(female announcer)this is part of a seriesof videotapes intended to help health professionalsunderstand their responsibilities for protecting human subjectsin biomedical and behavioral research. one program discusses the criteria used byirbs for reviewing research.another shows how to apply the basic ethical principleswhich underlie the involvement of human subjects. the series begins with this program,which looks at the historical backdrop of concernfor human subject protection. it then follows the evolution of these concernstoward present-day practices.
(male narrator) in 1926, paul de kruif publishedmicrobe hunters, a popular history of biomedicine.in it, he portrayed researchers such as louis pasteur and walter reedas independent visionaries struggling alone to understand and conquerdisease. we start our examination of concernfor protecting human research subjects by recalling de kruif's popular book,because it represents a transition. the great researchers of the past worked aloneand took sole responsibility for their experiments with humans.but the entire scale of research was expanding. by the second half of the 20th century,science had provided numerous new techniques
in the diagnosis, prevention, and cure ofdisease. public appeal and support encouraged evenmore research. the number of experiments,and thus the number of human subjects, dramatically increased,and scientists were in the forefront of those reminding usof our responsibility to research subjects. researchers were increasingly concernedthat 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 researchmight go undetected.
in many instances,independent committees of researchers were formedto review proposed research from an ethical perspective.increasingly, government, scientists, and the publicagreed 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 irbs. the irb is a committee of scientists and nonscientistsat the local level that reviews research protocols and consentforms
to ensure that the rights and welfareof research subjects are protected. to understand the multifaceted rolesinvolved in assuring these protections, one must look at the recent historyof medical and behavioral research. part of that history are the key eventsthat resulted in the protective mechanisms we have today.there was no clear first step-in this evolution of concernfor the rights of research subjects. antecedents appear during the 20th centuryand before. this consent form from the year 1900, though,serves as a point of departure. the form was used for the yellow fever experimentsthat made walter reed famous.
it was provided in both spanish and english,5:18. signed by the subject as well as the researcher. (narrator)the form was evidence that reedbelieved sound ethical practices go hand in handwith 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 tenetof experimental medicine. but medical research is characteristicallyfrustrated by blind leads, ambiguous results,and negated hypotheses. yet there is pressure to continue medicalprogress,
and occasionally, investigators have beeninadequately sensitive to the need to protect the interestsof 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 experimentalwork, but they did stimulate researchersand the public to improve systems for protecting research subjects.in december 1946, 23 medical professionals from nazi germanywent on trial in nuremberg.
they are important because their actionsprecipitated the first modern effort to formulate an international code of ethicsprotecting human research subjects. (man)"the victims of these crimesare 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 outrightor died in the course of the tortures to which they were subjected.(narrator)the offenses ranged from subjecting prisonersto extremes of altitude and cold to using them as human typhus and malariacultures
for testing vaccines.it is our deep obligation to all the peoples of the worldto show why and how these things could happen. it is incumbent upon usto set forth with conspicuous clarity"-- the court, in condemning these doctors,accepted and codified ethical standards that the defendants had grossly violated.these standards came to be known’s the nuremberg code,the first internationally recognized code of medical research ethics.the code sought not merely to prevent experimental abominations in the futurebut to increase the protection of the rights and welfareof human subjects everywhere
by clarifying the standards of integritythat constraint he pursuit of knowledge. the code was a guide, not a law.the first of its ten principles stresses the necessityfor voluntary informed consent from research subjects.it defines the meaning of informed consent and places the responsibilityfor 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 animalsand 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 timeif the subject is endangered. the nuremberg code enumerated the fundamentalprinciples that ought to guide research involving humansubjects, 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 associationbecame concerned about articles in a nationally syndicated columnsuggesting 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 grantto study a variety of legal issues, including jury behavior.in 1953, with the cooperation of the u.s. 10th circuit court of appeals,and approval of lawyers on both sides, university of chicago researchersrecorded six jury deliberations without the knowledge of the jurors.the transcripts were carefully guarded,
and names in the cases were changedto protect the identity of all involved. in 1955,senator james o. eastlandbrought 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 chicagodefended the study by explaining that prior knowledge of the recording by thejurors would alter their behavior.others agreed with the washington post. a jury imperatively needsto 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 legislationprohibiting the recording of juries in federal courts.behavioral researchers were required to respect the fundamental rights of the publicin their research. at about the same timethe juries were being taped in wichita, the national institutes of healthwas opening a new clinical research center in bethesda, maryland.rules of the new research hospital required a panel of qualified scientiststo 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 themselvesto 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 companiesto distribute new drugs for testing
without fda review.in the thalidomide case, it is estimated that more than 1,000 doctorsin the u.s. administered the drug.many of these doctors did not tell their patients the drug was experimental.when it was discovered that thalidomide taken by pregnant womencould 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 the1962 amendments to the food, drug, and cosmetic act,which included requirements that investigators must inform potential subjectsof the experimental status of the drug and
obtain consent.in requiring consent, congress allowed the physician to decidewhether 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 conceptof informed consent by subjects. the protection described in the nurembergcode was evolving and becoming mandatedthrough congressional legislation and government regulation.in 1963, another landmark incident furthered the evolution of concernfor research subjects. a group of well-respected physiciansfrom the sloan-kettering institute
approached the medical directorof the jewish chronic disease hospital in brooklynseeking help with a study of the immune system in cancer patients.the research protocol required injecting live cancer cells under the skinof 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 boardnot inquired about the propriety of injecting patients with cancer cellsand had he not taken the administration to
courtto obtain access to the patients ‘medical records.once the lawsuit drew public attention, the research was severely criticizedbecause of its failure to respect the research subjects.had the physicians betrayed their patients' trusts?were not the doctors facing conflict between their obligations to their patientsand their desire to obtain research results? the civil rights movementand the social climate at that time encouraged an increased concern for all humanrights. whether the subjects were elderly people,poor people, children in institutions,
or prisoners, researchers could expect criticismif the individuals' rights were not respected. during the late '50s and '60s,dr. james shannon, director of the nih, conceived a study to determinehow to protect research subjects adequately. in 1964, he appointed a committeeto review the study and design mechanisms to ensure that subjectswould be systematically and uniformly protected in all biomedical and behavioral researchfunded by the public health service. about the same time,with the public recalling american prisoners of warbeing brainwashed during the korean war, debate over the safetyof psychological research intensified
when yale university investigatorspublished a paper entitled conditions of obedience and disobedience toauthority. the situation in which one agent commandsanother to hurt a third turns up time and againas a significant theme in human relations. it is powerfully expressedin the story ofabraham. in the experiment,the subject was told to givewhat appeared to the subjectto be an electrical shockto another person for the stated purposeof studying the effects of punishment on learning.this allowed the investigator
to observe the subject's willingnessto carry out orders even if they resulted in painor harm to others. no electrical shocks were actually administered.afterwards, the principal investigator carefully explained the real purposeof 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 harmfulto a subject to commitin the course of an experimentacts which he himself considers unworthy, particularly when he has been entrapped.the subject’s personal responsibility
for his actions is not erasedbecause the experimenter reveals to him the means which he usedto stimulate theseactions. the subject realizes he would have hurt thevictim if the current were on.much valuable criticism of research practices has come from withinthe research community.in 1966, dr. henry k. beecher, a harvard medical school teacherand respectedresearcher, raised ethical questionsin an article in the new englandjournal of medicine.from published research papers, he cited serious ethical problemsin 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. beecher concluded: pappworth, in england, has collected, he says,more than 500 papers based uponunethical experimentation. it is evident from such observationsthat unethical or questionably ethical procedures are not uncommon.all so-called codes are basedon the bland assumption"--in the same year, the work begunby dr. james shannonfound fruition in a policy statement by the surgeon general of the united statesthat all research funded by the public health
serviceundergo prior review by an investigator’s institutional associates--to assure an independent determination of the protection of the rights and welfareof the individual or individuals involved. in 1972,public attention again focused on research subjects.the public health service study on the effects of untreated syphilisconducted in alabama, received extensive media coverage.the study, widely but misleadingly called the tuskegee study,started in 1932 as an offshoot of an experimental programin which nearly 300 black men with syphilis
were followed to determinethe natural course of the disease. the men did not understandthat they had syphilisor 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 severalprojects discussed by the senate health subcommittee.senator edward kennedy and others heard testimony from the scientific communityas well as from research subjects. they testified that human subjectsneeded 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 boardsto review all hew-funded human research. another result was the establishmentof the national commission for the protection of human subjectsof biomedical and behavioral research. the national commission was a diverse grouprepresenting both science and society. its detailed reports explored ethical considerationsin human experimentation and were widely viewed by the media and publicas authoritative. 1978, it issued what has become knownas the belmont report,
which summarizes the basic ethical principleswhich underlie research. it discusses those principles:respect for persons, maximizing possible benefitswhile minimizingpossible harms, and justice in sharing the risks of researchamong those who will benefit from it. it discusses the application of these principlesto informed consent, assessment of risks and benefits,and selection of subjects. if they decide they do not want to participate,is there any coercion? if that's an issue,then it's--the whole study'san issue, because-- despite the establishment of irbsand the heightened awareness of researchers,
the concern for protecting research subjectscontinues to prompt study and debate. there continues to be uncertaintyabout the limits of researchon special populations such as prisoners, infants, or the mentallyincapacitated. there is dispute about the legitimacyof various kinds of behavioral research, and there is ongoing considerationof the need for additional regulations and of the way irbs function.the refinement of our methods of protecting human subjectsthus continues, as it must. ultimately,it is the conscientiousnessof the irb and the researcher that will protect all of us:the research institution,
the research subject,and a society that benefits from research.
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