introduction to bioethics
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Introduction to Bioethics. Dr Adedeji O. Adekanye MBBS, FWACS( Urol ), Dip.(Health Res. Ethics) Director, CHAR & Program Coordinator, Residency Training Urology Unit, Department of Surgery, Federal Medical Centre, Bida . Nigeria. E-mail: [email protected]. Bioethics – what is it?. - PowerPoint PPT PresentationTRANSCRIPT
Introduction to Bioethics
Dr Adedeji O. AdekanyeMBBS, FWACS(Urol), Dip.(Health Res. Ethics)
Director, CHAR & Program Coordinator, Residency Training
Urology Unit, Department of Surgery, Federal Medical Centre, Bida. Nigeria.
E-mail: [email protected]
Bioethics – what is it? Morality is the general term for an individual
individual’s or society’s standard of conduct, both actual and ideal, and of the character traits that determine whether people are considered good or bad
The scientific study of morality is called descriptive ethics – in this case, a scientist describes the moral judgments, beliefs or actions of individuals or societies in empirical terms and the reasons given for actions and beliefs
Bioethics – what is it?• There are two philosophical approaches tostudying ethics
• Meta-ethics – analysis (meaning) of the methods, concepts and terms of reasoning• Normative Ethics – analysis of what thestandards of moral judgment ought to be. Areflection on the kinds of actions and principles that will promote moral behavior
Bioethics – what is it?Ethics is different from morals. Ethics tries to probe the reasoning behind
our moral life, by examining and analyzing the thinking used to justify our moral choices and actions in particular situations
Bioethics is a specific discipline that probes the reasoning behind our moral life within the context of the life sciences; how we decide what is morally right or wrong bioscience
Bioethics – what is it? Bioethics is normative ethics applied to the
practice of science and medicine. It falls under the general group of applied and professional ethics
It is predicated on an assumption that somesolutions to the ethical problems that arise in science and medicine are more moral than others and that these solutions can be arrived at by moral reasoning and reflections
Bioethics – what is it? It is a branch of knowledge like
mathematics, and thinking in this field isnot wholly different from thinking in thoseother fields, however it cannot be reducedto them.
Bioethical conclusions cannot beunambiguously proved like mathematicaltheorems
Let us remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who deplore that particular disease be not conquered, but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having - Jonas
History of research ethics• Perhaps the earliest clinical trial was that of
Lind – conducted over a 6 year period in the 18th century
Sailors were allocated to receive or not receive fruits and vegetables during an investigation of the etiology of scurvy
History of research ethics About 25 years after that, Edward Jenner
conducted his famous chickenpox vaccination studies for prevention ofsmallpox, using children in his neighbourhood including his own children
In 1897, Sanarelli discovered the cause of yellow fever and to prove his claim inoculated 5 people with his isolate withdisastrous consequences for the participants
History of research ethics 3 years later, the U.S. commissioned yellow
fever study under Walter Reed• There was public concern in the United
States about this research• Walter Reed Reed’s s “Yellow Fever Board
Board” sketched some guidelines for research ethics including• Self experimentation• Enrollment of only adults• Signed contract with sliding scale compensation
History of research ethics In 1931 Germany enacted arguably the first
research ethics regulations in response to the increasing use of human participants in research being driven by the strength of the
German health research and chemical industry
The very strict “Richtlinien” outlined how to conduct human experimentation and the use of innovative therapies in medicine
History of research ethics Two of the 14 provisions of these guidelines
concerned consent requirements Questions about nature of appropriate
information, bona fide consent, careful research design, special protections for vulnerable subjects were all carefully outlined
Experimentation on dying patients was completely forbidden
History of research ethics
No other nation had such legally and morally advanced regulations at this time
• These regulations were in force and binding throughout Germany before and through the duration of the Second World War
History of research ethics• Yet, the Nazi experiments comprehensively
ignored and violated every one of the regulations
• The Nuremberg trial that followed the second world war experiments focused attention on the need for a code of research ethics
• Prosecutors argued that the experiments violated fundamental ethical standards of civilized society
Nuremberg code 1948
While there was concern about ethical research before it, it was the Nuremberg trial that focussed attention on the need for a code of research ethics
This was the trial of Nazi doctors who conducted experiments on prisoners. Prosecutors argued that the experiments violated fundamental ethical standards of civilized society, however at that time, there were no codes of ethics for conducting research on human beings
Nuremberg code 1948 The main components of the code
are– Requirement for voluntary
participation– Informed consent– Favorable risk/benefit analysis– Right to withdraw without penalty
Criticized for being legalistic Largely ignored by medicine No mention of independent
review or fair selection of participants
Nuremberg code 1948 It also seem to prohibit many aspects of
medical research because of its unqualified demand for voluntary informed consent
The Nazi doctors themselves were not judged on the basis of the code as this would have been an instance of ex post facto justice
There is also controversy about the origins and inspirations for the Nuremberg code
1950s Wichita Jury Study Social science researchers from the University of
Chicago conducted a study involving secret audio taping of jury deliberations in order to better understand decision making process of jurors in criminal trials
Their hypothesis was that showmanship on the part of trial attorneys was affecting the outcome of trials
When the results were presented in respectable academic forums, public reaction was markedly negative
1950s Wichita Jury Study People objected to deception for research purposes in
a setting where privacy and confidentiality were critically important
This prompted the U.S. Congress to pass a law prohibiting recording of jury deliberations, marking the first time that actions of well meaning researchers will result in action to protect people from exploitation
Case highlighted the fact that some research questions cannot be answered without compromising the integrity of significant and cherished social institutions
1950 Willowbrook Hepatitis StudyResearchers deliberately exposed children and adolescents with disabilities to hepatitis virus in order to discover a way of preventing the disease
Critics claimed the study was coercive because • New admission into the institution was closed• Parents of children on the waiting list were written to inform t them that their children could be placed on a research ward after which they could be transferred to the facility
1950 Willowbrook Hepatitis Study The researchers argued that almost all the
children admitted into the facility develop hepatitis anyway and this mitigated the deliberate exposure for the benefit of science
However at the time the study was initiated, the rates of hepatitis had declined considerably
Researchers argued that they had obtained consent from the parents
1950 Willowbrook Hepatitis Study That all various university, state and U.S. Armed
Forces Epidemiological Board (which funded the study) committees had reviewed and approved the study
Critics argued that because the participants were severely mentally retarded children whose parents wanted placed in one of few public institutions available rendered the consent invalid
Researchers argued that the mental retardation was besides the point while critics retorted that that was precisely the point
1960s Thalidomide Study
Thalidomide was introduced for the treatment of hyperemesis gravidarum in Europe and while still undergoing review in the U.S., an influential group of East Coast practitioners started using it before it became clear that it was causing a large number of birth defects
Public outrage led to legislation that required investigators to obtain informed consent before administering investigational medications
Jewish Chronic Diseases HospitalStudies• In July 1963, 2 physicians at the Brooklyn Jewish
Chronic Disease Hospital injected ill elderly patients with live hepatic cancer cells without their informed consent
• The aim of the study was to study “rejection of human cancer cells cells”
• Background studies suggest that such cells would be rejected by immune reaction leading to their rejection from the body
• It was then argued that the experiments present no risk to the participants
Jewish Chronic Diseases HospitalStudies
•The researchers argued that informing participants about details of the research would have caused them needless
psychological distress
•Failure to inform was thus based on the need to minimize distress
Jewish Chronic Diseases HospitalStudies•The Board of Regents (Governing Council)
of the University of the State of New York argued that while “therapeutic privilege” may justify non-disclosure in a physician-patient relation, same is not true of researcher-participant relationship
• This case, among other things, highlighted the problem of conflicting loyalties for physician-researchers
Tuskegee• Study was initiated in Macon County,
Alabama in 1932• Designed to take advantage of an epidemic
of syphilis among the black population to take study the natural history of syphilis
• Over 400 sharecroppers were recruited• Neither they nor their partners were
informed about the nature of the research or about their condition
Tuskegee
• When penicillin became available, they were not given an opportunity to use it
• They were in fact prevented from accessing it or obtaining information about it
• Papers from the study were regularly published in medical journals and it did not evoke any ethical response
• In 1972, press reports finally prompted an investigation and stoppage of the study
Tuskegee
• 74 of the original participants remained alive• Some saw no reason for the outrage after all,
the study was not secret and was well known
• Others contented that the issues at stake were more about racism
• In the 70s participants were compensated and in 1997, U.S. government apologized for the study
1964 World Medical Association Declaration of Helsinki This basically builds on the Nuremberg code Started in 1953/1954, revised in 1975 and
subsequent revisions were in 1983, 1989, 1996 and 2000.
It adds two additional points– That the interests of the subject should always be
given a higher priority than those of society– That every subject in clinical research should get
the best known treatment They have been incorporated in many national
and international guidelines
Other seminal events Henry K.Beecher’s article in NEJM in 1966 1973 Congressional hearings on quality of health
care and human experimentation– Main catalyst for this was the Tuskegee Study (1932 –
1972), but there were others, like– 1950 Willowbrook Hepatitis Study– 1960 Jewish Chronic Diseases Hospital Studies– 1960 Milgram study of obedience to authority– 1970 San Antonio study of contraceptive pills– 1970 Tearoom Trade Study
1974 U.S. National Research Act This act established the modern IRB system. The act created
U.S. federal regulations that required IRB approval before most kinds of research involving human subjects can be conducted, defined policy and procedures that an IRB must follow when reviewing research, and established the criteria that an IRB must use to approve research conduct
The Institutional Review Board (IRB) – a committee mandated by the federal law to protect the rights and welfare of human subjects participating in research activities
1974 National Research Act
It also established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The function of the Commission is to issue recommendations when what to do is not clear to researchers.
In 1979, the Commission issued the Belmont Report
Ethical principles of the Belmont Report and their implications Respect for persons
– Participants must voluntarily consent– Informed consent must be obtained– Privacy and confidentiality must be guaranteed– Extra protection to those with limited autonomy
Beneficence– The risks of research are justified by their potential
benefits– Study is designed to minimize risk– Conflicts of interest are adequately managed
Ethical principles of the Belmont Report and their implications Justice
– Vulnerable subjects are not targeted for convenience
– People likely to benefit from research are not systematically excluded
i.e. equitable selection of subjects.
CIOMS Guidelines• The Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) developed its International Ethical Guidelines for Biomedical Research Involving Human Subjects with special attention to research in developing countries
• Particularly in response to growing research in HIV/AIDS
• It took the Nuremberg Code and Declaration of Helsinki into account
CIOMS Guidelines• Its principles are designed with the socio-economic and political circumstances of developing countries in mind• Development started in 1982• Involved consultation with participants fromdeveloped and developing countries includinghealth ministry officials, ethicists, philosophersand lawyers • First version was released in 1993 with 15 guidelines, while the second version was released in 2002 with 21 guidelines
CIOMS Guidelines• Starts with an argument on the necessity ofresearch• Proclaimed the need for researchers and
sponsors to make every effort to ensure that any intervention or product developed or knowledge generated will be made reasonably available for the benefit of the population or community
• The guidelines tackles the issue of placebo trials in guideline 11, articulating conditions when they can be used
ICH ICH-GCP guidelines
• International Committee on Harmonization Harmonized Tripartite Guideline – Guideline for Good Clinical Practice was promulgated in 1996 by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and has been agreed upon by the regulatory agencies in Europe, Japan and the United States
ICH-GCP guidelines• The ICH ICH-GCP guidelines delineates
detailed standards for review committees, investigators and sponsors
• It is particularly targeted at research on drugs or devices seeking regulatory approval
• While it is rooted in the Helsinki Declaration and applicable local codes, it is far more specific than the other codes but not wider in scope
• It is criticized for being lax on the use ofplacebos in clinical trials
Nigeria’s baby steps• National Health Research Ethics Committee
has been set up with the following membership • Chairman appointed by Hon. Minister of Health• Membership representing Law, Pharmacy,
Medicine, Nursing, Community Health Workers, Christians, Muslim, Researchers and 3 other persons
• Ex Ex-officio members from Ministries of Education, Environment, Women Women’s affairs, Agriculture etc. NAFDAC, NUC
Functions of NHREC• Determine guidelines for the functioning of health
research ethics committees• Register and audit health research ethics
committees• Set norms and standards for conducting research
on humans and animals, including norms and standards for conducting clinical trials
• Adjudicate in complaints about the functioning of health research ethics committees and hear any complaint by a researcher who believes that he has been discriminated against by a health research ethics committee
Functions of NHREC• Refer to the relevant statutory health professional
council matters involving the violation or potential violation of an ethical or professional rule by a health care provider
• Institute such disciplinary action as may be prescribed against any person found to be in violation of any norms and standards, or guidelines, set for the conduct of research under this Act
• Advise the Federal Ministry of Health and State Ministries on any ethical issues concerning research
Functions of NHREC• Review research proposals and protocols in order
to ensure that research conducted by the relevant institution, agency or establishment will promote health, contribute to the prevention of communicable or non-communicable diseases or disability or result in cures for communicable or non-communicable diseases; and
• Grant approval for research by the relevant institution, agency or establishment in instances where research proposals and protocol meet the ethical standards of that health research ethics committee
NHREC Current activitiesCode has been released and can be found athttp://nhrec.net where you have the opportunity
to either read or download it• Comments can be sent to [email protected],
[email protected] or [email protected]• Sub-codes for children, pregnant women,
prisoners, people living with AIDS, and others are in development
• Standard Operating Procedures (SOPs), prototype MTA, consent forms etc are available on NHREC website
Thank you for your attention