HRPO Frequently Asked Questions (FAQs)

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 (CCDC ARL Form 401)
  • Scope of work (sometimes called the task order, grant, or agreement)
  • Current CV or Biosketch for principal investigator (PI)
  • Documentation of current human subjects training for PI
  • All documents submitted to the external IRB for review
  • Determination letter from the external IRB/HRPP
  • Copies of any stamped approved documents

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

  • HRPO Submission Form (CCDC ARL HRPP Form 401)
  • Scope of Work (task order/contract, grant, or agreement information)
  • Assurance and reliance agreement information
  • All documents submitted to the external IRB for review:
    • Protocol
    • Instruments and questionnaires
    • Submission cover sheet
  • Documentation of Scientific Review
  • Current CV or Biosketch for principal investigator (PI)
  • Documentation of current human subjects training for PI
  • IRB approval letter
  • IRB approved consent form, if applicable
  • Recruitment materials, if applicable
  • Equipment information, if applicable
  • Command approval, if applicable. Command approval is required when Soldiers are the target subject population.

Amendments

  • All documents submitted to the external IRB for amendment review
  • Final version of all documents, including new consent forms and study instruments
  • IRB approval of amendment letter

Prompt Reportable Events

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

Continuing Review

  • All documents submitted to the external IRB for continuing review
  • Continuing Review Approval letter

Closure

  • All documents submitted to the external IRB for closure review
  • IRB acknowledgement of closure letter

FAQs

What is an Assurance?
An assurance is common terminology for a "Federalwide Assurance (FWA)" which is obtained through HHS OHRP. Any institution receiving federal funds for research with humans must obtain/maintain an FWA.
What is an IRB Reliance Agreement?
It is an agreement between engaged institutions for the single IRB review for a research study. The agreement is made between the institutions for one or more institutions to cede review to another institution that is not organizationally or legally part of the institution. DoD calls these agreements Institutional Agreement for Institutional Review Board (IRB) Review (IAIR).

If you have further questions contact your program manager or the ARL HRPP office at: usarmy.apg.ccdc.mbx.arl-irb-office@mail.mil.
What does it mean "Documentation of Scientific Review"?
Documentation of Scientific Review means the project must be reviewed for scientific merit by independent subject matter expert(s).
Three possible ways this can be done are:

1) Scientific review is incorporated into the IRB process and documented in IRB approval letter.
2) SOP from the reviewing institution detailing the scientific review process.
3) Completion of the ARL scientific review form by an independent subject matter expert.

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), and subcategory (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.
 

Last Update / Reviewed: September 23, 2019