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Consent Documentation The person who has oriented and obtained consent must also sign and date the consent form, after the participant signs. A witness signature is not required except in limited circumstances.
Who signs the informed consent form?
The subject or the subjects legally authorized representative or the parent(s) must sign the short form, and the person actually obtaining the consent must sign the copy of the summary (45 CFR 46.117(b)(2)).
Does the investigator need to obtain new informed consent from the participants?
Yes, investigators are responsible for obtaining and documenting the informed consent of research subjects or their legally authorized representatives, unless the IRB approves a waiver of informed consent, or a waiver of documentation of informed consent, respectively (45 CFR 46.116, 45 CFR 46.117).
Who is responsible for obtaining informed consent?
THE DUTY TO OBTAIN INFORMED CONSENT The duty to obtain a patients consent for treatment rests on the patients treating physician (6). Hospitals, nurses, surgical assistants, and referring physicians do not owe this duty to their patients (7).
Who is responsible for obtaining the signature from the client on the informed consent?
Informed Consent Process Generally, the physician who performs the procedure is responsible for obtaining the patients consent. If a nonphysician will perform the procedure, then the ordering physician is responsible for obtaining consent.
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People also ask
What are the guidelines for signing an informed consent?
Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision.
Who is the witness in informed consent?
Considering that the witness is only required to attest the voluntary nature of the patients consent, it would seem like any individual apart from the patient and doctor is eligible to be the witness to the procedure. This is why in most hospitals, the witness is often a relative/attender of the patient.
Related links
Obtaining and Documenting Informed Consent
Sep 27, 2023 A signature of the witness means: The requirements for informed consent have been satisfied.
Yes, under certain circumstances. First, the investigator and the IRB need to be aware of relevant laws pertaining to electronic signatures in the jurisdiction
Sep 26, 2018 Determine the IRBs instructions to clinical investigators for obtaining translations of informed consent documents. signed a written consent.
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