qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.
24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
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 conflicts of
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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.
American Nurses Association (2011)
Provision 3.3 : Protection of participants in research
Each individual has the right to choose whether or not to participate in research.
Patient or legally authorized surrogate receive sufficient information that is in material to an informed decision, to comprehend that information, and to know how to discontinue participation in research without penalty.
Necessary information to achieve an adequately informed consent (nature of participation, potential harms and benefits, available alternatives to taking part in the research, how the data will be protected)
Research should be conducted and directed only by qualified person.
All research should be approved by a qualified review board to ensure patient protection and the ethical integrity of the