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The protocol must be submitted in Microsoft word with subsequent versions submitted in tracked changes. When submitting documents to the IRB, each electronic regulatory file must have a consistent format, including naming of folders and files, to ensure required information is maintained and easily accessible.
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- For proper nomenclature study teams are required to use when submitting documents to the NIH IRB refer to the OHSRP webpage How to Name Documents for Submission which outlines protocol, consent and other study document nomenclature. For example:
- Update the version date of the document each time you submit the document to the IRB.
- Update the version date of the document (within the document and in the filename) with each response to stipulations.
- When responding to corrections, update the version of the document within the document AND filename.
- If the IRB returns a document with stipulations and they have changed the filename of the document, remove the words "IRB Edits" or "Pre-review Edits" from the document title before you resubmit.
What is my responsibility as PI to ensure only authorized study personnel obtain consent?
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Visiting Fellows, Intramural Research Training Awardees (IRTAs), and Cancer Research Training Awardee (CRTAs) serving as Associate Investigators may observe or participate in the informed consent process only if they are under direct and constant supervision by a qualified NIH federal employee investigator. These trainees may not sign the informed consent document. (See Policy 300 Investigator Responsibilities and 2300-320-7 – Intramural Research Training Award (IRTA) Program
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Section C of this policy states. “Trainees are prohibited from having any human subject/patient contact unless they are entirely under the direct supervision, at all times, by an appropriately qualified NIH employee (FTE).” |
Section C of this policy states. "Trainees are prohibited from having any human subject/patient contact unless they are entirely under the direct supervision, at all times, by an appropriately qualified NIH employee (FTE)."
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What is my responsibility as PI to ensure only authorized study personnel obtain consent?
- You must ensure that investigators delegated to obtain informed consent are qualified to obtain informed consent (e.g., based on familiarity with the protocol, research, clinical experience, and qualifications) and have completed appropriate training per Policy 103, Education Program and other NIH requirements as applicable.
Except as described below, Visiting Fellows, Intramural Research Training Awardees (IRTAs), and Cancer Research Training Awardee (CRTAs) serving as Associate Investigators may observe or participate in the informed consent process only if they are under direct and constant supervision by a qualified NIH federal employee investigator. These trainees may not sign the informed consent document. (See Policy 300 Investigator Responsibilities and 2300-320-7 – Intramural Research Training Award (IRTA) Program
- Those designated to obtain informed consent must be identified in the approved electronic IRB application system prior to initiating informed consent.
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