Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, MD 20814
Phone: (301) 295-9534
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).
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))
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:
*This applies only to projects in which there is an existing DoD Institutional Review Board Agreement for IRB Review (IAIR).
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.
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.
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.