The informed consent documents must include: (Select all that apply.)
a. an explanation of potential risks and benefits to participants in the study.
b. medical terminology rather than lay terms to prevent misunderstanding of the study.
c. a statement on how the anonymity and confidentiality of participants are protected.
d. explanation of the cost of the study.
e. details on how to contact the investigator.
ANS: A, C, E
Correct:
a. Informed consent explains the study to the participants and assures them of their rights, including their right to refuse to participate or to withdraw from the study.
c. The informed consent must include protection of anonymity and confidentiality, voluntary participation, compensation, and alternative treatment.
e. The informed consent must include specific information on how to contact the investigator.
Incorrect:
b. Informed consent is always written in lay terminology so that participants can clearly understand.
d. The actual cost of the study is not included on the informed consent form.
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