Research involving human beings and/or animals
Experimentation on human subjects
Scientific research and experimentation involving human subjects is a right and duty of the scientific and biomedical community. Scientific experimentation is an important means of advancing knowledge about human nature. This knowledge must be used to improve human well-being, health and quality of life.
Regarding papers involving human subject research, the following items must be made explicitly stated in a separate document to be attached to the article:
- In human subject research, the interests of science and society may never prevail over the well-being of the subject. The subject's right to protect his or her integrity must always be respected. Every precaution should be taken to preserve the physical and psychological integrity of individuals participating as experimental subjects.
- Experimentation on human subjects which may involve risk or discomfort to the subjects should only be conducted when there are no alternative procedures of comparable efficacy.
- Biomedical research involving human subjects must conform to generally accepted scientific and ethical standards. It shall be grounded in the assessment of risks based on prior, adequately performed laboratory and animal experimentation and on a thorough knowledge of the possible consequences of the research. No experiments may be performed on human subjects unless there is no comparably effective alternative method to human experimentation.
- Risk-benefit ratio of research. The risks or discomfort involved in experimentation on human subjects shall not be disproportionate nor shall it impair moral conscience or dignity. In the case of biomedical research, the importance of the objective shall in proportion to the inherent risk to the subject.
- Any biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.
- Concern for the interests of the subject must always prevail over the interests of science and society. Any research or experiment must be discontinued if the risks are found to outweigh the calculated benefits.
- Participation in any research or experiment shall involve the free and informed consent of the subject after being adequately informed of the nature and purpose of the investigation, the aims, methods, anticipated benefits, and potential risks or discomforts it may entail. Subjects shall be free to withdraw their consent at any time, without any detriment to themselves. In the case of participation in research or experiments in minors or disabled persons with impaired competence or autonomy, consent shall always be given in writing by their legal guardian, relative, the person who has the duty of care.
- In the event that researchers offer subjects financial incentives or rewards, or incentives of any other kind, for their participation in the research or experiment, in no case this shall be so high that the subject cannot reasonably refuse it.
- Researchers must ensure the subjects' right to privacy. In teamwork, each investigator is responsible for maintaining complete confidentiality. All participants in human subject research shall maintain the strictest confidentiality such that the subjects' personal and family privacy is not violated.
- In any scientific experiment or research, experimental subjects or participants must be treated with the utmost respect for their dignity, beliefs, privacy, and modesty, with special protection for the most vulnerable.
- In all scientific research or experiments, the identity of the researcher(s) responsible for the investigation or analysis must be clearly stated as well as that of the rest of the research team collaborating on the experiment or research.
- The responsibility for the research must always rest with the investigator, and never on the research subject, even though subject has given their consent. Approval from an ethics committee of the experimental protocols does not exempt investigators from their direct responsibility.
