Human subject research

From New World Encyclopedia
The Milgram Experiment represents an example of human subject research. In this diagram, the subject is listed as "T," the experimenter as "E," and a accomplice of the experimenter as "L."

Human subject research may be considered a systematic investigation designed to contribute to generalizable knowledge in which the focus for gathering data is a living human being. The exact parameters of what constitutes human subject research can vary depending on how one defines "human subject" and "research," as well as "generalizable," as detailed in "Definitions" below. Human subject research can be conducted via such research methods as experiments, surveys, interviews, participant and non-participant observation, and so forth.

 

Human subject research offers a vital avenue for gathering important information, such as effectiveness and side-effects of vaccines and treatments for diseases; public opinions on key issues; observations of human behavior; and so forth. However, the history of human subject research is also replete with unethical research actions, such as seen in the Nazi human experiments, Tuskegee Syphilis Study, and innumerable other questionable or outright immoral or illegal actions that have led to physical, emotional, psychological, financial, legal, and other harms to subjects. Various codes and statements on research ethics have been adopted to try to curtail improper research, such as the Declaration of Helsinki, Belmont Report, Nuremberg Code, and the Common Rule. Ultimately, researchers need to have the mindset to treat their subjects as they themselves would wish to be treated and their loved ones to be treated.

Definitions

What constitutes "human subject research" is contingent upon how one defines the terms "human subject" and "research."

For the first term, "human subject," what if the individuals are ancillary to the research, such as an investigation into airflow in a home or in an underground, rapid transit system (subway, tube, etc.), in which people are present in the home or transit location at the time of the research, but are not the focus of the research, and the researchers do not interact with them? Are they considered human subjects? What if the researchers are only working with already de-identified data, so that the identities of the individuals cannot be ascertained? What if the individuals are no longer living, such as use of information gleamed from cadavers?

For the second term, "research," how broadly is this term defined? Does the decennial collection of census data by a government constitute research? What about if one is gathering information for personal use, or the use of one's office, such as a survey of office workers on what food they want for the company picnic? What about producing a biography for a newspaper article or book? What about a lawyer questioning witnesses to prepare for a court case? Or a media organization conducting a survey to ascertain voting preferences? Do these meet the definition of research?

In order for protections to be put in place by organizations or governments, then it is important that the term "human subject research" be precisely defined.

Definition according to U.S. Common Rule

In the United States, there is a federal policy for protection of human subjects known as the Common Rule. In the Common Rule, the terms "human subject" and "research" are defined as follows:

Human subject

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (Code of Federal Regulations, subpart A, 45 CFR, part 46.102).

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For the purposes of this part, the following activities are deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. (Code of Federal Regulation, subpart A, 45 CFR, part 46.102).

The term "generalizable," used above as a condition for an investigation to be research, is defined by the U.S. Department of Energy as follows:

Generalizable. Information/research findings are intended to be applied to populations or situations beyond that which was studied/will have meaning and impact outside of the single immediate activity itself (White and Hautala-Baseman 2019; NISA 2019).

Essentially, to be generalizable according to the U.S. Department of Energy, the research must be shared beyond one location or agency, such as via a presentation and publication. Any institution using a definition such as this would consider a survey aimed at figuring out its staff preferred to have served for a company outing, or what computer operating system to use office-wide, would determine that such do not meet the definition of generalizable and thus not the definition of research.

Different institutions or governments may have diverse definitions of these terms (human subject, research, generalizable) and thus the applicability of protections put in place for human subject research within that body. For example, the U.S. Common Rule considers human subjects to be "living individuals"; however, some U.S. states and institutions include deceased individuals as human subjects when including certain information in the research, such as health records.

Examples of human subject research: Some classic studies

Human subject research can be conducted via a wide varied of methodologies. The following are a selection of some classic studies that exemplify some of those methods.

Hawthorne Experiments

Hawthorne Works Division of the Western Electric Company (1925), site of the Hawthorne Experiments

In 1939, F. J. Roethlisberger and W. J. Dickson published Management and the Worker (Cambridge: MA: Harvard University Press). The authors detailed a series of experiments conducted at the Hawthorne Works Division of the Western Electric Company in Illinois from 1924 to 1932. The human subjects in this case were factory workers and the experiments were designed to study factory worker output at their site of employment. In all, there were four types of studies. The first group of experiments, conducted between 1924 and 1927, were designed to study the impact of illumination, including raising the illumination in three departments, adding a control group with no changes in lighting, adding the covering of windows to exclude variation in daylight, and setting up a group of just two workers in which the researchers only pretended to increase and decrease the lighting. The second group of studies were conducted from 1927 to 1929 in the Relay Assembly Test Room with a small group of six, trained, telephone relay assemblers to measure output under varying conditions and introducing at one point a nonparticipating observer. The third group of studies involved interviews of some 21,000 employees over a three-year period (1928 to 1930). The final series of studies were conducted in the Bank Wiring Observation Room in 1932 and involved observation and interviews with a group of workers. Among the findings from this classic study was one that became known as the Hawthorne Effect: Individuals modify behavior in response to awareness of being observed. For example, during the study, the researchers found that increased attention to the workers (such as changes in lighting, working hours) improved productivity even if the changes were deleterious (such as decreased lighting).

Robbers Cave Experiment

The Robbers Cave Experiment was a field experiment (also participant observation) that took place at a Boy Scout Camp in Robbers Cave State Park in Oklahoma. It was published in 1961 by M. Sherif, O. J. Harvey, B. J. White, W. R. Hood, and C. W. Sherif under the title "Intergroup Conflict and Cooperation: The Robbers Cave Experiment" (University of Oklahoma Institute of Group Relations). The subjects in this study were fifth-grade boys. There were three studies, conducted over three summers. Each study involved three stages: (1) an "experimental in-group formation" stage (five to six days); (2) an "intergroup relations: friction phase" stage (four to six days), and an (3) an "intergroup relations: integration phase (six to seven days). The researches added a camp counselor as a participant observer, so the studies involved both an experiment methodology and participant observation. The researchers divided the boys into two groups in each case and set up conditions to study cooperation and friction between and within the groups, among other goals.

The American Soldier

In 1948, Samuel A. Stouffer et al. published The American Soldier: Adjustment during Army Life, Volume 1 and The American Soldier: Combat and its Aftermath, Volume 2 (Princeton: Princeton University Press). The human subjects in this case were members of the American armed forces and a survey methodology was employed. This was a massive undertaking: overall, more than 500,000 soldiers completed over 200 different surveys (Cargan 2007).

Street Corner Society

In 1943, William Foote Whyte published Street Corner Society: The Social Structure of an Italian Slum (Chicago: University of Chicago Press). This is an example of human subject research that involved participant observation. From 1938 to 1941, Whyte participated in the activities of the people in a community he called "Cornerville," which he identified as a "slum district" in the heart of an "Eastern City" (actually an area in north end of Boston with about 20,000 inhabitants, mostly Italian immigrants and their children). The human subjects were the ones being observed by Whyte, and in particular the "Norton Gang" (a group of young Italian Americans whose activities centered on Norton Street), as well as an Italian Community Club, a local senator's political organization, and a local racketeer (Cargan 2007).

Historical overview

In the first century, a Roman encyclopedist, Aulus Cornelius Celsus (c. 25 B.C.E. to c. 50 C.E.), published the medical treatise De Medicina. Celsus offered an early defense for human subject research, justifying experiments on condemned criminals in Egypt by stating: "It is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries" (Das and Sil 2017). Modern codes of research ethics oppose such use of vulnerable subjects, and its abuse can be seen repeatedly in history, but the reasoning does present an early rendering of one of the core principles of research ethics, the importance of weighing potential benefits versus risks. That is, the potential benefits to society of the research have to outweigh the risks of the research (which is primarily assumed by individuals, the research subjects).

Edward B. Jenner (1749-1823) conducted important human subject research on developing a vaccine for smallpox. Smallpox (now eradicated) was a very deadly disease that killed an estimated 400,000 Europeans each year during the eighteenth century and perhaps three hundred million to five hundred million worldwide during the twentieth century and later part of the nineteenth century. Jenner, an English physician and scientist, introduced and popularized an effective and relatively safe means of vaccination against smallpox using material from cowpox. He tested his theory by inoculating James Phipps, a young boy of eight years old, and then exposing him to smallpox (and repeated this numerous times during Phipps life), as well as testing on his own son and other neighborhood children.

Louis Pasteur (1822-1895) conducted important human subject research on developing a vaccine for rabies. He produced the vaccine by growing it in rabbits and then weakening it by drying the affected nerve tissue. He had tested it only one eleven dogs before its first human trial. He actually felt years of research were still needed when he encountered a situation in which a nine-year-old boy, Joseph Meister, was badly mauled by a rabid dog. After consulting with colleagues, and at some personal risk (he was not a licensed physician), he treated Meister on July 6, 1885, and the treatment was a great success, with Meister avoiding the disease.

Jadwiga Dzido, a Polish resistance worker and pharmacy student, who was subjected to forced Nazi medical experimentation in the Ravensbrück concentration camp. Here she is showing scars at the Doctor's Trial.

Beginning on December 9, 1946, a trial began for Nazi medical doctors and researchers accused of criminal human experimentation. Known as the Doctor's Trial (officially United States of America v. Karl Brandt et al.), this was part of a series of trials held in Nuremberg, Germany, after World War II, for individuals being charged as war criminals. Two doctors who were working with the prosecution during the trial, Dr. Andrew Ivy and Dr. Leo Alexander, drew up six points delineating legitimate research principles, and they submitted this memorandum on April 17, 1947, to the U.S. Counsel for War Crimes. When on August 19, 1947, the verdict was issued, these six points had been revised into ten points and issued as part of the verdict. These ten points became known as the Nuremberg Code (United States Holocaust Memorial Museum).

On October 27, 1962, the British Medical Journal announced a draft code of ethics for human experimentation. This was revised and the new version, titled Declaration of Helsinki (with the subtitle "Recommendations Guiding Doctors in Clinical Research"), was adopted in June 1964 at the 18th World Medical Association (WMA) General Assembly in Helsinki, Finland, being approved by three-quarters majority vote. The Declaration of Helsinki has become a important document relative to medical research involving human subjects. It has been revised several times, the most recent version being approved by the WMA in 2013.

A 1966 publication in the New England Journal of Medicine drew awareness to continuing unethical research with human subjects. Titled "Ethics of Clinical Research," this article by Henry Beecher of Harvard Medical School detailed 22 studies published in prestigious journal articles that had questionable research ethics, such as increased risk to subjects and lack of informed consent. Amdur and Bankert (2022) described Beecher's article as "a milestone in the history of research ethics because it was an unprecedented attempt by a respected member of the research community to focus attention on the need to improve the ethical standards for conducting clinical research in this country."

On July 25, 1972, Jean Heller of the Associated Press published an article that exposed a major U.S. government research study with human subjects that had such ethical failings its revelations shocked those learning about the study for the first time and lead to major human subject research reforms. Titled, "Syphilis Victims in U.S. Study Went Untreated for 40 years," the article first ran in the Washington Star (Thomas and Crouse Quinn 1991), and the following day, on July 26, the New York Times published this story on its front page. Known as the Tuskegee Syphilis Study, this was a forty-year, observational research endeavor funded by the U.S. Public Health Service (USPHS) that included as research subjects six hundred African American men of low educational and socioeconomic levels with the goal to evaluate the natural course of syphilis, without treatment, until the death and autopsy of the subjects. The revelations about the Tuskegee Syphilis Study, and its numerous unethical actions — including lack of informed consent, use of a vulnerable population, deception, withholding treatment, and racism — led to a public outcry and became the main catalyst for conducing a series of congressional subcommittee hearings in February and March of 1973, directed by Senator Edward Kennedy. (There were other unethical research endeavors with human subjects, some also high profile, that contributed as well.)

Largely spurred by the Tuskegee Syphilis Study, the U.S. Congress passed in 1974 the National Research Act, which was signed into law by U.S. President Richard M. Nixon on July 12, 1974. This law was in response to concerns regarding the exploiting and harming of human subjects in medical, biomedical, and social science research. This Act both established the modern system of Institutional Review Boards (IRBs) and created the National Commission for Protection of Human Subjects of Biomedical and Behavior Research. This commission, which had the goal of identifying ethical guidelines for human subject research, would issue a number of reports between 1975 and 1978 dealing with the conduct of research in various populations, such as research involving children, prisoners, pregnant women, and people with dementia. In 1978, the commission issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; the three main principles identified in this report are widely used to guide human subject research.

Following the direction of the National Research Act, the main IRB regulations were established by diverse government agencies. Ultimately, this gave rise to the Common Rule, a federal policy governing the protection of human research subjects as uniformly codified in separate regulations of numerous United States departments and agencies.

Codes of ethical conduct for human subject research

The following are some widely recognized codes of ethical conduct for research with human subjects.

Nuremberg Code

The Nuremberg Code is a landmark document that delineates a set of fundamental ethical standards for research with human subjects that arose as a result of that portion of the Nuremberg Trials dealing with the atrocities of Nazi human experimentation (the "Doctors' Trial," officially United States of America v. Karl Brandt et al.). The principles of the Nuremberg Code were released as part of the judges' decision in August 1947. The Nuremberg Code played a pivotal role in the development of other ethical codes for researchers, including having key principles incorporated in the Declaration of Helsinki, the Belmont Report, and the United States' Common Rule. The Nuremberg Code has represented an important step in recognizing the fundamental rights and dignity of human beings in the research environment.

Declaration of Helsinki

The Declaration of Helsinki (DoH) is a cornerstone document outlining ethical principles for conducting medical research with human subjects. The Declaration of Helsinki is produced by the World Medical Association (WMA), an international body representing physicians. The full title of the statement is "WMA Declaration of Helskini: Ethical Principles for Medical Research Involving Human Subjects." While the Declaration's preamble notes it is "addressed primarily to physicians," the WMA encourages its wider use by all those involved in medical research involving human subjects. Originally adopted in Helsinki, Finland in June 1964, it has undergone several revisions, the most recent being the 2013 version. As a product of a nongovernmental organization, rather than a governmental or intergovernmental body, the Declaration of Helsinki is not legally binding. However, it is influential, impacting official policies of organizations and governmental regulations, and has been incorporated into some national legislation.

Belmont Report

The Belmont Report is an eight-page document that identifies basic ethical principles and corresponding applications for the conduct of research involving human subjects. Its issuance in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, an entity created by United States law, the National Research Act of 1974, is considered a major milestone in research ethics. At the heart of the Belmont Report are the three ethical principles: (1) Respect for Persons; (2) Beneficence; and (3) Justice. The Belmont Report, and its three core ethical principles, provides a reference and guidance document for researchers and for Institutional Review Boards that review research.

Common Rule

The Common Rule is a federal policy governing the protection of human research subjects as uniformly codified in separate regulations of numerous United States departments and agencies. Originally published in 1991, the Common Rule later was substantially revised and the revised Common Rule published in the Federal Register in 2017 and then further amended and finalized in 2018; it outlines provisions for Institutional Review Boards (IRBs), informed consent, and other aspects related to research involving human subjects.

Infamous cases of unethical human subject research

Below is a selection of a few examples of unethical human subject research.

Tuskegee Syphilis Study

The Tuskegee Syphilis Study (1932-1972), officially titled "The Tuskegee Study of Untreated Syphilis in the Negro Male," was a forty-year, observational research endeavor funded by the U.S. Public Health Service (USPHS) that is infamous as an case of unethical human subject research. The study participants included six hundred African American men of low educational and socioeconomic levels in Macon County, Alabama, with an initial group of 399 with syphilis and 201 later added as a control population. The goal was to evaluate the natural course of syphilis, a serious, sexually transmitted bacterial disease, while foregoing treatment, with the endpoint (after modification of the original short-term timeframe) including up to death and postmortem evaluation.

Numerous unethical actions — including lack of informed consent, use of a vulnerable population, deception, and withholding treatment— make the Tuskegee Syphilis Study one of the most notorious chapters in human subject research. For example, the men serving as subjects were not properly informed about the study in which they were asked to volunteer, with outright deception used in enrolling the men and keeping them in the study. A particularly well-known and scandalous aspect of the study was the effort made to deprive the men of treatment for the disease. There were treatments available from the start of the study, albeit those carried significant risks. However, by the time of World War II, penicillin, which offered a very effective treatment, was being mass produced and became widely available for civilian populations after the war, including being used for those with syphilis in Macon Country. However, penicillin was withheld from those in the study, with other physicians and agencies persuaded to aid in that effort, resulting in serious health complications (organ damage, blindness, mental impairment, etc.) and death of study subjects, the spreading of the disease to sexual partners, and children born with congenital syphilis.

The exposure of this study in July 1972 by Associated Press reporter Jean Heller led to a public outcry and the termination of the study the same year. The revelations of the unethical actions in this study became a milestone as it catalyzed efforts to address the ethics of human subject research, including Congressional hearings and the formulation of the Belmont Report and the Common Rule. The Tuskegee Syphilis Study also has been cited as an example of racism and the "Tuskegee Effect" as deterring participation of African-Americans in medical research and fostering distrust of the health-care system.

Guatemala STD Experiments

In a medical research study conducted from 1946 to 1948, but which only gained widespread public awareness in 2010, vulnerable human populations in Guatemala were intentionally infected, without their consent, with syphilis, gonorrhea, and chancroid (all three are serious, sexually transmitted, bacterial infections). From a total study population of over 5,500 vulnerable people (prisoners, soldiers, mental patients, child and adult prostitutes, children, orphans, and more), at least 1,308 soldiers, prisoners, sex workers, and psychiatric patients, ranging from ages 10 to 72, were deliberately infected with these diseases. The study was conducted by the U.S. Public Health Service in cooperation with Guatemalan authorities and with funding by the U.S. National Institutes of Health, with the goal of improving STD prophylaxis. Means for transmitting the disease included inoculation of the cervix in sex workers; cisternal puncture (insertion of a needle in back of the skull); direct inoculation of the urethra, rectum, or eyes; skin abrasion; oral ingestion, and normal exposure (having the infected sex workers transmit the disease through sexual intercourse to unsuspecting prisoners). There are no records of any consent having been obtained, and there is evidence of deceit having been used. Only about half of the participants received treatment. During the experiment, 83 subjects died, although it is unclear whether the deaths resulted from the experiments. Each of these sexually transmitted. bacterial illnesses — syphilis, gonorrhea, and chancroid — can be treated effectively with penicillin, which in 1943 PHS researchers already discovered could treat syphilis (Spector-Bagdady and Lomardo 2019; Rodriguez and Garcia 2013; Rogers 2018).

The lead investigator was John c. Cutler, a senior surgeon at PHS, who was also involved with the Tuskegee Syphilis Study and with a study at Terre Haute prison in Indiana (where consenting prisoners were used). Cutler made effort to keep the studies from the public eye. American historian Susan M. Reverby began an investigation of documents in 2003, after Cutler's death, and in 2010 reported her findings, leading to a public outcry. Among the ethical issues were use of a vulnerable population, lack of informed consent, active deceit, harm of test subjects, and failure to provide treatment (Spector-Bagdady and Lomardo 2019; Rodriguez and Garcia 2013; Rogers 2018).

Willowbrook Hepatitis Studies

The Willowbrook Hepatitis Studies were a series of human subject research investigations conducted on intellectually disabled students who resided at the Willowbrook State School, a state-supported, extended care facility located in the Willowbrook neighborhood on Staten Island in New York City. These studies were conducted in the 1950s to investigate aspects of the hepatitis virus, including its transmission and the effectiveness of an agent to inoculate against it. One aspect of the study design "involved intentionally infecting healthy children with hepatitis by feeding them a solution made from the feces of children with active hepatitis" (Amdur and Bankert 2022). The infected children became ill with the disease, including some quite severely. Such deliberate infection of the children was justified by the researchers based on the reason that that most would get hepatitis anyway. While parental permission was obtained, the parents were not fully informed about the possible risks and they also had undue pressure placed on them by being told that the children would not be enrolled at the institution unless the consent form was signed. The medical research was discontinued due to a public and professional awareness of the project. The 1966 Beecher article in the New England Journal of Medicine listed this research among those highlighted as ethically dubious. Maurice Ralph Hillman, an American microbiologist and vaccinology specialist, who developed over forty vaccines, said of the studies, they "were the most unethical medical experiments ever performed on children in the United States" (Offit 2007).

Milgram's Obedience to Authority Studies

Stanley Milgram, an American psychologist, conducted a famous series of studies in the early 1960s related to the willingness of the study participants to obey authority figures when, under the particular confines of the experiment, the authority figures instructed them to do things that one would perceive as cruel and unethical. The volunteers (human subjects) were deceived into thinking they were helping in research designed to study the impact on learning and memory of negative reinforcement. The researchers worked together with an assistant who was presented as another volunteer and as the "learner." The study participants, in the role of a "teacher," were told to administer electric shocks to the learner when the the learner answered incorrectly, in increasing increments of shock level during the study. In reality, the electric shocks were fake, but the learner made it seem as if they were real, including, in later variations, to the point of pleading for mercy and claiming a heart condition. A high proportion of the study participants administered, on the direction of the researcher, what they thought were severe electric shocks to the learner, including potentially lethal voltages. The study was conceived in the aftermath of the trial of a German Nazi war criminal (Adolf Eichmann) to understand the psychology of why people followed authority figures even when what they were asked to do conflicted with what they felt was correct. The Milgram studies brought concerns about the ethics of such a research design. The human subjects were deceived, many experienced severe emotional stress, and the researchers continued despite a subject's (the volunteers) displaying signs of distress. Amdur and Bankert (2022) said that after the subjects were debriefed about the study, "many of the subjects said that the cruelty of their actions was profoundly upsetting."

Allen's Nazi Seizure of Power study

Willian Sheridan Allen, an American historian of German history, published a book in 1965 called The Nazi Seizure of Power: The Experience of a Single German Town, 1930-1935 (revised later to include the years 1922 to 1945) that was based on an exhaustive study of one town and its embrace of Nazism. Allen used a variety of sources for his research (local newspaper articles, reports, court cases, and so forth), as well as interviews with residents (oral history). Those he interviewed (the human subjects) were promised confidentiality and in both his 1962 doctoral dissertation for the University of Minnesota (upon which the book was based) and the first editions of the book (in English and German), Allen used pseudonyms for the individuals and the town, giving the town the fictional name of Thalburg. However, to be faithful to his subject matter, Allen included many details about the town (such as its location in a river valley, characteristics of its population, etc.) Thus, it was not difficult for a journalist to uncover the real name of the town (Northeim) and unmask many of the identifies of Allen's informants. After the book was published, a German magazine did publish this information, violating the confidentiality. Beginning with the second edition, Allen abandoned the pseudonyms (Bergerson 2018).

This is a common ethical problem in human subject research, the ability to maintain the confidentiality of the subjects. In human subject research training sessions for researchers and IRB members, including governmental trainings, Allen's study is often included as an example of unethical research.

Note that not everyone agrees with the placement of Allen's study as an example of unethical research. Bergerson, a professor in the Department of History at the University of Missouri-Kansas City, in a publication in Studies in Contemporary History, had this to say on the matter (Bergerson 2018):

In the computerized training sessions used by many American universities to inform researchers about these regulations [U.S. regulations governing human subject research], Allen's study serves as an example of unethical research practices because of his alleged failure to protect his human subjects from potential harm. What is happening, in fact, is that non-historians are misapplying principles from clinical, therapeutic, and behavioural research to oral history and thereby undermining the crucial role that oral history plays in the public sphere. It represents a gross injustice to a scholar whose innovative research played a catalytic role in changing the way democratic societies relate to their troubled pasts. Allen's oral history was responsible precisely because Allen challenged Northeimers to consider their complicity, and that of their neighbours, in the Nazi revolution. In light of the fact that Allen explained how ordinary people can undermine democracy in Germany, it is a scary irony that American scholars and public officials, who have no real understanding of historical scholarship, are using Allen's study to sanitise oral history as a critical practice.

San Antonio Contraceptive Study

In an early-1970s study designed to study the efficacy and side effects of female contraceptive pills, the human subjects were 76 poor Hispanic woman who came to a clinic in San Antonio seeking contraceptives. A researcher at San Antonio's Southwest Foundation for Research and Education, Dr. Joseph Goldzieher, enrolled the women in the study, many of whom came from a Planned Parenthood agency. The women were told that they were going to receive birth control pills and agreed to participate. The women were randomized into two groups. Unbeknownst to the women, not all actually received birth control pills. While half of the women received oral contraceptives, the other half received a placebo; in the middle of the study, the sides were switched in terms of which received the placebo and which received the contraceptive. None of the women were informed regarding the exact nature of the experiment and that they might receive a pill of no therapeutic value. Ten of the women subsequently became pregnant during the study. This study violated several ethical principles. There was a lack of informed consent: None of the women knew the nature of the experiment to which they agreed and the extent of the risk. There was use of a vulnerable population. There was deception. And there was a failure to report adverse effects and follow study protocols (Kim 2012, Amdur and Bankert 2022, Curtis et al. 1973).

Concerning the pregnancies, the researcher, Dr. Goldzieher, placed blame on Texas law rather than his study design: "We could have aborted them if the abortion statue here in Texas weren't in limbo right now. A court order overturned the law and the case is awaiting Supreme Court review. if we had a liberalized law, we'd abort them" (Curtis et al. 1973).

See also

References

  • Allen, William Sheridan. 1965. The Nazi Seizure of Power: The Experience of a Single German Town, 1930–1935. Chicago: Quadrangle Books. (also London: Eyre & Spottiswoode 1966)
  • --- 1984. The Nazi Seizure of Power: The Experience of a Single German Town, 1922-1945, Revised Edition. New York: Franklin Watts. ISBN 0531099350
  • Amdur, Robert J., and Elizabeth A. Bankert. 2022. Institutional Review Book: Member Handbook, 4th Edition. Burlington, MA: Jones & Bardett Learning.
  • Baker, Shamim M., Otis W. Brawley, and Leonard S. Marks. 2005. Effects of untreated syphilis in the Negro male, 1932 to 1972: A closure comes to the Tuskegee study, 2004. Urology 65(6): 1259-1262.
  • Beecher, H. K. 1966. Ethics and clinical research. New England Journal of Medicine 274:1354-1360. Retrieved September 28, 2021.
  • Bergerson, Andrew Stuart. 2018. All politics is local: revisiting William Sheridan Allen's Northeim. Studies in Contemporary History/Zeithistorische Forschungen 5: 469-474.
  • Brandt, Allan M. 1978. Racism and research: the case of the Tuskegee Syphilis Study. The Hastings Center Report 8(6): 21-29.
  • Cargan, Leonard. 2007. Doing Social Research. Lanham, Maryland: Rowman and Littlefield. ISBN 9788131601785
  • Curtis, Gregory, Ron White, and Martha Hume. 1973. Maybe Baby. Texas Monthly October 1873.
  • Das, Nilay Kanti, and Amrita Sil. 2017. Evolution of ethics in clinical research and ethics committee. Indian J. Dermatol. 62(4): 373-379. Retrieved September 28, 2021.
  • Heller, Jean. 1972. Syphilis victims in U.S. study went untreated for 40 years. New York Times July 26, 1972.
  • Kim, Won Oak. 2012. Institutional review board (IRB) and ethical issues in clinical research. Korean J. Anesthesiol. 62(1): 3-12. Retrieved September 28, 2021.
  • National Commission for the Protection of Human Subjects of Biomedical and Behavior Research. April 18, 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Retrieved July 23, 2021.
  • National Nuclear Security Administration. 2019. Standard Operating Procedures- Definitions (Version 4/29/19). HSPP Training/Reference Materials, CDOEIRB September 2019. (This section begins: "This policy establishes the definitions followed by the Department of Energy (DOE) Human Subjects Protection Program.)
  • Offit, Paul A. 2007. Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases. Smithsonian Books/Collins. ISBN 978-0-06-122795-0.
  • Rodriguez, Michael A., and Robert Garcia. 2013. First, do no harm: the US sexually transmitted disease experiments in Guatemala. American Journal of Public Health 103(12): 2122-2126.
  • Roethlisberger, F. J., and W. J. Dickson. 1939. Management and the Worker. Cambridge: MA: Harvard University Press.
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