Contact Information

Human Research Protections Program Office

Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Room A2051
Bethesda, MD 20814
Phone: (301) 295-9534

Frequently Asked Questions

How will I know if my research project requires IRB review?

IRB review is required if you are engaged in human subjects research. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information about the subjects of the research. (32 CFR § 219.102 (f))

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (32 CFR § 219.102(d))

Please note that obtaining consent from individuals to participate as human subjects for a research study even if there is no data being collected is still considered ”engaged “ in human subjects research. Please use the Human Research Decision Charts and refer to the OHRP Guidance link for additional information. The official determination will be made by the Exemption Determination Official (EDO).

What are the steps to have my research project reviewed and approved by the IRB?

  1. Determine if your research study involves human subjects. Refer to the Human Research Decision Charts for guidance or consult with the HRPPO for guidance and/or concurrence.
  2. Take the HRPP Training if your study involves human subjects.
  3. Determine if your research involves greater than minimal risk or if your study poses only minimal risk to human subjects.
    • Greater than minimal risk – requires full board review
    • Minimal risk - May be exempt from the requirements of IRB review or it may be reviewed via expedited/administrative review procedures.
  4. Register and submit your study in IRBNet for exempt and non-exempt studies.

What does "minimal risk" mean?

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (32 CFR § 219.102(i))

If my study received IRB approval from another DoD IRB, how do I obtain a second level review at USU?

For projects that USU conducts a *second level review, you will need to "share" this project in IRBNet and submit to USU using the multi-site function. Instructions on how to convert this to a multi-site study. Once setup as a multi-site study, please make certain the project contains the following documents:

  1. DMRN cover page
  2. Approved 3208 assurance document (must be signed by the Office of Research)
  3. 3204 IRB protocol form (only page 1 AND the following sections: 1, and 8 through 11)
  4. Approved grant
  5. Researcher Responsibility forms

*This applies only to projects in which there is an existing DoD Institutional Review Board Agreement for IRB Review (IAIR).

How does the USU IRB/HRPP office work with the other research offices at USU?

The USU IRB/HRPP and the USU Office of Research are operationally independent with separate functions. The IRB/HRPP is mainly responsible for the ethical and regulatory review of the research. Human research projects should only be submitted for IRB review once the PI has received approval and recommendation for IRB review from the Office of Research including a fully signed USU Form 3208 or 3202.

How do I proceed with my Multisite Project?

Consult with the HRPPO staff early in the planning stages because there might already be a DoD Institutional Agreement for IRB Review (IAIR) in place with some sites that are not organizationally or legally part of USU. Sites engaged in human subject research must have a Human Research Protections Program and a federal wide assurance and/or a DoD Assurance of Compliance.

Does my QA/PI project require IRB approval?

Quality Assurance and Research both involve a systematic approach in data collection and analysis. The main difference is in how the results will be used. Quality Assurance, also referred to as "quality improvement," refer to activities that use the results for the improvement of current practices or to determine best practice for implementation at the local level. This type of activity does not require IRB review. IRB approval is required for research that results in generalizable knowledge aimed at changing current common perceptions or adding new knowledge across a wider population other than for internal use only. Research-related activities must be reviewed by the IRB to assess the risk to participants.