Department of the Navy
Human Research Protection Program

DON HRPP Guidance


 

General Guidance

  • DON-Supported Research - Includes all research for which the Navy or Marine Corps provides:
    • personnel (including researchers or subjects), or
    • materiel (including nonpublic information used to identify or contact prospective subjects), or
    • property / facilities, or
    • funding, regardless of source (intramural or extramural)
  • Are You Engaged in Human Research?  Research that requires an Institutional Assurance - Decision Charts (Under Construction)
  • SOP for Requesting SECNAV Designee Status for Human Subjects Enrolled In Research Protocols

Guidance for Training and Education

Guidance for Navy Commands

  • Assurances - Do you need an Assurance?  What kind?
  • Key Command HRPP Responsibilities - Areas of research responsibility for command with its own IRB, command relying on another command's IRB, and command providing only IRB services to another command.
  • Research Protocol Documentation Table - Department of the Navy commands, through their investigators and Institutional Review Boards (IRB), must maintain adequate documentation of human subject research protocols and IRB records.  [32 CFR 219 and SECNAVINST 3900.39D]  This table lists which protocol-related documents need to be maintained by PIs and IRBs and which need to be sent to DON HRPP for headquarters-level administrative review.

Guidance for Extramural Performers