Which of the following are true statements about informed consent? Select all that apply.
A) Informed consent is the process of providing information to a potential subject and the opportunity to participate in the study.
B) The process ends with the subject's signature on a document agreeing to be in a study.
C) A potential subject's decision about whether to participate is the informing part of the process.
D) Informed consent is incomplete or unethical unless all three elements are incorporated.
E) The documentation of informed consent depends on the study's level of risk and the requirement of the IRB who approves the study.

Question

Quizplus · Accepted Answer

Informed consent requires researchers to obtain a potential subject's voluntary participation in a study,after informing them of possible risks and benefits.The documentation of informed consent does depend on the study's level of risk and the requirements of the IRB.The process of informed consent does not end with the subject's signature on a document agreeing to be in a study.A potential subject's decision about whether to participate is the consenting part of the process.Informed consent is incomplete or unethical unless four elements (disclose,comprehends,competence,and voluntary agreement)are incorporated.

Which of the Following Are True Statements About Informed Consent