HRPP Review Process
Submit the following information for HRPO Review to: usarmy.apg.devcom.mbx.arl-irb-office@army.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.