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👍 | Do not use for "anti-mask activity"!A series of users contrary to the purpose ... Anguish of the manifestation card creator


Do not use for "anti-mask activity"!A series of users contrary to the purpose ... Anguish of the manifestation card creator

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Human experimentation

Human experimentation(Ligaments,British: Human subject research) Is a human research, a systematic scientific survey,Human capitalRefers to those that include as a research subject[1].


Research on humans is medical research (Clinical research) And non-medical research (eg social science)[1]..In these studies, data collection and analysis are conducted as a systematic survey to obtain answers to specific problems.

Medical researchBiological specimenAnalysis,EpidemiologicalAnd many behavioral studies, medical record reviews, etc.[1], Specific (and especially tightly regulated types) medicalHuman capitalThe research targetingClinical trial(Say in JapanClinical trialIncluding) ”.Drugs, vaccines, and medical devices are evaluated there.

On the other hand, in social scienceA humanStudies of people often consist of questions about a specific group of people.ResearchThe method is a questionnaire,Interview,andFocus groupAnd so on.this isBiology,Medical science,Nursing,Psychology,Sociology,politics,AnthropologyIt is carried out in such fields.

In order to deal with the abuse of research mainly targeting humans, as research was formalized, the academic community became "research targeting humans.Human capitalHas established a formal definition of "human subject research".


The United States of America

United States Department of Health and Human Services(HHS) defines "human research" as research in which researchers (whether experts or students) obtain data from living individuals in the following ways: There is. ( 32 CFR 219.102 (f)[2]

  1. Those with intervention or interaction
  2. Identifiable personal information

The definitions of each term in HHS regulation are as follows.

  • Intervention-Physical procedures for collecting data and manipulation of the subject and / or its environment for research purposes [ 45 CFR 46.102 (f)] [2]
  • "Interaction"-Communication or interpersonal relationships between the researcher and the subject [ 45 CFR 46.102 (f)]) [2]
  • "Personal Information"-Information about behavior that occurs in situations where an individual can reasonably expect that it has not been observed or recorded, and is provided by the individual for a specific purpose and is not reasonably disclosed to the individual. What is supposed to be [ 45 CFR 46.102 (f)])] [2]
  • "Identifiable Personal Information"-Specific information that can be used to identify an individual[2].

Subject rights

The United States of America

In 2010, the National Institute of Justice in the United States announced the recommended rights of subjects.

In addition, each university including Harvard University publishes the list as "Participant Rights".[5]


Ethical guidelines

In researchOversees the safety of human subjectsEthical guidelines to doA relatively new concept.

Basic common rules

The United States of America

First announced in 1991, "(English edition(Federal Regulations "Federal Policy for the Protection of Human Subjects") [6]It is,United States Department of Health and Human ServicesIt is regulated by the Human Protection and Protection Agency. "Institutional Review Board (tentative translation)" (IRB) guidelines,Informed consentAssurances of Compliance for human subjects studied[6].. The final rule with the official effective date of January 2017, 1, July 19, 2018Federal registration [7]Added to[8].


Nuremberg Code

In 1947, German doctors who conducted fatal or harmful experiments on prisoners in concentration campsNuremberg TrialsWas accused of being a war criminal (Doctor trial).That same year, the AlliesNuremberg Codepublish.This is the first international document to support the notion that "subject's voluntary consent is absolutely essential".The Nuremberg Code emphasized individual consent to prevent coercion of prisoners of war, patients, prisoners of war, and soldiers.It is also emphasized to inform participants of the risks-benefits of the experiment.

Helsinki Declaration

The Declaration of Helsinki was adopted to regulate international research in humans (first adopted in 1964 and subsequently revised).World Medical AssociationAdopted by, this Declaration proposes guidelines for physicians conducting biomedical studies in humans.Some of these guidelines include "research protocols should be reviewed by an independent committee prior to initiation" and "studies in humans should be based on results from laboratory animals and experiments". Includes principles.

This Declaration of Helsinki is for humansResearch ethicsWidely regarded as a basic document about [9] [10] [11].

Belmont Report

The Belmont Report sets out a code of ethics for human research, the government committee "(English editionIt was created by.This report is the most frequently used to protect humans in research trials in the current US system.[6].

By focusing primarily on human biomedical and behavioral studies, the report was prepared to ensure that ethical standards are followed as standards in the study of human subjects.[12]..There are three criteria for how the report is based and how to investigate human subjects.It is "respect for persons", "Beneficence(Beneficence) ", and"正義". "Beneficence"Beneficence" states that by ethical and protecting the subject from harm, it (2) protects the well-being of people and (XNUMX) respects their decisions.These two benefits are to maximize the benefits from research and to minimize all possible risks.[13]..It is the researcher's job to inform people about the benefits and risks of human research.The principle of justice is important because researchers are fair about their findings and need to share what they discover, whether the information is good or bad.[13]..It also states that the process of selecting subjects should be fair and should not be distinguished by race, sexual orientation or ethnic group.[14].

Finally, respecting people means that those involved in the study can decide at any time whether they want to participate, not, or withdraw completely from the study.These two are humanAutonomyIt means that people whose autonomy is impaired for some reason (such as prisoners) should also be entitled to protection.[12]..The sole purpose of these principles is to ensure subject autonomy and to protect those who have difficulty maintaining autonomy due to some environments not under their control.[12].

Ethical concerns

As science and medicine evolveBioethicsThe field is facing difficulties as the guidelines and rules to be followed are not updated in time.[15].

In addition, clinical trial rules and regulations vary from country to country. [16]..To minimize ethical issues, it is recommended to establish a committee to carefully record research information and ensure that everything is properly documented. [16] [17] [18]..One concern that the research team has is that the rules, even if they are ethical, are not suitable for research.

Research in non-urban areas

In recent years, the transition from conducting research at research institution facilities and academic centers to rural areas has progressed.There has been debate, especially in relation to the involvement of the fund, the overall effectiveness of the treatments studied, and whether such studies are based on the best ethical standards and in relation to the specific demographics of the participants. Concerns surrounding the topic have been raised.

Ann Cook and Freeman Hoas of the University of Montana School of Psychology study what influences potential subjects on whether they agree to participate in clinical trials[17]Was done.They announced the findings in February 2015. Surveyed 2 doctors and researchers and 34 research coordinators[19]It turns out that only 17% of doctors have undergone ethical research training.

Cook and Hoas found that investment funds play an important role in subject selection, and raised concerns about how much it would lead to compensation for subjects. [19].

Moral issues

Typical ethical issues that arise in this type of study trial include recruitment of participants, coercion issues when doctors refer their patients, and misunderstandings about therapeutic benefits.Patients are more likely to participate in the study if the community physician or trusted healthcare provider recommends the study. "I don't want to use the word coercion, but it's like leaning in that direction, because basically they're tied up here. It's these people who entrust themselves, they're very Depends on and receives medical care from them. " [19]..Also, the research participantsInformed consentThere were a large number of survey respondents who believed they did not read or understand the documents provided for [19]..Those respondents were unaware that it was an ethical issue.

Clinical trials / clinical trials

British: Clinical trials

Clinical trials TheClinical researchFor humans performed inExperimentIs. (Nuremberg CodeUntil now, the term "Human Experimentation" has been used, but it reflects changes in medical practice and is used in the medical field.Clinical trialsThe name changed to)

Such a "" for human participantsProspective studyBiomedical or behavioral research, also known as ", is newTreatment(Newvaccine,Medicine,diet remedy,Dietary supplement,Medical equipment) Etc., and for comparison to confirm the validity of known methods.In clinical trials安全 性EffectivenessYou can get data about[20].

These are the Institutional Review Board (IRB) in the United States-in other countriesEthics Committee --Implemented only after approval by health authorities.These authorities are responsible for examining the risk / benefit ratio of the study-this approval does not mean that the treatment is "safe" or effective, but that the study can be conducted. Means only.

Depending on the product type and development stage, researchers first volunteer and / or treat patients on a small scale.Preliminary testAfter that, a large-scale comparative test was gradually conducted.Clinical trials vary in size and cost and may target one or more research centers in one or more countries.Clinical study design is the scientific validity of the results andReproductionIt is designed for the purpose of ensuring sex.


In Japan, about pharmaceuticals and devices generally performed by pharmaceutical companies, etc.Clinical trialEspecially distinguishing "Clinical trial".again,Third-party review and supervisory body (ethics committee)about,Drug clinical trials only, Obliged to install by GCP of the former Ministry of Health and WelfareClinical trial screening committee However, there are no legal provisions for other general clinical trials.for that reason,NichibenrenAs well[21],Japan Medical AssociationCriticism from[22]Has been done.

実 例

Psychology / Sociology

Stanford Prison Experiment

In 1971Philip GimbaldoThe study done byStanford UniversityWe investigated the impact of social roles on college students. Twenty-four schoolboys were assigned to the random role of prisoners or guards in the basement of Stanford University to mimic a mock prison.

Milgram experiment

1961 years,Yale UniversitypsychologistStanley MilgramLed a series of experiments to determine how well an individual would follow the experimenter's instructions [23] [24] [25].

Asch conformity experiment

1951 psychologistSolomon ashExperiments on classical entrainment[26]..This studySocial influenceTuning pressureHas been regarded as important evidence of[27].

Roberts Cave Study

Muzafer Sherif's Robber's Cave experiment, a classic proponent of Realistic conflict theory, reveals how collective competition fosters hostility and prejudice. [28].. The 1961 study comes from a study conducted at Robbers Cave State Park in Oklahoma. [29].

Bystander effect

Bystander effectWas demonstrated in a series of well-known experiments by Bibb Latane and John Darley. [29].

Cognitive dissonance

Human subjectsLeon FestingerAnd after a groundbreaking study by Merrill CarlsmithCognitive dissonanceHas been commonly used in experiments to test the theory of[30].

Social media

Increasing as a data source for researchersSocial mediaUtilization has introduced new uncertainties regarding the definition of human studies.Policies,confidentiality,andInformed consentIs an important point, but it is unclear whether social media users are eligible for human targeting. [31]..Defining the characteristics of human studies in accordance with United States federal regulations means that researchers either interact directly with the subject or obtain identifiable personal information about the subject.[2]..Social media studies may or may not meet this definition.Research instituteJudging Committee (IRBs) are often responsible for reviewing potential studies on human subjects, but IRB protocols for social media studies can be ambiguous or outdated. [31].

Concerns about privacy and informed consent have surfaced and controversial regarding multiple social media studies. Known as "Tastes, Ties, and Time"HarvardA sociologist research project at "Anonymous Northeastern American Universities"FacebookData obtained from the profile ofNumber official[32]..Immediately after this issue became apparent, this dataset was removed from public data.[33]..The problem is that this research projectNational Science Foundation Complicated by the fact that it was partially funded, it [33]It had the nature of a project to promote information sharing.

2014 years,Proceedings of the National Academy of SciencesAnnouncedFacebookandOf Cornell UniversityResearch by researchers has collected data from hundreds of thousands of Facebook users [34]..Many considered this a breach of informed consent requirements in human studies.[35] [36]..The data was collected by the private company Facebook in a manner consistent with its privacy policy and user terms of use, and the Cornell University Ethics Board has determined that this investigation does not fall under its jurisdiction. [34]..Nevertheless, the study is alleged to have violated the law by violating state law regarding informed consent. [36]..Sharing this method or findings with scientists or the general public is not encouraged [37].

Recommended considerations for social media research are 1) determining whether the study is eligible for the study, 2) considering the risk level of the content, and 3) accurately presenting the study and motivation when working on social media. , 5) Provide contact information through the consent process, 5) Make sure the data is identifiable or non-searchable (avoid direct quotes identifiable by online search), 6) Pre-project privacy policy Consider developing, 7) Note that each state and region has its own law on informed consent. [31]..Careful consideration of these ethical issues before using social media sites provides access to hard-to-reach research subjects and groups, captures the subject's natural "real-world" reactions, and is affordable. It can be said that it offers great potential as a data source in order to provide an efficient data collection method. [31] [38].


Research on humans has been conducted in many industries in the development of devices used by humans.

Vehicle safety test

Automotive industrySo, to collect more data on the tolerance of the human body in the event of a car accident and to improve the safety function of the car, sledding to evaluate head and neck injuries,AirbagExams and evenMilitary vehicleAnd various human experiments have been conducted, including tests involving those restraint systems.

Importantly, after thousands of tests on subjects, serious injuries did not persist, researchers adhered to all ethical guidelines, and researchers ensured the safety and well-being of subjects. This is due to the preparatory efforts of.This surveycadaverTests andCrash test dummy testAdditional data that cannot be found by.cadaverCrash test dummyIs used when testing higher tolerances beyond human ability[39].

Racing driverEiji Yamada TheVideo optionsAs a plan ofAirbag,Seat belt,Roll cage,Bucket seatWe were conducting experiments to prove the effectiveness of equipment aimed at protecting occupants such as[40].


aircraftIn the early days of, the theory and materials such as aerodynamics were underdeveloped, so the design method was not established and it was unknown even if it could fly.At that time, the designer himselfTest pilotHowever, the first flight is basically a life-threatening event.Self experimentMet.The development of theory and technology has reduced the danger in normal flight, but the physiological phenomenon that gravitational acceleration gives to the human body as the aircraft speeds up (BlackoutEtc.) to verifyRocket sledHuman experimentation using this has come to be carried out.Of an aviation medical researcherJohn StappHe himself rode a rocket sled and became a test bench for the effects of sudden deceleration on the human body.Ejection seatDevelopment andAviation accidentDummy dolls are used for the investigation.


Edo PeriodIn Japan,Japanese swordAs a performance testTrial slashHowever, the execution of sinners is used because the sword is a weapon for slashing humans.Living bodyWas being done.

Body armorIn the early days of development, public experiments were conducted to shoot humans wearing bulletproof vests.

Medicine / pharmacy

Before the code of ethics and guidelines were created, human experimentation led by the state and research groups and self-experimentation by researchers were openly conducted.

Hellenistic era Ofア レ ク サ ン ド リ アThen,Death row prisonerThere is a theory that was used for human experimentation.Ptolemy IIIPtolemy IIIAllowed biopsy of convict on death row, because it was interpreted that convict on death row had a large debt to society, and it was always necessary to acquire new medical knowledge.[41].

HerophilosErasistratusVivisectioned as many as 600 prisoners in AlexandriaCelsus,TertullianWas criticized by.Celsus denied vivisection as "cruel and meaningless."However, there is no convincing evidence that Herophilos and others actually conducted human experimentation, and some historians questioned it (critical to Erasistratus).GalenDoes not mention a single word about vivisection, etc.)[42].

13st century OfアルメニアThen, a vivisection of a convict on death row was being carried out.According to Armenian scientist and philosopher Hovannes JersengazziBlood vesselbloodIn order to investigate the circulation and the relationship with each organ, the convict on death row should be in advance.fastingWeakened by a large amountWineIt is said that he was dissected alive when he was drunk and became intoxicated.[43].

FranceThen the kingLouis XVIAllowed a vivisection of a convict on death row.The convict on death row was naked and tied to the operating table,麻 酔Dissected alive without.The dissection of the convict on death row provided a lot of medical knowledge, and Louis XI was praised for contributing to his medical progress.[44].

Even in modern timesMedical equipmentIn the development ofAnimal experimentationAfter stackingClinical trialApproval is obtained after confirming the safety in the human body.

Organs removed from the human body by surgery may be used for experiments.With the development of medical technology, it has become possible to maintain function for a certain period of time even after excision, which has made it possible to investigate in detail.[45].

Unethical human experimentation

Medical ethicsMany experiments have been conducted on humans who violate the principle, and many self-experiments have been conducted by doctors and researchers.

patient'sInformed consentIt also includes denying the right of.Also, "race science" etc.PseudoscientificIt is not possible to use a simple framework or torture people under the guise of research.ethicsIt is regarded as a typical human experiment.731 units,Josef MengeleBrutal experiments were conducted on prisoners and the general public through personal acts such as. "Nuremberg CodeWas born after the war in response to these crimes.

In Japan,A-bomb survivorSurvey on Japanese GovernmentWas dropped in Hiroshima and Nagasaki under the initiative ofAtomic bombA medical investigation was conducted on the survivors.Tokyo UniversityMore than 1300 doctors and scientists gathered from universities and hospitals nationwide, including the survey contents.ア ド レ ナ リ ンIt is said that the contents unrelated to the treatment were also included, such as injecting the drug and examining the reaction.From the beginning, it was decided to provide the results to the United States without disclosing them in Japan.[48].

Throughout the 20th century, governments conducted inhumane human experimentation.America also saidProject MKUltra (MKULTRA project)"and"Tuskegee Syphilis Experiment"such asUnethical human experimentationWas done.There are also examples of indigenous peoples treatment in Canada and Australia.On themWorld Medical Association Adopted by (WMA)Helsinki Declaration"WidelyHuman capital OfResearch ethicsIt has come to be regarded as a laying-down document about[49][50][51].


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