The Declaration of Helsinki is a set of ethical principles regarding human experimentation Clarifications of Articles 29, 30 (–); Sixth revision (); Seventh revision (). 3 Future; 4 Timeline (WMA meetings); 5 See. Helsingforsdeklarationen som en sam- ling etiska principer i syfte att vägleda läkare och andra som medverkar i medi- cinsk forskning som omfattar männi- skor. Från Helsingforsdeklarationen och Biomedicinkonventionen till den svenska Genom en ändring i lagen ändras etikprövningslagens definition av.

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The World Medical Association WMA has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians.

The WMA encourages others who are involved in medical research involving human subjects to adopt these principles. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. Medical progress is based on research that ultimately must include studies involving human subjects. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions methods, procedures and treatments.

Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

Medical research should be conducted in a manner that minimises possible harm to the environment. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

Declaration of Helsinki – Wikipedia

Groups that are underrepresented in medical research should be provided appropriate access to participation in research. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by helsingforsdfklarationen potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study helsingforsdeklaratioben not adversely affect the health of the patients who serve as research subjects.

Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

All medical research involving human subjects must be preceded by heksingforsdeklarationen assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

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Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. Physicians may not be involved in a research helsingforsdeklaraitonen involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

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When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

Forskning som involverar människan

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot helsiingforsdeklarationen carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

The welfare of animals used for research must be respected. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. Helsingforsveklarationen protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. In clinical trials, the protocol must also describe appropriate arrangements for helsingforsdeklarationeb provisions.

The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events.

No amendment to the protocol may be made without consideration and approval by the committee. Every precaution must be taken to protect the privacy of helsingfordseklarationen subjects and the confidentiality of their personal information.

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although helsingforsdeklagationen may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits helsingforrsdeklarationen potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.

The potential subject must be informed of the right to refuse to participate in the study or to helsijgforsdeklarationen consent to participate at any time without reprisal.

Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress.

In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

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When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee.

Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative. The physician must fully inform the patient which aspects of their care are related to the research.

There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention sexcept in the following circumstances:. Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention.

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.

Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.

All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.

Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

Risks, Burdens and Benefits Vulnerable Groups and Individuals All vulnerable groups and individuals should receive specifically considered protection. Scientific Requirements and Research Protocols Research Ethics Committees Privacy and C onfidentiality Use of Placebo The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention sexcept in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option. Research Registration and Publication and Dissemination of Results Unproven Interventions in Clinical Practice This website uses cookies to ensure you get the best experience on our website.

Last modified: July 31, 2020