IF INFORMED CONSENT IS AN ONGOING PROCESS, WHAT DOES RE-CONSENT MEAN?

Informed consent is a fundamental ethical requirement in clinical research. It is more than signing a form; it is also a process. Information must be presented in a way to enable an individual to voluntarily decide whether to participate in a research study. This information exchange occurs between the Investigator, research team, and the participant, but may lack documentation to support the research participant’s informed decision to continue participation based on the information exchange.

By the end of this session, the learner will be able to:

1. Define re-consent and reaffirmation.

2. Explain three types of research situations that warrant participant re-consenting.

3. Discuss the clinical research nursing implications for re-consenting research participants.

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