A Public Documentary on the History of Research Ethics

Summary

This 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

00:00

📚 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.

05:02

🔍 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.

10:02

💊 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.

15:03

🛡️ 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.

20:03

🌟 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.

Keywords

💡Human Subject Protection

Human Subject Protection refers to the ethical and legal safeguards that are put in place to ensure that the rights, safety, and well-being of participants in research are maintained. In the video's theme, this concept is central as it discusses the evolution of concern for protecting human subjects in biomedical and behavioral research. The script mentions the formation of Institutional Review Boards (IRBs) and the development of ethical guidelines like the Nuremberg Code, which were established in response to historical abuses to better protect research subjects.

💡Institutional Review Boards (IRBs)

Institutional Review Boards, or IRBs, are committees that consist of scientists and non-scientists whose responsibility is to review research proposals involving human subjects to ensure that the rights and welfare of the subjects are protected. The script explains that IRBs are a shared responsibility involving clinical investigators, institutions, government officials, and the boards themselves. They play a crucial role in the video's narrative by illustrating the systematic approach to safeguarding research subjects.

💡Informed Consent

Informed Consent is a fundamental principle in research ethics where participants are given comprehensive information about a study and voluntarily agree to participate, understanding the potential risks and benefits. The script discusses the evolution of informed consent, from its roots in the Nuremberg Code to its legal enforcement through the Food Drug and Cosmetic Act amendments of 1962, emphasizing the importance of transparency and autonomy in research involving human subjects.

💡Nuremberg Code

The Nuremberg Code is the first internationally recognized set of ethical guidelines for conducting research involving human subjects, established in response to the atrocities committed by Nazi doctors during World War II. The script highlights the Nuremberg Code as a pivotal moment in the history of human subject protection, emphasizing principles such as voluntary informed consent and the necessity of prior animal testing before human experimentation.

💡Ethical Principles

Ethical Principles in the context of the video refer to the fundamental moral values and standards that guide the conduct of research, particularly concerning the treatment of human subjects. The script outlines these principles through the Belmont Report, which discusses respect for persons, beneficence (maximizing benefits and minimizing harm), and justice (fair subject selection and risk distribution). These principles are integral to the video's exploration of the ethical underpinnings of human subject research.

💡Biomedical Research

Biomedical Research encompasses a wide range of scientific investigations aimed at understanding the processes of disease and developing treatments, often involving the use of living organisms or human subjects. In the video, biomedical research is a key focus, illustrating the historical context and ethical considerations of conducting such research, including the development of new drugs and therapies.

💡Behavioral Research

Behavioral Research is the study of human or animal behavior, often involving direct observation or experimentation. The script touches upon behavioral research through examples such as the University of Chicago's study of jury deliberations and the infamous Milgram experiment, which raised ethical concerns about the treatment of subjects and the potential psychological harm that can result from research.

💡Research Ethics

Research Ethics involves the moral principles and guidelines that govern the conduct of research, particularly concerning honesty, integrity, and respect for the rights and dignity of research subjects. The video script discusses the evolution of research ethics from the atrocities committed during WWII to the development of ethical guidelines and regulatory bodies designed to prevent such abuses in the future.

💡Thalidomide

Thalidomide is a drug that was once widely prescribed for morning sickness in pregnant women but later found to cause severe birth defects. The script mentions thalidomide as a case study in the need for stringent ethical oversight in drug testing and informed consent, highlighting the tragic consequences when research ethics are not properly adhered to.

💡Tuskegee Study

The Tuskegee Study refers to a notorious and unethical clinical study conducted by the U.S. Public Health Service between 1932 and 1972, where African-American men with syphilis were left untreated to study the disease's progression. The script uses the Tuskegee study as an example of a gross violation of research ethics and human rights, which led to significant reforms in the protection of human subjects.

💡Milgram Experiment

The Milgram Experiment was a series of psychological studies conducted by Yale University psychologist Stanley Milgram, which examined obedience to authority by having participants administer what they believed were electric shocks to others. The script cites this experiment as an example of the ethical dilemmas in behavioral research, where the line between scientific inquiry and the psychological well-being of subjects can become blurred.

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