HRPP Review Process

Submit the following information for HRPO Review to:

usarmy.apg.ccdc.mbx.arl-irb-office@mail.mil

Initial Review

If your study was determined to be Exempt, submit the following:

  • HRPO submission form
  • Scope of work (sometimes called the task order)
  • Current CV or Biosketch for principal investigator (PI)
  • All documents submitted to the external IRB for review
  • Determination letter from the external IRB

If your study was determined to be Non-exempt submit the following:

  • HRPO Submission Form
  • Scope of Work (task order/contract information)
  • Assurance and reliance agreement information
  • Protocol, including instruments, surveys
  • Protocol cover sheet
  • Documentation of Scientific Review
  • Current CV or Biosketch for principal investigator (PI)
  • Documentation of current human subjects training for PI
  • IRB approval
  • IRB approved consent form, if applicable
  • Recruitment materials, if applicable
  • Equipment information, if applicable
  • Command approval, if applicable

Amendments

  • Amendment Form
  • Final version of all documents, including new consent forms and study instruments
  • IRB approval of amendment

Prompt Reportable Events

  • Contact the ARL HRPO about the incident as soon as possible.
  • Report sent by the investigator to the IRB
  • Determination from the IRB

Continuing Review

  • Report sent by the investigator to the IRB
  • Continuing Review Approval letter

Closure

  • Report sent by the investigator to the IRB
  • IRB acknowledgement of closure letter


Things to keep in mind for the IRB Approval/Determination letters for submission:

  • Determination Letters: must include what the determination is and if it is exempt, the exemption category(ies) must be stated
  • Expedited Review: must include the risk level and expedited review category(ies)
  • Convened Board: must include if the study was determined to be no greater than minimal risk or greater than minimal risk. If greater than minimal risk, a research monitor must be assigned and the research monitor duties must be approved in writing by the IRB.
  • Misc. determinations, such as waiver of documentation of consent must be explicitly included in the IRB approval letter.