Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review. Show
WHO works with Member States and partners to promote ethical standards and appropriate systems of review for any course of research involving human subjects. Within WHO, the Research Ethics Review Committee (ERC) ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects involving human participants supported either financially or technically by WHO. The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964), last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016). Enter the characters you see belowSorry, we just need to make sure you're not a robot. For best results, please make sure your browser is accepting cookies. Type the characters you see in this image:Try different image Conditions of Use Privacy Policy © 1996-2014, Amazon.com, Inc. or its affiliates International Ethical Guidelines for Biomedical Research Involving Human SubjectsWHO/CIOMS, Geneva, 1993Guideline 1: Individual informed consentFor all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the proxy consent of a properly authorized representative. Guideline 2: Essential information for prospective research subjectsBefore requesting an individual's consent to participate in research, the investigator must provide the individual with the following information, in language that he or she is capable of understanding: Guideline 3: Obligations of investigators regarding informed consentThe investigator has a duty to: Guideline 4: Inducement to participateSubjects may be paid for inconvenience and time spent, and should be reimbursed for expenses incurred, in connection with their participation in research; they may also receive free medical services. However, the payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in the research against their better judgment ("undue inducement"). All payments, reimbursements and medical services to be provided to research subjects should be approved by an ethical review committee. Guideline 5: Research involving childrenBefore undertaking research involving children, the investigator must ensure that: Guideline 6: Research involving persons with mental or behavioural disordersBefore undertaking research involving individuals who by reason of mental or behavioural disorders are not capable of giving adequately informed consent, the investigator must ensure that: Guideline 7: Research involving prisonersPrisoners with serious illness or at risk of serious illness should not arbitrarily be denied access to investigational drugs, vaccines or other agents that show promise of therapeutic or preventive benefit. Guideline 8: Research involving subjects in underdeveloped communitiesBefore undertaking research involving subjects in underdeveloped communities, whether in developed or developing countries, the investigator must ensure that: Guideline 9: Informed consent in epidemiological studiesFor several types of epidemiological research individual informed consent is either impracticable or inadvisable. In such cases the ethical review committee should determine whether it is ethically acceptable to proceed without individual informed consent and whether the investigator's plans to protect the safety and respect the privacy of research subjects and to maintain the confidentiality of the data are adequate. Guideline 10: Equitable distribution of burdens and benefitsIndividuals or communities to be invited to be subjects of research should be selected in such a way that the burdens and benefits of the research will be equitably distributed. Special justification is required for inviting vulnerable individuals and, if they are selected, the means of protecting their rights and welfare must be particularly strictly applied. Guideline 11: Selection of pregnant or nursing (breastfeeding) women as research subjectsPregnant or nursing women should in no circumstances be the subjects of non-clinical research unless the research carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge about pregnancy or lactation. As a general rule, pregnant or nursing women should not be subjects of any clinical trials except such trials as are designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects. Guideline 12: Safeguarding confidentialityThe investigator must establish secure safeguards of the confidentiality of research data. Subjects should be told of the limits to the investigators' ability to safeguard confidentiality and of the anticipated consequences of breaches of confidentiality. Guideline 13: Right of subjects to compensationResearch subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependants are entitled to material compensation. The right to compensation may not be waived. Guideline 14: Constitution and responsibilities of ethical review committeesAll proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees. The investigator must obtain such approval of the proposal to conduct research before the research is begun. Guideline 15: Obligations of sponsoring and host countriesExternally sponsored research entails two ethical obligations: What are the ethical guidelines for biomedical research?All research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for person, beneficence and justice.
What are the ethical guidelines for research with human participants?NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:. Social and clinical value.. Scientific validity.. Fair subject selection.. Favorable risk-benefit ratio.. Independent review.. Informed consent.. Respect for potential and enrolled subjects.. What ethical standards are required to protect human subjects of medical research?Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
How do you cite international ethical guidelines for health related research involving humans?This is the correct citation: International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016.
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