Certification for IRB Professionals (CIP) Practice Exam

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Which of the following best describes "informed consent" in human subjects research?

  1. Participants must agree to participate with no further information provided

  2. Participants should be uninformed to avoid bias

  3. Participants should be fully informed about the study and voluntarily agree to participate

  4. Participants are consented only after the study is completed

The correct answer is: Participants should be fully informed about the study and voluntarily agree to participate

Informed consent is a fundamental ethical principle in human subjects research that emphasizes the importance of transparency and autonomy. The correct description states that participants should be fully informed about the study and voluntarily agree to participate. This means that researchers are obligated to provide comprehensive information about the research's purpose, procedures, risks, benefits, and any alternatives to participation. This ensures that participants can make knowledgeable decisions regarding their involvement, thus upholding their autonomy and rights. The essence of informed consent is that it must be obtained before any research involvement, allowing individuals the opportunity to assess the information and decide if they wish to participate freely, without coercion or undue influence. This process not only protects the rights of participants but also enhances the credibility and integrity of the research itself by ensuring ethical standards are upheld. The other options differ significantly from this principle. For example, suggesting that participants must agree to participate with no further information contradicts the requirement for transparency and informed decision-making. Proposing that participants should be uninformed to avoid bias directly undermines ethical standards, as it removes the participant's ability to make an informed choice. Lastly, the notion that consent is only obtained after the study is completed is unethical and fails to respect the voluntary nature of participation that informed consent embodies.

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