What is the IRB and its purpose?
The Institutional Review Board (IRB) is a group of scientists, engineers and non-scientists, appointed by the Superintendent, that protect the rights and welfare of human subjects. The IRB reviews and recommends approval for all human subject research at USNA. The Superintendent is the Institutional Official and must approve research with human subjects at USNA. Research that has been reviewed by the IRB and approved by the Superintendent is subject to continuing IRB review and must be reevaluated at least annually, or more frequently if specified by the IRB.
What is research?
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Research projects ask a question, state a method to seek an answer or solution, recruit subjects, and share the results with the public. Research can take the form of a project, pilot study, experiment, survey, evaluation, development study, clinical study, investigation, questionnaire, focus group, etc.
What if I'm not sure if my project is research with human subjects?
Please contact the HRPP Office to determine if you need to get IRB approval or a Determination of Non Research.
Who must apply for human subjects research review?
Anyone who intends to conduct research that involves people or private identifiable information about them must apply for and receive IRB approval before beginning any research.
I'm not applying for funding for my research. Do I still have to go through the HRPP Office?
Yes. Any research involving human subjects must be submitted to the HRPP Office whether or not there is funding. Review for the protection of human subjects is necessary regardless of the funding source.
Are end of course evaluations research?
Course evaluations are not considered research for the purposes of applying the Code of Federal Regulations (32 CFR 219) and you are not required to submit a protocol for review to the USNA IRB. The submission which involves voluntary course evaluation by midshipmen is for the purposes of internal evaluation and program development. This does not constitute a systematic evaluation for the purpose of creating “generalizable knowledge” and therefore does not meet the definition of research as given at 32 CFR 219. As such there is no need to submit your proposal for IRB review. Please see the IRB before giving evaluations if you already know that you may want to publish/externally or present results.
What are the different types of IRB review?
There are three main types of IRB review:
- Exempt Review: minimal risk or less than minimal risk studies that fit into one of the exempt categories of research are reviewed by the IRB Chair. ("Exempt" does not mean the protocol is exempt from IRB review.)
- Expedited Review: minimal risk studies that meet one of the expedited categories of research are reviewed by the IRB Chair.
- Full Board Review: greater than minimal risk studies are reviewed by a fully-convened IRB.
The IRB can also do an official determination of “non-research” usually for internal assessment purposes.
Where do I send my continuing review/final report, amendment/modification forms and what happens after I turn in my forms?
The forms are found on the HRPP Website. Forms can also be emailed to you upon request from the HRPP Office. Completed forms can be signed electronically and emailed to us at HRPPOffice@usna.edu or hardcopy’s can be dropped off at the HRPP Office, room G10 ground floor of Nimitz Library. Once the forms are submitted, it is routed for review. Investigators are notified as soon as possible, via email, of the Superintendents approval or if any changes are required by the IRB.
How long does review and IRB approval take?
Please note: You may not begin your research until you have received full approval from the Superintendent.
Exempt or Expedited protocols take about two to three weeks for review. The review process for protocols submitted for Full Board Review can take up to a month or longer to complete. You should always include adequate time in your research plan to allow for any IRB-required changes to the research protocol.
Do I need any special training for research involving human subjects?
Yes. The Department of Navy requires training for anyone involved with human subject research. This would include persons who have direct and substantive involvement in proposing, performing, reviewing, analyzing, or reporting research and includes midshipmen if they are conducting research.
The CITI training will satisfy this training requirement. Certificates are issued at the completion of the training. Please contact our office for more details on what courses are required.
Can I offer Midshipmen incentive to participate in a research study?
Midshipmen cannot receive cash payments. With Superintendent approval, rewards such as Mid Store/gift cards, extra credit, time off, etc. can be authorized under specific conditions.
What is the USNA Human Subjects Institutional Assurance Number?
Assurance Number: DOD N-40052
Expiration Date: 30 June 2019
I still have questions. Who can help?
E-mail or call the HRPP Office at (410) 293-2513 or HRPPOffice@usna.edu for assistance.