A Public Documentary on the History of Research Ethics
Summary
TLDRThis video series educates health professionals on the critical responsibility of protecting human subjects in biomedical and behavioral research. It delves into the historical context of ethical concerns, the evolution of these concerns into current practices, and the establishment of Institutional Review Boards (IRBs). Highlighting key events like the Nuremberg trials and the Tuskegee study, it underscores the importance of informed consent, minimizing risks, and ensuring justice in research. The series also addresses ongoing debates and the need for continuous improvement in safeguarding participants, emphasizing the shared responsibility of researchers, institutions, and IRBs.
Takeaways
- 📚 The video series aims to educate health professionals about their responsibilities in protecting human subjects in biomedical and behavioral research.
- 🔍 The script discusses the historical context of human subject protection, starting from the portrayal of researchers as independent visionaries to the evolution of ethical practices.
- 🧬 The expansion of research in the 20th century led to an increase in human subjects and a growing concern for their protection against potential risks.
- 🏥 The formation of independent committees to review research from an ethical perspective marked a significant step towards strengthening human subject protection.
- 🛡️ The Institutional Review Boards (IRBs) are now recognized as a shared responsibility involving scientists, institutions, government officials, and non-scientists to ensure the rights and welfare of research subjects.
- 📜 The Nuremberg trials following World War II led to the creation of the Nuremberg Code, the first internationally recognized code of medical research ethics emphasizing voluntary informed consent.
- 🎓 The University of Chicago's jury deliberation study in the 1950s highlighted the importance of respecting the privacy and rights of research subjects, even in legal research.
- 💊 The thalidomide case in the early 1960s underscored the need for informed consent and the experimental status of drugs, leading to amendments in the Food Drug and Cosmetic Act.
- 🏥 The Jewish Chronic Disease Hospital incident in 1963 highlighted the importance of transparency and trust in research, especially when dealing with vulnerable populations.
- 🤔 The debate over the ethics of psychological research, exemplified by the Milgram experiment, raised questions about the potential harm to subjects and the ethics of obedience to authority in research settings.
- 📊 Dr. Henry K. Beecher's 1966 article in the New England Journal of Medicine brought attention to numerous ethical issues in the protection of human subjects, emphasizing the need for ethical standards in research.
Q & A
What is the purpose of the videotape series mentioned in the script?
-The purpose of the videotape series is to help health professionals understand their responsibilities for protecting human subjects in biomedical and behavioral research.
What does the term 'IRB' stand for and what is its role?
-IRB stands for Institutional Review Board. It is a committee of scientists and non-scientists that reviews research protocols and consent forms to ensure the rights and welfare of research subjects are protected.
What is the significance of the 1900 consent form used in the yellow fever experiments?
-The 1900 consent form is significant because it serves as an early example of ethical practices in research involving human subjects, showing that even at that time, there was an understanding of the importance of informed consent.
What is the 'Nuremberg Code' and why was it established?
-The Nuremberg Code is the first internationally recognized code of medical research ethics, established in response to the atrocities committed by Nazi doctors during World War II. It outlines the ethical standards for conducting research on human subjects, emphasizing voluntary informed consent and the protection of subjects' rights and welfare.
What was the Wichita jury deliberations study and why did it cause controversy?
-The Wichita jury deliberations study was a research project where University of Chicago researchers recorded jury deliberations without the knowledge of the jurors. It caused controversy because it raised ethical concerns about privacy and consent in research involving human subjects.
What was the thalidomide incident and how did it impact research practices?
-The thalidomide incident involved a drug that, when taken by pregnant women, caused severe birth defects. The drug was widely prescribed without informing patients of its experimental status. This led to public outrage and changes in legislation, including requirements for informed consent in research.
What was the significance of the study involving live cancer cell injections at the Jewish Chronic Disease Hospital in Brooklyn?
-The study was significant because it highlighted a failure to respect research subjects' rights to informed consent. Patients were injected with live cancer cells without being informed of the nature of the procedure, leading to severe ethical criticism and a call for stronger protections for research subjects.
What is the Belmont Report and what does it summarize?
-The Belmont Report is a document issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It summarizes the basic ethical principles underlying research, including respect for persons, beneficence (maximizing benefits and minimizing harms), and justice in the selection of subjects.
What ethical issues were raised by the 'conditions of obedience and disobedience to authority' experiment?
-The experiment raised ethical issues regarding the subjects' consent and the potential psychological harm caused by entrapping them into committing acts they considered unworthy, even though they were later debriefed about the true nature of the experiment.
What was the Tuskegee study and why did it lead to additional protections for research subjects?
-The Tuskegee study was a 40-year-long study on untreated syphilis in black men, where participants were not informed of their condition or that they were part of a research study. The lack of informed consent and the denial of treatment even after the discovery of penicillin led to public outcry and the establishment of additional protections for research subjects, including the requirement for Institutional Review Boards.
What ongoing debates and considerations are there regarding the protection of human subjects in research?
-Ongoing debates and considerations include the limits of research on special populations such as prisoners, infants, or the mentally incapacitated, the legitimacy of various kinds of behavioral research, and the need for additional regulations and improvements in the functioning of Institutional Review Boards.
Outlines
📚 Evolution of Human Subject Protection in Research
This paragraph outlines the historical context and evolution of the protection of human subjects in biomedical and behavioral research. It begins by discussing the shift from individual researchers taking full responsibility for their experiments to the collective responsibility shared by various stakeholders, including clinical investigators, institutions, government officials, and Institutional Review Boards (IRBs). The paragraph highlights the growing concern for subject protection as research expanded and became more complex in the 20th century. It also touches on the establishment of IRBs as committees that review research protocols and consent forms to ensure the rights and welfare of subjects are protected. Key historical events that shaped current protective mechanisms are alluded to, setting the stage for a deeper dive into the subject.
🔍 Ethical Concerns and the Nuremberg Code
This paragraph delves into the ethical concerns surrounding human subject research, referencing the 'do no harm' principle attributed to Hippocrates. It recounts the infamous yellow fever experiments by Walter Reid, emphasizing the importance of ethical practices in research. The Nuremberg trials of 1946 are highlighted as a pivotal moment that led to the creation of the Nuremberg Code, the first international code of ethics for human research subjects. The code established principles such as voluntary informed consent, necessity of experiments, and the responsibility of researchers to protect subjects. It also discusses the impact of the Wichita jury deliberations case and the National Institutes of Health's Clinical Research Center's protocol review requirements, illustrating the ongoing development of ethical standards in research.
💊 The Thalidomide Crisis and the Emergence of Informed Consent
The paragraph discusses the thalidomide crisis, which exposed the need for better informed consent practices. Thalidomide, a drug administered to pregnant women, led to severe fetal deformities and public outcry. This incident, along with the Kefauver Harris hearings, resulted in the 1962 amendments to the Food, Drug, and Cosmetic Act, which mandated informed consent for experimental drugs. The paragraph also covers the 1963 Jewish Chronic Disease Hospital scandal, where patients were injected with live cancer cells without their knowledge, underscoring the importance of transparency and trust in research. These events contributed to the growing awareness and legal requirements for the protection of human subjects.
🛡️ The Development of Institutional Review Boards and Ethical Guidelines
This paragraph describes the development of Institutional Review Boards (IRBs) and the establishment of ethical guidelines for research. It details Dr. James Shannon's initiative to ensure the protection of research subjects, leading to the creation of a committee that would review and design mechanisms for uniform subject protection. The paragraph also discusses the impact of the civil rights movement on the increased concern for human rights in research, including the rights of vulnerable populations. It highlights the significance of the Public Health Service policy statement and the National Research Act of 1974, which mandated IRB review for all federally funded human research and led to the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
🌟 The Belmont Report and Ongoing Ethical Considerations
The final paragraph focuses on the Belmont Report, which encapsulates the basic ethical principles underlying research: respect for persons, beneficence, and justice. It discusses the application of these principles to informed consent, risk-benefit assessment, and subject selection. The paragraph acknowledges the ongoing debate and refinement of methods for protecting human subjects, emphasizing the role of IRBs and researchers in ensuring ethical research practices. It also touches on the persistent challenges in defining the limits of research on special populations and the need for continuous improvement in ethical guidelines and regulations.
Mindmap
Keywords
💡Human Subject Protection
💡Institutional Review Boards (IRBs)
💡Informed Consent
💡Nuremberg Code
💡Ethical Principles
💡Biomedical Research
💡Behavioral Research
💡Research Ethics
💡Thalidomide
💡Tuskegee Study
💡Milgram Experiment
Highlights
Introduction to a series of videotapes designed to educate health professionals on the protection of human subjects in biomedical and behavioral research.
Historical context provided by 'Microbe Hunters', illustrating the transition from individual researchers to a collective responsibility for human subject protection.
The scale of research expanded in the 20th century, leading to increased concern for the protection of a growing number of human subjects.
The establishment of independent committees to review research from an ethical perspective as a response to the complexity of scientific research.
The shared responsibility of human subject protection among clinical investigators, institutions, government officials, and Institutional Review Boards (IRBs).
The significance of the 1900 yellow fever experiments and the early use of consent forms, reflecting ethical considerations in human subject research.
The 'do no harm' principle attributed to Hippocrates as a foundational ethical tenet in experimental medicine.
The Nuremberg trials of 1946 and the creation of the Nuremberg Code, the first international code of ethics for human research subjects.
The Nuremberg Code's emphasis on voluntary informed consent and the responsibility of researchers to obtain it.
The case of the University of Chicago's secret jury deliberation recordings and the ensuing debate on privacy and research ethics.
The formation of early review boards in institutions as a precursor to modern Institutional Review Boards (IRBs).
The thalidomide tragedy and its role in shaping informed consent requirements in the 1962 amendments to the Food Drug and Cosmetic Act.
The 1963 Jewish Chronic Disease Hospital incident, where live cancer cells were injected into patients without proper disclosure.
The influence of the civil rights movement on increasing concern for human rights in research, including the rights of vulnerable populations.
Dr. James Shannon's initiative to systematically protect research subjects and the formation of a committee to review study designs.
The publication of Dr. Henry K. Beecher's article in the New England Journal of Medicine, highlighting unethical practices in human subject research.
The National Research Act of 1974 and the establishment of Institutional Review Boards (IRBs) and the National Commission for the Protection of Human Subjects.
The Belmont Report of 1978, summarizing the basic ethical principles underlying research and discussing their application to informed consent and subject selection.
Ongoing debates and uncertainties regarding the limits of research on special populations and the need for additional regulations and IRB refinements.
The importance of conscientiousness of IRBs and researchers in protecting research subjects, institutions, and society.
Transcripts
this is part of a series of videotapes
intended to help health professionals
understand their responsibilities for
protecting human subjects in biomedical
and behavioral research one program
discusses the criteria used by IRB s for
reviewing research another shows how to
apply the basic ethical principles which
underlie the involvement of human
subjects the series begins with this
program which looks at the historical
backdrop of concern for human subject
protection it then follows the evolution
of these concerns toward present-day
practices
in 1926 Paul dick rife published microbe
hunters a popular history of biomedicine
in it he portrayed researchers such as
Louis Pasteur and Walter Reed as
independent visionaries struggling alone
to understand and conquer disease we
start our examination of concern for
protecting human research subjects by
recalling the crimes popular book
because it represents a transition the
great researchers of the past worked
alone and took sole responsibility for
their experiments with humans but the
entire scale of research was expanded by
the second half of the 20th century
science had provided numerous new
techniques in the diagnosis prevention
and cure of disease public appeal and
support encouraged even more research
the number of experiments and thus the
number of human subjects dramatically
increased and scientists were in the
forefront of those reminding us of our
responsibility to research subjects
researchers were increasingly concerned
that the growing numbers of subjects
receive adequate protection from risk
given the increasing complexity and
scale of scientific research some began
to wonder if possible negative effects
from the research might go undetected in
many instances independent committees of
researchers were formed to review
proposed research from an ethical
perspective increasingly government
scientists and the public agreed on the
need for strengthening protection of
research subjects today we recognize
that human subject protection is the
shared responsibility of many clinical
investigators institutions government
officials and the institutional review
boards or IRB
the IRB is a committee of scientists and
non-scientists at the local level that
reviews research protocols and consent
forms to ensure that the rights and
welfare of research subjects are
protected to understand the
multi-faceted roles involved in assuring
these protections one must look at the
recent history of medical and behavioral
research
part of that history are the key events
that resulted in the protective
mechanisms we have today there was no
clear first step in this evolution of
concern for the rights of research
subjects antecedents appear during the
20th century
and before this consent form from the
year 1900 though serves as a point of
departure the form was used for the
yellow fever experiments that made
Walter Reid famous it was provided in
both Spanish and English signed by the
subject as well as the researcher
understands that he in dangers his life
to a certain extent but it being
entirely impossible for him to avoid the
infection during his stay in this island
he prefers to take the chance of
contracting it intentionally the form
was evidence that Reid believed sound
ethical practices go hand in hand with
research involving human subjects
ethical concern has deep roots back to
the do no harm principle attributed to
Hippocrates protecting research subjects
has been a long-standing basic tenet of
experimental medicine
but medical research is
characteristically frustrated by blind
leads ambiguous results and negated
hypotheses yet there is pressure to
continue medical progress and
occasionally investigators have been
inadequately sensitive to the need to
protect the interests of those who are
actually at risk the research subjects
as we follow the evolving concern for
research subjects we will encounter some
occasions when subjects were not
adequately protected such examples of
research constitute a tiny minority of
experimental work but they did stimulate
researchers and the public to improve
systems for protecting research subjects
in December 1946 23 medical
professionals from Nazi Germany went on
trial in Nuremberg they are important
because their actions precipitated the
first modern effort to formulate an
international code of ethics protecting
human research subjects the victims of
these crimes are numbered in the
hundreds of thousands a handful only are
still alive a few of the survivors will
appear in this courtroom but most of
these miserable victims were slaughtered
outright or died in the course of the
tortures to which they were subjected
the offences ranged from subjecting
prisoners to extremes of altitude and
cold to using them as human typhus and
malaria cultures for testing vaccines it
is our deep obligation to all the
peoples of the world to show why and how
these things could happen it is
incumbent upon us to set forth with
conspicuous clarity the court you are
condemning these doctors accepted and
codified ethical standards that the
defendants had grossly violated these
standards came to be known as the
Nuremberg code the first internationally
recognized code of medical research
ethics
the codes sought not merely to prevent
experimental abominations in the future
but to increase the protection of the
rights and welfare of human subjects
everywhere by clarifying the standards
of integrity that constrain the pursuit
of knowledge the code was a guide not a
law the first of its ten principles
stresses the necessity for voluntary
informed consent from research subjects
it defines the meaning of informed
consent and places the responsibility
for obtaining adequate informed consent
on the researcher other points include
experiments should not be random or
unnecessary experiments with humans
should be preceded by experiments on
animals and surveys of the natural
history of the disease unnecessary
physical and mental suffering should be
prevented experiments should be
conducted by scientifically qualified
professionals subjects should be
permitted to withdraw at any time and
investigators should be prepared to stop
an experiment at any time if the subject
is endangered the Nuremberg code
enumerated the fundamental principles
that ought to guide research involving
human subjects but it was not the last
word although the role of informed
consent seemed clear enough in
biomedical experiments this was not
always the case for other research
involving human subjects in the early
1950s the Wichita Kansas Bar Association
became concerned about articles and a
nationally syndicated column suggesting
trickery when lawyers argue before
juries the Wichita lawyers wanted
reliable information on how juries
deliberate and reach decisions at the
same time the University of Chicago
received a Ford Foundation grant to
study a variety of legal issues
including jury behavior in 1953 with the
cooperation of the US Tenth Circuit
Court of Appeals and approval of lawyers
on both sides University of Chicago
researchers recorded six jury
deliberations without the knowledge of
the jurors
the transcripts were carefully guarded
and names in the cases were changed to
protect the identity of all involved in
1955 Senator James O Eastland
brought this matter before the Senate
Internal Security subcommittee
how could researchers justify recording
jurors without first obtaining their
permission behavioral scientists at the
University of Chicago defended the study
by explaining the prior knowledge of the
recording by the jurors would alter
their behavior others agreed with the
Washington Post a jury imperatively
needs to carry on its deliberations in
private when it retires to consider the
evidence its members must be free from
any outside pressure or fear of reprisal
after weighing the arguments Congress
enacted legislation prohibiting the
recording of juries in federal courts
behavioral researchers were required to
respect the fundamental rights of the
public in their research at about the
same time the juries were being taped in
Wichita the National Institutes of
Health was opening a new Clinical
Research Center in Bethesda Maryland
rules of the new research hospital
required a panel of qualified scientists
to review the protocol for any research
involving healthy volunteer subjects
other institutions also were beginning
to form committees to review research
these were often informal groups
convened by the scientists themselves to
discuss ethical aspects of research
these boards were to some degree an
innovation they were not the
institutional review boards of today
they did not for example include members
from the community but they were a step
toward the IRB
in the early 1960s a new drug
thalidomide was introduced for
experimental use in the United States it
had been prescribed extensively in
Germany and England The 1938 Food Drug
and Cosmetic Act allowed pharmaceutical
companies to distribute new drugs for
testing without FDA review in the
thalidomide case it is estimated that
more than 1,000 doctors in the u.s.
administered the drug many of these
doctors did not tell their patients the
drug was experimental when it was
discovered that the lead AMA had taken
by pregnant women could produce tragic
deformities in the fetus there was a
wave of public reaction and the use of
the drug was stopped the Kefauver Harris
hearings resulted in the 1962 amendments
to the Food Drug and Cosmetic Act which
included requirements that investigators
must inform potential subjects of the
experimental status of the drug and
obtain consent in requiring consent
Congress allowed the physician to decide
whether or not obtaining consent was in
the best interest of the subject the new
amendments and the resulting regulations
were a major step in the developing
concept of informed consent by subjects
the protection described in the
Nuremberg code was evolving and becoming
mandated through congressional
legislation and government regulation in
1963 another landmark incident furthered
the evolution of concern for research
subjects a group of well-respected
physicians from the sloan-kettering
Institute approached the medical
director of the Jewish chronic disease
Hospital in Brooklyn seeking help with a
study of the immune system in cancer
patients the research protocol required
injecting live cancer cells under the
skin of feeble and seriously ill
patients the injections were given
apparently the patients were told their
resistance was being tested they were
not told the injections contained live
cancer cells the story would have
remained untold had a non physician on
the hospital board not inquired about
the propriety of and
acting patients with cancer cells and
had he not taken the hospital
administration to court to obtain access
to the patient's medical records once
the lawsuit drew public attention the
research was severely criticized because
of its failure to respect the research
subjects had the physicians betrayed
their patients trusts
we're not the doctors facing conflict
between their obligations to their
patients and their desire to obtain
research results the civil rights
movement and the social climate at that
time encouraged an increased concern for
all human rights whether the subjects
were elderly people poor people children
in institutions or prisoners researchers
could expect criticism if the
individuals rights were not respected
during the late 50s and 60s dr. James
Shannon director of the NIH conceived a
study to determine how to protect
research subjects adequately in 1964 he
appointed a committee to review the
study and design mechanisms to ensure
that subjects would be systematically
and uniformly protected in all
biomedical and behavioral research
funded by the Public Health Service
about the same time with the public
recalling American prisoners of war
being brainwashed during the Korean War
debate over the safety of psychological
research intensified when Yale
University investigators published a
paper entitled conditions of obedience
and disobedience to Authority the
situation in which one agent commands
another who heard a third turns up time
and again as a significant theme in
human relations it is powerfully
expressed in the story of Abraham the
experiment the subject was told to give
what appeared to the subject to be an
electrical shock to another person for
the stated purpose of studying the
effects of punishment on learning
this allowed the investigator to observe
the subjects willingness to carry out
orders even if they resulted in pain or
harm to others no electrical shocks were
actually administered afterwards the
principal investigator carefully
explained the real purpose of the events
to the
subject the study caused a furor in the
American psychologist dr. diana baumrind
a behavioral scientist spoke for many it
is potentially harmful to a subject to
commit in the course of an experiment
acts which he himself considers unworthy
particularly when he has been entrapped
the subjects personal responsibility for
his actions is not erased because the
experimenter reveals to him the means
which he used to stimulate these actions
the subject realizes he would have hurt
the victim if the current were on much
valuable criticism of research practices
has come from within the research
community in 1966 dr. Henry K Beecher a
Harvard Medical School teacher and
respected researcher raised ethical
questions in an article in the New
England Journal of Medicine from
published research papers he cited
serious ethical problems in the
protection of human subjects in numerous
cases in some of them the controls were
denied treatment in others risky
surgical procedures were attempted dr.
Becher concluded Papworth in england has
collected he says more than 500 papers
based upon unethical experimentation it
is evident from such observations that
unethical or questionably ethical
procedures are not uncommon also called
codes are based on the blind assumption
in the same year the work begun by dr.
James Shannon found fruition in a policy
statement by the Surgeon General of the
United States that all research funded
by the Public Health Service undergo
prior review by an investigator's
institutional associates to assure and
independent determination of the
protection of the rights and welfare of
the individual or individuals involved
in 1972 public attention again focused
on research subjects the Public Health
Service study on the effects of
untreated syphilis conducted in Alabama
received extensive media coverage the
study widely but misleadingly called the
Tuskegee study started in 1932 as an
offshoot of an
program in which nearly 300 black men
with syphilis were followed to determine
the natural course of the disease the
men did not understand that they had
syphilis or that they were participants
in a research study they were not
offered treatment even after penicillin
became available although the experiment
was originally intended to last only a
few months it was continued for 40 years
the study was the most visible of
several projects discussed by the Senate
health subcommittee Senator Edward
Kennedy and others heard testimony from
the scientific community as well as from
research subjects they testified that
human subjects needed additional
protections as a result of the hearings
Congress passed the National Research
Act of 1974 one of the requirements was
the establishment of institutional
review boards to review all hgw funded
human research another result was the
establishment of the National Commission
for the protection of human subjects of
biomedical and behavioral research the
National Commission was a diverse group
representing both science and society
it's detailed reports explored ethical
considerations in human experimentation
and were widely viewed by the media and
public as authoritative in 1978 it
issued what has become known as the
Belmont report which summarizes the
basic ethical principles which underlie
research it discusses those principles
respect for persons maximizing possible
benefits while minimizing possible harms
and justice in sharing the risks of
research among those who will benefit
from it it discusses the application of
these principles to informed consent
assessment of risks and benefits and
selection of subjects they decide they
do not want to participate is there any
coercion if that's an issue then it's
the whole studies in issue
because despite the establishment of ir
bees and the heightened awareness of
researchers the concern for protecting
research subjects continues to prompt
study and debate there continues to be
uncertainty about the limits of research
on special populations such as prisoners
infants or the mentally incapacitated
there is dispute about the legitimacy of
various kinds of behavioral research and
there is ongoing consideration of the
need for additional regulations and of
the way ir bees function the refinement
of our methods of protecting human
subjects thus continues as it must
ultimately it is the conscientiousness
of the IRB and the researcher that will
protect all of us the research
institution the research subject and
society that benefits from research
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