Definition of Human Subjects Research
The proposed activities must involve both:
- A systematic investigation designed to develop or contribute to generalizable knowledge.
- A collection of information (e.g., Personal Identifiable Information or Personal Health Information) or biospecimens through intervention or interaction from a living individual.
Examples of human subjects research:
- Activities falling into the exempt categories under the Common Rule (32 CFR 219.104(d))
- Off label drug or device testing
- Involving protected populations such as children
- Using invasive tools or techniques to collect data and biospecimens
Examples of activities that do not qualify as human subjects research:
- Health surveillance for the purpose of diagnosis, treatment, or prevention of injury and disease (public health surveillance)
- Medical activities for the purpose of diagnosis, cure, mitigation, treatment, or prevention of disease
- Medical quality assurance
- Operational testing and evaluation (quality assurance, process improvement, evidence-based practice)
- Assessment of compliance in programs such as occupational drug testing, occupational health and safety reviews, network monitoring, and protection of classified information
- Program evaluation and surveys to assess the performance of DOD programs
Approval of Research Activities
No research activities should start before receiving a comprehensive review and approval or concurrence. Appropriate review and documentation can be obtained from a HRPP office, IRB, or Exemption Determination Official. Failing to do so can result in confiscation of data and loss of DOD privileges. Reach out to the local HRPP office for assistance with obtaining a review. For more information on the nearest office, email DHA.HRPP@health.mil.
Protocols involving the use of DHA data, may need to obtain a formal agreement with DHA for the sharing and use of those data elements. The DHA Privacy and Civil Liberties Office manages the DHA Data Sharing Agreement program. Visit the PCLO website for contact information and processing details.
If your protocol intends to survey DOD affiliated personnel, it may require review and approval from an Information Management Control Officer. Visit the Information Collections website for contact information and processing details.
A collaboration agreement may be required when transferring intellectual properties between facilities. Contact the institution's Office of Technology Transfer or Legal Department for assistance. The process for collaborative agreements runs parallel with IRB approval process. Do not wait for the IRB to complete their review to contact T2 or Legal.
For information about additional reviews that may be required and resources to facilitate your research, visit the DHA Research Resources website.
Reviews conducted by non-DOD IRBs
The DOD may support research reviewed by a non-DOD IRB. Best practice is to establish communication between the DOD Institution(s) involved and the non-DOD IRB during the project’s design phase, since the appropriate agreement must be put in place. This can prevent delays.
Before the research can begin, the principal investigator must secure DOD concurrence with the non-DOD IRB approval. A Human Research Protections Official review will meet this requirement (DFARS). Contact the nearest HRPP office for assistance with transfer of IRB oversight and securing DOD concurrence.
Prepare for DOD Review
The DHA ORP and HRPPs utilize the Electronic Institutional Review Board. Account requests can be submitted by contacting the Global Service Center. The request form must include the name of the command or institution the user supports. This is to affiliate the appropriate review workflow to the user’s profile. Most often the command or institution name is the same as the user’s physical duty location. Also required on the request form is a copy of the user’s DOD Cyber Awareness training. For troubleshooting or reporting issues with EIRB, contact the GSC.
Material for EIRB use and tips can be found after logging into EIRB. Look for the Resource Center (? Help) in the top right corner of the screen. For more in-depth guidance, contact the local HRPP office.
This program is hosted on a DOD server, so a Common Access Card or External Certification Authority is required. Individuals without any DOD credentials must contact a third party that grants certificates for EIRB use. The DHA ORP has no affiliation with these third parties and therefore researchers must obtain the certificate to access EIRB on their own. For more information on obtaining an ECA, visit the IDEAS page.