Risk in Human Subjects Research

Research often exposes human subjects to risks, which can range from minimal harms, such as mild bruising or headache, to significant harms, such as liver toxicity or even death. Researchers have ethical and legal obligations to use research designs, methods, and procedures that minimize risks to human subjects, to ensure that risks are reasonable in relation to benefits to subjects or society, and to inform subjects about risks. This entry defines research risks; distinguishes between different types of risks; describes researchers’ ethical and legal obligations related to risks, strategies for minimizing risks, and methods for assessing risks; and reviews some of the controversial issues pertaining to research risks.

Research Risks

Risk can be defined as the chance that an adverse outcome (or harm) will occur. Risk is ...

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