You are on page 1of 7

Kurjak-13.

qxd 5/13/2006 11:33 AM Page 139

13 Ethical committees
J. G. Schenker

In the last two decades, ethical issues in medicine response to the atrocities committed by Nazi research
have come to the forefront of public consciousness, physicians that were revealed at the Nuremberg War
with concern focusing on several important areas. Crimes Trials. Many of their experiments had entailed
Advances in scientific and technological knowledge the deliberate killing of, or infliction of grievous injuries
have created ethical dilemmas about what is right and on, prisoners whose rights to consent or refuse were
wrong, about life and death issues, as well as issues of ignored. Thus, it was to prevent repetition by physi-
equality, justice, and personal preferences. Biomedical cians of such attacks on the rights and welfare of human
ethics also raised issues on patients’ rights, which beings that human-research ethics came into being. The
required steps to be taken to protect the patient’s Nuremberg Code, issued in 1947,1 laid down the stan-
welfare and to promote the patients’ autonomy. dards for carrying out human experimentation, empha-
Society’s concern for ethical issues in medical prac- sizing the subject’s voluntary consent:
tice has led to a growing need for the medical profes-
sion to become fully aware of the public view not only
(1) The voluntary consent of the human subject is
on individual patient–physician relationships, but also
essential. This means that the person involved
on how medical developments affect social structure
should have legal capacity to give consent;
and health policies. Health policy makers as well must
should be so situated as to be able to exercise free
examine the ethical basis of decision making, prioriti-
power of choice without the intervention of any
zation, and conflicts of interest as they influence health
element of force, fraud, deceit, duress, over-
care locally, nationally, and internationally.
reaching, or other ulterior form of constraint or
Biomedical ethical issues, guidelines, principles and
coercion; and should have sufficient knowledge
regulations cut across national boundaries and often
and comprehension of the elements of the sub-
have universal implications. Although cultures differ,
ject matter involved so as to enable him to make
certain values are common to all. In this context, the
an understanding and enlightened decision. This
most important is respect for human dignity, and this
latter element requires that before the acceptance
should not be negotiable. The establishment of interna-
of an affirmative decision by the experimental
tional and interdisciplinary forums in which scientists
subject there should be made known to him the
and lay people can exchange views on topics of imme-
nature, duration, and purpose of the experiment;
diate concern, unhampered by administrative, politi-
the method and means by which it is to be con-
cal, or other considerations was needed. They are
ducted; all inconveniences and hazards reason-
intended especially for the discussion of the scientific
ably to be expected; and the effects upon his
and technical bases of advances in biology and medi-
health or person that may possibly come from
cine and other related areas and their social, economic,
his participation in the experiment. The duty
ethical, administrative, and legal implications.
and responsibility for ascertaining the quality of
The range of ethical questions raised by new scien-
the consent rests upon each individual who ini-
tific achievements in the life science and methods of
tiates, directs, or engages in the experiment. It is
taking care of women’s health, especially assisted repro-
a personal duty and responsibility that may not
duction, have been debated by international political
be delegated to another with impunity.
and professional bodies. Within international commit-
(2) The experiment should be such as to yield fruit-
tees, diverse geographic, ethnic, cultural, linguistic, and
ful results for the good of society, unprocurable
religious backgrounds are represented.
by other methods or means of study, and not
random and unnecessary in nature.
The Nuremberg Code (3) The experiment should be so designed and
based on the results of animal experimentation
The first international code of ethics for research involv- and knowledge of the natural history of the
ing human subjects – the Nuremberg Code – was a disease or other problem under study that the

139
Kurjak-13.qxd 5/9/2006 11:33 AM Page 140

140 Ethical committees

anticipated results will justify the performance is to contribute to peace and security in the world
of the experiment. by promoting collaboration among nations through
(4) The experiment should be so conducted as to education, science, culture, and communication to
avoid all unnecessary physical and mental further universal respect for justice, for the rule of
suffering and injury. law, and for the human rights and fundamental free-
(5) No experiment should be conducted where doms that are affirmed for the peoples of the world
there is an a priori reason to believe that death without distinction of race, sex, language, or religion.
or disabling injury will occur, except, perhaps, At the international level, UNESCO has been one of the
in experiments where the experimental physi- principal promoters of the reflection on ethics of living.
cians also serve as subjects. In 1993, UNESCO created the International Bioethics
(6) The degree of risk to be taken should never Committee (IBC). The IBC3 is a forum for debate and
exceed that determined by the humanitarian reflection and for the elaboration of UNESCO’s norma-
importance of the problem to be solved by the tive actions, particularly with regard to the imple-
experiment. mentation of the Universal Declaration on the Human
(7) Proper preparations should be made and adequate Genome and Human Rights. It is up to the IBC to keep
facilities provided to protect the experimental up with progress in genetics while taking care to
subject against even remote possibilities of injury, ensure respect for the values of human dignity and
disability, or death. freedom in view of the potential risks of irresponsible
(8) The experiment should be conducted only by attitudes in biomedical research. The IBC has drafted
scientifically qualified persons. The highest statutes and published reports on the ethical aspects of
degree of skill and care is required through all human embryonic stem cell research and its use in ther-
stages of the experiment of those who conduct apeutic research; ethical issues on genetic screening and
or engage in the experiment. the testing, treatment, storage, and use of genetic data on
(9) During the course of the experiment, the human genetic screening; and human gene therapy.
subject should be at liberty to bring the experi-
ment to an end if he has reached the physical or
mental state where continuation of the experi- WHO – World Health Organization
ment seems to him to be impossible.
(10) During the course of the experiment, the scien- The Health Organization of the League of Nations was
tist in charge must be prepared to terminate the set up in Geneva in 1919. In 1945, the United Nations
experiment at any stage if he has probable cause Conference on International Organization established
to believe, in the exercise of the good faith, a new, autonomous, international health organization –
superior skill, and careful judgment required of the World Health Organization (WHO). The objective
him, that a continuation of the experiment is of the WHO is the attainment by all peoples of the
likely to result in injury or death to the experi- highest possible level of health.4
mental subject. All research involving human The WHO’s constitution affirms fundamental ethi-
subjects should be conducted in accordance cal principles, such as the equality of rights and the
with three basic ethical principles, namely, unalienable dignity of all human beings. The WHO
respect for persons, beneficence, and justice. has set technical standards and proposed guidelines
and codes of good practice in virtually all its fields
The Nuremberg Code document was criticized of activity, including the widely publicized areas of
because it does not distinguish between different organ transplantation, breast-milk substitutes, essen-
types of biomedical experimentation. The Nuremberg tial drugs, the marketing of pharmaceuticals, and,
Code makes the subject’s legal capacity to consent a more recently, reproductive health, environmental
prerequisite to experimentation, thus excluding from health, and emerging diseases. The WHO also con-
participating in research many people who might ben- tributes to harmonizing legislation and terminology
efit from the results obtained, including children, the and fosters the dissemination and exchange of infor-
mentally ill, and others who are unable to give legal mation on these subjects. Ethics continues to provide
consent. the basis for the WHO’s activities and functions. Several
WHO programs have their own ethical review com-
mittees; additional activities are carried by consulta-
UNESCO – The United Nations tion on ethics and health at the global level.

Educational, Scientific and Cultural


Organization The Declaration of Helsinki
The United Nations Educational, Scientific and The Declaration of Helsinki, promulgated in 1964 by
Cultural Organization (UNESCO) was established on the World Medical Association, is the fundamental
November 16, 1945.2 The main objective of UNESCO document in the field of ethics in biomedical research
Kurjak-13.qxd 5/9/2006 11:33 AM Page 141

The Declaration of Helsinki 141

and has had considerable influence on the formulation non-beneficial research fall solely on the research
of international, regional, and national legislation and subject, whereas the benefits may extend beyond the
codes of conduct. The Declaration, revised in Tokyo research subject to the population as a whole.
in 1975, in Venice in 1983, and again in Hong Kong in The spirit of the Declaration of Helsinki is that, in
1989,5 is a comprehensive international statement medical research, the interests of science and society
of the ethics of research involving human subjects. It is should never take precedence over considerations
the mission of the physician to safeguard the health of related to the well-being of the subject. Only a minimal
the people. The physician’s knowledge and conscience level of risk may be allowed for volunteers to subject
are dedicated to the fulfillment of this mission. Medical themselves for the benefit of others. However, it
progress is based on research that ultimately must rest remains a problem to decide what sorts of levels of
in part on experimentation involving human subjects. In risk are acceptable in the case of pregnant women and
current medical practice, most diagnostic, therapeutic, where the subjects of non-therapeutic research are not
or prophylactic procedures involve hazards. autonomous (e.g. premature and newborn babies).
The purpose of biomedical research involving It is generally accepted that pregnant and nursing
human subjects must be to improve diagnostic, thera- women are not suitable subjects of clinical trials other
peutic, and prophylactic procedures and the under- than those that are designed to respond to the health
standing of the etiology and pathogenesis of disease. In needs of such women or their fetuses or nursing
the field of biomedical research, a fundamental distinc- infants. Clinical trials for conditions associated with
tion must be recognized between medical research in or aggravated by pregnancy and to test the safety and
which the aim is essentially diagnostic or therapeutic efficacy of drugs, methods, and devices for detecting
for a patient and medical research the essential object of fetal abnormalities and well-being are of primary
which is purely scientific and without implying direct importance in the medical field of perinatology. The
diagnostic or therapeutic value to the person subjected justification for the participation of pregnant women
to the research. in clinical trials is that they should not be deprived
In 1992, International Ethical Guidelines for arbitrarily of the opportunity to benefit from investi-
Biomedical Research Involving Human Subjects were gational drugs, vaccines, or other agents that promise
introduced by The Council for International therapeutic or preventive benefit. In all cases, risks to
Organizations of Medical Sciences and WHO based pregnant women, fetuses, and newborns should be
on ethical principles.6 All research involving human minimized, as far as sound research design permits.
subjects should be conducted in accordance with As a general rule, pregnant or nursing women should
three basic ethical principles: respect for persons, not be the subjects of clinical trials except when such
beneficence, and justice. Respect for persons incorpo- trials are designed to protect or advance the health of
rates at least two fundamental ethical considerations: pregnant or nursing women or fetuses or nursing
(1) respect for autonomy, which requires that those infants and for which women who are not pregnant or
who are capable of deliberation about their personal nursing would not be suitable subjects.
choices should be treated with respect for their capa- Some therapeutic research on fetuses in utero must be
city for self-determination and (2) protection of persons allowed. It contributes to the discovery of new methods
with impaired or diminished autonomy, which for treating fetal health problems. There is a consensus
requires that those who are dependent or vulnerable that research on fetuses in utero should be treated as
be afforded security against harm or abuse. human subjects research, and governed by the policies
For all biomedical and clinical research involving for human subjects research. Because fetuses in utero
human subjects, the investigator must obtain the and pregnant women are linked to each other, research
informed consent of the prospective subject. Informed on one may affect the other. Such research may have a
consent is based on the principle that competent indi- differential impact on the pregnant woman and the
viduals are entitled to choose freely whether to par- fetus, with one benefiting while the other does not, and
ticipate in research. Informed consent protects the may be harmful to the other. At the extreme, the
individual’s freedom of choice and respects the indi- research that is beneficial to the one may actually be
vidual’s autonomy. In the case of an individual who harmful to the other. The fundamental presupposition
is not capable of giving informed consent (e.g. a fetus, of all ethical policies is that the independent review
a newborn, or a small child), the proxy consent of process for human subjects research must consider the
a properly authorized representative should be interests and rights of both parties in reviewing research
obtained. In all human research, ethical guidelines protocols. Most guidelines have also imposed addi-
have differentiated between beneficial (therapeutic) tional requirements on the acceptable level of risk to the
and non-beneficial (non-therapeutic) research. The fetuses involved in the research protocol. It is assumed
therapeutic research subject stands to gain as much that fetuses have some moral standing so that some
from the research, whether it be a procedure or a drug, concern must be devoted to their interests and rights.
as to lose from it. In the non-therapeutic research, the Sir John Peel’s report, published in 1972,7 presented
subject cannot possibly benefit himself, and any ben- governmental guidelines concerning the ethics of fetal
efits can therefore only add to others. The risks of a research. The recommendations were as follows:
Kurjak-13.qxd 5/9/2006 11:33 AM Page 142

142 Ethical committees

• Viable fetuses should not be subjected to non- the aim of providing guidelines for the attention of
beneficial research. physicians and the public in developed and developing
• Research is permitted on the whole alive previable countries.
fetus, dead fetus, or its organs. From its inception this committee was not
• Dead fetuses or tissues may be used in accordance intended to solve these ethical dilemmas, but rather to
with the provisions of the Human Tissue Act, which raise discussion by suggesting the perspectives that
governs the postmortem use of human tissue. this group of health professionals, lawyers, and ethi-
• Parental informed consent should be obtained. cists arrived at after carefully crafted analysis and
• The validity of the research should be assured. debate over these issues. Given the rich field of ethical
issues in women’s health that derive from not only the
The National Commission for the Protection of reproductive life cycle, but also the economic and
Human Subjects in Biomedical and Behavioral political status of women internationally – this com-
Research was established in July 19748 and issued its mittee will always confront new issues and even new
recommendations. The guidelines have certain things aspects of old issues that challenge ethical perspec-
in common with the British guidelines but differ on tives and practice. There are continual variations on
some grounds. The common points are that dead themes the committee has raised in the past through
fetuses and their tissues are to be afforded the respect new medical developments. The social status of women,
of other dead human bodies and tissues. Fetuses with the constraints on health care dollars, and the health
a chance of survival are to be treated like children. status of women have also increased the need for the
Willful damage to the fetus in utero may not be committee to address the broader set of rights and
caused, presumably lest a mother change her mind economic issues that directly influence the health of
about abortion. Significant differences are that in the women and the ethical setting of their care.
United States, regulations fathers can veto the The committee was composed of a range of inter-
research, whereas in the British guidelines there is no national members who represented developing and
such specific provision. In Britain it is proposed that developed countries and had a significant interest and
non-beneficial research is to be done on the fetus expertise in medical ethics. The members of the FIGO
in utero or on the viable fetus, whereas in the United Committee are obstetricians, gynecologists, oncolo-
States it may be done if there is minimal risk. gists, lawyers, and public health workers, all of whom
represent diverse geographic, ethnic, cultural, linguis-
tic, and religious backgrounds. Among the 14 members,
Council of Europe 13 were chairs of leading obstetric and gynecologic
departments.
In 1985, the Council of Europe created a multidisci- The initial task of the FIGO Committee for the
plinary body with experts appointed by each member Study of Ethical Aspects of Human Reproduction was
country. This committee has already produced docu- to identify and study the important ethical problems
ments on reproduction research on human subjects, confronting health care practitioners in human repro-
prenatal diagnosis and screening, and genetic testing. duction. The ethical problems identified were to be
Once the Committee of Ministers approves these docu- brought to the attention of physicians and the public
ments, they become recommendations for the national in the developed and developing countries to provide
parliaments, which may or may not decide to follow ethical guidelines where appropriate. This task has
them. The European assembly and other committees assumed greater importance with the continuing
have also issued reports related to bioethical prob- challenge of ensuring that women are granted human
lems. The Council of Europe, which represents all the and reproductive rights worldwide. Furthermore, the
democratic countries of Europe, has organized a complexity of incorporating the many ethical aspects
European Convention on Bioethics. The Committee of reproductive issues in different societies, for issues
published protocols regarding human experiments such as cloning, or patenting of the human genome,
and organ transplantation.9 argues for the need for such a consensus body.
There is no other body internationally that confronts
these issues with a view toward the impact on the
FIGO Committee for the Study health care of women. Because of this, the opinions of
the committee are used by women’s health practition-
of Ethical Aspects of Human ers internationally to assist them in setting national or
Reproduction local standards, to expand the depth of discussion of
these issues locally, and to support their advocacy for
In 1985, the FIGO Committee for the Study of Ethical improvements in the health and status of women inter-
Aspects of Human Reproduction was established.10 Its nationally. In the face of rapid cultural and scientific
main objectives were the recording and study of gen- change, this is a critical role of ever-greater need.
eral ethical problems emanating from the research Women are clearly vulnerable in countries where their
and practice of human reproductive medicine, with health care rights are either non-existent or threatened,
Kurjak-13.qxd 5/9/2006 11:33 AM Page 143

FIGO Committee for the Study of Ethical Aspects of Human Reproduction 143

and thus, these guidelines can be a powerful force to after fertilization (not including any time during
support the rights of women. which the embryo had been frozen).
The work of the Committee: In its first Congress as a (3) Research projects on pre-embryos should be
standing committee, the Ethics Committee presented authorized by ethical and/or other appropriate
three seminars: on medical ethics and medically assisted bodies in the country and, if allowed, appropri-
reproduction, on AIDS with emphasis on ethical ate informed consent must be obtained before
aspects, and on refusal of obstetrical care (maternal undertaking research on pre-embryos, normally
health, fetal health, and neonatal health), which were from both gamete donors. Furthermore, provision
published in the proceedings of the Rio Congress. of gametes and pre-embryos should not be
The early focus of the Committee, from 1985 to subject of commercial profit.
1991, was clearly in areas central to obstetrics and (4) The Committee was unable to reach a consensus
gynecology practice, with a focus on such areas as as to whether research should be limited to sur-
sterilization, research on pre-embryo, and elective plus pre-embryos or should also include pre-
reduction of multiple pregnancies. In the same time embryos specifically generated for research, a
period, however, the committee began to explore what debate that continues worldwide. The discussion
the ethical responsibilities of societies of gynecology over this issue established the precedent that
and obstetrics were for the broader issues of provision committee statements required consensus, and
of reproductive health care and women’s health in where that was not possible, debates were either
general. This led to a seminar during the FIGO Singapore not included or included with the caveat that
Congress focusing on issues such as: there was no consensus.

• How much are mothers worth? The deliberations are made public through committee
• Distribution of resources between primary and statements published in scientific journals and in
tertiary reproductive care. specific reports. The FIGO Committee has discussed
• Availability of resources for newborn care. and provided guidelines on general issues in women’s
• Macroethical issues in obstetrics and gynecology. health and advocacy, issues on genetics, embryo
research, contraception, abortion, and reproductive
This key seminar was chaired by Profs. Sureau and endocrinology issues regarding pregnancy, maternal–
Schenker, and marked an important expansion of the fetal health, and neonates. The first bound publica-
thinking of the Committee beyond that of the common tion of the collated Issues and Guidelines appeared in
bioethical analysis of the time, which focused on 1994, 1997, and 2000, and by 2003 had grown to a
principles such as benefit (beneficence), harm (mal- body of work that, with the translations into Spanish
eficence), and patient autonomy in the area of human and French, covers 232 pages.11
rights and justice. During this time, the Committee The method of analysis adopted by the committee
also began to align its meetings with regional meet- evolved early on and consisted of position papers on a
ings that paralleled the focus of the committee on eth- topic identified by the committee that were circulated
ical aspects of human reproduction. The first of these prior to committee meetings in the working language of
took place in Cairo in 1991 and focused on bioethics the committee, English.
in human reproduction research in the Muslim These research papers explicated the problem, the
World. The committee meeting foreshadowed an area present status of knowledge, and the various ethical
of ongoing controversy in medicine – that of trans- stances or issues that were identified in the literature.
plantation. At that time the group considered whether At times, the committee invited outside experts in
research on pre-embryos was required in order to areas where there was not felt to be adequate depth of
broaden our knowledge of the developmental process, expertise or where there were other FIGO committees
to improve the treatment of infertility and the control working on the medical or rights aspects of the same
of reproduction, and to permit genetic screening with issue. The papers were presented at the meeting and a
its potential for the prevention and treatment of birth consensus about the important background and ethi-
defects. The Committee recognized and tried to incor- cal issues was identified.
porate the diverse spectrum of ethical, cultural, and Depending on the issues, further work on synthe-
religious values regarding the status of the pre- sizing these into a set of reflections or guidelines
embryo. However, agreement was reached on some might take place at the meeting or over several meet-
key areas even with these divergent views: ings, until every word of each document was reviewed,
read, and revised by all the members of the commit-
(1) First, research on pre-embryos is only ethically tee. Proposed statements were read line by line and
acceptable when its purpose is for the benefit of edited by the entire committee to assure that not only
human health and only if animal models would the content was acceptable to the committee, but that
not suffice. the translations to French and Spanish would not
(2) The Committee felt that no developing human contain errors because of the likely translation from
pre-embryo might be kept alive beyond 14 days English.
Kurjak-13.qxd 5/9/2006 11:33 AM Page 144

144 Ethical committees

The committee statements and opinion are inde- bioethical committees protect the public by monitoring
pendent from FIGO member societies or the executive and, when necessary, regulating scientific practice.
board. The documents represent the result of that There is no single solution to a moral problem. A com-
carefully researched and considered discussion. This mittee must incorporate a number of different moral
independence has been particularly helpful to FIGO ideals and reach a workable compromise. The law that
in providing ethical guidance regarding the relation- these committees create must be in step with moral
ship of the federation to industry, initially formulated beliefs, or it will not be implemented. It is the task of the
as internal ‘Guidelines for Relations between Industry ethics committee to try to produce some consensus,
and FIGO’ in 1991. The committee collaborates with based on all considerations, and to recommend it for
international organizations – such as the WHO – on practice. Several problems arise in the setup of the
various aspects of women’s health to ensure that the committees. Who should make moral decisions in
ethical aspects are fully covered. controversial public issues? How is the committee’s
The committee members represent a wide spectrum membership to be determined? In a pluralistic, mainly
of religions and countries, and numerous members have secular society there are no moral experts per se.
co-coordinated with multiple international committees Committees who serve public morality must conform to
to encourage and ensure inclusion of these ethical certain specifications of expertise. The committee mem-
aspects in regular and extraordinary meetings. bers must be capable of understanding the scientific
background of the subject matter of the issue. They must
be acquainted with moral philosophy and understand
WAPM – World Association the nature of ethics. The members must be intelligent
and creative and not dogmatic. It is imperative that
of Perinatal Medicine people who hold particular moral or religious views
In 1999, the World Association of Perinatal Medicine that make them impervious to the language of consen-
established an Ethical Committee. The main objec- sus are not included in the committee’s team. They may
tives of the committee are:12 be incapable of sympathy and flexibility and thus not be
of use. The members must also be readily available to
• To study the ethical problems that emanate from perform this extremely time-consuming task. One major
practice and research in perinatal medicine. disadvantage of these committees is that sometimes the
• To provide guidelines for the practice of obstetrics advent of new technologies is ahead of committee delib-
and neonatology. erations. If a previous committee decision was opposed
• To bring the ethical issues to the attention of physi- to specific new advances, their use may be delayed until
cians, nurses, paramedical staff, and the public. the committee changes its original decision. In most
Western countries, committees are set up ad hoc to
address specific subjects of public bioethical concern.
National Ethics Committees The Warnock Committee on Human Fertilization and
Embryology (1984) had a great influence on subse-
National ethics committees are set up by governments quent legislation in the United Kingdom.13 In the
to advise on regulations or proposed legislation con- United States, legislation that seems to reinforce ethi-
cerning moral bioethical programs that raise contro- cal conduct may actually replace the exercise of ethi-
versy among professionals and the public. National cal judgment with unreflective obedience to law. The
committees were originally created due to an increas- Belmont Report (1979) identified the basic ethical
ing demand among doctors and researchers for some principles that should emphasize the conduct of
authoritative guidance as to what was permissible in biomedical and behavioral research involving human
issues where no law exists. The nature of the member- subjects and developed guidelines that should be fol-
ship of such committees is of even greater importance. lowed to ensure that such research is conducted in
The chairman must be unrelated to the medical or accordance with those principles.14 The guidelines
research profession. The members of national ethics provided by national committees are usually converted
committees must represent a broad range of values and into laws by legislation that introduces criminal
professional expertise in the fields of medicine, law, punishment for violation. The experience of Assisted
administration, media, economics, public policy, and Reproductive Technology (ART) practice demonstrated
moral philosophy. Within committees dealing with that countries with voluntary guidelines seem to enjoy
reproductive health, for example, at least 50% of public confidence, and public pressure for a change
the members must be women. Governmental or non- seems minimal. Countries with legislative surveillance
governmental bodies have issued reports on ethical seem to agree that it works well, although there are
and legal aspects, especially in the fields of perinatal understandable complaints about the slowness of the
care, assisted reproduction technologies, and human legislative process and the difficulty of having regula-
experimentation. Scientific progress is ahead of what tions changed once they are in place, and thus, not be
society is willing to accept, and the reports of the of use.
Kurjak-13.qxd 5/9/2006 11:33 AM Page 145

Summary 145

Summary administrative, political, or other considerations, was


needed. They are intended especially for the discus-
The range of ethical questions raised by new scientific sion of the scientific and technical bases of advances
achievements in the life science, and methods of in biology and medicine and other related areas and
taking care of women’s health especially, has been their social, economic, ethical, administrative, and legal
debated by international political and professional implications. Commissions appointed by institutions,
bodies. Biomedical ethical issues, guidelines, princi- governments, and international bodies serve to relieve
ples, and regulations cut across national boundaries the medical profession from making ethical decisions
and often have universal implications. Although cul- and to protect human subjects from any harm. The
tures differ, certain values are common to all. In this deliberations of these committees are usually followed
context, the most important value is respect for human by guidelines of operation, which in many cases have
dignity, and this should not be negotiable. The estab- become abiding law. For these committees to be of full
lishment of international and interdisciplinary forums advantage, they must convene promptly as issues
in which scientists and lay people can exchange views arise so as not to delay medical advances from being
on topics of immediate concern, unhampered by implemented.

REFERENCES

1. The Nuremberg Code. In Anna GJ, Grodin MA, eds. The Nazi concerning fetuses, pregnant women, and in vitro fertilization.
Doctors and the Nuremberg Code: Human Rights in Human Fed Reg 1977;42(9)2792–3.
Experimentation. New York: Oxford University Press, 1992. 9. The Council of Europe. Principles concerning medical research
2. Constitution. London: UNESCO, 1945. on human beings. WHO Int Digest Health Legislation 1990;
3. International Bioethics Committee. Statutes of the International 41:3–6.
Bioethics Committee. London: UNESCO, 1998. 10. Schenker JG, ed. Recommendations on Ethical Issues in
4. WHO. From small beginnings. World Health Forum 1988; Obstetrics and Gynecology by the FIGO Committee for the
9:29–34. Study of Ethical Aspects of Human Reproduction. London: FIGO
5. World Medical Association. Declaration of Helsinki. In Anna GJ, 1994:7–8,11.
Grodin MA, eds. The Nazi Doctors and the Nuremberg Code: 11. Recommendations on Ethical Issues in Obstetrics and
Human Rights in Human Experimentation. New York: Oxford Gynecology by the FIGO Committee for the Study of Ethical
University Press, 1992:311–343. Aspects of Human Reproduction. London: FIGO, 1994, 1997,
6. International ethical guidelines for biomedical research involving 2000, 2003.
human subjects. In: Bankowski Z, Levine RJ, eds. Proceedings of 12. Schenker JG. Report from the Ethical Committee of the World
the 26th CIOMS Conference, Geneva, Switzerland, February 5–7, Association of Perinatal Medicine. J Perinat Med 2000;28:3–6.
1992. Geneva: CIOMS, 1993:1–36. 13. Warnock DM. Report of the Committee of Inquiry into Human
7. Department of Health and Social Security, Scottish Home and Fertilization and Embryology. London: HMSO, 1984.
Health Department, Welsh Office. The Use of Fetuses and Fetal 14. National Commission for the Protection of Human Subjects
Material for Research: Report of the Advisory Group. London: of Biomedical and Behavioral Research. The Belmont Report:
Her Majesty’s Stationery Office, 1972. Ethical Principles and Guidelines for the Protection of Human
8. US Department of Health, Education, and Welfare, Office of the Subjects of Research. United States: Office for Protection from
Secretary. Protection of human subjects: proposed amendments Research Risks, 1979:1–8.

You might also like