...

• 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 
  • Post-doctoral IRTAs/CRTAs and post-doctoral VFs who are Associate Investigators may obtain the informed consent of a prospective subject without the presence of a qualified NIH federal employee investigator after sufficient training by the PI about the protocol. The post-doctoral IRTA/CRTA or post-doctoral VF must be knowledgeable, and be able to explain, about the protocol and all of the information contained the informed consent document and be capable of addressing all subject questions. In addition, to be eligible to obtain consent, the post-doctoral IRTA/CRTA or post-doctoral VF must have also completed Elements of a Successful Informed Consent course and the validated Objective Structured Clinical Examination (OSCE) for the Informed Consent Process offered by the NIMH Human Subjects Protection Unit (HSPU). 
• Those designated to obtain informed consent must be identified in the electronic IRB system prior to initiating informed consent.

...

• Additional reviews may be required including, but are not limited to, Concept Review, Scientific Review, Protocol Resource Impact Assessment for protocols conducted at the Clinical Center, multisite research review, FDA review and ancillary reviews such as Radiation Safety Committee, Deputy Ethics Counselor Review, and other possible reviews as noted below.
• Investigators should be aware of the additional ancillary reviews that are required and ensure these are completed and documented prior to submission of their protocol in the electronic IRB system.

...

• For protocols conducted at the Clinical Center (CC), a Protocol Resource Impact Assessment (PRIA) must be completed and reviewed by the CC prior to initiation of research. 
• All protocols submitted through the PRIA process will receive a regulatory assessment from the Office of Research Support and Compliance (ORSC) Regulatory Support Section.  This review is done to point out regulatory items related to FDA (21 CFR 312 and 21 CFR 812) about which the IRB may need to make determinations during the its review.  The IRB administrator can access this regulatory assessment with the PRIA in the electronic IRB system.  Depending on the institute, PIs may receive the review as well or it may be sent to the IC's regulatory support office.

...