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"I can't accept the proposal to dispose of the citizens" Honda, consent sexual intercourse remarks
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The Constitutional Democratic Party is consulting with the Ethics Committee on a disposition plan and will decide soon.
Constitutional Democratic Party member Hiranao Honda remarks that it is strange to be arrested for sexual intercourse with a 14-year-old child ... → Continue reading
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Ethics Committee(Rinri is good,British: Ethics committee) Is a medical experiment (Clinical trial-Clinical trial) And human research (behavioral research), etc.Research and experiments on humansAccording to national and international lawEthical methodIt is the institution responsible for ensuring that it is carried out in.
The specific system differs from country to country, but the system of this ethics committee isWorld Medical Association(WMA) "Helsinki DeclarationIt is based on what was added and specified in the 1975 revision..
Research Ethics Committee
23. The research plan must be submitted to the relevant research ethics committee prior to the start of the study for review, opinion, guidance and approval.This committee must be transparent in its function and must operate properly without the influence of researchers, sponsors and any other improper influence.The Commission must consider the laws and regulations of the country or country in which the study is conducted, as well as the applicable international norms and standards.However, it must not be allowed to reduce or eliminate the protection for the subject indicated by this Declaration.The Research Ethics Committee must have the right to monitor ongoing research.Researchers must provide the Commission with monitoring information, especially information on serious adverse events.The plan must not be amended without the deliberation and approval of the committee.At the end of the study, the researcher must submit a final report to the committee containing a summary of the research findings and conclusions.— World Medical Association(WMA) "Helsinki Declaration'Japan Medical AssociationTranslation (2013 edition)
There are two types of ethics committees, one isResearch on humans (human experimentation)Each country's system (Research Ethics Committee) is legally positioned as an independent organization that supervisesEthical issues related to treatment in hospitals, etc.Is an internal "ethics committee" to consider..It was also founded in 1990International Council for Harmonization of Pharmaceutical Regulations (ICH)Set byClinical trial(Say in JapanClinical trialCriteria for implementing (including) "Good clinical criteria (GCP)Also includes the provisions of the "Independent Ethics Commission (IEC)".
In Japan, for clinical trials of pharmaceutical products, see the 1997 "Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceutical Products (GCP Ministerial Ordinance)".Clinical trial screening committeeAlthough the installation ofIn other research areas, the establishment of an ethics review committee is required in the guidelines (guidelines) such as "Ethical Guidelines for Medical Research for Humans"..
System of each country
In European countries, committees that are independent of the facility are often set up in each region, and are called the Research Ethics Committee (REC).
Is the institution responsible for overseeing medical or human studies in EU member states.The national committees under the European Ethics Commission include:
- UK Research Ethics Committee (REC) -A Research Ethics Committee in the United Kingdom
- Dutch Medical Research Ethics Committee-(MREC) A Medical Research Ethics Committee in the Netherlands.
- French Human Protection Commission (CPP) -A Comités de Protection des Personnes in France.
The United States of America
In the United States, which first publicly adopted the concept of reviewing clinical research, the equivalent of an ethics committee is the "Institutional Review Board (tentative translation)". Institutional review board (IRB).In general,IRBIt is a system unique to the United States known as, and individual facilities may have individual names. "Beacher treatiseIn the wake of "" (National Research Act of 1974) and "" in 1974Belmont Report"(Belmont Report) has a historical origin,Informed consentIt is to supplement and supervise by a third party organization.
It is a Research Ethics Board (REB) similar to the United States.
(National Health and Medical Research Council) (NHMRC).
- Clinical trial screening committee - Of pharmaceuticalsClinical trialonly.. Mandatory installation by "Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceuticals (GCP Ministerial Ordinance)".
- Clinical trialOther than generalClinical trialAnd othersResearch and experiments on humansThere is no statutory stipulation regarding the case of implementing.
About the name of IRB
JapaneseClinical trial screening committeeRefers to the IRB, which is a system in the United States, so in Japan it is sometimes referred to as "IRB" to refer to clinical trial examinations...However, the system is also different and it belongs to the United States, so when the government uses the term IRB, it is necessary to be careful, such as distinguishing correctly..
The Japanese notation is also the Japan Medical Association "Institutional Examination Committee (IRB), Osaka City University School of Medicine "Research Ethics Review Committee (IRB)", "Clinical Trial Review Board (IRB)There is chaos not only in the meaning but also in the notation.
Experiments on humans (human experimentation)One of the most basic ethical principles in is that the experimenter must not undertake any experiment that the subject does not want.This idea was in 1947Nuremberg CodeWas codified for the first time in..This platform tried doctors who killed and tortured subjects in worthless experimentsNuremberg TrialsOne ofDoctor trialIt was decided as a result of the above, and some of the defendant doctors were hanged.Paragraph 5 of the Platform states that dangerous human experimentation should not be conducted unless the experimenter himself is the subject.This Nuremberg Code later influenced medical ethics standards around the world,Tuskegee Syphilis ExperimentInfamous experiments that violate the platform like this have also come to light... In 1966, "Ethics and Clinical Research (Beacher treatise) ”Written by Professor of Anesthesiology, Harvard Medical SchoolWorked to establish this ethics committee system as an additional oversight system for research protocols, as well as defining rules and conditions for informed consent. .
In addition, volunteer subjects must benefit from the experiment or study, even if the benefit is only in the distant future for the treatment of diseases that the subject is unlikely to suffer. There are also ethical principles to do.Experimental drugs are sometimes tested on patients suffering from an illness that cannot be treated, but if the researcher himself does not have the disease, it would be beneficial for the researcher to become a subject. It cannot be a subject because it is unlikely to be obtained.As an example, researcher Ronald C. Desrosiers was developing himself.AIDSWhen asked why he didn't test the vaccine himself, he said he wouldn't have benefited from testing because he wasn't at risk for AIDS..
It is important from the subjects in the supervision of the ethics committeeInformed consentIs to ensure that you get.Informed consent is the principle that volunteers participating in an experiment fully understand the procedures performed, are aware of all risks involved, and consent to participate in the experiment before the experiment is conducted.The principle of informed consent was in 1901.キ ュ ー バMade inUS Army Ofyellow feverIt was first set in the survey, but there were no general and official guidelines at the time...Principles for the issue of yellow fever are referred to when drafting the Nuremberg Code,Year 1964World Medical AssociationbyHelsinki DeclarationFurther developed and became the basis of this ethics committee system.
The first revision of the Declaration of Helsinki first stated in international guidelines that it would convene an ethics committee to approve research protocols in human experimentation (Helsinki II, 1975)...In developing countriesplaceboThere is controversy over the fourth revision of the test (4).This is an antiretroviral drug that the United States took in IndiaZidovudineThe test is criticized for violating the declaration, and in response to thisUS Food and Drug AdministrationDid not adopt the new revision of the Declaration of Helsinki, but instead referred to the 1989 revision..
The Ethics CommitteewhoIs an institution established byInternational Council of Medical SciencesCreated by (CIOMS)International Ethical Guidelines for Biomedical Research for HumansHowever, installation is required. First published in 1993The (CIOMS Ethics Guidelines) have had no legal effect but have influenced the drafting of national ethics committee systems.Another feature is that it is a guideline with the problem of infectious diseases in developing countries in mind..
- Clinical research ethics
- Medical ethics
- Research integrity
- Research ethics
- Beacher treatise
- Good clinical criteria (GCP)
- (Ethical issues of using children in clinical trials)
- ^ a b Gandevia, pp. 43–44
- ^ a b c "What is the Research Ethics Review Board (IRB)? | RecNet Fukuoka | Fukuoka Clinical Research Ethics Review Board Network RecNet Fukuoka". www.med.kyushu-u.ac.jp. 2019/5/30Browse.
- ^ "Declaration of Helsinki-World Medical Association-International Activities-To Doctors- Japan Medical Association". www.med.or.jp. 2019/6/1Browse.
- ^ a b "Current status and future prospects of the Ethics Committee Akira Akabayashi Graduate School of Medicine, Kyoto University”. Ministry of Education, Culture, Sports, Science and Technology-Life Science Square. 2019/5/31Browse.
- ^ "Basic knowledge of medical ethics | To doctors | To doctors | Japan Medical Association". www.med.or.jp. 2019/6/1Browse.
- ^ "About research guidelines”(Japanese). www.mhlw.go.jp. 2019/5/29Browse.
- ^ "Historical Background e-Learning | Fukuoka Clinical Research Ethics Review Committee Network RecNet Fukuoka". www.med.kyushu-u.ac.jp. 2019/6/1Browse.
- ^ a b "Judging Committee (IRB) ｜ Osaka City University Hospital Clinical Research and Innovation Promotion Center". www.hosp.med.osaka-cu.ac.jp. 2019/5/30Browse.
- ^ "Basic knowledge of medical ethics | To doctors | To doctors | Japan Medical Association". www.med.or.jp. 2019/5/30Browse.
- ^ The Nuremberg Code, US Department of Health & Human Services, accessed and archived, 20 December 2015
- ^ Altman, pp. xv-xvii
- ^ Rothman, DJ (1987). “Ethics and Human Experimentation” (Pdf). New England Journal of Medicine 317 (19): 1195–1199. two:10.1056 / NEJM198711053171906. PMID 3309660.
- ^ Kopp, V. (1999). “Henry Knowles Beecher and the development of informed consent in anesthesia research”. Anesthesiology 90 (6): 1756–1765. two:10.1097 / 00000542-199906000-00034. PMID 10360876.
- ^ Altman, p. xx
- ^ Gandevia, p. 43
- ^ Altman, pp. Xvi, 157
- ^ Riis, p. 173
- ^ Carlson, Boyd & Webb, pp. 698-699 Levine, p. 170
- ^ "International Ethical Guidelines for Biomedical Research for Humans (2002)”. Life Science Collaboration Promotion Council. 2019/5/31Browse.
- ^ Largent, p. 207
- Lawrence K. Altman, Who Goes First ?: The Story of Self-experimentation in Medicine, University of California Press, 19870520212819.
- SC Gandevia, "Self-experimentation, ethics, and efficacy", Monash Bioethics Review (Ethics Committee Supplement), vol. 23, no. 4, 2005.
- Povl Riis, "Planning of scientific-ethical committees", British Medical Journal, vol. 2, pp. 173–174, 1977.
- Emily A. Largent, "Recently proposed changes to legal and ethical guidelines governing human subjects research", Journal of Law and the Biosciences, vol. 3, iss. 1, pp. 206–216.
- RJ Levine, "Some recent developments in the international guidelines on the ethics of research involving human subjects", Annals of the New York Academy of Sciences, vol. 918, pp. 170–178, November 2000.
- Robert V Carlson, Kenneth M. Boyd, David J Webb, "The revision of the Declaration of Helsinki: past, present and future", British Journal of Clinical Pharmacology, vol. 57, iss. 6, pp. 695–713, June 2004.