Are investigators responsible for obtaining and documenting informed consent?
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). Investigators must give a copy of the informed consent document to each research subject (or the subject’s legally authorized representative), and keep the signed original or a copy of it for their records (45 CFR 46.117(a); 45 CFR 46.115(b)). When the documentation requirement is waived, the IRB may require investigators to provide subjects with a written statement regarding the research (45 CFR 46.117(c)). (For information about parental permission and assent, see the FAQs related to subpart D of 45 CFR part 46.
