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Human Research Protection Program (HRPP)

FAQs

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, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
What is Exempt research?

Exempt is a project that does not require further review after initial consideration by the IRB or its designated review body.  The "Exempt" status is granted based on criteria specified in the federal regulations.   Research that is categorized as exempt by the IRB review includes research that does not involve directly or indirectly human subjects or any data about human subjects. 

Unforeseeable risk includes "research involving the collection or study of existing data, documents, records, pathologic specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects [emphasis added]" (Title 45 Code of Federal Regulations, Part 46 Protection of Human Subjects}. Exempt Research involves human subjects where the only involvement of the human subjects in the research will be in one or more of the categories identified in section 32 CFR 2019 (b) or Section 4 of USNA Policies and Procedures.

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 2023

I still have questions. Who can help?

E-mail or call the HRPP Office at (410) 293-2513 or HRPPOffice@usna.edu for assistance.

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