Helsinki Declaration Flashcards
What is the duty of the physician?
To promote and safeguard the health of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.
What is the definition of Medical research?
The basic research, applied research, or translational research conducted to aid and support the development of a body of knowledge in the field of medicine. Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy and what are termed clinical trials, and all other research that contributes to the development of new treatments.
What should take precedence in medical research?
The well-being of the individual research subject.
What research populations are considered vulnerable and need special protection?
Those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.
To whom should the experimental protocol be submitted?
The research protocol must be submitted for consideration, comment, guidance, and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor, and any other undue influence.
Who is responsible for the human subject?
The responsibility for the protection of research subjects must always rest with the physician or other healthcare professional and never the research subjects, even though they have given consent.
What is the role of risks and benefits to the subject?
Most interventions involve risks, but these must be minimized, and the importance of the objective must outweigh the risks to research subjects. Research must be preceded by an assessment of potential risks, and these must be continuously monitored. When risks outweigh potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify, or immediately stop the study.
When is medical research justified?
When its potential preventative, diagnostic, or therapeutic value are apparent and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
What safeguards must be provided to research subjects?
Protection of health and rights. The primary purpose of research of generating new knowledge can never take precedence over the rights and interests of individual research subjects. Any possible harm to the environment should be minimized. Research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training, and qualifications. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
What requirements are there for “informed?”
Being adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and to the discomfort it may entail, post-study provisions, and any other relevant aspects of the study as well as the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
For persons who are unable to give consent, what 2 requirements must be met?
- The physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group.
- The physician must seek informed consent from the legally authorized representative.
At the conclusion of the study, what must be assured to every patient?
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.
