79C3C34C52B45572883A05D425EB0F82
Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
http://leaux.net/URLS/ConvertAPI Text Files/F4C47E6FD26CBAA2A71C53975B698946.en.txt
Examining the file media/Synopses/F4C47E6FD26CBAA2A71C53975B698946.html:
This file was generated: 2020-12-01 05:06:53
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
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p.(None):
p.(None): 14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justi ed by its potential preventive, diagnostic or therapeutic value and
p.(None): if the physician has good reason to believe that participation in the research study will not adversely a ect the health of the patients who serve as research subjects.
p.(None):
p.(None): 15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
p.(None):
p.(None): Risks, Burdens and Bene ts
p.(None):
p.(None): 16. In medical practice and in medical research, most interventions involve risks and burdens.
p.(None):
p.(None): Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
p.(None):
p.(None): 17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with
p.(None): foreseeable bene ts to them and to other individuals or groups a ected by the condition under investigation.
p.(None):
p.(None): Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
p.(None):
p.(None): 18. Physicians may not be involved in a research study involving human subjects unless they are con dent that the risks have been adequately assessed and can be satisfactorily managed.
p.(None):
p.(None): When the risks are found to outweigh the potential bene ts or when there is conclusive proof of de nitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
p.(None):
p.(None): Vulnerable Groups and Individuals
p.(None):
p.(None): 19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.
p.(None):
p.(None): All vulnerable groups and individuals should receive speci cally considered protection.
p.(None):
p.(None): 20. Medical research with a vulnerable group is only justi ed if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In
p.(None): addition, this group should stand to bene t from the knowledge, practices or interventions that result from the research.
p.(None):
p.(None): Scienti c Requirements and Research Protocols
p.(None):
p.(None): 21. Medical research involving human subjects must conform to generally accepted scienti c principles, be based on a thorough knowledge of the scienti c literature, other relevant sources of information,
p.(None): and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
p.(None): 22. The design and performance of each research study involving human subjects must be clearly described and justi ed in a research protocol.
p.(None):
p.(None): The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information
p.(None): regarding funding, sponsors, institutional a liations, potential con icts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a
p.(None): consequence of participation in the research study.
p.(None):
p.(None): In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
p.(None):
p.(None): Research Ethics Committees
p.(None):
p.(None): 23. 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
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.(None): under duress. In such situations the informed consent must be sought by an appropriately quali ed individual who is completely independent of this relationship.
p.(None):
p.(None): 28. 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
p.(None): included in a research study that has no likelihood of bene t for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed
p.(None): with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
p.(None):
p.(None): 29. 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
p.(None): to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
p.(None):
p.(None): 30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving
p.(None): informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is
p.(None): available and if the research cannot be delayed, the study may proceed without informed consent provided that the speci c reasons for involving subjects with a condition that renders them unable to give
p.(None): 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
p.(None): the subject or a legally authorised representative.
p.(None):
p.(None): 31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study
p.(None): must never adversely a ect the patient-physician relationship.
p.(None):
p.(None): 32. For medical research using identi able human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.(None): The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the speci c
p.(None): information needs of individual potential subjects as well as to the methods used to deliver the information.
p.(None):
p.(None): After ensuring that the potential subject has understood the information, the physician or another appropriately quali ed individual must then seek the potential subject’s freely-given informed consent,
p.(None): preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
p.(None):
p.(None): All medical research subjects should be given the option of being informed about the general outcome and results of the study.
p.(None):
p.(None): 27. 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
p.(None): under duress. In such situations the informed consent must be sought by an appropriately quali ed individual who is completely independent of this relationship.
p.(None):
p.(None): 28. 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
p.(None): included in a research study that has no likelihood of bene t for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed
p.(None): with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
p.(None):
p.(None): 29. 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
p.(None): to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
p.(None):
p.(None): 30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving
p.(None): informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is
p.(None): available and if the research cannot be delayed, the study may proceed without informed consent provided that the speci c reasons for involving subjects with a condition that renders them unable to give
p.(None): 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
p.(None): the subject or a legally authorised representative.
p.(None):
p.(None): 31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study
p.(None): must never adversely a ect the patient-physician relationship.
p.(None):
p.(None): 32. For medical research using identi able human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None):
p.(None): 23. 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
p.(None): in its functioning, must be independent of the researcher, the sponsor and any other undue in uence and must be duly quali ed. It must take into consideration the laws and regulations of the country or
p.(None): 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
p.(None): forth in this Declaration.
p.(None):
p.(None): 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
p.(None): amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a nal report to the committee containing a summary
p.(None): of the study’s ndings and conclusions.
p.(None):
p.(None): Privacy and Con dentiality
p.(None):
p.(None): 24. Every precaution must be taken to protect the privacy of research subjects and the con dentiality of their personal information.
p.(None):
p.(None): Informed Consent
p.(None):
p.(None): 25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no
p.(None): individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
p.(None):
p.(None): 26. 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 con icts of
p.(None): interest, institutional a liations of the researcher, the anticipated bene ts and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.
p.(None): The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the speci c
p.(None): information needs of individual potential subjects as well as to the methods used to deliver the information.
p.(None):
p.(None): After ensuring that the potential subject has understood the information, the physician or another appropriately quali ed individual must then seek the potential subject’s freely-given informed consent,
p.(None): preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
p.(None):
p.(None): All medical research subjects should be given the option of being informed about the general outcome and results of the study.
p.(None):
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.(None): under duress. In such situations the informed consent must be sought by an appropriately quali ed individual who is completely independent of this relationship.
p.(None):
p.(None): 28. 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
p.(None): included in a research study that has no likelihood of bene t for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed
p.(None): with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
p.(None):
p.(None): 29. 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
p.(None): to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
p.(None):
p.(None): 30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving
p.(None): informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is
p.(None): available and if the research cannot be delayed, the study may proceed without informed consent provided that the speci c reasons for involving subjects with a condition that renders them unable to give
p.(None): 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
p.(None): the subject or a legally authorised representative.
p.(None):
p.(None): 31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study
p.(None): must never adversely a ect the patient-physician relationship.
p.(None):
...
Health / Unconscious People
Searching for indicator unconscious:
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p.(None):
p.(None): 28. 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
p.(None): included in a research study that has no likelihood of bene t for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed
p.(None): with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
p.(None):
p.(None): 29. 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
p.(None): to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
p.(None):
p.(None): 30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving
p.(None): informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is
p.(None): available and if the research cannot be delayed, the study may proceed without informed consent provided that the speci c reasons for involving subjects with a condition that renders them unable to give
p.(None): 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
p.(None): the subject or a legally authorised representative.
p.(None):
p.(None): 31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study
p.(None): must never adversely a ect the patient-physician relationship.
p.(None):
p.(None): 32. For medical research using identi able human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None):
p.(None): 9. 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 con dentiality of personal information of research
p.(None): 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
p.(None): consent.
p.(None):
p.(None): 10. 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
p.(None): national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
p.(None):
p.(None): 11. Medical research should be conducted in a manner that minimises possible harm to the environment.
p.(None):
p.(None): 12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scienti c education, training and quali cations. Research on patients or healthy
p.(None): volunteers requires the supervision of a competent and appropriately quali ed physician or other health care professional.
p.(None):
p.(None): 13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
p.(None):
p.(None): 14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justi ed by its potential preventive, diagnostic or therapeutic value and
p.(None): if the physician has good reason to believe that participation in the research study will not adversely a ect the health of the patients who serve as research subjects.
p.(None):
p.(None): 15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
p.(None):
p.(None): Risks, Burdens and Bene ts
p.(None):
p.(None): 16. In medical practice and in medical research, most interventions involve risks and burdens.
p.(None):
p.(None): Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
p.(None):
p.(None): 17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with
p.(None): foreseeable bene ts to them and to other individuals or groups a ected by the condition under investigation.
p.(None):
p.(None): Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
p.(None):
p.(None): 18. Physicians may not be involved in a research study involving human subjects unless they are con dent that the risks have been adequately assessed and can be satisfactorily managed.
p.(None):
p.(None): When the risks are found to outweigh the potential bene ts or when there is conclusive proof of de nitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
p.(None):
...
p.(None): consideration and approval of a research ethics committee.
p.(None):
p.(None): Use of Placebo
p.(None):
p.(None): 33. The bene ts, risks, burdens and e ectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
p.(None):
p.(None): Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.(None):
p.(None): Where for compelling and scienti cally sound methodological reasons the use of any intervention less e ective than the best proven one, the use of placebo, or no intervention is necessary to determine the
p.(None): e cacy or safety of an intervention
p.(None):
p.(None): and the patients who receive any intervention less e ective 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
p.(None): the best proven intervention.
p.(None):
p.(None): Extreme care must be taken to avoid abuse of this option.
p.(None):
p.(None): Post-Trial Provisions
p.(None):
p.(None): 34. 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 identi ed as bene cial in
p.(None): the trial. This information must also be disclosed to participants during the informed consent process.
p.(None):
p.(None): Research Registration and Publication and Dissemination of Results
p.(None):
p.(None): 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the rst subject.
p.(None):
p.(None): 36. 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
p.(None): 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.
p.(None): Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional a liations and con icts of interest must be declared in the
p.(None): publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
p.(None):
p.(None): Unproven Interventions in Clinical Practice
p.(None):
p.(None): 37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ine ective, the physician, after seeking expert advice, with informed consent
p.(None): from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it o ers hope of saving life, re-establishing health or alleviating su ering. This
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None): collection, storage and/or reuse. 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
p.(None): consideration and approval of a research ethics committee.
p.(None):
p.(None): Use of Placebo
p.(None):
p.(None): 33. The bene ts, risks, burdens and e ectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
p.(None):
p.(None): Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.(None):
p.(None): Where for compelling and scienti cally sound methodological reasons the use of any intervention less e ective than the best proven one, the use of placebo, or no intervention is necessary to determine the
p.(None): e cacy or safety of an intervention
p.(None):
p.(None): and the patients who receive any intervention less e ective 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
p.(None): the best proven intervention.
p.(None):
p.(None): Extreme care must be taken to avoid abuse of this option.
p.(None):
p.(None): Post-Trial Provisions
p.(None):
p.(None): 34. 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 identi ed as bene cial in
p.(None): the trial. This information must also be disclosed to participants during the informed consent process.
p.(None):
p.(None): Research Registration and Publication and Dissemination of Results
p.(None):
p.(None): 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the rst subject.
p.(None):
p.(None): 36. 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
p.(None): 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.
p.(None): Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional a liations and con icts of interest must be declared in the
p.(None): publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
p.(None):
p.(None): Unproven Interventions in Clinical Practice
p.(None):
p.(None): 37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ine ective, the physician, after seeking expert advice, with informed consent
...
Social / education
Searching for indicator education:
(return to top)
p.(None):
p.(None): 8. 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.
p.(None):
p.(None): 9. 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 con dentiality of personal information of research
p.(None): 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
p.(None): consent.
p.(None):
p.(None): 10. 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
p.(None): national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
p.(None):
p.(None): 11. Medical research should be conducted in a manner that minimises possible harm to the environment.
p.(None):
p.(None): 12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scienti c education, training and quali cations. Research on patients or healthy
p.(None): volunteers requires the supervision of a competent and appropriately quali ed physician or other health care professional.
p.(None):
p.(None): 13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
p.(None):
p.(None): 14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justi ed by its potential preventive, diagnostic or therapeutic value and
p.(None): if the physician has good reason to believe that participation in the research study will not adversely a ect the health of the patients who serve as research subjects.
p.(None):
p.(None): 15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
p.(None):
p.(None): Risks, Burdens and Bene ts
p.(None):
p.(None): 16. In medical practice and in medical research, most interventions involve risks and burdens.
p.(None):
p.(None): Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
p.(None):
p.(None): 17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with
p.(None): foreseeable bene ts to them and to other individuals or groups a ected by the condition under investigation.
p.(None):
p.(None): Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
p.(None):
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None):
p.(None): 26. 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 con icts of
p.(None): interest, institutional a liations of the researcher, the anticipated bene ts and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.
p.(None): The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the speci c
p.(None): information needs of individual potential subjects as well as to the methods used to deliver the information.
p.(None):
p.(None): After ensuring that the potential subject has understood the information, the physician or another appropriately quali ed individual must then seek the potential subject’s freely-given informed consent,
p.(None): preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
p.(None):
p.(None): All medical research subjects should be given the option of being informed about the general outcome and results of the study.
p.(None):
p.(None): 27. 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
p.(None): under duress. In such situations the informed consent must be sought by an appropriately quali ed individual who is completely independent of this relationship.
p.(None):
p.(None): 28. 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
p.(None): included in a research study that has no likelihood of bene t for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed
p.(None): with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
p.(None):
p.(None): 29. 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
p.(None): to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
p.(None):
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None):
p.(None): Policy / Current Policies / WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human
p.(None): Subjects
p.(None):
p.(None):
p.(None):
p.(None): WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
p.(None):
p.(None):
p.(None):
p.(None): Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
p.(None): and amended by the:
p.(None): 29th WMA General Assembly, Tokyo, Japan, October 1975
p.(None): 35th WMA General Assembly, Venice, Italy, October 1983
p.(None): 41st WMA General Assembly, Hong Kong, September 1989
p.(None): 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
p.(None): 52nd WMA General Assembly, Edinburgh, Scotland, October 2000
p.(None): 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clari cation added)
p.(None): 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clari cation added)
p.(None): 59th WMA General Assembly, Seoul, Republic of Korea, October 2008
p.(None): 64th WMA General Assembly, Fortaleza, Brazil, October 2013
p.(None):
p.(None): Preamble
p.(None):
p.(None): 1. 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 identi able
p.(None): human material and data.
p.(None):
p.(None): 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.
p.(None):
p.(None): 2. 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
p.(None): these principles.
p.(None):
p.(None): General Principles
p.(None):
p.(None): 3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my rst consideration,” and the International Code of Medical Ethics declares that, “A
p.(None): physician shall act in the patient’s best interest when providing medical care.”
p.(None):
p.(None): 4. 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. The physician’s knowledge and conscience are
p.(None): dedicated to the ful lment of this duty.
p.(None):
p.(None): 5. Medical progress is based on research that ultimately must include studies involving human subjects.
p.(None):
p.(None): 6. The primary purpose of medical research involving human subjects is to understand the causes, development and e ects of diseases and improve preventive, diagnostic and therapeutic interventions
p.(None): (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, e ectiveness, e ciency, accessibility and quality.
p.(None):
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.(None): available and if the research cannot be delayed, the study may proceed without informed consent provided that the speci c reasons for involving subjects with a condition that renders them unable to give
p.(None): 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
p.(None): the subject or a legally authorised representative.
p.(None):
p.(None): 31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study
p.(None): must never adversely a ect the patient-physician relationship.
p.(None):
p.(None): 32. For medical research using identi able human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its
p.(None): collection, storage and/or reuse. 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
p.(None): consideration and approval of a research ethics committee.
p.(None):
p.(None): Use of Placebo
p.(None):
p.(None): 33. The bene ts, risks, burdens and e ectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
p.(None):
p.(None): Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.(None):
p.(None): Where for compelling and scienti cally sound methodological reasons the use of any intervention less e ective than the best proven one, the use of placebo, or no intervention is necessary to determine the
p.(None): e cacy or safety of an intervention
p.(None):
p.(None): and the patients who receive any intervention less e ective 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
p.(None): the best proven intervention.
p.(None):
p.(None): Extreme care must be taken to avoid abuse of this option.
p.(None):
p.(None): Post-Trial Provisions
p.(None):
p.(None): 34. 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 identi ed as bene cial in
p.(None): the trial. This information must also be disclosed to participants during the informed consent process.
p.(None):
p.(None): Research Registration and Publication and Dissemination of Results
p.(None):
p.(None): 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the rst subject.
p.(None):
p.(None): 36. 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
p.(None): 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.
p.(None): Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional a liations and con icts of interest must be declared in the
p.(None): publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| dependent | Dependent |
| education | education |
| family | Motherhood/Family |
| helsinki | declaration of helsinki |
| incapable | Mentally Incapacitated |
| mentally | Mentally Disabled |
| physically | Physically Disabled |
| placebo | participants in a control group |
| unconscious | Unconscious People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
harm
protect
protection
risk
self-determination
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input