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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.

Who is listed on the Study Personnel Page (SPP)?

• The following individuals, should be listed on the SPP (also referred to as the Key Study Personnel) based on their identified roles, and affiliation to the NIH:
  • Principal Investigator
  • NIH Associate Investigators
  • Referral Contact
  • Study Coordinator
  • Non-NIH Associate Investigators (working on the NIH study team)
  • Non-NIH Collaborators
• For each person listed above on the SPP/KSP page, ensure their roles are identified using the appropriate letter(s) below:

1. 1. Obtain information by intervening or interacting with living individuals for research purposes
   2. Obtaining identifiable private information about living individuals
   3. Obtaining the voluntary informed consent of individuals to be subjects
   4. Makes decisions about subject eligibility
   5. Studying, interpreting, or analyzing identifiable private information or data/specimens for research purposes
   6. Studying, interpreting, or analyzing coded, linked data or specimens for research purposes
   7. Some/all research activities performed outside NIH

What is my responsibility as PI to ensure only authorized study personnel obtain consent?

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