A report on Human subject research

Systematic, scientific investigation that can be either interventional or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects.

- Human subject research

16 related topics with Alpha

Overall

Example of informed consent document from the PARAMOUNT trial

Informed consent

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Principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care.

Principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care.

Example of informed consent document from the PARAMOUNT trial
In this Ottoman Empire document from 1539 a father promises to not sue a surgeon in case of death following the removal of his son's urinary stones.

Historians cite a series of human subject research experiments to trace the history of informed consent in research.

A clinical trial participant receives an injection

Clinical trial

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A clinical trial participant receives an injection
Edward Jenner vaccinating James Phipps, a boy of eight, on 14 May 1796. Jenner failed to use a control group.
Austin Bradford Hill was a pivotal figure in the modern development of clinical trials.
Example of informed consent document from the PARAMOUNT trial
Timeline of various approval tracks and research phases in the US
Newspaper advertisements seeking patients and healthy volunteers to participate in clinical trials

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.

Institutional review board

5 links

Independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.

Independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.

While the IRB approval and oversight process is designed to protect the rights and welfare of the research subjects, it has been the subject of criticism, by bioethicists and others, for conflicts of interest resulting in lax oversight.

Jewish twins were kept alive to be used in Josef Mengele's medical experiments. These children from Auschwitz were liberated by the Red Army in January 1945.

Unethical human experimentation

2 links

Jewish twins were kept alive to be used in Josef Mengele's medical experiments. These children from Auschwitz were liberated by the Red Army in January 1945.
Japanese Unit 731 Complex that used humans for experimentation for biological and chemical weapons, as well as live vivisections and other experiments

Unethical human experimentation is human experimentation that violates the principles of medical ethics.

Basrelief sculpture "Research holding the torch of knowledge" (1896) by Olin Levi Warner. Library of Congress, Thomas Jefferson Building, in Washington, D.C.

Research

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Research is "creative and systematic work undertaken to increase the stock of knowledge".

Research is "creative and systematic work undertaken to increase the stock of knowledge".

Basrelief sculpture "Research holding the torch of knowledge" (1896) by Olin Levi Warner. Library of Congress, Thomas Jefferson Building, in Washington, D.C.
Aristotle, (384–322 BC), one of the early figures in the development of the scientific method
Primary scientific research being carried out at the Microscopy Laboratory of the Idaho National Laboratory
Scientific research equipment at MIT
German maritime research vessel Sonne
German historian Leopold von Ranke (1795–1886), considered to be one of the founders of modern source-based history
Research design and evidence
Research cycle
The research room at the New York Public Library, an example of secondary research in progress
Maurice Hilleman, the preeminent vaccinologist of the 20th century, is credited with saving more lives than any other scientist in that time.
Cover of the first issue of Nature, 4 November 1869

Ethical issues may arise in the design and implementation of research involving human experimentation or animal experimentation.

Rudolf Brandt, the defendant in the U.S. military trial that resulted in the Nuremberg Code.

Nuremberg Code

3 links

Rudolf Brandt, the defendant in the U.S. military trial that resulted in the Nuremberg Code.

The Nuremberg Code (Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.

Cell culture vials

Medical research

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Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials.

Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials.

Cell culture vials
The University of Florida Cancer and Genetics Research Complex is an integrated medical research facility
Cold Spring Harbor Laboratory on Long Island, home to eight scientists awarded the Nobel Prize in Physiology or Medicine, is an internationally renowned basic medical research institution.
The headquarters of the Wellcome Trust in London, United Kingdom

Medical research on humans has to strictly follow the medical ethics sanctioned in the Declaration of Helsinki and hospital review board where the research is conducted.

"A prisoner in a special chamber responds to changing air pressure during high-altitude experiments. For the benefit of the Luftwaffe, conditions simulating those found at 15,000 m in altitude were created in an effort to determine if German pilots might survive at that height."

Nazi human experimentation

2 links

"A prisoner in a special chamber responds to changing air pressure during high-altitude experiments. For the benefit of the Luftwaffe, conditions simulating those found at 15,000 m in altitude were created in an effort to determine if German pilots might survive at that height."
A cold water immersion experiment at Dachau concentration camp presided over by Ernst Holzlöhner (left) and Sigmund Rascher (right). The subject is wearing an experimental Luftwaffe garment.
Child victims of Nazi experimentation show incisions where axillary lymph nodes had been surgically removed after they were deliberately infected with tuberculosis at Neuengamme concentration camp. They were later murdered.
A victim loses consciousness during a depressurization experiment at Dachau by Luftwaffe doctor Sigmund Rascher, 1942.

Nazi human experimentation was a series of medical experiments on large numbers of prisoners, including children, by Nazi Germany in its concentration camps in the early to mid 1940s, during World War II and the Holocaust.

Survey (human research)

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In research of human subjects, a survey is a list of questions aimed for extracting specific data from a particular group of people.

A subject of the Tuskegee syphilis experiment has his blood drawn, c. 1953

Unethical human experimentation in the United States

1 links

A subject of the Tuskegee syphilis experiment has his blood drawn, c. 1953
Cover of the final report of Project 4.1, which examined the effects of radioactive fallout on the natives of the Marshall Islands
Chloracne resulting from exposure to dioxins, such as those that Albert Kligman injected into prisoners at the Holmesburg Prison

Numerous experiments which are performed on human test subjects in the United States are considered unethical, because they are illegally performed or they are performed without the knowledge, consent, or informed consent of the test subjects.