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The Declaration of Helsinki (2013, Article 26) declares that, "In medical research involving human subjects capable of giving ____________________, 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 and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study".

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Ethical clinical research should be designed in a methodologically rigorous manner (design, methods, statistical power and methods, etc.) that will yield valid, reliable, generalizable, and _______________ data, and that is feasible.

Ethical clinical research should answer a valuable question, i.e., one that will generate new knowledge or understanding about human health or __________, i.e. a socially, clinically, or scientifically useful question.

Ethical clinical research ensures independent __________, i.e. ensuring that ethical requirements have been fulfilled, investigator biases and conflicts have been checked, and assuring the public that research is not exploiting individuals or groups.

Tobeethical,researchersmustobtainthefullandinformed___________ofparticipatinghumansubjects. If the patient is unable to consent for him/herself, researchers can seek consent from the patient's legally authorized representative. One of the IRB's main functions is to ensure potential patients are adequately informed about the clinical trial.