HRPP Submission 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 and Informed Consent Documents 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.
- Informed Consent Document: must include language stating the study sponsor is the Department of Defense. It must also include language stating the Department of Defense or Federal Representatives may access research records for the protection of human subjects.
- Misc. determinations, such as waiver of documentation of consent must be explicitly included in the IRB approval letter.