human subjects of experiment

Defining Research with Human Subjects

A study is considered research with human subjects if it meets the definitions of both research AND human subjects, as defined in the federal regulations for protecting research subjects.

Research.  A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

Human subject:  A living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following sections will explain some of the words in the previous definitions.

The regulatory language:

A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

The explanation:

Understanding what constitutes a systematic inquiry varies among disciplines and depends on the procedures and steps used to answer research questions and how the search for knowledge is organize and structured.

Pilot Studies and Research Development

Pilot studies are designed to conduct preliminary analyses before committing to a full-blown study or experiment.

Research development includes activities such as convening a focus group consisting of members of the proposed research population to help develop a culturally appropriate questionnaire.

Practical applications:

• You are conducting a pilot study or other activities preliminary to research; or
• You have designed a study to collect information or biospecimens in a systematic way to answer a research question; or
• You intend to study, analyze, or otherwise use existing information or biospecimens to answer a research question.

Human Subjects

Human subjects are living individuals about whom researchers obtain information or biospecimens through interaction, intervention, or observation of private behavior, to also include the use, study, and analysis of said information or biospecimens.

Obtaining, using, analyzing, and generating identifiable private information or identifiable biospecimens that are provided to a researcher is also considered to be human subjects.

To meet the definition of human subjects, the data being collected or used are about people. Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.

• Interacting with people to gather data about them using methods such as interviews, focus groups, questionnaires, and participant observation; or
• Conducting interventions with people such as experiments or manipulations of subjects or subjects' environments; or
• Observing or recording behavior, whether in-person and captured in real time or in virtual spaces, like social media sites (e.g., Twitter) or online forums (e.g., Reddit); or
• Obtaining existing information about individuals, such as students’ school records or patients’ health records, or data sets provided by another researcher or organization.

Interactions and Interventions

Interventions are manipulations of the subject or the subject's environment, for example is a behavioral change study using text messages about healthy foods.

Interactions include communication or interpersonal contact between investigator and participant.

A study may include both interventions and interactions.

Interactions and interventions do not require in-person contact, but may be conducted on-line.

Private Information

Private information  includes information or biospecimens: 1) about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place; 2) that has been provided for specific purposes by an individual; and 3) that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the information to constitute research involving human subjects.

The regulations are clear that it is the subjects’ expectations that determine what behaviors, biospecimens, and identifiable information must be considered private. Subjects’ understanding of what privacy means are not universal, but are very specific and based on multiple interrelated factors, such as the research setting, cultural norms, the age of the subjects, and life experiences. For example, in the United States, health records are considered private and protected by law, but in some countries, health information is not considered private but are of communal concern. 

Identifiable Information

The identity of the subject is associated with the data gathered from the subject(s) existing data about the subjects. Even if the data (including biospecimens) do not include direct identifiers, such as names or email addresses, the data are considered identifiable if names of individuals can easily be deduced from the data.

If there are keys linking individuals to their data, the data are considered identifiable.

Levels of Review

Not all projects that meet the definition of research with human subjects need review by the actual committee. For example, projects that pose  negligible risk to participants may be reviewed and recommended for approval by IRB staff ; other projects may need to undergo review and approval by at least one member of the IRB committee or a quorum of the full board. Determination as to the need for review should always be made by the IRB staff.

Examples of Studies That MAY Meet the Definition of Research with Human Subjects

The following examples will likely require further consultation with an IRB staff member.

Analysis of existing information with no identifiers

If researchers have no interaction with human subjects, but will be conducting a secondary analysis of existing data without individual identifiers, the analysis of those data may not be research with human subjects. 

Expert consultation

Key words in the definition of a human subject are "a living individual about whom" a researcher obtains, uses, studies, analyzes, or generates information. People can provide you information that is not about them but is important for the research. For example, a researcher may contact non-governmental organizations to ask about sources of funding.

Program evaluations and quality improvement studies

Program evaluations are generally intended to query whether a particular program or curriculum meets its goals. They often involve pre- and post-surveys or evaluations.

Some program evaluations include a research component. If data are collected about the characteristics of the participants to analyze the relationship between demographic variable and success of the program, the study may become research with human subjects.  Research question:  Are there different learning outcomes associated with different levels of participant confidence?

Classroom research

Classes designed to teach research methods such as fieldwork, statistical analysis, or interview techniques, may assign students to conduct interviews, distribute questionnaires, or engage in participant observation. If the purpose of these activities is solely pedagogical and are not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects. 

Vignettes: Applying the Definitions

Art in Cambodia

An art history student wants to study art created by Cambodians in response to the massacres committed by the Khmer Rouge. The art she will study includes paintings, sculpture, video, and the performing arts.

Much of the research will be archival, using library and online resources. In addition, she will visit Cambodia. While there, she will speak with several museum curators for assistance locating and viewing art collections related to the massacres.

Is this research with human subjects?

No. Although the student will speak with curators, they are not the subjects of her research and she is not interested in learning anything about them. They will, in effect, serve as local guides.

What would make the study research with human subjects?

The student interviews people as they interact with art to understand the role of the arts in evoking and/or coming to terms with traumatic past events. She interviews people who view the art, such as visitors to museums, and discusses what the art means to them. She may collect information about their experiences during the genocide and compare those experiences with their reactions to the art. 

Bank-Supported Micro-Finance in Chile

A researcher is interested in the practice of microfinance in the Chilean Mapuche community. She meets with bankers and asks about the criteria for granting loans, the demographics of the people who receive loans, the types of businesses to which the bank prefers to grant loans, how many loans they give, the payback rates, and other data about the bank’s loan practices.

No. Although the researcher is interviewing bankers, the bankers are only providing information about their banking practices and are not providing any information about themselves. The questions are about “what” rather than “about whom.” The bankers are not human subjects. This type of interview is sometimes referred to as expert consultation.

The researcher explores the impact of small loans, both intended and unintended, on the recipients of the loans. The researcher interviews the recipients of the loans and gathers information from them about their lives before and after they received funding, how the loans affected their relationships with family members and other community members, the impact of the loans on their aspirations, and so on. He asks “about whom” questions designed to understand the impact of micro-loans.

Developing Teaching Materials

A researcher goes to a country in which the infrastructure has been severely damaged to help rebuild schools. The student interviews community members about what curricular materials they need, develops some materials, and teaches a math class.

No. Although interviews are conducted, the intent of interviewing is to assist in resource development rather than answer a research question designed to contribute to a field of knowledge.

If the researcher does pre- and post-testing to assess student learning in his class, is this research with human subjects?

No. The intent is to find out if the materials are effective. This is sometimes referred to as program assessment.

What would make this research with human subjects?

The researcher studies the impact of nutrition and personal variables on learning. He assesses the nutritional composition of the local diet, assesses students’ general health, and compares those data with test scores. He also measures motivation, family composition, and other characteristics of the students using written questionnaires.

Water Conservation

A researcher wants to find out if the campus water conservation program is effective. She will gather some information about water volume usage from the University engineering department. She will also survey residential students about their water usage habits over the last six months, their perceptions of the campus drought education program, and their reactions to the incentives offered by the program (water-saving competitions, free water-saving devices, etc.) She will report her findings to the program’s steering committee and administrators.

No. Although the researcher will systematically survey other students and will be collecting information about them, her intention is to assess the effectiveness of the conservation program.

The researcher designs an online survey to collect information that may help understand factors that influence the residential students’ responses to the conservation program. She asks questions about green attitudes and behaviors, positions on social and political issues, as well as motivation and narcissism.

Campus IRB Guides

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Human Subjects Research - Home page

Find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training and resources.  Learn about considerations for human subjects research when planning and submitting a research application or contract proposal, and throughout the extramural funding cycle.

Definition of Human Subjects Research

Are you planning on conducting human subjects research? Learn more about research that meets the definition human subjects research, Federal regulation requirements, and whether your project may be considered exempt. Also, learn about NIH-specific considerations and become more familiar with NIH policies, and other regulations as it relates to human subjects research protections.

Pre-Award and Post-Award Processes

Learn about the process of applying for a grant, cooperative agreement, or R&D contract, as it relates to the involvement of human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section, and learn about next steps after submitting your grant application or proposal.

Certificates of Confidentiality (CoC)

Learn more about the NIH Certificates of Confidentiality policy. Determine if your research is eligible for receiving a CoC and use our online system to get a certificate. 

Clinical Trial Requirements for Grants and Contracts

If you are submitting a grant application or responding to a contract proposal to NIH that includes a clinical trial, or are involved with conducting, managing, or overseeing clinical trials, learn about NIH policies, and find resources to guide you in your work.

Inclusion Policies

NIH is committed to supporting clinical research that benefits individuals of all sexes/genders, races, ethnicities, and ages. The information provided on this website is designed to assist the extramural community in addressing inclusion, including the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy, in NIH grant applications and progress reports.

NIH Single IRB Policy

Learn about the NIH single IRB policy for NIH-funded domestic multi-site studies involving non-exempt human subjects studies. Find key resources to understand the policy expectations and the process for requesting exceptions. 

Policies & Regulations

Find information about human subjects research policies, and NIH-specific requirements for humans subjects research studies.

Training & Resources

Training and tools to learn about human subjects research, exemptions, and NIH requirements for human subjects research.

This page last updated on: February 28, 2019

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Human research protections

Research with human participants has proven invaluable in advancing knowledge in the biomedical, behavioral, and social sciences. Such research is strictly regulated, with laws at the federal, state, and local levels. Further, professional societies have developed discipline-specific standards, policies, and guidelines for ensuring that the rights and welfare of research participants is protected.

In the early 1970s, following widely publicized cases of research abuse, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created to study issues surrounding the protection of humans in research. In 1979 the Commission issued a report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly called the Belmont Report), which provided the ethical framework on which current federal regulations for the protection of human participants in research are based.

Legislation and regulations

Legislation and regulations that affect the conduct of research with human participants:

• Department of Health and Human Services - 45CFR46
• Food and Drug Administration - 21CFR50 and 21CFR56
• The privacy rule
• Mandatory reporters: Summary of state laws (PDF, 493KB)
• NIH policy and compliance: Human subjects research

Resources that provide additional guidance on various human research protection issues:

Institutional review boards (IRBs)

• IRB guidebook
• Expedited review categories
• IRBs and psychological science (APA report)
• Recommendations of the 2007 APA Presidential Task Force on IRBs and psychological science (PDF, 36KB)
• Protecting personal health information in research: Understanding the HIPAA privacy rule (PDF, 3.59MB)
• HIPAA frequently asked questions

Research on the internet

• Psychological research online: Opportunities and challenges

Federal offices

U.S. federal agency offices charged with regulating research with human participants:

• Office for Human Research Protections (DHHS)
• Policy and compliance: Human subjects research (NIH)

Training resources

• Ethical and policy issues in research involving human participants (PDF, 2MB) (NBAC report)
• National Library of Medicine bibliography
• Protecting participants and facilitating social and behavioral sciences research (NRC report)
• Research involving persons with mental disorders that might affect decision-making capacity (NBAC report)
• Resources for research ethics education: Human subjects
• Responsible research: A systems approach to protecting research participants (IOM report)
• University of Minnesota consent module

APA resources

• Guidelines for ethical conduct of behavioral projects involving human participants by high school students
• Researchers and regulators hammer out guidelines for research risk ( Monitor on Psychology , 2005)
• Ethics in research with human participants (APA book)
• Committee on Human Research (CHR)
• Conducting research

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Human Experimentation: An Introduction to the Ethical Issues

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In January 1944, a 17-year-old Navy seaman named Nathan Schnurman volunteered to test protective clothing for the Navy. Following orders, he donned a gas mask and special clothes and was escorted into a 10-foot by 10-foot chamber, which was then locked from the outside. Sulfur mustard and Lewisite, poisonous gasses used in chemical weapons, were released into the chamber and, for one hour each day for five days, the seaman sat in this noxious vapor. On the final day, he became nauseous, his eyes and throat began to burn, and he asked twice to leave the chamber. Both times he was told he needed to remain until the experiment was complete. Ultimately Schnurman collapsed into unconsciousness and went into cardiac arrest. When he awoke, he had painful blisters on most of his body. He was not given any medical treatment and was ordered to never speak about what he experienced under the threat of being tried for treason. For 49 years these experiments were unknown to the public.

The Scandal Unfolds

In 1993, the National Academy of Sciences exposed a series of chemical weapons experiments stretching from 1944 to 1975 which involved 60,000 American GIs. At least 4,000 were used in gas-chamber experiments such as the one described above. In addition, more than 210,000 civilians and GIs were subjected to hundreds of radiation tests from 1945 through 1962.

Testimony delivered to Congress detailed the studies, explaining that “these tests and experiments often involved hazardous substances such as radiation, blister and nerve agents, biological agents, and lysergic acid diethylamide (LSD)....Although some participants suffered immediate acute injuries, and some died, in other cases adverse health problems were not discovered until many years later—often 20 to 30 years or longer.” 1

These examples and others like them—such as the infamous Tuskegee syphilis experiments (1932-72) and the continued testing of unnecessary (and frequently risky) pharmaceuticals on human volunteers—demonstrate the danger in assuming that adequate measures are in place to ensure ethical behavior in research.

Tuskegee Studies

In 1932, the U.S. Public Health Service in conjunction with the Tuskegee Institute began the now notorious “Tuskegee Study of Untreated Syphilis in the Negro Male.” The study purported to learn more about the treatment of syphilis and to justify treatment programs for African Americans. Six hundred African American men, 399 of whom had syphilis, became participants. They were given free medical exams, free meals, and burial insurance as recompense for their participation and were told they would be treated for “bad blood,” a term in use at the time referring to a number of ailments including syphilis, when, in fact, they did not receive proper treatment and were not informed that the study aimed to document the progression of syphilis without treatment. Penicillin was considered the standard treatment by 1947, but this treatment was never offered to the men. Indeed, the researchers took steps to ensure that participants would not receive proper treatment in order to advance the objectives of the study. Although, the study was originally projected to last only 6 months, it continued for 40 years.

Following a front-page New York Times article denouncing the studies in 1972, the Assistant Secretary for Health and Scientific Affairs appointed a committee to investigate the experiment. The committee found the study ethically unjustified and within a month it was ended. The following year, the National Association for the Advancement of Colored People won a $9 million class action suit on behalf of the Tuskegee participants. However, it was not until May 16, 1997, when President Clinton addressed the eight surviving Tuskegee participants and others active in keeping the memory of Tuskegee alive, that a formal apology was issued by the government.

While Tuskegee and the discussed U.S. military experiments stand out in their disregard for the well-being of human subjects, more recent questionable research is usually devoid of obvious malevolent intentions. However, when curiosity is not curbed with compassion, the results can be tragic.

Unnecessary Drugs Mean Unnecessary Experiments

A widespread ethical problem, although one that has not yet received much attention, is raised by the development of new pharmaceuticals. All new drugs are tested on human volunteers. There is, of course, no way subjects can be fully apprised of the risks in advance, as that is what the tests purport to determine. This situation is generally considered acceptable, provided volunteers give “informed” consent. Many of the drugs under development today, however, offer little clinical benefit beyond those available from existing treatments. Many are developed simply to create a patentable variation on an existing drug. It is easy to justify asking informed, consenting individuals to risk limited harm in order to develop new drug therapies for a condition from which they are suffering or for which existing treatments are inadequate. The same may not apply when the drug being tested offers no new benefits to the subjects because they are healthy volunteers, or when the drug offers no significant benefits to anyone because it is essentially a copy of an existing drug.

Manufacturers, of course, hope that animal tests will give an indication of how a given drug will affect humans. However, a full 70 to 75 percent of drugs approved by the Food and Drug Administration for clinical trials based on promising results in animal tests, ultimately prove unsafe or ineffective for humans. 2 Even limited clinical trials cannot reveal the full range of drug risks. A U.S. General Accounting Office (GAO) study reports that of the 198 new drugs which entered the market between 1976 and 1985, 102 (52 percent) caused adverse reactions that premarket tests failed to predict. 3 Even in the brief period between January and August 1997, at least 53 drugs currently on the market were relabeled due to unexpected adverse effects. 4

In the GAO study, no fewer than eight of the drugs in question were benzodiazepines, similar to Valium, Librium, and numerous other sedatives of this class. Two were heterocyclic antidepressants, adding little or nothing to the numerous existing drugs of this type. Several others were variations of cephalosporin antibiotics, antihypertensives, and fertility drugs. These are not needed drugs. The risks taken to develop these drugs by trial participants, and to a certain extent by consumers, were not in the name of science, but in the name of market share.

As physicians, we necessarily have a relationship with the pharmaceutical companies that produce, develop, and market drugs involved in medical treatment. A reflective, perhaps critical posture towards some of the standard practices of these companies—such as the routine development of unnecessary drugs—may help to ensure higher ethical standards in research.

Unnecessary Experimentation on Children

Unnecessary and questionable human experimentation is not limited to pharmaceutical development. In experiments at the National Institutes of Health (NIH), a genetically engineered human growth hormone (hGH) is injected into healthy short children. Consent is obtained from parents and affirmed by the children themselves. The children receive 156 injections each year in the hope of becoming taller.

Growth hormone is clearly indicated for hormone-deficient children who would otherwise remain extremely short. Until the early 1980s, they were the only ones eligible to receive it; because it was harvested from human cadavers, supplies were limited. But genetic engineering changed that, and the hormone can now be manufactured in mass quantities. This has led pharmaceutical houses to eye a huge potential market: healthy children who are simply shorter than average.

Short stature, of course, is not a disease. The problems short children face relate only to how others react to their height and their own feelings about it. The hGH injection, on the other hand, poses significant risks, both physical and psychological.

These injections are linked in some studies to a potential for increased cancer risk, 5-8 are painful, and may aggravate, rather than reduce, the stigma of short stature. 9,10 Moreover, while growth rate is increased in the short term, it is unclear that the final net height of the child is significantly increased by the treatment.

The Physicians Committee for Responsible Medicine worked to halt these experiments and recommended that the biological and psychological effects of hGH treatment be studied in hormone-deficient children who already receive hGH, and that non-pharmacologic interventions to counteract the stigma of short stature also be investigated. Unfortunately, the hGH studies have continued without modification, putting healthy short children at risk.

Use of Placebo in Clinical Research

Whooping cough, also known as pertussis, is a serious threat to infants, with dangerous and sometimes fatal complications. Vaccination has nearly wiped out pertussis in the U.S. Uncertainties remain, however, over the relative merits and safety of traditional whole-cell vaccines versus newer, acellular versions, prompting the NIH to propose an experiment testing various vaccines on children.

The controversial part of the 1993 experiment was the inclusion of a placebo group of more than 500 infants who get no protection at all, an estimated 5 percent of whom were expected to develop whooping cough, compared to the 1.4 percent estimated risk for the study group as a whole. Because of these risks, this study would not be permissible in the U.S. The NIH, however, insisted on the inclusion of a placebo control and therefore initiated the study in Italy where there are fewer restrictions on human research trials. Originally, Italian health officials recoiled from these studies on ethical as well as practical grounds, but persistent pressure from the NIH ensured that the study was conducted with the placebo group.

The use of double-blind placebo-controlled studies is the “gold standard” in the research community, usually for good reason. However, when a well-accepted treatment is available, the use of a placebo control group is not always acceptable and is sometimes unethical. 11 In such cases, it is often appropriate to conduct research using the standard treatment as an active control. The pertussis experiments on Italian children were an example of dogmatic adherence to a research protocol which trumped ethical concerns.

Placebos, Ethics, and Poorer Nations

The ethical problems that placebo-controlled trials raise are especially complicated in research conducted in economically disadvantaged countries. Recently, attention has been brought to studies conducted in Africa on preventing the transmission of HIV from mothers to newborns. Standard treatment for HIV-infected pregnant women in the U.S. is a costly regimen of AZT. This treatment can save the life of one in seven infants born to women with AIDS. 12 Sadly, the cost of AZT treatment is well beyond the means of most of the world’s population. This troubling situation has motivated studies to find a cost-effective treatment that can confer at least some benefit in poorer countries where the current standard of care is no treatment at all. A variety of these studies is now underway in which a control group of HIV-positive pregnant women receives no antiretroviral treatment.

Such studies would clearly be unethical in the U.S. where AZT treatment is the standard of care for all HIV-positive mothers. Peter Lurie, M.D., M.P.H., and Sidney Wolfe, M.D., in an editorial in the New England Journal of Medicine , hold that such use of placebo controls in research trials in poor nations is unethical as well. They contend that, by using placebo control groups, researchers adopt a double standard leading to “an incentive to use as research subjects those with the least access to health care.” 13 Lurie and Wolfe argue that an active control receiving the standard regimen of AZT can and should be compared with promising alternative therapies (such as a reduced dosage of AZT) to develop an effective, affordable treatment for poor countries.

Control Groups and Nutrition

Similar ethical problems are also emerging in nutrition research. In the past, it was ethical for prevention trials in heart disease or other serious conditions to include a control group which received weak nutritional guidelines or no dietary intervention at all. However, that was before diet and lifestyle changes—particularly those using very low fat, vegetarian diets—were shown to reverse existing heart disease, push adult-onset diabetes into remission, significantly lower blood pressure, and reduce the risk of some forms of cancer. Perhaps in the not-too-distant future, such comparison groups will no longer be permissible.

The Ethical Landscape

Ethical issues in human research generally arise in relation to population groups that are vulnerable to abuse. For example, much of the ethically dubious research conducted in poor countries would not occur were the level of medical care not so limited. Similarly, the cruelty of the Tuskegee experiments clearly reflected racial prejudice. The NIH experiments on short children were motivated to counter a fundamentally social problem, the stigma of short stature, with a profitable pharmacologic solution. The unethical military experiments during the Cold War would have been impossible if GIs had had the right to abort assignments or raise complaints. As we address the ethical issues of human experimentation, we often find ourselves traversing complex ethical terrain. Vigilance is most essential when vulnerable populations are involved.

• Frank C. Conahan of the National Security and International Affairs Division of the General Accounting Office, reporting to the Subcommittee of the House Committee on Government Operations.
• Flieger K. Testing drugs in people. U.S. Food and Drug Administration. September 10, 1997.
• U.S. General Accounting Office. FDA Drug Review: Postapproval Risks 1976-85. U.S. General Accounting Office, Washington, D.C., 1990.
• MedWatch, U.S. Food and Drug Administration. Labeling changes related to drug safety. U.S. Food and Drug Administration Home Page; http://www.fda.gov/medwatch/safety.htm . September 10, 1997.
• Arteaga CL, Osborne CK. Growth inhibition of human breast cancer cells in vitro with an antibody against the type I somatomedin receptor. Cancer Res . 1989;49:6237-6241.
• Pollak M, Costantino J, Polychronakos C, et al. Effect of tamoxifen on serum insulin-like growth factor I levels in stage I breast cancer patients. J Natl Cancer Inst . 1990;82:1693-1697.
• Stoll BA. Growth hormone and breast cancer. Clin Oncol . 1992;4:4-5.
• Stoll BA. Does extra height justify a higher risk of breast cancer? Ann Oncol . 1992;3:29-30.
• Kusalic M, Fortin C. Growth hormone treatment in hypopituitary dwarfs: longitudinal psychological effects. Canad Psychiatric Asso J . 1975;20:325-331.
• Grew RS, Stabler B, Williams RW, Underwood LE. Facilitating patient understanding in the treatment of growth delay. Clin Pediatr . 1983;22:685-90.
• For a more extensive discussion of the ethical status of placebo-controlled trials see especially: Freedman B, Glass KC, Weijer C. Placebo orthodoxy in clinical research II: ethical, legal and regulatory myths. J Law Med Ethics . 1996;24:252-259.
• Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunnodeficiency virus in developing countries. N Engl J Med . 1997:337:12:853.

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Types of Human Subjects Research

On this page, analysis of existing data or specimens, observational studies, interventional studies.

If you're using private information, data, or specimens, your research may be exempt from the Code of Federal Regulations 45 Part 46. You may refer to the NIH Office of Extramural Research (OER) decision tool or consult with your institutional review board (IRB) or independent ethics committee (IEC). The NIDCR evaluates each project independently to determine oversight needs and whether the NIDCR Clinical Terms of Award (CToA) applies.

Toolkit for Analysis of Existing Data

In an observational study, the investigator simply records observations and analyzes data, without assigning participants to a specific intervention or treatment. These studies may focus on observation of risk factors, natural history, variations in disease progression or disease treatment without delivering or assigning an intervention. They often assess specific health characteristics of the enrolled human subjects by collecting medical/dental history, exposure, or clinical data; obtaining biospecimens (e.g., for biomarker or genomic analyses); or obtaining photographic, radiographic or other images from research subjects.

Toolkit for Observational Studies

The NIH defines an intervention as a manipulation of the subject or the subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. The NIH further defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Toolkit for Interventional Studies

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• > The Cambridge World History of Medical Ethics
• > The Ethics of Experimenting on Human Subjects

Book contents

• Frontmatter
• PART I AN INTRODUCTION TO THE HISTORY OF MEDICAL ETHICS
• PART II A CHRONOLOGY OF MEDICAL ETHICS
• PART III DISCOURSES OF MEDICAL ETHICS THROUGH THE LIFE CYCLE
• PART IV THE DISCOURSES OF RELIGION ON MEDICAL ETHICS
• PART V THE DISCOURSES OF PHILOSOPHY ON MEDICAL ETHICS
• PART VI THE DISCOURSES OF PRACTITIONERS ON MEDICAL ETHICS
• PART VII THE DISCOURSES OF BIOETHICS
• PART VIII DISCOURSES ON MEDICAL ETHICS AND SOCIETY
• Ethical and Legal Regulation of Medical Practice and Research
• 46 The Medical Market place, the Patient, and the Absence of Medical Ethics in Early Modern Europe and North America
• 47 The Legal and Quasilegal Regulation of Practitioners and Practice in the United States
• 48 The Ethics of Experimenting on Animal Subjects
• 49 The Ethics of Experimenting on Human Subjects
• 50 The Historical Development of International Codes of Ethics for Human Subjects Research
• 51 International Ethics of Human Subjects Research in the Late Twentieth Century
• B Medical Ethics, Imperialism, and the Nation-State
• C Medical Ethics and Health Policy
• Appendix: Biographies: Who Was Who in the History of Medical Ethics
• Bibliography

49 - The Ethics of Experimenting on Human Subjects

from Ethical and Legal Regulation of Medical Practice and Research

Published online by Cambridge University Press:  28 May 2012

INTRODUCTION

Experimentation on human beings may be as old as medicine itself. The search for new therapies – drugs, devices, and procedures – required that someone go first, some individual participate in the trial of an innovative treatment, and experience both the risks and benefits of that participation. Although these risks and benefits remain for research subjects, the norms governing research with human subjects, the understanding of the ethical responsibilities of investigators and the rights of research subjects has undergone a profound transformation over the course of the twentieth century. Once implicit and informal understandings of the limits of appropriate experimentation have become codified into federal regulations that require (in the United States) written and informed consent of participants and institutional review of the proposed research (see Chapter 50). Ethical issues in the use of human subjects remain (for example, the conduct of human research by Western investigators in developing countries, an issue intensified by the acquired immunodeficiency syndrome (AIDS) pandemic), but there are some legal protections for human subjects and more clearly defined responsibilities for individual researchers and their institutions (see Chapter 51).

Legal restrictions on the use of laboratory animals preceded legal protections for human subjects by decades or more (see Chapter 48). The moral status of animal experimentation remains, in many respects, more highly contested than human experimentation.

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• The Ethics of Experimenting on Human Subjects
• By Susan Lederer
• Edited by Robert B. Baker , Union College, New York , Laurence B. McCullough
• Book: The Cambridge World History of Medical Ethics
• Online publication: 28 May 2012
• Chapter DOI: https://doi.org/10.1017/CHOL9780521888790.051

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Scientific Methods and Human Subjects Research

Introduction to Experimental Methods

Karri Haen Whitmer

Our understanding of the methods used to conduct good scientific research is important for progress in our scientific understanding but also impacts our daily lives. Understanding good scientific methodology allows us to not only conduct experiments, but it helps us to analyze research conducted by others. For example, it helps us to determine whether research studies reported in the news are reliable. Research knowledge also helps us to discriminate among different medical treatments when it comes to making personal health decisions.

Scientific research methods include several steps, which may differ depending upon the topic to be addressed by a study. Standard scientific methods typically include: definition of the research problem, conducting background research, formulation of hypotheses, designing and conducting experiments, analysis of results, formulation of conclusions, and communication of research results to the public.

Central to our acquisition of scientific knowledge is the concept of the experiment. Researchers do experiments to answer questions about the world around us. The following are examples of simple research questions in human physiology:

• Does changing the respiratory rate affect heart rate?
• Does caffeine consumption affect blood glucose levels?
• Does body temperature affect blood oxygen levels?

In order to answer these questions, researchers begin by formulating testable hypotheses . A hypothesis is a tentative statement describing the relationship between the variables in an experiment. Research hypotheses are written as if/then statements that include dependent and independent variables.

A variable is any factor that can change, affecting the experimental results. The dependent variable is the variable in the experiment that is measured by the researcher. The independent variable is the variable that is manipulated by the researcher in order to exert an effect on the dependent variable. In the first example research question, the heart rate is the dependent variable, and the respiratory rate is the independent variable. The researcher will use an experimental method (for example deep breathing) to manipulate a subject’s respiratory rate to measure whether any changes occur in the heart rate.

Dependent variable: the variable that is measured as the output of an experiment (the result)

Independent variable: a variable that is manipulated by the researcher

Writing Hypotheses

A hypothesis is a “tentative statement that proposes a possible explanation to some phenomenon or event.” [1]   Hypotheses written for the purpose of conducting experiments must be testable. Formalized hypotheses use an if/then format that helps to assure that all important aspects of the hypothesis are intact, including the independent and dependent variables. Additionally, a good research hypothesis has three parts: an explanation of a phenomenon to be tested, a method, and a prediction. A research hypothesis must be written before an experiment is conducted.

Imagine students working on a physiology project involving muscle contraction and temperature. The students observe that cold hands do not function as well at performing certain tasks requiring manual dexterity than do warm hands. The students decide to test grip strength under different temperature conditions using a handgrip dynamometer, which measures the strength of contraction of hand and forearm muscles.

The following are examples of bad and good research hypotheses for this experiment:

• My grip strength will be stronger with warm hands than with cold hands.

This example is not a research hypothesis because it only includes a prediction. A prediction by itself is never a formalized hypothesis.

• If I test grip strength with a handgrip dynamometer, then my grip strength will be stronger with warm hands than with cold hands.

This example is not a research hypothesis because it only includes a method (a test) and a prediction. It does not include any explanation of the phenomenon to be tested.

• If low temperatures suppress muscle contraction, and I test grip strength at different temperatures with a handgrip dynamometer, then my grip strength will be stronger with warm hands than with cold hands.

This is an example of a correct research hypothesis. Note the three parts: “if low temperatures suppress muscle contraction” (a possible explanation of the phenomenon to be tested), “and I test grip strength at different temperatures with a handgrip dynamometer” (the method used for the test), and “then my grip strength will be stronger with warm hands than with cold hands” (the prediction).

This writing sample is also an example of a formalized hypothesis due to the use of the if/then format. In this hypothesis, the independent variable is muscle temperature, and the dependent variable is muscle contraction strength.

Exercise: Practice writing a research hypothesis

Background: The ad for a creatine supplement claims ingesting 10g of creatine once a day for four weeks results in measurable increases in muscle mass. A student decided to test the claim in 10 subjects by measuring the circumference of the upper arm, around the belly of the biceps muscles, before and after treatment. The subjects were not allowed to take part in weight or resistance training during the testing period.  

Write a hypothesis as an if/then statement for this experiment:

What is the dependent variable?

What is the independent variable?

Designing Experiments involving Humans

Well-designed experiments must minimize the effects of extraneous environmental and physiological factors, in order to make sure changes recorded in the dependent variable are actually the result of manipulating the independent variable. Experimental controls  establish a baseline for the experiment. When conducting human subject experiments in physiology, the control might consist of a separate group of people, the control group , who are not exposed to any manipulation of the independent variable, or it might be the same group of subjects tested before (and then after) altering the independent variable.

Experimental studies may be in vitro , conducted in highly controlled laboratory conditions (example: in a test tube), or in vivo , conducted in a live organism. Controlled laboratory experiments (also called “bench research,” molecular, or cellular research) allow for a great amount of control over the variables that could affect experimental outcomes because all the components in the experimental system can typically be easily accounted for and measured. In human subject research , studies that use human participants to answer a research question, there is typically much less control over experimental variables due to the natural anatomical, physiological, and environmental variation innate to human populations. These are called external variables and can profoundly affect the outcome of an experiment. For example, two subjects may metabolize a compound differently due to differences in enzymes or two subjects that may react to cardiovascular stress differently due to their sex, age, or fitness level. To account for these external, or uncontrolled, variables in human subjects, experiments often use a within-subjects design (below) where the dependent variable is measured in the same subjects before and after manipulating the independent variable.

In human subjects research, there are two main types of experimental designs: within-subjects design and between-subjects design.  In a within-subjects design , the subjects of the study participate under each study condition, including in the control group. In the most simplistic design, the subjects participate in baseline measurements for the control (no treatment) and then participate under experimental conditions. Because the subjects in this kind of study serve as their own control group, variation in the results due to many external variables can be reduced.

An example of a simple within-subjects design can be found in many pharmaceutical studies where a group of participants is given a placebo drug for a defined amount of time, and then the same group is given an experimental drug. Differences in physiological measurements after treatment with the experimental drug are inferred as effects of drug administration.

One disadvantage of this research design is the problem of carryover effects , where the first test adversely influences the other. Two examples of this, with opposite effects, are fatigue and practice. In a complicated experiment, with multiple treatment conditions, the participants may be tired and thoroughly fed up of researchers prying and asking questions and pressuring them into taking tests. This could decrease their performance on the last study. [2]

Alternatively, the practice effect might mean that they are more confident and accomplished after the first condition, simply because the experience has made them more confident about taking tests. As a result, for many experiments, a counterbalance design, where the order of treatments is varied, is preferred, but this is not always possible.

Another type of experimental design is the between-subjects design . In the between-subjects design, there are separate participants for the control and treatment groups, which avoids carryover effects. However, the between-subjects design may make it impossible to maintain homogeneity across the groups: age, gender, and social class are just some of the obvious factors that could result in differences between control and treatment groups, skewing the data.

Within-subjects design: the subjects in the study participate in the control and treatment conditions

Between-subjects design: different groups of subjects participate in the control and treatment conditions

Experimental Error

No matter how careful we are in creating an experimental design, no experiment can be perfect. We must assume there is some margin of error in the collected data. There are three general types of errors that can impact the outcome of an experiment:

• Human error: human errors are simple mistakes made by an experimenter. For example, the experimenter didn’t appropriately attach a sensor or read a patient’s blood pressure wrong.
• Sampling bias: the participants in the study are not representative of the population at large; thus, the results cannot be generalized outside of the study population. For example, data from a study conducted on only 80- year-old men may not be generalized to everyone else in the human population.
• Selection bias: the assignment of subjects to control and treatment groups was not random, resulting in experimental results highly impacted by external variables. For example, a control group that included only females and a treatment group that contained only males.
• Measurement bias: the experimenters rate subjects differently due to their own expectations of experimental outcomes.
• Random error: by-chance variations in measurements that cannot be controlled. Random errors can be reduced by repeated measurements.

The box below lists some sources of error that are possible in all human subject experiments.

Common factors adversely affecting the outcome of human subject experiments:

• Subjects in the study are not representative of the human population at large: e.g., small sample size is too small to fully account for variation in the population
• Interference due to external variables
• Problems with the reliability or accuracy of instruments: e.g., equipment does not have the precision to detect changes in the dependent variable
• Human error: the researcher makes an erroneous measurement or other error

Please cite:

Haen Whitmer, K.M. (2021). A Mixed Course-Based Research Approach to Human Physiology . Ames, IA: Iowa State University Digital Press.  https://iastate.pressbooks.pub/curehumanphysiology/

• http://www.accessexcellence.org/LC/TL/filson/writhypo.html ↵
• Martyn Shuttleworth  (May 16, 2009). Within Subject Design . Retrieved Jul 30, 2019 from Explorable.com:  https://explorable.com/within-subject-design   Creative Commons-License Attribution 4.0 International (CC BY 4.0) . ↵

A Mixed Course-Based Research Approach to Human Physiology Copyright © 2021 by Karri Haen Whitmer is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License , except where otherwise noted.

Nuremberg Code: Directives for Human Experimentation

ORI  Introduction  to RCR: Chapter 3. The Protection of Human Subjects

• The voluntary consent of the human subject is absolutely essential. 
• The experiment should be such as to yield fruitful results for the good of society. 
• The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease.
• The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
• No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur.
• The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
• Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
• The experiment should be conducted only by scientifically qualified persons.
• During the course of the experiment the human subject should be at liberty to bring the experiment to an end.
• During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of thegood faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. ( Link )

Email Updates

This page can't be displayed due to a potential IT security or service issue. Contact the NIH OD Security Team for additional information. Please provide the following Information: Incident ID: N/A Host/IP : history.nih.gov Event ID : 7291643297421257201 Date : Can AI Replace Human Subjects? A Large-Scale Replication of Psychological Experiments with LLMs 65 Pages Posted: Tsinghua University Tsinghua University - Tsinghua University School of Economics and Management Huaikang Zhou Date Written: August 25, 2024 Artificial Intelligence (AI) is increasingly being integrated into scientific research, particularly in the social sciences, where understanding human behavior is critical. Large Language Models (LLMs) such as GPT-4 have shown promise in replicating human-like responses in various psychological experiments. However, the extent to which LLMs can effectively replace human subjects across diverse experimental contexts remains unclear. Here, we conduct a large-scale study replicating 154 psychological experiments from top social science journals with 618 main effects and 138 interaction effects using GPT-4 as a simulated participant. We find that GPT-4 successfully replicates 76.0% of main effects and 47.0% of interaction effects observed in original studies, closely mirroring human responses in both direction and significance. However, only 19.44% of GPT-4's replicated confidence intervals contain the original effect sizes, with the majority of replicated effect sizes exceeding the 95% confidence interval of the original studies, and showing a 71.6% rate of unexpected significant results where the original studies reported null findings, suggesting potential overestimation or false positives. Our results demonstrate the potential of LLMs as powerful tools in psychological research but also emphasize the need for caution in interpreting AI-driven findings. While LLMs can complement human studies, they cannot yet fully replace the nuanced insights provided by human subjects. Keywords: Generative AI, GPT-4, AI for social science, Psychological Experiment, Research Replication, LLM, Effect Size JEL Classification: C91, D91, C81 Suggested Citation: Suggested Citation Tsinghua University ( email ) Ning li (contact author), tsinghua university - tsinghua university school of economics and management ( email ). Beijing China Beijing China 13570476247 (Phone) Do you have a job opening that you would like to promote on SSRN? Paper statistics, related ejournals, behavioral & experimental economics ejournal. Subscribe to this fee journal for more curated articles on this topic Humanistic Management eJournal Subscribe to this free journal for more curated articles on this topic Artificial Intelligence eJournal Psychology research methods ejournal, computational & mathematical sociology ejournal, other organizational behavior research ejournal. The role of predation and pesticides in shaping phytoplankton dynamics in a short microcosms experiment Published: 18 September 2024 Cite this article Suzie Kuyet Zaky 1 , María Florencia Gutierrez 2 , 3 & Diego Frau 2   Aquatic organisms are subject to various forcing factors that affect their structure, some of which are natural, while others result from human activities, both having variable effects. This study aimed to determine the importance of a natural stressor (zooplankton) and an herbicide (atrazine) on phytoplankton density and morphological composition in a microcosm experiment. A natural phytoplankton assemblage was exposed to two zooplankton predators: a copepod ( Argyrodiaptomus falcifer ) and a cladoceran ( Ceriodaphnia dubia ), and to atrazine (27 µg L −1 ), in three combinations of factors (zooplankton treatments (Z), atrazine treatment (A), the combination of both (ZA)) plus a Control. The experiment lasted 48 h. Samples were taken at the beginning and the end of the experiment, and relevant limnological variables, including inorganic nutrient concentrations, were considered. Results indicated differences in phytoplankton densities when treatments were compared with Control. In this respect, Chlorophyceae, Euglenophyceae, and Bacillariophyceae exhibited more changes than other phytoplankton classes. Chlorophyceae densities tended to be higher in the Control than in the treatments; the combination of zooplankton and atrazine favored Euglenophyceae, while atrazine favored Bacillariophyceae densities. Regarding morphological groups, unicellular and small colonies (<35 µm), showed differences between the Control and particularly with Z treatment, colonial-cenobia forms were negatively affected by atrazine and silica forms were favored by both stressors combined. It is concluded that interactions among natural and anthropogenic stressors could be complex, influencing factors such as phytoplankton taxonomical affinities, morphological groups, and the nature of the stressor applied. This is a preview of subscription content, log in via an institution to check access. Access this article Subscribe and save. Get 10 units per month Download Article/Chapter or eBook 1 Unit = 1 Article or 1 Chapter Cancel anytime Price includes VAT (Russian Federation) Instant access to the full article PDF. Rent this article via DeepDyve Institutional subscriptions Explore related subjects Environmental Chemistry APHA (2005) Standard methods for the examination of water and wastewater, 21st ed. American Public Health Association, USA Barnett AJ, Finlay K, Beisner BE (2007) Functional diversity of crustacean zooplankton communities: towards a trait‐based classification. 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Sci Total Environ 780:146481 Wood RJ, Mitrovic SM, Lima RP, Kefford BJ (2017) Chronic effects of atrazine exposure and recovery in freshwater benthic diatoms from two communities with different pollution histories. Aquat Toxicol 189:200–208 Zalocar de Domitrovic Y, Maidana NI (1997) Taxonomic and ecological studies of the Parana River diatom flora (Argentina). In: Lange-Bertalot F, Kociolek P (Eds.) Bibliotheca Diatomologica. J. Cramer, Berlin Zar JH (1996) Biostatistical analysis. Prentice Hall, New York, p 918 Zwart JA, Solomon CT, Jones SE (2015) Phytoplankton traits predict ecosystem function in a global set of lakes. Ecology 96:2257–2264 Download references Acknowledgements We thank C. Mora for her help in nutrient quantification and the two anonymous reviewers who improved this manuscript with their comments and suggestions. Dr. Zaki academic visit to Argentina was supported by a post-doctoral TWAS UNESCO-CONICET scholarship. This research was made possible by financial support from the National Council for Scientific and Technical Research (CONICET) through the project grant PICT n° 1586-2019 awarded by D. Frau. Author information Authors and affiliations. Department of Biological Science, Kaduna State University, P.M.B 2339, Tafawa Balewa Way, Abuja, Kaduna State, Nigeria Suzie Kuyet Zaky Instituto Nacional de Limnología (CONICET-UNL), Ciudad Universitaria, 3000, Santa Fe, Argentina María Florencia Gutierrez & Diego Frau Escuela de Sanidad. Facultad de Bioquímica y Ciencias Biológicas, Ciudad Universitaria, 3000, Santa Fe, Argentina María Florencia Gutierrez You can also search for this author in PubMed   Google Scholar Contributions DF and MFG designed the experiment, SKZ performed the experiment and processed phytoplankton samples, DF analyzed data and wrote the manuscript, SKZ, MFG, and DF revised the manuscript. All the authors agreed with the final version of the manuscript. Corresponding author Correspondence to Diego Frau . Ethics declarations Conflict of interest. The authors declare no competing interests. Supplementary information Supplementary information, rights and permissions. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Reprints and permissions About this article Zaky, S.K., Gutierrez, M.F. & Frau, D. The role of predation and pesticides in shaping phytoplankton dynamics in a short microcosms experiment. Ecotoxicology (2024). https://doi.org/10.1007/s10646-024-02805-4 Download citation Accepted : 30 August 2024 Published : 18 September 2024 DOI : https://doi.org/10.1007/s10646-024-02805-4 Share this article Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative Phytoplankton Zooplankton Microcosms experiment Find a journal Publish with us Track your research An official website of the United States government The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Publications Account settings The PMC website is updating on October 15, 2024. Learn More or Try it out now . Advanced Search Journal List Elsevier Sponsored Documents The victims of unethical human experiments and coerced research under National Socialism Paul weindling. 1 Oxford Brookes University, History, Philosophy and Religion, Headington Campus, Oxford OX3 0BP, United Kingdom Anna von Villiez 2 Independent Data Analyst Aleksandra Loewenau 3 Oxford Brookes University, Centre for Medical Humanities, Department of History, Philosophy and Religion, Gypsy Lane, Oxford OX3 0BP, United Kingdom 4 University of Calgary, Cumming School of Medicine, 2500 University Drive NW, Calgary T2N 1N4, Canada Nichola Farron 5 Independent Holocaust Historian • Human experiments were more extensive than often assumed with a minimum of 15,750 documented victims. • Experiments rapidly increased from 1942, reaching a high point in 1943 and sustained until the end of the war. • There were more victims who survived than were killed as part of or as a result of the experiments. Many survived with severe injuries. • Victims came from diverse nationalities with Poles (Jews and Roman Catholics) as the largest national cohort. • Body parts, especially from euthanasia killings, were often retained for research and teaching after 1945. There has been no full evaluation of the numbers of victims of Nazi research, who the victims were, and of the frequency and types of experiments and research. This paper gives the first results of a comprehensive evidence-based evaluation of the different categories of victims. Human experiments were more extensive than often assumed with a minimum of 15,754 documented victims. Experiments rapidly increased from 1942, reaching a high point in 1943. The experiments remained at a high level of intensity despite imminent German defeat in 1945. There were more victims who survived than were killed as part of or as a result of the experiments, and the survivors often had severe injuries. The coerced human experiments and research under National Socialism constitute a reference point in modern bioethics. 7 Yet discussions of consent and the need for safeguards for research subjects to date lack a firm basis in historical evidence. There has been no full evaluation of the numbers of victims of Nazi research, who the victims were, and of the frequency and types of experiments and research. The one partial estimate is restricted to experiments cited at the Nuremberg Medical Trial. This paper gives the first results of a comprehensive evidence-based evaluation of the different categories of victims. In 1945 liberated prisoners from German concentration camps began to collect evidence of the experiments. The scientific intelligence officer John Thompson then pointed out not only that 90% of all medical research under National Socialism was criminal, but also the need to evaluate all criminal experiments under National Socialism, and not just those whose perpetrators were available for arrest and prosecution. 8 The Nuremberg Medical Trial of 1946–47 was necessarily selective as to who was available for prosecution, and since then only clusters of victims have been identified. 9 In the early 1980s Günther Schwarberg named a set of child victims: his reconstruction the life histories of the ‘twenty children’ killed after transport from Auschwitz for a tuberculosis immunisation experiment at Neuengamme concentration camp was exemplary. 10 The question arises whether what Schwarberg achieved in microcosm can be achieved for the totality of victims. Our aim is to identify not just clusters of victims but all victims of unethical medical research under National Socialism. The methodology is that of record linkage to reconstruct life histories of the total population of all such research victims. This allows one to place individual survivors and groups of victims within a wider context. This project on the victims of Nazi medical research represents the fulfilment of Thompson's original scheme of a complete record of all coerced experiments and their victims. 11 Our project identifies for the first time the victims of Nazi coercive research, and reconstructs their life histories as far as possible. Biographical data found in many different archives and collections is linked to compile a full life history, and subjective narratives and administrative data are compared. Results are aggregated here as cohorts because of undertakings as regards anonymisation, given in order to gain access to key sources. All data is verifiable through the project database. The criterion for unethical research is whether coercion by researchers was involved, or whether the location was coercive. The project has covered involuntary research in clinical contexts as psychiatric hospitals, incarceration in concentration camps and prisoner of war camps, the ‘euthanasia’ killings of psychiatric patients with subsequent retention of body parts for research, and executions of political victims, when body parts were sent to university anatomical institutes, and persons subjected to anthropological research in coercive and life threatening situations as ghettoes and concentration camps. Without a reliable, evidence-based historical analysis, compensation for surviving victims has involved many problems. Victim numbers have been consistently underestimated from the first compensation scheme in 1951 when the assumption was of only few hundred survivors. 12 The assumption was that most experiments were fatal. This project's use of several thousand compensation records in countries where victims lived (as Poland) or migrated to (as Israel), or were collected by the United Nations or the German government has corrected this impression. The availability of person-related evidence from the International Tracing Service at Bad Arolsen further helps to determine whether a victim survived. Major repositories of documents like the United States Holocaust Memorial Museum and the Yad Vashem archives, court records in war crimes proceedings, and oral history collections notably the Shoah Foundation have been consulted. Record linkage of named records is essential for the project, and shows how a single person could be the victim of research on multiple occasions. Father Leon Michałowski, born 22 March 1909 in Wąbrzeźno, was subjected to malaria in August 1942 and then to freezing experiments in October 1942 ( Figure 1 ). Malaria card of Father Bruno Stachowski from Claus Schilling's research at Dachau. Approximately 1000 cards were kept back from destruction by the prisoner assistant Eugène Ost. International Tracing Service, source number 1079406301. A further issue relates to the methods and organisation of the research. From the 1950s the experiments were viewed as ‘pseudo-science’, in effect marginalising them from mainstream science under National Socialism. For the purpose of this study, the experiments have been viewed as part of mainstream German medical research, as this renders rationales and supportive networks historically intelligible. It is clear that prestigious research institutions such as the Kaiser Wilhelm Society and funding agencies such as the German Research Fund were involved. 13 It has been argued more recently that some experiments were cutting edge science. 14 Another view is that the approach and methods were scientific albeit of varying quality. For the purpose of this study, the experiments have been viewed as part of mainstream German medical research, as this renders rationales and supportive networks intelligible. Defining what constitutes research is problematic. For example, a listing of operations in a concentration camp may be nothing more than a clinical record, may have been undertaken by young surgeons seeking to improve their skills, or may indeed have involved research. As stated above, only confirmed data of research has been utilised in the project's category of a verified instance of unethical research. The only exception is the corpses sent to anatomical institutes for research purposes. 15 Separating these out often does not appear possible, but the project includes anatomical research on body parts and brains as separate categories. The project has graded victim evidence into two categories, so that there should be a set of verifiable and proven victims established as incontestable evidence of having been a victim. The unexpectedly high numbers of identified experiment victims makes this necessary. The two categories are: 1. those who were identified as confirmed victims through a reliable source such as experimental records kept at the time. 2. those who have claimed to have been experimented on, but confirmation could not so far be obtained. The project did not set out to adjudicate on the authenticity of victims’ claims. In Warsaw ca. 3600 compensation files of victims of human experiments were viewed, while there are a further 10,000 files representing claims deemed unsuccessful. It is sometimes unclear whether extensive injuries were retrospectively defined to have resulted from an experiment to meet the criteria of the compensation scheme offered by the Federal Republic of Germany in various forms since 1951, or whether experimentation had taken place in a hitherto unknown location. The project discounted claims of abuse when no experiment or research was involved, or when victims having misunderstood compensation schemes for experiments being about ‘experiences’. It is hoped that further research will provide confirmation of experiments in disputed locations like the concentration camps of Stutthof and Theresienstadt. 16 While Yugoslav victims were abused for experiments in German concentration camps, claims for experiments in the former Yugoslavia and Northern Norway have not so far been confirmed. The grading of victims’ claims into the verified and as yet unverified enable the project to establish verifiable minimum numbers, while indicating the possibility of higher numbers being confirmed by further research. Project findings The project is able to present results on: how many victims were killed in the course of the experiment, how many died from the consequences of the experiment or were killed as potential evidence of Nazi criminality, and how many survived? The project has covered experiments, as the most notorious experiments taken to the point of death and supported by the SS in concentration camps, as well as dispersed experiments in a variety of clinical contexts, particularly on psychiatric patients. Some sets of experiments and locations, not least those sponsored by German pharmaceutical companies remain shadowy, and require more detailed research possibly on the basis of further disclosure of documents held in company archives. The extent of involvement of German pharmaceutical companies like that of IG-Farben (using the branded product names of ‘Bayer’, ‘Hoechst’ and ‘Behringwerke’) remains contentious. The company supplied Helmuth Vetter with samples for experiments at Auschwitz and Mauthausen. Similarly problematic is the extent that Schering-Kahlbaum supported Clauberg's uses of X-ray contrast fluids and a substance to seal the fallopian tubes at Auschwitz. Initially, Clauberg asked for deliveries to his clinic at Königshütte (so making the experiments appear as taking place in a consensual clinical context), but later on to Auschwitz. The extent that the company's senior staff knew that their employee and Clauberg's pharmaceutical assistant Johannes Goebel worked at Auschwitz is contentious ( Figure 2 ). 17 Carl Clauberg and Horst Schumann at Block 10 in Auschwitz. United States Holocaust Memorial Museum W/S #67417. The occurrence of unethical research provides insight into the structure of Nazi medical research. The project traced how Nazi coercive research began in the context of eugenic research in the mid-1930s. After numbers of experiments dipped in 1940 due to military call-up of medical researchers, the research rapidly intensified both in terms of numbers of experiments and victims, and in terms of severity for victims. This can be seen from 1942 with the notorious and often fatal experiments on low pressure, exposure to freezing temperatures, and infectious diseases when research could be taken to the point of death. Pharmacological experiments on therapies for tetanus, typhus and typhoid were spurred by the realisation that Allied military medical research on infectious diseases was outstripping German military medical expertise. From November 1942 racial priorities came increasingly to the fore, as exemplified by Schumann's X-ray sterilisation experiments on Jews in Auschwitz. Victims were a highly international group. The above table ( Table 1 ) shows numbers of nationalities, using nationality as in 1938. The table indicates the distribution of nationalities. The largest national group, that of Polish victims, includes both Roman Catholics and Jews. There were high numbers of German and Austrian victims, in part as a result of the experiments and dissections that accompanied the killing of psychiatric patients. While there were other large groups, there are also smaller national groups, as Swiss, British and Irish, all highly remarkable in how their citizens became caught up in the experimentation. We find victims include a Swiss conscientious objector used for malaria experiments at Dachau, and British commandos captured in Norway used for amphetamine and high performance experiments on the shoe track at Sachsenhausen, and subsequently executed. Nationality (as at March 1938). Nationality Confirmed victim Pending Total Austrian 782 17 799 Belgian 16 32 48 British 16 2 18 Czechoslovakian 264 1020 1284 Danish 2 1 3 Dutch 265 26 291 French 156 57 213 German 2254 123 2377 Greek 426 18 444 Hungarian 609 1393 2002 Irish (Republic) 1 1 Italian 71 6 77 Latvian 1 1 2 Lithuanian 4 2 6 Luxembourgian 1 1 Norwegian 11 1 12 Polish 2737 4168 6905 Romanian 51 39 90 Soviet 1022 26 1048 Spanish 22 4 26 Stateless 449 4 453 Swedish 1 1 Swiss 3 3 Yugoslav 536 3421 3957 Unknown 6054 1644 7698 Grand total 15,754 12,005 27,759 Statistics on gender indicate a proportion of male to female of approximately 2:1 ( Table 2 ). One possible reason is the high number of military experiments as related to infectious diseases. Another is that more men than women were held in concentration camps, so that there was a higher male availability in the predominately male camps. In Ravensbrück the situation was reversed with the large female camp and a small male compound ( Figure 3 ). Clandestine photograph of a mutilated leg of the Polish political prisoner Bogumiła Babińska-Dobrowska at Ravensbrück concentration camp. United States Holocaust Memorial Museum, courtesy of Anna Hassa Jarosky and Peter Hassa W/S #69340. Gender Confirmed victim Pending Total Female 3960 4381 8341 Male 9700 7188 16,888 Unknown 2094 436 2530 Total 15,754 12,005 27,759 While for most nationalities male victims were the majority, in the case of certain national groups, female victims were in the majority. This is the case for victim groups from the Netherlands (in the case of sterilisation at Auschwitz), and Greece (for the Jewish skeleton collection). Children were often victims of experiments in psychiatric clinics. Later in the war, Roma and Jewish children were targeted for research by Mengele in Auschwitz. The statistics show the age distribution was the same for men and women. While there was a very wide age spectrum, the peak is of victims born in 1921, so in their early twenties at the time of the experiment ( Figure 4 ). Several hundred Jewish children were held by Mengele for twin research, and batches of Jewish children were dispatched for hepatitis and tuberculosis research, and body parts of small children were retained by psychiatric researchers. Age of victims at the start of experiment. Ethnicity and religion have been recorded, as for the definitively confirmed experiment victims ( Table 3 ). Here, one is thrown back on the categories imposed by the Nazis. Thus a victim of the Jewish skeleton collection for the anatomy department at Strasbourg was baptised Protestant. 18 Generally, the Nazis used the generic and stigmatising term of ‘Zigeuner’ or gypsy rather than the self-identifying terms of ‘Sinti’ and ‘Roma’. Ethnicity Confirmed victims (15,754) Jewish 20% (3098) Roma and Sinti 2% (335) Unknown or other 78% (12,321) In addition to the experiment victims are Roma and Sinti victims of large scale anthropological investigations of Ritter, Justin, and Ehrhardt, amounting to at least a further 21,498 persons ( Figure 5 ). A gypsy used for seawater experiments in Dachau to test methods of making seawater drinkable, ca. July–September 1944. United States Holocaust Memorial Museum, courtesy of National Archives and Records Administration, College Park W/S #78688. If however one takes the year 1943 we find a higher proportion of Jewish victims, in part because of the intensification of experiments on Jews (particularly on women and children) at Auschwitz and Auschwitz-Birkenau. This would again indicate that there was an intensification of racial research ( Table 4 ). Religion Confirmed victims Pending Total Jewish 3076 792 3868 Other or unknown 12,678 11,217 23,891 Grand total 15,754 12,008 27,759 Victim number indicates how from 1942 onwards there was an overall intensification of research ( Figure 6 ). Start year of experiments. The life history approach allows appraisal of both experiments and victim numbers over time. The period 1933–39 shows sporadic experimentation in the context of racial hygiene. Mixed race adolescents were sterilised and evaluated by anthropologists. The concerns of racial hygiene with mental illness explain why psychiatrists and neurologists conducted experiments in psychiatric institutions. The psychiatrist Georg Schaltenbrand pointed out that his neurological research subjects were transferred to other institutions, many as we now know to be killed. This interrupted his research on the transmissibility of multiple sclerosis. The numbers of brains and body parts increased. From 1942 onwards there was an overall intensification of research. The chart ( Figure 7 ) shows when experiments started, but not the distribution of victims over time. Victims by start year of each experiment. The largest series of experiments were for infectious diseases. Malaria research at Dachau between 1942 and 1945 had 1091 confirmed victims, and after infection different combinations of drugs were tested. These experiments by Schilling began in 1942 and remarkably Schilling tried to continue the research after the liberation of the camp. 19 He pleaded at his trial to be allowed to continue the research, albeit on volunteers. The highest numbers were in 1943. The momentum continued even though the war was clearly lost. Other large groups included the twins researched on by Mengele, and to date 618 individuals are known ( Figure 8 ). Twins Frank (lt) and Otto (rt) Klein attend a world gathering of survivors of Dr. Joseph Mengele's medical experiments at Auschwitz. United States Holocaust Memorial Museum W/S #05586. The overall findings provide an accurate basis for analysis of experiments to date. First, nearly a quarter of confirmed victims were either killed to obtain their organs for research, or died as a result of experiments taking the research subject to the point of death (notoriously, the experiments on freezing and low pressure at Dachau). The euthanasia killings and executions were sources of bodies for research, and the extent that this happened and research conducted before and after the end of the war is still being documented. Of the fully documented victims died 781 died before the end of the war as a result of the experiments: research subjects were weakened by the strain of the experiment such as a deliberate infection or severe cold, or they were deliberately killed because it was feared that they would testify against the perpetrators ( Table 5 ). Fatalities. Circumstances of death Confirmed victim Pending Total Body used for research (e.g. euthanasia and executed victims) 2956 50 3006 Died (e.g. from injuries) or killed after the experiment 781 23 804 Died from experimental procedures (e.g. when onset of death studied from freezing) 383 171 554 Grand total 4120 244 4364 While, most subjects survived, amounting to 24,010 persons, many had severe physical disabilities with life-long consequences. 20 The analysis presented here shows that several types of unethical medical research occurred under National Socialism. Not only were large numbers of victims affected, but also overall, numbers of surviving victims were far higher than anticipated. The survivors were often seriously disabled and handicapped for the remainder of their lives. The experiments gained in numbers with the war and the implementation of the Holocaust, and were sustained at a high level of intensity despite imminent defeat. One issue arising is that body parts of deceased victims were retained by medical research and teaching institutes, notably for anatomy and brain research. While there was meant to be full disclosure of specimens deriving from euthanasia victims and executed persons by 1990, specimens continue to be identified. 21 The complex data is to be further augmented and refined, the history of specimens retained for research during and after WW2 is being documented, and the narratives of survivors analysed in order to understand more fully the consequences of coerced research. This research provides a basis in historical evidence for discussions of the ethics of coerced medical research. Acknowledgments Wellcome Trust Grant No 096580/Z/11/A on research subject narratives. AHRC GRANT AH/E509398/1 Human Experiments under National Socialism. Conference for Jewish Material Claims Against Germany Application 8229/Fund SO 29. 7 Annas G, Grodin M. The Nazi Doctors and the Nuremberg Code . New York: Oxford University Press; 1992; Weindling P. Nazi Medicine and the Nuremberg Trials: From Medical War Crimes to Informed Consent . Basingstoke: Palgrave Macmillan; 2000. 8 Weindling P. John Thompson (1906–1965): Psychiatrist in the Shadow of the Holocaust . Rochester: Rochester University Press; 2010. 9 Klee E. Auschwitz, die NS-Medizin und ihre Opfer . Frankfurt am Main: S. Fischer Verlag; 1997; Mitscherlich A, Mielke F. Wissenschaft ohne Menschlichkeit . Heidelberg: Lambert Schneider; 1949. See also Schwarberg G. The Murders at Bullenhuser Damm: The SS Doctor and the Children . Bloomington: Indiana University Press; 1984. 10 Lang H-J. Die Namen der Nummern: Wie es gelang, die 86 Opfer eines NS-Verbrechens zu identifizieren. Hamburg: Hoffmann und Campe; 2004. 11 Brody H, Leonard S, Nie J-B, Weindling P. United States Responses to Japanese Wartime Inhuman Experimentation after World War II: National Security and Wartime Exigency. Cambridge Quarterly of Healthcare Ethics 2014; 23: 220–230. 12 Baumann S. Menschenversuche und Wiedergutmachung . München: Oldenbourg; 2009. 13 Schwerin A von. Experimentalisierung des Menschen: Der Genetiker Hans Nachtsheim und die vergleichende Erbpathologie 1920–1945 . Göttingen: Wallstein Verlag; 2004; Schmuhl H-W. The Kaiser Wilhelm Institute for Anthropology, Human Heredity and Eugenics, 1927–1945: Crossing Boundaries . Dordrecht: Springer; 2008. 14 Roelcke V. Fortschritt ohne Rücksicht, In: Eschebach I, Ley A. eds . Geschlecht und “Rasse” in der NS-Medizin . Berlin: Metropol Verlag; 2012: 101–114. 15 Hildebrandt S. Anatomy in the Third Reich: An outline, Part 1. National Socialist politics, anatomical institutions, and anatomists. Clinical Anatomy 2009; 22: 883–893. 16 Hunt N. The Soviet Experience of Nazi Medicine: Statistics, Stories and Stereotypes . MPhil thesis, Oxfrod Brookes University; 2011; and Loewenau A. The impact of Nazi medical experiments on Polish inmates at Dachau, Auschwitz and Ravensbück . PhD thesis, Oxford Brookes University; 2012. 17 Weindling, P. Victims and Survivors of Nazi Human Experiments: Science and suffering in the Holocaust. London: Bloomsbury; 2014. 18 www.die-namen-der-nummern.de/html/the_names.html (accessed 8 October 2014). 19 Eckart WU, Vondra H. Malaria and World War II: German malaria experiments 1939–45 . Parassitologia 2000; 42:53–58. 20 Loewenau A. Die “Kaninchen” von Ravensbrück: Eine Fotogeschichte. In: Eschebach I, Ley A eds. Geschlecht und “Rasse” in der NS-Medizin . Berlin: Metropol Verlag; 2012:115–140. 21 Weindling P. “Cleansing” Anatomical Collections: The Politics of Removing Specimens from German Anatomical and Medical Collections 1988–92. Annals of Anatomy 2012; 194:237–242. 111 IMAGES Definition of Human Subjects Research Human behavioural experiment. (A) Human subjects were presented with Radiation Experiments On Humans: When And Why It Happened Illustration (a) and photo (b) of the experiment setup for human Human Radiation Experiments Illustration (a) and photo (b) of the experiment setup for human VIDEO The Terrifying Experiments of Unit 731 An experiment in experiments What happened inside UNIT 731? science experiments Discoveries from the Lab Part 2: Human Studies Craziest human experiments #shorts COMMENTS Why Human Subjects Research Protection Is Important Background: Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study. The road leading to the current regulations and ethical considerations ... Human subject research Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects.Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1] Systematic investigation incorporates both the ... Federal Policy for the Protection of Human Subjects ('Common Rule The Federal Policy for the Protection of Human Subjects or the "Common Rule" was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the "Common Rule"; subpart B ... Definition of Human Subjects Research According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or. Obtains, uses, studies, analyzes, or ... PDF WHAT IS HUMAN SUBJECTS RESEARCH? Exempt Human Subjects Research . Common Rule Exemptions Videos . Determining When the Common Rule Requirements Apply . Conclusion. Wrap Up . Overview. Part 1: Background of Human Subjects Research. Part 2: Is the Activity Research? Part 3: Does the Research Involve Human Subjects? Part 4: Is the Human Subjects Research Exempt? Conclusion Defining Research with Human Subjects Human subjects are living individuals about whom researchers obtain information or biospecimens through interaction, intervention, or observation of private behavior, to also include the use, study, and analysis of said information or biospecimens. Obtaining, using, analyzing, and generating identifiable private information or identifiable ... Human Subjects Research Pre-Award and Post-Award Processes. Learn about the process of applying for a grant, cooperative agreement, or R&D contract, as it relates to the involvement of human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section, and learn about next steps after submitting your grant application or proposal. Human Subject Research Core issues regarding human subject research. Basic ethical principles such as respect for persons, beneficence, and justice are common to most ethical codes in the world, and in turn inform and are linked to (1) the notion of informed consent, (2) the assessment of risks and benefits, and (3) the selection of human subjects and discrimination. Social Benefits of Human Subjects Research Introduction. One of the primary ethical justifications for conducting research with human subjects is to benefit society.[1-5] This normative principle is explicitly stated or implied in many codes, guidelines, and regulations pertaining to research with human subjects.[6-10] According to the Nuremberg Code, an experiment with a human subject should "be such as to yield fruitful results for ... Human research protections Human research protections. Research with human participants has proven invaluable in advancing knowledge in the biomedical, behavioral, and social sciences. Such research is strictly regulated, with laws at the federal, state, and local levels. Further, professional societies have developed discipline-specific standards, policies, and ... Human Experimentation: An Introduction to the Ethical Issues The Ethical Landscape. Ethical issues in human research generally arise in relation to population groups that are vulnerable to abuse. For example, much of the ethically dubious research conducted in poor countries would not occur were the level of medical care not so limited. Similarly, the cruelty of the Tuskegee experiments clearly reflected ... Office for Human Research Protections The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of ... Types of Human Subjects Research The NIH defines an intervention as a manipulation of the subject or the subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. The NIH further defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more ... 49 INTRODUCTION. Experimentation on human beings may be as old as medicine itself. The search for new therapies - drugs, devices, and procedures - required that someone go first, some individual participate in the trial of an innovative treatment, and experience both the risks and benefits of that participation. Scientific Methods and Human Subjects Research Experimental controls establish a baseline for the experiment. When conducting human subject experiments in physiology, the control might consist of a separate group of people, the control group, who are not exposed to any manipulation of the independent variable, or it might be the same group of subjects tested before (and then after) altering ... Guidelines for human subject research The main points of the 1931 Guidelines for Human Experimentation are as follows: [5] Full unambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances. Risks should be balanced out by potential benefits. Caution should be taken for subjects under 18 years old. Extreme caution should be taken if ... Nuremberg Code: Directives for Human Experimentation ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects. The voluntary consent of the human subject is absolutely essential. The experiment should be such as to yield fruitful results for the good of society. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural ... Human Subjects Timeline Likewise, the discovery in the 1970s that unwitting subjects had been allowed to suffer syphilis in the 1930s Tuskegee Experiment preceded a call for tighter regulation of federally-funded human research. Between these unfortunate incidents, groups of regulators and researchers have worked to refine the protections provided to human subjects. Treat Human Subjects with More Humanity Prior to World War II, there were no international ethics codes concerning research with human subjects, and only one country, Prussia (now part of Germany), had any human experimentation laws. The first known use of an informed consent form in medical research was by U.S. Army physician Walter Reed (1851-1902). Nazi human experimentation Nazi human experimentation was a series of medical experiments on prisoners by Nazi Germany in its concentration camps mainly between 1942 and 1945. There were 15,754 documented victims, of various nationalities and age groups, although the true number is believed to be more extensive. ... In these experiments, subjects had their bones, muscles ... Nuremberg Code The Nuremberg Code. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have ... Can AI Replace Human Subjects? A Large-Scale Replication of ... However, the extent to which LLMs can effectively replace human subjects across diverse experimental contexts remains unclear. Here, we conduct a large-scale study replicating 154 psychological experiments from top social science journals with 618 main effects and 138 interaction effects using GPT-4 as a simulated participant. Japan: Japanese scholar unveils Unit 731's war crimes of human experiments "Maruta" was the code-name for the human experimentation project. In Japanese the word directly translates as "wood that has been skinned" or "logs," which is how the test subjects were referred to. Does the human professor or artificial intelligence (AI) offer better Three within-subject experiments were conducted by providing students with answers to content questions across different subject matters (a definition, explanation, and example) offered by a human professor (subject-matter expert) versus generative artificial intelligence (ChatGPT). In a randomized order, students read both the expert and ... Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp ... The role of predation and pesticides in shaping ... Aquatic organisms are subject to various forcing factors that affect their structure, some of which are natural, while others result from human activities, both having variable effects. This study aimed to determine the importance of a natural stressor (zooplankton) and an herbicide (atrazine) on phytoplankton density and morphological composition in a microcosm experiment. A natural ... The victims of unethical human experiments and coerced research under Background. The coerced human experiments and research under National Socialism constitute a reference point in modern bioethics. 7 Yet discussions of consent and the need for safeguards for research subjects to date lack a firm basis in historical evidence. There has been no full evaluation of the numbers of victims of Nazi research, who the victims were, and of the frequency and types of ... essay homework paper phd project resume review study thesis