by which they may seek redressal for any harm
that may be done to them.
Survey practices within the institution on a continuing basis, standards of
patient care, unnecessary expenditure enforced on patients, obtaining truly
informed
consent.
Patients
and
relatives
could
be
polled
on
deficiencies/malpractice witnessed by them and their suggestions for
improvement.
Obtain feedback from faculty, other staff on the functioning of the ethics
i
committee; perceived deficiencies and suggestions on how it might function
more effectively. It may be necessary to permit anonymity of those making
observations in order to safeguard them from victimisation and encourage free
and frank observations.
Conduct seminars/workshops/mini-conferences on biomedical ethips and
better research practices.
20
The basic responsibility of the Ethical Review Committees is to ensure a
competent review of all ethical aspects of the problem and to execute its responsibility
free from bias and influence that could affect their objectivity.
The ICMR in its guidelines of the year 2000 states that for smaller facilities the
Ethical Review Committee should take up a dual responsibility of scientific and ethical
review. The overall objective pertains to precautions and risk minimization23.
In its present form, Ethical Review Committees are constituted to protect people
from harm. The world is now looking at a new generation of ethical principles24.
C de Sweemer Ba suggests that Ethical Review Committees should go beyond
review. She suggests the creation of two further mechanisms
an ombudsman and a
watchdog. The Ethical Committee should be ombudsman of groups or individuals who
feel that their rights have been infringed by design. This facility should be accessible
even to those not categorised as vulnerable. As a watchdog, an ethical committee closely
monitors whether ethical guidelines and principles are followed and thereby maximises
protection and increases autonomy of the vulnerable groups .
23.
Ethical Guidelines for Biomedical Research on Human Subjects, Supra note 5, at 9.
24.
W.K. Mariner, Supra note at 3.
25.
C de Swccmcr Ba, Supra note at 21.
21
The ICMR in its publication of ethical guidelines in year 2000 describes the scope of the
ethical review committee as follows:
•
To review ethical, social and other issues of research involving/affecting subjects.
•
To formulate general principles for such research.
•
To formulate guidelines on specific areas of such research.
•
To examine the possibilities of setting up machinery and mechanism to
monitor, implement and review the general and specific guidelines so formulated, and
to further formulate such guidelines as may be necessary from time to time.
•
To examine and review the guidelines, machinery and mechanism so formulated in
the light of experience gained from time to time.
•
To consider the wider implication on biomedical and health research and suggest
ways and means in which inter-disciplinary and inter-agency discussions and
consultations can take place on an ongoing basis26.
Ethical Review Committees should also play a part in increasing public
consciousness of the rights of vulnerable groups and individuals.
Ethical Review Procedures
The aim of the 1982 guidelines to encourage and facilitate establishment of
prospective ethical review committees has been at best only partially achieved.
Particularly but not only in developing countries, such review does not occur or does not
conform to reasonably vigorous standards of independent scrutiny27.
26. Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects,
Supra note 7, at 10.
27. Bernard M. Dickens, Introduction to the draft revised guidelines ethics & research on human subjects International Guidelines, Supra note 6, at 21.
22
It should be remembered that the CIOMS guidelines, though meant for universal
application will be used mostly by developing countries. The industrialised countries
have their own institutions and commissions for biomedical ethics and use the CIOMS
guidelines largely for research sponsored by them in developing countries.
Few developing countries have created independent Ethical Review Committees.
In many countries the committees that evaluate projects for scientific quality and
allocation of funds perform this function. This arrangement may be viewed as
satisfactory if ethicists, jurists and lay representatives of the community are included in
the membership of the committee.
Lack of formal education should not bar the
participation of community representatives in the community28.
Levine proposes certain procedural approaches for resolving problems of
informed consent in applying ethical guidelines in different cultures. The application of
ethical guidelines in poor, developing countries however requires consideration of
additional factors not only to adapt to various cultures but also overcome the negative
effects of poverty, squalor and lack of education or literacy29.
28.
M. Abdussalam, Application of Ethical Guidelines in Non-Westem Cultures in Capacity Building
for Ethical Consideration of Epidemiological Studies: Perspective of Developing Countries,
126-36,(1991).
29.
Levine R.J., Informed Consent: Some Challenge to the Universal Validity of the Western Model,
Z. Bankowski, J.H. Bryant and J.H. Last, eds., Ethics and Epidemiology: International Guidelines,
(Geneva: CIOMS) 47-58.
>
23
I he volume of health research is steadily increasing in many developing countries
but mechanisms lor ethical review is still quite weak or non-existent. Although in the
words of Osuntokum (1991), “It would be naive to expect guidelines to be quickly and
effectively established in Third World Countries”, every effort should be made to enable
these countries to apply the core elements of the guidelines.
This can be done by ■
devising procedures suited to local socio-cultural conditions and through WHO and
bilatcial co-opcration in building up local capacity in ethical review30.
The conduct of the Ethical Review Committee meetings is in itself important.
Sunil K. Pandya is of the opinion that if the ethics committee is charged with three
principal goals: patient care, research and education of faculty and other personnel; it is
logical to entrust each of these to a sub-committee. Meetings of a large, single committee
once a month, over an hour or two are unlikely to do justice to the goals.
Sunil K. Pandya states that the frequency of meetings will depend entirely on its
scope.
If it restricts itself only to process applications for research, the number of
proposals will govern the dates of the meeting. He states that most Ethical Committees
should meet at least once a month to ensure that no research proposal is held up31.
30.
B.O_ Osuntokum, Epidemiology and Ethics: A Perspective of Developing Countries, cited in
A Bankowski, J.H. Byrant and J.M. Last, Ethics and Epidemiology: International Guidelines
(Geneva: CIOMS, 1991) 150-52.
31.
Sunil K. Pandya, Supra note 12, at 51-53
24
The 1CMR in its guidelines states that, ethical review should be done through
formal meetings and should not resort to decisions through circulation of proposals. The
ICMR also defines the protocol that is to be followed in submitting application for
research or clinical trials. It also clearly states that all records pertaining to sanction for
trials is to be kept for at least 15 years after termination of the study32.
Moral objectives of Ethical Review Committees
The moral objectives of an Ethical Review Committee in its present-day
connotation are to
•
Promote potentially beneficial medical research of a sort that protects the research
subject from unjustified risk of harm.
•
Ensure respects for his or her autonomy.
•
Ensure that the research is scientifically valid and can thus in principle produce
benefits and is explicit about who are the intended beneficiaries.
•
Meet the moral requirements of justice in terms of respect for subjects’ rights and
respect for morally acceptable laws.
What Ethical Review Committees so far rejected is any role in assessing resource
implications of research proposals i.e. the moral requirement of distributive justice33.
32.
Ethical Guidelines for Biomedical Research on Human Subjects, Supra note 5, at 12-16.
33.
R. Gillon, Ethical Review Procedures: A Developed Countries’ Perspective - A Common
Framework, in M Brazier and M Lobjoit, eds., Research on the Vulnerable: An Ethical Overview,
(London: Routledge, 1991) 52-76.
25
Necessary membership of Ethical Review Committees
The membership of Ethical Review Committees in its present scope should be
designed so as to promote its moral objectives. There is no agreed blueprint for an ideal
committee but multi-disciplinary membership is needed to provide the range of
perspectives needed.
1. Expert medical researchers are needed to provide the expertise necessary for
evaluation of the scientific validity of research proposals.
2. Doctors who are primarily or entirely clinicians (non-researchers) are needed to
provide the Hippocratic perspective, in which the interest of the patient/subject is
paramount.
3. In Britain, a non-hospital doctor (a General Practitioner) and a clinical nurse are also
included in the committee to strengthen the “subject-protecting” perspective.
4.
A public perspective is needed and hence at least one respected member of the public
who has no professional or institutional ties with the organisation setting up the
Ethical Review Committee34.
In this regard, the CIOMS guidelines are too weak in stating that Ethical
Committees are essentially Peer Review Committees and may include non-medical health
professional and laymen35.
34.
Ibid.
35.
International Guidelines for Ethical Review ofEpidemiological Studies (Geneva: CIOMS, 1991).
26
In Britain, both, the government’s regulations for Ethical Committees and the
much older Royal College of Physicians’guidelines require ‘lay’ representations36. The
American regulations also require lay representation37.
Sunil K. Pandya says that the Hospital Ethics Committee should have at its helm
at least two senior persons complementing and supplementing each other and should
preferably belong to different disciplines. He also emphasises the need for all members to
have a deep commitment to medical ethics. It is also important not to skew membership
in favour of individuals of the same discipline. It is essential to ensure representation
from
Administration
•
Clinicians from different disciplines
•
Basic sciences
Social Worker
Nurse
•
Rehabilitation personnel
•
Priest/Philosopher
•
Lawyer
•
Statistician 38
36.
Royal College of Physicians, London, Guidelines in the Practice of Ethics Committees in Medical
Research Involving Human Subjects, 2nd edn.(1990).
37.
United States, Department of Health and Human Services, Rules and Regulations, Reprinted in
Levine R.J., Ethics and Regulations of Clinical Research (Baltimore, Munich: Urban and
Schwarxenberg, 1981) 259-73
38.
Sunil K. Pandya, Supra note 12.
27
T/ie ICII Harmonised Tripartite Guidelines for Good Clinical Practice states that
the Review Committee should consist of a reasonable number of members who
collectively have the qualifications and experience to review and evaluate the science,
medical aspects and ethics involved in the process39.
There is no agreed blueprint for the numbers of members of an Ethical Review
Committee. Again, it should be sufficient to achieve its moral objectives.
Should Ethical Committee sit in public or in private?
American regulations do not require rights of public access but
Levine in his
report states that the Yale University Ethical Review meetings are open to public, though
not advertised.
The British Review Committees meet in private and their proceedings are
confidential though an annual report is submitted to the authority to which the Review
Committee reports and this is available for public inspection.
There is no clear answer as to which is better _an open or closed meeting. Open
meetings provide a public perception that the community is protected. Closed meetings
tend to provoke suspicion in members of the public used to democratic processes. Closed *
meetings enable health care professionals to come out openly with doubts, criticisms
which is unlikely to happen at open meetings40.
39.
I.C.H., Harmonised Tripartite Guidelines for Good Clinical Practice (Surrey: Brookwood
Medical Publications, 1996) 12, para 3.2.1.
40.
R. Gillon, Supra note 33 at 52-76.
28
Reasons for failure of some Ethical Review Committees
Committee set up for the wrong reasons:
Such reasons include
a) An attempt at avoiding prosecution under the Consumers
Protection Act
b) Ensuring that research proposals made by members of the faculty sail
smoothly through national and international agencies that offer grants and
require clearance by a local ethics committee before they will take up the
proposal for scrutiny
c) Formation of yet another ‘power group’ within the institution that can hold the
rest of the faculty to ransom.
Goals that are too ambitious:
Silverman refers to the phase when Ethics Committees, like infants, ‘fail to
thrive.’
When fonned, there is much enthusiasm and activity by members of the
committee. A little later, a feeling of frustration emerges as unrealistic goals, such as
plans to educate the entire faculty and resident staff on medical ethics (including those in
research) in a short while are impossible to achieve41.
Lack of support by the institution:
If all research protocols and matters of ethical concern are not placed before the
the committee and if the recommendations of the committee are flouted by the
administration, demoralisation is inevitable.
41.
J Henry Silverman, Supra note 22 at 189-222.
29
The committee must also be provided adequate infrastructure for its deliberations,
inquiries, follow up studies and maintenance, and analysis of records.
It will be
necessary for the committee to enter into correspondence with other experts and groups,
record proceedings of its meetings, circulate the minutes, interact with experts on other
ethics committees, funding agencies and similar groups.
Funds and secretarial help are mandatory for the proper functioning of such a
committee.
The entire institution must want and welcome the formation of such a committee,
seeing it as a means for improving standards, providing better care to patients and
carrying out research of the highest standards.
Poor selection of members on the committee:
If these individuals are already short of time, it is unlikely that they will pay much
attention to the tasks to be attended to on behalf of the committee. Cursory inspection of
documents, little or no follow-up action and frequent absenteeism from meetings of the
■
committee are expected consequences.
The members must possess a strong motivation for improving the conditions
under which patients are treated and research practised. They should have already
devoted some time and energy in identifying current slip-ups and malpractice and the
means to be employed in correcting them.
They must also be conversant with current trends in national and international
biomedical ethics. Without continued self-education, they are likely to lapse into rigidity
of approach and dogmatic decisions42.
42.
Sunil K. Pandya, Supra note 12.
30
I
A Case Study
Study of a Hospital Ethics Committee at Kansas University Medical Centre
This is a case study of a Hospital Ethics Committee, which aims to provide functions
such as
a)
Easy access to staff of information regarding the committee
b)
Providing guidelines and policies adopted by this institution for responding to
ethical issues in patient care
c)
Providing scope for suggestions, revision and expansion.
d)
Contacting members of the Ethical Review Committee in the cvQnt of any
emergency ethical decisions
Policies and Procedures of Hospital/Medical Staff Ethics Committee
Function: The Hospital/Medical Staff Ethics Committee (hereafter referred to as "the
committee") has three functions or roles:
Education: In cooperation with the hospital administration, the various departments and
divisions of the hospital staff and the executive committee of the medical staff, the
committee undertakes educational efforts in clinical ethics. Depending on the availability
of resources, the committee develops or assists others in the development of lectures,
seminars, workshops, courses, rounds, "in-service" educational programmes or the like in
clinical ethics. The aims of these educational efforts are to provide members of the
hospital/medical staff with access to the language, concepts, principles and body of
knowledge about ethics that they need in order to address the complex ethical dimensions
of contemporary hospital practice. Material would include comprehensive analysis of the
wide variety of roles played by health care providers and their attendant ethical duties;
the various provider-patient relationships and their associated obligations; the ethical
rights of providers, patients and their families; and the ethical responsibilities of
providers to their professions, patients/families, the institution and the larger society.
31
‘
Policy review and development: The committee assists the hospital and medical staff in
the development of policies and guidelines regarding recurrent ethical issues, questions or
problems which arise in the care of patients. In this role the committee provides analysis
of the ethical aspects of existing or proposed policy or assists in the development of new
institutional policy in areas of need.
Case review: An important function of the committee is its role as a forum for analysis
of ethical questions which arise in the care of individual patients. In most circumstances
these questions concern appropriate care of patients with diminished capacity to
participate in decision-making regarding their care. In this role the committee attempts to
provide support and advice to those responsible for treatment decisions, including health
care providers, patients, surrogates and members of the patient's family.
Case review is recommended in three specific categories of decision-making:
Decisions involving significant ethical ambiguity and perplexity in which case review
may provide insight into complex ethical issues;
2)
Decisions involving disagreement between care providers or between providers
and patients/families regarding the ethical aspects of a patient's care; or
3)
Decisions that involve withholding or withdrawal of life-sustaining treatment.
In this role the committee does not act as a decision-making body, but attempts to
assist and to provide support to those who do have this responsibility. Its role is advisory.
Appointment and Membership: The committee membership is multi-disciplinary. A
majority of the membership comprises of non-physicians. Membership includes at least
the following disciplines: medicine, nursing, social work, pastoral care and clinical
ethics, In view of the unique ethical problems involved in situations involving pregnant
women, one physician member is from the Department of Obstetrics and Gynaecology.
The Chief Executive Officer of the Hospital (or designee), the Chief of the Medical Staff
(or designee) and an attorney employed by the Medical Center are ex-officio, non-voting
members. The committee also identifies and nominates for appointment at least one
32
community representative who is not an employee of the Medical Center. For purposes of
conducting business a quorum is a simple majority of the membership.
Members are appointed for a two-year renewable term by the Chief of Staff as
approved by the Executive Committee. Candidates for Chair and Vice-Chair of the
Committee are recommended to the Chief of Staff for consideration annually by a
majority of the members present at a meeting announced in advance for that purpose. It is
recommended that the Chair be identified from among those who have served at least one
year.
I.
Jurisdiction
In view of the establishment of a separate Paediatric Ethics Committee, the mandate
I
of the committee is to engage in its functions of education, policy development and case
review as these relate to the care of patients who are adults, i.e. greater than 18 years of
age.
The committee’s jurisdiction also includes the unique ethical issues involved in
decision-making involving pregnant women when gestation is felt to have progressed to
the stage of foetal viability. Policies and procedures and all non-case review activities of
the Paediatric Ethics Committee are subject to the review and approval of the
Hospital/Medical Staff Ethics Committee. The Paediatric Ethics Committee also submits
an annual report of all its case review functions to this committee.
Although review of any specific case by the committee is not mandatory, it is
anticipated that the committee will rarely be utilized in this capacity in a case involving
an adult with decisional capacity unless the review was requested by the patient or
undertaken with his/her consent. It is anticipated that the primary case review role of the
committee will be cases involving adults who have lost decisional capacity or who have
diminished capacity to participate in decision-making and who have not provided
’’advance directives" regarding their care, e.g. "living will", advance treatment directive,
33
designation of surrogate by appointment of an agent, "durable power of attorney for
health care" or the like.
In cases involving patients who have been legally designated as incompetent,
review would only be undertaken upon request by or with the approval of the court
appointed guardian.
IL
Procedures
Educational Functions: A primary educational emphasis for the committee is its own
education and mechanisms to insure its "continuing education". The field of clinical
ethics is a new, broad and rapidly evolving one. In order to maintain an appropriate level
of expertise the committee develops means of providing members information about
clinical ethics and access to the rapidly expanding body of literature in this field.
Methods include orientation of new members, specific reading assignments, seminars,
mock case/policy review exercises and the like. In addition, the committee participates in
networking with area/regional ethics committees and continuing education programs for
ethics committee members as feasible.
Any educational efforts undertaken by the committee for members of the hospital
community are coordinated with existing educational efforts as much as possible.
Primary emphasis is on assisting departments and divisions to incorporate material about
the committee and about the field of clinical ethics into their existing programs and
activities.
Access to Committee: Upon approval of the Chair, or in his/her absence, the Vice-Chair
or a member designated by the chair, a case review team undertakes case review in
response to any reasonable and appropriate request for review by a member of the
medical staff, house staff, hospital staff, hospital administration, patient, patient's
guardian, surrogate or member of the patient's family. Prior to the convening of a meeting
a member of the case review team notifies the patient's designated attending physician of
34
the request for review, discusses the possible basis for the review and requests his/her
support and involvement.
Preparation for Review Team Meeting: When requested to provide case review
regarding the care of any patient, the Chair or his/her designee appoints an ad hoc Case
Review Team. The team consists of three to five members of the committee and reflects
the multidisciplinary composition of the committee. The individual appointed to lead the
case review team, reviews the request to determine the nature of the case, the status of the
patient, the ethical question(s), concem(s) or problem(s) prompting the request and any
other information needed in order to determine if review is appropriate.
If in the judgment of the leader of the case review team the request is appropriate,
he/she contacts the patient's attending physician to discuss the request, to request his/her
participation and to schedule the case review meeting. If the patient’s attending physician
feels that ethics case review is not appropriate, this conflict is referred to the Chief of the
Medical Staff for resolution. In the event of persistent conflict, the Chief of the Medical
Staff assists in the orderly transfer of responsibility to another attending physician. The
leader of the review team also ascertains if appropriate consent of the patient or
permission of the family or guardian to committee review has been obtained.
Any member of the hospital staff who is directly involved in providing care to the patient
or family is invited to attend the meeting. The team leader also invites "resource
personnel" with special expertise to attend the meeting. The patient and/or members of
the patient's family (with the permission of a patient with decisional-capacity) is also
allowed to be present for at least part of the meeting if they desire.
If in the judgment of the case review team, the request for ethics case review is
inappropriate, the team leader informs the party requesting consultation and/or the
attending physician of his/her determination. This action is also reported to the full
committee at its next regularly scheduled meeting.
35
Conduct of Case Review Meeting: The case review meeting is held within twenty-four
hours of the request for case review whenever possible. At the meeting of the case review
team, the leader of the team instructs all non-members present regarding the advisory role
of the ethics committee; the intent of the committee to serve as a supportive forum for
those who have the primary decision-making responsibility; and the need for strict
confidentiality of all material presented and discussed.
The patient’s physician and other health care providers are asked to present
information to the review team regarding the history of the patient, the present condition
of the patient, the prognosis and any other material felt to be relevant to the case review.
The leader asks those involved, including patient/family members if present, to describe
what specific ethical questions, problems or issues prompted the request for case review.
Following appropriate discussion of these and issues identified by committee
members, the team leader convenes a ’’closed” (members only) session in order to
develop a specific recommendation if appropriate.
Members of the Case Review Team may also decide before or after the case
review meeting that formal review of the case by the entire ethics committee is
appropriate. In this case the leader of the review team will notify the Chair (or designee)
who will convene an emergency meeting of the entire committee as soon as possible.
Recommendations: The results of the case review and any recommendations are
communicated to the individual who requested the case review; to the attending
physician; to other members of the staff; and, to the patient/patient's family as
appropriate. Following these discussions, and upon request of the attending physician, the
(cam leader records (he results of the ethics case review in (he patient's medical record.
36
V. Meetings
The committee meets monthly in addition to any meetings called for specific case
review. The Chair in consultation with the Chief of Staff develops an agenda as needed
and distributed a week prior to the meeting. Meetings, which do not involve review of
specific case material, are open to any member of the hospital community. Guests and
other interested parties are allowed to attend at the discretion of the chair or designee.
Five members constitute a quorum. Each member is required to attend at least five of the
committee's regularly scheduled meetings each year. Failure to do so constitutes a
resignation and the vacancy is filled by appointment of a new member by the Chief of
Staff.
Record keeping: The committee maintains minutes of all of its meetings, which include
summaries of all case reviews and recommendations. Minutes are submitted by the Chair
for approval by the committee and submitted to the Chief of Staff.
Records do not include identifying information about specific patients, family
members, individuals requesting case review or staff members participating in the case
review process. These records are maintained in accordance with hospital policy and *
applicable law governing the confidentiality of records of medical review committees.
Liability: The Hospital takes whatever steps are necessary in order to provide liability
protection for committee members who do not have such protection by virtue of their
status as members of the medical/hospital staff.
Adoption and approval of policies and procedures: Policies and procedures of this
committee are reviewed on an annual basis. Proposed modifications of approved policies
or procedures are submitted to the committee in writing at least four weeks in advance of
a regularly scheduled meeting. Following approval by the committee, they are forwarded
to the Executive Committee for review and approval.
37
II. Paediatric Ethics Committee
Policies and Procedures:
Introduction
The Pediatric Ethics Committee (PEC) of the University of Kansas Medical
Center was established in 1984 by its parent committee _ the Hospital/Medical Staff
Ethics Committee
to deal specifically with ethical issues involving the care of infants
and children. The development of such a committee was also recommended in federal
legislation (Child Abuse Amendments of 1984: P.S. 98457) dealing with so-called "Baby
Doe" cases, i.e. decisions regarding the care of imperiled and/or handicapped infants.
Other than in its case review function, all actions of the PEC are to be submitted for
review and approval by its "parent committee".
Purpose
The jurisdiction of the Pediatric Ethics Committee includes clinical situations involving:
(a) infants: children from birth to 2 years of age; (b) children or "minors" age 2 to 18 •
unless otherwise "emancipated." Emancipated minors include individuals who are self-
supporting and/or not living at home; married minors; any minor who is pregnant or a
parent; or, a minor who has been declared emancipated by a court. Minors may also be
treated as "mature minors" in some situations (rarely applies to a hospitalised minor); or,
can be "medically emancipated" in situations involving selected legally designated
medical disorders, e.g. sexually transmitted diseases, drug or alcohol abuse and the like.
The purpose and role of the Pediatric Ethics Committee encompasses the following:
38
a) Educational: To assist the Department of Paediatrics, and other departments and
divisions which provide services to children in development of appropriate educational
programs in clinical ethics for all providers of care to paediatric patients. Such
programmes would have as their goal the fostering of sensitivity and an ability to respond
appropriately to the ethical aspects of the care of patients and families.
b) Policy review and development: To assist the Medical Center and it’s component
institutions in the review and development of institutional policies relating to the care of
patients under the jurisdiction of the PEC.
c) Case review: To serve as a forum for discussion and analysis of complex individual
cases, particularly those involving withholding or withdrawal of life-sustaining treatment;
and for discussion and resolution of conflicts regarding the ethical aspects of a patient's
care among members of the staff providing care to the patient; or, conflict between staff
and patient or family members.
The committee will also undertake retrospective review and analysis of selected
cases to ensure that ethical issues were dealt with in an appropriate manner.
d) Responding to reports of medical neglect of disabled infants: To serve as a
mechanism by which cases can be reviewed in which a report of "medical neglect" has
been received by the Kansas Department of Social and Rehabilitative Services (SRS)
regarding an infant patient hospitalised at KUMC.
III. Committee Structure
Membership: Membership on the Paediatric Ethics Committee is representational and
multi-disciplinary. The Chief of the Medical Staff appoints members.
39
The PEC consists of at least 12 members, including the following physicians: one
from the Division of Neonatology, one from the Division of Oncology/ Haematology;
one from the Division of Cardiology or Intensive Care and one from the Ambulatory
Division; and the Paediatric Chief Resident.
The Committee includes the following nursing members: one from Nursing
Administration; and one each from neonatal and paediatric nursing units. It includes two
members from the Department of Social Work: the Director or his/her designee and one
member of the paediatric social work staff. In addition the Committee includes one
representative of pastoral care; and one representative with training and/or experience in
the area of clinical ethics, if available.
Ex-Officio members include the following: Chair of the Department of
Paediatrics; Chief of the Medical Staff or designee; and a representative of the Office of
the Legal Counsel. Members are appointed for a two-year renewable term by the Chief of
Staff as approved by the Executive Committee. Members must attend at least five of the
committee's regularly scheduled meetings each year. Failure to do so will constitute
resignation and the vacancy will be filled by appointment of a new member by the Chief
of Staff.
The committee recommends an individual for consideration as Chair and vice
chair of the committee from amongst its members. Individuals recommended will have
served at least two years on the committee. The Chief of the Medical Staff appoints a
chair and vice-chair.
Meetings: The committee meets regularly but in no event less than quarterly. Written
notice of meetings is distributed to each member at least five days before the date of the
meeting. Special meetings of the Committee may be called by the Chair as needed. For
all regularly scheduled meetings, a quorum shall be one half of the number of members
of the committee.
40
Meetings, which do not include review or discussion of specific cases, arc open to
anyone expressing an interest in the subject being considered.
Minutes/Records: The Chair or the Chair's designee keeps minutes of all meetings.
Minutes of the meetings are maintained by the Office of the Chairman of the Department
of Pediatrics and by the Hospital/Medical Staff Ethics Committee.
In order to maintain the privacy of patients and their families, patients are identified
in minutes by initials only. The Chair maintains a master list of all initials, names and
medical record numbers should more complete identification of patients be needed in the
future.
All committee members receive copies of the minutes. In addition, minutes are
submitted to the Chief of the Medical Staff and the Hospital/Medical Staff Ethics
Committee.
The Chair in consultation with the Office of the Legal Counsel considers any
other request for access to committee materials or minutes.
Administration: The office of the Chair of the Department of Paediatrics provides
administrative support for the Committee. In addition to its minutes, the committee
prepares an annual report of its activities, which are submitted, to the Department of
Pediatrics and to the Hospital/Medical Staff Ethics Committee.
Sub-Committees: The Chair creates ad-hoc sub-committees and appoints their
membership as needed in order to carry out the work of the Committee.
41
IV. Procedures for Case Review
Prospective Case Review
Prospective review
review prior to the undertaking of a particular course of
action in the treatment of a patient
is conducted by the committee when indicated.
Mandatory Case Review: Mandatory review is initiated in response to a report received
by the Kansas State Department of Social and Rehabilitative Services, Division of Child
Protection, which alleges "medical neglect" of a hospitalised infant. The term medical
neglect is defined in the Child Abuse Amendments of 1984 (P.S. 98457, 1340.25 (b) as
the "withholding of medically indicated treatment" from an infant disabled by a life
threatening condition. Following its review of the case, the Chair reports the Findings and
recommendations of the committee to the designated hospital liaison to the Department
ofSRS.
Recommended Case Review: Case review may be appropriate in situations in which a
proposed course of treatment of a patient involves the withholding or withdrawal of life
sustaining medical or surgical treatment. Case review is recommended in cases in which ,
there is unresolved disagreement regarding the ethical aspects of a proposed course of
treatment involving a pediatric patient, the parent(s)/ guardian and/or the professional
staff providing care to the patient.
Discretionary Case Review: Since one of the essential responsibilities of the Committee
is that of assisting patients, families and staff facing difficult ethical decisions regarding
health care, it is anticipated that most requests for case review will arise in a voluntary
context. The patient, the parent(s)/guardian, or any member of the professional staff
providing care to the patient makes requests for review.
42
Review Procedure: 'The primary role of the committee in case review is to provide
advice and support to those who have primary responsibility as decision makers, i.e. the
patient, the parcnt(s)/guardian and the professional staff providing care. The committee is
not be viewed as a decision-making body. Even in situations in which the committee
plays a role in identifying ethical problems involved in proposed courses of treatment, the
committee does not recommend specific alternative treatments to be undertaken.
a) Case Review Team: Upon notification to the Chair of a case requiring mandatory
review or following receipt of a request for consultation and review, the Chair appoints
an ad hoc Case Review Team. The team consists of three to five members of the
committee
and
reflects
the
multidisciplinary
composition of the
committee.
b) Involvement of the attending physician: The individual appointed to lead the case
review team reviews the request to determine the nature of the case, the status of the
patient, the ethical question, concern or problem prompting the request and any other
information needed in order to determine if review is appropriate.
If in the judgement of the leader of the case review team the request is
appropriate, he/she contacts the patient's attending physician to discuss the request, to •
request his/her participation and to schedule the case review meeting. If the patient’s
attending physician feels that ethics case review is not appropriate; this conflict is
referred to the Chief of the Medical Staff for resolution.
In the event of persistent conflict, the Chief of the Medical Staff assists in the
orderly transfer of responsibility to another attending physician. The leader of the review
team also ascertains if consent of the patient (where appropriate) has been obtained; or
permission of the family or guardian to committee review has been sought.
43
c) I he case review meeting: The case review meeting is held within twenty-four hours
of the request for case review whenever possible. Any member of the hospital staff who
is directly involved in providing care to the patient or family may be invited to attend the
meeting. The patient, his/her parents and other members of the patient's family are also
allowed to be present for at least part of the meeting if they desire.
At the meeting the leader of the team instructs all non-members present regarding
the advisory role of the ethics committee; the intent of the committee to serve as a
supportive forum for those who have the primary decision-making responsibility; and the
need for strict confidentiality of all material presented and discussed. The patient's
attending physician and other health care providers are asked to present infonnation to
the review team regarding the history of the patient, the present condition of the patient,
the prognosis and any other material felt to be relevant to the case review.
The leader asks those involved, including the patient/family members if present,
to describe what specific ethical questions, problems or issues prompted the request for
case review.
Following appropriate discussion of these and issues identified by committee
members, the team leader may convene a "closed" (members only) session in order to
develop a specific recommendation if appropriate.
Members of the Case Review Team may also decide before or after the case
review meeting that formal review of the case by the entire ethics committee is
appropriate. In this case the leader of the review team notifies the Chair (or designee)
who will convene an emergency meeting of the entire committee as soon as possible.
44
d) Recommendations: The results of the case review and any recommendations are
communicated to the individual who requested the case review; the attending physician;
the patient/patient's family and to appropriate members of the staff. Following these
discussions, and upon request of the attending physician, the team leader records the
results of the ethics case review in the patient’s medical record.
Retrospective Case Review: In order to evaluate its utilization and effectiveness, the
Committee undertakes periodic retrospective review and analysis of selected cases or
categories of cases. Examples would include: cases in which a "Do Not Resuscitate"
("DNR") decision had been made; cases in which decisions were made to withhold or
withdraw a medical or surgical intervention; cases in which the Committee had provided
prospective case review; and others as appropriate. The results of this review are used to
identify educational needs; to evaluate existing policies or procedures; and, to determine
areas in which existing policy requires modification or in which policies need to be
developed.
V. Adoption and approval of policies and procedures
Policies and Procedures of the Paediatric Ethics Committee are reviewed
annually. Suggested modifications of approved policies or procedures are submitted to
the Committee in writing at least four weeks in advance of a regularly scheduled meeting.
Following approval by the Committee, they are forwarded to the Hospital/Medical Staff
Ethics Committee for review and then forwarded to the Executive Committee for
consideration.
Policies and Procedures will become effective when approved by the Executive
Committee of the Medical Staff.
This study has been downloaded from website http://www.kumc.edu/liospital/ethics.htm
45
‘
PART II
SCOPE OF THE PRESENT STUDY
46
Application of Ethical Review Committees to
the Corporation health facilities
With advancement in technology and diagnostic techniques, medical practice
today is undergoing rapid change but ethics in the modem context has not kept pace with
the norms of a rapidly changing world.
Health professionals face ethical dilemmas all the time. In the changed cultural
and social milieu, patients no longer view their doctor as a know-all or “God”. The
patient demands a right to know what illness he is suffering from and how he will be
treated. With advances in Information Technology medical knowledge is no longer the
purview of the medical professional.
In this changing scenario, the health professional sometimes flounders with no
guidelines or protocols being established.
Often he finds himself in an unenviable
position of facing a court of law due to non-resolution of ethical conflicts.
This researcher has found several cases of negligence and malpractice, which
seems to be the norm practised by doctors in certain hospitals. In some cases the woman
in the slum who is by far the most vulnerable is subjected to willful neglect and faces
life-long morbidity from which she never gets relief. In some cases the patient perceives
negligence, as doctors who are poor communicators do not take the patient into
confidence.
The quality of services in a hospital is an important element in the package of
services that the poor rely on during illness. While medical services have in recent times
seen many a technical advance, it‘has been accompanied by increases in cost and
complexity. There has been a growing concern over the deteriorating quality of health
care provided by public hospitals. These problems become more visible when it comes
to the question of the service to the poor. Lack of awareness and education and difficulty
47
to pay open market rates for health services compounds the problems associated with
quality of public health care.
In the above context, this researcher feels that a time has come when redressal of
issues between the doctor and his patient is of prime importance. Hence the need to
examine the prospect of having Ethical Review Committees in health facilities of
Bangalore Mahanagara Palike.
Situational Analysis
The researcher having worked in the hospitals of the Bangalore Mahanagara
Palike will restrict the scope to these institutions.
There are 27 Maternity Homes with about 24 beds each and 6 Referral Hospitals
with about 30 beds each. In addition there are about 80 day-care facilities called Health
Centres where the prime beneficiaries are women and children from the urban poor. The
Maternity Homes and Referral Hospitals of Bangalore Mahanagara Palike are situated in
different parts of Bangalore, mainly near or in the slums and cater to the urban poor.
All the hospitals have very good infrastructure and modem equipment like
ultrasounds, phototherapy units, etc., since the World Bank has funded up-gradation of
infrastructural facilities. Gynaecologists and paediatricians are employed in these
hospitals. Specialised training for relevant clinical skills up-gradation has been given to
all employees. However, despite all these inputs the utilisation of these facilities remains
poor and the image of government-run health institutions continues to be poor.
The Public Affairs Centre and the Citizens Action Group, two NGOs concerned
with these issues, undertook a study to assess the difficulties the poor encounter while
accessing public health facilities. They also designed the study to assess perceived quality
of specific services and ratings of different areas of action for improving services.
48
The findings of this survey have motivated the present study. Amongst the
number of options available for improved governance of public hospitals, this study
focuses on the constitution of Ethical Review Committees and examines it in detail.
According to the study by the Public Affairs Centre public health facilities are
accessed mainly by the poor. Here, experiences were sometimes so inhuman that patients
were forced to seek treatment at private facilities.
Table I — Reasons for visiting hospitals
(Given as a percentage of respondents)
Government
Child Birth
29
Family Planning
5
Corporation
—
Mission
Private
89
13
8
11
2
2
Source: The Public Affairs Centre Report Card
Since it was assumed that costs were ‘free’ in public facilities, the main reason for
people accessing these facilities was the low cost of treatment, second to proximity of the
facility.
Table 2 - Principal reason for selecting a hospital
(Given as a percentage of respondents)
Government
Corporation
Mission
Private
Proximity
22
72
24
63
Acquaintances
28
17
31
30
Good treatment
21
17
34
22
Recommended
27
2
27
26
Inexpensive
30
30
10
2
Others
6
14
8
2
Source: The Public Affairs Centre Report Card
49
The study by the Public Affairs Centre went into details of quality of service. The waiting
time of a patient before being examined by a doctor tends to be ominous, leading to
prolongation of agony and sometimes deterioration of the condition of the patent and
onset of complications. In most public health facilities over 25 percent of patients had to
wait over 30 minutes to be attended.
The most vital aspect of health care to the poor is availability of free or subsidised
treatment and availability of doctors. The major problem was in Corporation hospitals
where 22 per cent of patients expressed difficulty in obtaining the services of a doctor.
Chart I: Availability of doctors
□ Very helpful
100% -
80% -
Helpful
31
37
57
78
60% 40% -
46
S«
20% 0____ ]
Govt.
IS Unhelpful
w
Corpn.
Mission
i
“
Private
r
Hie overall areas that require improvement are indicated in the chart below.
Chart II: Areas calling for improvement
■1
100%-,
90%80%-
■
70% —
60%-
Cleanliness
*
EJ Information from staff
[J Avallabliny of facilities
S Quality of treatment
50%-
S Staff behaviour
40%-
I
[
<1
30%-
I
20%10%o?;--
Govt
Corpn.
Mission
Prlvala
i
50
Speed money for obtaining services seems to be the blight of all public facilities.
According to the Public Affairs Centre survey, 87 percent of patients using Corporation
hospitals are paying speed money. Case studies indicate money is paid for delivery, to
get hot water, to get the baby examined, etc.
Several innovations have been instituted in the Corporation Health Facilities to
improve governance. These are:
a)
Citizen Charters indicating the Rights of the citizen has been developed
and displayed in all the hospitals. These charters indicate the services the
patient can expect in the facility.
'
51
Citizen Charter - Rights of the Citizen
The Citizen has a Right to the following
List of Services
General Medical Care
:
Ante Natal Care
:
M.T.P. Services
:
Sterilization
e
Laboratory
:
e>
Delivery
:
©
Immunisation
:
Family Welfare Services
:
(Copper ‘T’/Oral Pills/Condoms)
Tuberculosis Control
:
Day
Daily
Monday/Friday
Daily
Tuesday/Wednesday/Saturday
Daily
Round the clock
Thursday
Daily
Daily
The services of the Medical Officer from 9.00 AM to 4.00 PM.
The services of the doctor for emergencies round the clock.
*
*
In-patient services round the clock.
*
*
*
*
*
*
*
*
*
*
Timely Appropriate Referral Care.
Ambulance services in Emergencies.
Demand Admission Slip
Clean and Neat environment with good house keeping.
Hospital will be cleaned at 7.00 AM, 2 P.M. & 9.00 P.M.
Toilet will be cleaned at 7.00 AM, 2 P.M. & 9.00 P.M.
Clean Linen will be provided daily.
Polite courteous behaviour from all staff to preserve Human Dignity.
Be attended to within ‘/z an hour. In emergencies attention will be
immediate
Milk (250ml) twice daily and 1 loaf of bread.
Displaying the Citizens Charter informs patients of her rights. This empowers her to
demand her rights and seek redressal if denied the services.
b)
Twelve boards of visitors have been constituted zone-wise for a group of health
facilities. The objectives of these boards are
52
1)
Quarterly review meetings
2)
Review of activities of the health facilities in its jurisdiction
3)
Review plans, budgets, programmes and performances of the health
facilities
4)
Review and approve income from the user charges or other sources and
expenditure met out of such funds
5)
Resource mobilisation
6)
Review and redressal of un-resolved public complaints received
7)
Proposal of measures for better governance
This committee has no jurisdiction over administrative matters like appointment of staff,
transfers and confidential reports. But it can recommend suggestions to improve the
management practices and services. However, the scope of these boards is very limited.
Neither the medical education nor the in-service training provides any inputs on
ethical issues, problems and solutions. Hence the doctors are left to fend for themselves
in a society, which is now very much aware of its rights and has a good knowledge of
medicine.
It may be too ambitions to have an Ethical Review Committee for each health
facility. But it is certainly worthwhile to examine the feasibility of one Ethical Review
Committee for all the health facilities of the Bangalore Mahanagara Palike.
Definition of an Ethical Review Committee for Bangalore Mahanagara Palike
health facilities
The Ethical Review Committee is an advisory group of individuals from different
spheres of medical and non-medical arenas who should review ethical and moral
questions that may come up during patient care in Referral Hospitals, Maternity Homes
and Health Centres of Bangalore Mahanagara Palike. This committee should be easily
53
available to doctors, nurses, other members of the health team and also patients and their
families when difficult and ethical decisions are to be made. The committee should aim at
helping everyone decide on the right thing to do.
In general the Ethical Committee should give advice on moral questions in
clinical care, educate clinical staff and public on issues in medical ethics and develop
policies related to patient care.
The women who access the Corporation health facilities are amongst the poorest
of the poor. Their literacy levels are very low and they have no knowledge of their
rights, leave alone seeking redressal. In such circumstances, the Ethical Committees
should also suggest measures for enabling the slum women obtain their rights.
Goals of constituting an Ethical Review Committee for Corporation facilities
The goal of constituting an Ethical Review Committee is to develop the ability to
a)
Identify the underlying ethical issues and problems.
b)
Consider the alternatives under the given circumstance without
compromising ethical principles.
c)
Make decisions based on more acceptable concepts as also traditions
and practices.
d)
Make known the need to respect the rights of the patient and also the
duties and responsibilities of the doctor
e)
Provide knowledge to the medical fraternity within the hospital on
value dimensions of interactions with patients, relatives, public and
colleagues
0
Facilitate communication between all persons involved in the care and
treatment process
g)
Be available for consultation on difficult cases
h)
Provide policy recommendations to the institution
54
i)
Consider ethical implications of research proposals
The responsibilities of the proposed Ethical Review Committee
Historically Ethical Review Committees were constituted as a fallout of the
Nuremberg Trials of the Second World War.
From Review of Clinical Trials to development of ethical codes of organ
transplantation to the more recent assisted reproductive technologies, the scope of the
Ethical Review Committees has certainly increased in strength.
The time is now right to constitute ethical codes for Basic Comprehensive Health
Care facilities providing services to the poorest and most vulnerable sections of our
society.
An overview of the responsibilities of the Ethical Review Committee
1)
The Ethical Review Committee should seek a mandate from the
administration of the Bangalore Mahanagara Palike, which should
constitute it.
2)
The Ethical Review Committee should meet periodically to examine all
complaints of unethical practices received.
3)
To provide consultation to the medical and professional staff and
patients/families on ethical, moral, philosophical problems and issues
encountered in the course of managing inpatient and outpatient care.
55
4)
To provide education and advice to the staff, patients and families on case
based ethical issues as well as on ethical medical practice standards, in the
provision of inpatient and outpatient adult and paediatric health care.
5)
To initiate and, on request, formulate policies on the ethical aspects of
clinical care at organisational level of Bangalore Mahanagara Palike.
6)
To assist the Bangalore Mahanagara Palike in complying with ethical
regulatory standards, as required by law
7)
The Ethical Review Committee should be given a mandate to review in
depth all maternal and infant deaths with a view to identify and prevent
ethical loopholes leading to these incidents.
8)
If behavioral change is to be seen in health professionals, the findings of
the Ethical Review Committee on a case-by-case basis is to be made
public at meetings of professionals, which is to be made mandatory.
Ethical issues involved can be discussed at length and corrective actions
for future introspected.
9)
Ethical Review Committee, during its sitting, should identify the
mismatch between services and procurements of medicines, drugs, etc by
public institutions.
10)
Ethical Review Committee should receive a mandate to highlight ethical
issues and concerns relevant to the organising, financing and delivery of
health care services.
11)
The health facilities of the Bangalore Mahanagara Palike display the
“Rights of the Citizen” as a means of improving governance. The Ethical
56
Review Committee should be given a mandate to assess the extent to
which this right is delivered to the patient.
12)
The Ethical Review Committee should ensure proper functioning of a
redressal system for complaints received from patients or their families.
The illiterate patients who access the Corporation health facilities are the
targets of a majority of unethical practices. They have no knowledge of
their rights, no information regarding existence of a public complaint
redressal system or how to approach it. Further, poor women do not even
have the time or empowerment to follow up their complaint to its logical
end. Most often, the complaint is withdrawn or not followed up either due
to pressure from the hospital mafia or due to the laborious redressal
processes.
13)
The Ethics Committee should also produce a document for the benefit of
patients and families informing them of services provided by the
institution, rights of the patients and relatives, their responsibilities, means
of seeking redressal for any unethical practices either real or perceived.
14)
The Ethics Committee should also survey practices within the institutions
in its purview on a continuing basis, standards of patient care, unnecessary
expenditure enforced on patients, issues of informed consent, etc. Periodic
exit survey of patients to obtain information on deficiencies or
malpractices and suggestion for improvements could be obtained.
15)
Obtain feedback from hospital functionaries regarding functioning of the
Ethics
Committee,
perceived
deficiencies
and
suggestions
for
improvement. It may be worthwhile, considering providing scope for
anonymity in order to avoid victimisation and encourage free and frank
observations.
57
>
16)
Conduct
seminars/workshops/mini-conferences
periodically
for
all
categories of hospital personnel regarding ethical concerns.
Constitution of the Ethical Review Committee
The Ethical Review Committee should comprise of individuals who are
committed and knowledgeable citizens from different walks of life. It should comprise of
persons who should
•
Bea part of the system for which the committee is constituted.
Have deep insight into ethical issues and concerns.
Have problem-solving skills.
Be from clinical and non-clinical arenas.
Include non-medical persons like sociologists and psychologists.
The more diverse the members, the more enriching will be their viewpoints.
Their rich experiences will widen the scope of the Ethical Review Committee and enable
finding acceptable solutions to ethical dilemmas.
Although there is no agreed blueprint for an ideal committee, it is universally
agreed that a multi-disciplinary one is needed to provide the range of perspectives
needed. Members should include:
1.
Representation from the Bangalore Mahanagara Palike Health
Administration will be Member Secretary.
2.
One obstetrician and one paediatrician from outside Bangalore Mahanagara
Palike structure selected based on expertise and interest in ethical concerns,
3.
A social scientist or anthropologist
4.
Nurse
5.
Lawyer or retired judge
58
6.
Priest/philosopher
7.
Statistician
8.
Any invitee as a specific case warrants.
9.
A respected member of the public who has no professional or institutional ties
with Bangalore Mahanagara Palike.
Only the member secretary will be from Bangalore Mahanagara Palike. The
Commissioner, Bangalore Mahanagara Palike, with approval of the Corporation Council,
will appoint members for a two years renewable term. The members at the first meeting
will select the Chairperson.
Meetings
The Committee should meet quarterly in addition to any meetings called for in
special circumstances.
An agenda should be prepared by the member secretary and
signed by the chairperson. This should be circulated to all members at least one week
prior to the meeting. Depending on the issues to be discussed, it is the discretion of the
committee whether to sit in public or private.
At least five members will constitute a quorum. If a member does not attend three
consecutive meetings, he/she is deemed to have resigned and the vacancy will be filled.
No quorum should consist of members of only one profession or gender.
Special invitees may be called in case expert opinions are required in a specific
case. In cases of redressal of complaints the hearing will be held in the presence of both
parties. In emergency situations like ethical conflicts in case review, the meeting can be
convened without advance notice.
The committee will maintain minutes of all its meetings, which will include
summaries of case reviews, recommendations, etc.
Confidential records will be
59
maintained in accordance with Bangalore Mahanagara Palike policy and applicable laws
governing confidentiality of records.
The Bangalore Mahanagara Palike will provide liability protection for committee
members who do not have such protection by virtue of their status as employees of the
Bangalore Mahanagara Palike.
Any administrative decisions that need to be made based on the recommendations
of the ethics committee shall be forwarded to the regular administration of the Bangalore
Mahanagara Palike.
Steps in requesting an Ethical Review Committee meeting
®
Any health care team member, patient, or patients’ family member may request a
consultation
®
The patients’ medical situation and treatment options are reviewed.
In addition,
concerns, and feelings of the patient, family members, and the health care team are
looked into. Members of the committee may meet with patients, families and medical
personnel to discuss these concerns.
•
Ethics Committee members discuss the information, which has been gathered.
The Ethics Committee makes suggestions about the best course of action. Often there
are a number of options available in the course of a patient’s care. The patient, family
and the health care team make final decisions.
If a patient, attendant or health provider has an issue, which raises ethical concerns,
he can request for a meeting by giving a requisition.
60
The basic rules are
1)
Existing principles of natural justice should be observed. This can further
be classified, as “procedural fairness” because fairness should be the
institutions governing principles to its employees or its patients.
2)
Proper notice is to be given to both parties regarding complaint, identity of
each party, time and place of hearing. Rules governing the hearing, e.g., right to speak
and cross-examine, etc, should also be made known. Written submissions of each of the
parties should be obtained. Both the parties should be aware of their right to appeal.
3)
Both parties must receive a fair hearing.
4)
No bias or appearance of bias among committee members.
5)
The case should not be pre-judged.
6)
If committee members are better trained and hearings are open it can be
expected that over time the quality and consistency of the process will
grow.
7)
Provision should be made for dissenting opinions, which should be
published along with the majority decision.
8)
To the limits of its resources, powers and abilities in every case, the ethics
committees should seek to determine the truth of the matter.
61
Discussion and Conclusion
Ethics and ethical codes of conduct are important for any professional, more so
for the medical profession. The steady deterioration of ethical value systems has
pervaded all cultures. There is now conflict between traditional values and changing
ethos and insights. Contemporary ethos should strive to preserve what is essential from
older traditions and modify others to suit changes in the perception of society.
In the backdrop of these issues, the basic health of the urban poor is seen as a
major area of concern. Even today, the women in the slums do not access health care
unless it becomes inevitable and too late. Antenatal care, maternal nutrition and care of
the high-risk pregnant mother is still very low on the list of priorities of the community
and health professionals.
While availability of health facilities, infrastructure and trained staff has improved
significantly over the year, quality care continues to be denied to the urban poor. It is this
that should be the focus of the civic administration.
Exploitation of the poor and non-availability of complaint redressal systems for
the illiterate, apathetic vulnerable is the main reason for continued high maternal and
child mortalities and morbidities even in the 21st Century.
Several reports pinpoint issues and suggest corrective mechanisms but system
responses to these needs to be energised. It is the duty of every medical practitioner who
believes in ethics and value systems to utilize available opportunities to bring to the
limelight these concerns.
It is not as if the government is insensitive to these issues. Several laws, and
legislations are in place. But it is the people who have to make them work.
62
In this study, a detailed review of one such mechanism, the Ethical Review
Committee has been done. The study encompasses such committees constituted for bio
medical research, clinical trials and for review of hospital ethical issues.
The study has traced the evolution of Ethical Review Committees since the Nuremberg
Code was formulated in 1947. The steps taken by the World Medical Association to
adopt the Declaration of Helsinki that laid down guidelines for research involving human
subjects has also been studied in detailed. The applicability of the Nuremberg Code and
the Declaration of Helsinki for developing countries, which was further consolidated by
the CIOMS and WHO was also examined.
In the Indian context, the ICMR guidelines prepared by the Central Ethical Committee on
human research under the chairmanship of Hon’ble Justice M N Venkatachaiiah was
studied in-depth and inputs on legal and social dimensions of research on humans
obtained.
The scope of the existing review committees to other emerging issues like ethical
principles involved in HIV infections, research into the human genome, assisted
reproductive technologies, etc. was also looked into. The evolution of existing hospital
ethics committees, their jurisdiction, responsibilities was reviewed in detail. The
development of ethical codes and its purpose, for instance, how these ethical codes
enable self-description for others and influence actions of practitioners is an important
function of the Ethical Review Committee.
Ethics Committees provide a platform for redressal of complaints and queries from both,
the patients and the health providers. In public hospitals where doctors are forced to work
with limited resources and unresolved constraints, the Ethics Committees can provide
assistance to safeguard the doctors, in the event of unreasonable litigation. The basic
overall responsibility of the hospital Ethical Review Committee is to ensure a competent
review of all ethical problems without bias, to act as an ombudsman and watchdog, to
play a role in increasing public consciousness of the rights of vulnerables and to ensure
63
that standards of clinical practice arc maintained, creating thereby a harmonious milieu in
which the patient receives the best possible treatment and the health providers have the
satisfaction of having delivered their best. This would in essence mean ensuring equity
and distributive justice in patient care in a beleaguered health system.
Having studied in detail the existing literature on formation of Ethical Review
Committees, their jurisdiction, constitution and job responsibilities, the researcher
suggests the creation of such an Ethical Review Committee for the Bangalore
Mahanagara Palike health institutions.
Several studies have shown that a number of unethical practices are in existence in the
Bangalore Mahanagara Palike Maternity Homes and Referral Hospitals. In addition to
the redressal mechanisms already attempted by the Bangalore Mahanagara Palike, the
proposed Ethical Review Committee for the Bangalore Mahanagara Palike health
institutions can seek to streamline standards of medical practice and ensure that the vast
resources of the civic body being spent on these facilities actually reaches those who
hitherto have been unreached.
Training on ethical practices with case studies and implications of the Consumer
Protection Act should be the focus of motivating the health system to make the Ethical
Review Committees functional. The benefits of constituting an ethical review committee
will not be seen immediately. It will take at least a year or two for the positive spin-off to
be visible.
The Ethical Review Committee will no doubt face many challenges. Its very existence
may sometimes be seen as a threat to entrenched vested interests in a public system.
Other departments in the government system may also attempt to derail the efforts
because success of the Ethical Review Committees in health facilities may stimulate
administrators to replicate this best practice in these departments as well.
64
Yet the Ethical Review Committee has a moral responsibility to ensure the success of its
task as this could be the beginning of a new era in cleansing the system of this cancer.
65
il
Bibliography
Amar Jesani, “Broad Issues: Ethics in Health Care,” Issues in Medical Ethics, 4(2), 1996.
Bernard M. Dickens, “Introduction to the Draft Revised Guidelines: Ethics and Research on Fluman
Subjects — International Guidelines, in Z Bankowski and R. J. Levine, eds. Ethics and Research on Human
Subjects (Geneva: CIOMS, 1993).
B. O. Osuntokum, “Individual Consent: A Perspective of Developing Countries”, in Z Bankowski and R. J.
Levine, eds. Ethics and Research on Human Subjects (Geneva: CIOMS, 1993).
C. de Sweemar Ba, “Informed Consent: Protecting the Vulnerable”, in Z Bankowski and R. J. Levine, eds.
Ethics and Research on Human Subjects (Geneva: CIOMS, 1993).
C. M. Francis,
Conflicts and Confluences: Ancient and Modern - Medical Ethics in India.
C.M. Francis, Medical Ethics, 1st edn. (New Delhi: Jaypee Brothers Medical Publishers, 1993).
Council for International Organisations of Medical Sciences (CIOMS), International Guidelines for Ethical
Review of Epidemiological Studies (Geneva: CIOMS, 1991).
Council for International Organisations of Medical Sciences (CIOMS), in collaboration with the World
Health Organization (WHO), International Ethical Guidelines for Biomedical Research. Involving Human
Subjects (Geneva: CIOMS 1993).
Council of Europe, Convention for the Protection of Human F'J
~f
‘ Human Being with
Rights and' Dignity
of the
Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,
European Treaty Series - No. 164 (1997).
Department of Health, Education, and Welfare, Office of the Secretary, Protection of Human Subjects,
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
Report of the National Committee for the Protection of Human Subjects of Biomedical and Behavioural
Research (Belmont: DHEWPublication, 1979).
Indian Council for Medical Research, Consultative Document on Ethical Guidelines on Biomedical
Research Involving Human Subjects (New Delhi: ICMR, 1997).
Indian Council for Medical Research, Ethical Guidelines for Biomedical Research on Human Subjects
(New Delhi: ICMR, 2000).
International Conference on IHannonisation
’
of Technical Requirements for the Registration of
Pharmaceuticals for Human Use (ICH), Guidance■ on Good Clinical Practice (Surrey: Brookwood Medical
Publication, 1996).
J. Henry Silverman, ‘’Revitalising a Hospital Ethics Committee,” HEC Forum, 6, 1994.
Kannamma Raman, “Ethics in Health Care: A Report on the XXII Annual Meet of Medico Friends Circle,
Wardha 27-29 December 1995”, 4(2), Issues in Medical Ethics (1996).
Medical Council of India, Code of Medical Ethics (New Delhi: MCI, 1970).
66
L
26?1*1993iCS and
Felcicr’ “Applying Brakes to the Runaway American Health Care System,” JAMA,
NIMHANS, Ethical Guidelines ofNIMHANS, (Bangalore: NIMHANS, 1999).
R. Gillon, Ethical Review Procedures: A Developed Countries’ Perspective — A Common Framework,” in
M. Biazier and M. Lobjoit, eds., Research on the Vulnerable: An Ethical Overview (London: Routledge,
Royal College of Physicians, London, Guidelines in the Practice of Ethics Committees in Medical
Research Involving Human Subjects, 2nd edn., (1990).
Sunil K. Pandya, “Hospital Ethics Committee,” in Issues in Medical Ethics, 4(2), 1996.
Suresh Balakrishnan and Anjana Iyer, Bangalore Hospital and the Urban Poor: A Report Card (Bangalore:
Communications for Development and Learning, 1998).
W K Mariner, “Distinguishing ‘exploitable’ from ‘vulnerable’ populations,” in Z Bankowski and R. J.
Levine, eds. Ethics and Research on Human Subjects (Geneva: CIOMS, 1993).
World Health Organisation, Operational Guidelines for Ethics Committees that Review Biomedical
Research (Geneva: WHO, 2000).
World Medical Association, Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical
Research Involving Human Subjects (Adopted by the 18,h World Medical Assembly, Helsinki, Finland,
June 1964, amended by the 29'1’ World Medical Assembly, Tokyo, Japan, October 1975; the 35lh World
Medical Assembly, Venice, Italy, October 1983; the 41st World Medical Assembly, Hong Kong, September
1989; and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996).
World Medical Association, Declaration of Lisbon on the Rights of the Patient, (Adopted by the 34lh World
Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47lh General Assembly,
Bali, Indonesia, September 1995).
United States Department of Health and Human Services, Rules and Regulations, reprinted in R. J. Levine,
Ethics and Regulations of Clinical Research (Baltimore, Munich: Urban and Scharxenberg, 1981).
!
Z Bankowski and R. J. Levine, eds. Ethics and Research on Human Subjects (Geneva: CIOMS, 1993).
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