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Question: 1 / 215

In which document must the informed consent process be documented?

Research proposal

Informed consent form

The informed consent process must be documented in the informed consent form. This is essential because the informed consent form serves as a formal record that outlines the purpose of the research, potential risks and benefits, the procedures involved, and the rights of the participants. It ensures that participants are fully aware of what they are agreeing to before they consent to take part in the study.

The informed consent form is specifically designed to capture the details of the consent process, including any discussions that took place, and it provides a tangible document that both the researchers and participants can refer to. This is crucial for ethical research practices, ensuring that participants feel informed and empowered to make a decision about their participation.

Other documents, such as the research proposal and IRB approval letter, are important in the context of the research process but do not specifically encapsulate the informed consent process itself. The research findings report, on the other hand, focuses on the results and outcomes of the research study, and does not go into detail about the consent process. Thus, the informed consent form is the appropriate document to thoroughly document the informed consent process.

IRB approval letter

Research findings report

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