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When to reconsent to research subjects?

Sites and sponsors should reconsent participants when the changes are so docHub or pervasive that it would require a thorough consent discussion to re-explain the study and that the participants will need to document their agreement to remain in the study.

Why might a participant need to re-consent?

An example of when re-consent might be required in this situation would be a new conflict of interest declaration by a newly named Principal Investigator. Typographical errors noted in the consent document unless the error docHubly changes the intent of the sentence.

What are the stages of consent?

Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patients role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patients

What is the process of Reconsent?

Re-Consent: Process of notifying research subjects of changes in the research including documentation of the subjects continued informed consent through signature on a revised written consent form.

When should informed consent be obtained?

Informed consent from the participant and/or his or her legally-authorized representative (surrogate) must be obtained prior to initiating any research activities, including screening procedures.

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