Submitting an Application
1. I developed my own research protocol and it is not funded by an outside party. Do I still need permission from the IRB before I conduct my research?
As required by law, the University of Hawaii follow government regulations on the protection of research subjects. These regulations apply to all research performed by UH faculty, staff or students or that meets the requirement for engagement of UH as a research institution. For help in determining whether your research requires IRB approval and oversight, and to determine the level of review, see the Resources page for more information.
By UH policy, masters theses and doctral dissertations that involve human subjects or use private identifiable information about living humans require IRB approval before research activities can be initiated. Graduate students who are unsure whether their project would be deemed human subjects research may inquire with the Human Studies Program Office for guidance. Documentation of approval by an IRB, or the Human Studies Program office is necessary to fulfill the paperwork required by the Office of Graduate Education to register for the thesis or dissertation courses (700 or 800 series) where the student indicates on Form II that Institutional Review Board (RB) approval may be required.
Other graduate-level work and most undergraduate activities performed to meet class requirements typically do not require IRB approval. However, if the research will be published or presented in a public forum, the study will require prior approval. Again, students should contact the Human Studies Program if unsure whether the activities would be considered human subjects research.
In general, researchers who have no formal affiliation with UH cannot submit applcations to the Human Studies Program or a UH IRB. If a UH-affiliated researcher is included on the study as a co-investigator, the Human Studies Program is likely to agree to review the research project. In this case, the UH-affiliated investigator (administrative Principal Inevestigator) will be the contact person with the UH IRB.
UH has formal agreements in place with a few unaffiliated institutions, under which research that does not involve UH can be reviewed by a UH IRB. See the Institutional Review Board page (https://manoa.hawaii.edu/researchcompliance/institutional-review-board-irb-0) for more information.
4. I am affiliated with UH, but my research project requires approval by another institution's IRB. Do I also need approval by the UH IRB?
For most research, yes, UH affiliated researchers need IRB approval from UH, as well as any other involved institutions. In limited circumstances, UH will accept human subjects approval and oversight by a non-UH IRB. For example, UH has an agreement with The Queen's Medical Center IRB intended to eliminate duplicate IRB review of must research projects. See the Institutional Review Board page (https://manoa.hawaii.edu/researchcompliance/institutional-review-board-irb-0) for more information about our existing agreements. Contact the Human Studies Program Director for more details.
Yes, there are two types of human subjects research: Exempt and Non-Exempt. These categories are defined by federal regulations. Both exempt and non-exempt research must be reviewed by the UH Human Studies Program. Exempt research is considered to be low risk and is subject to fewer requirements. There is an application for approval of exempt research on this website. Completing this application will help you determine whether your research qualifies as exempt.
Application forms and guidance provide include step-by-step instructions to help UH researchers apply for IRB approval. The HSP Investigator's Handbook provides addition details on how to apply for approval of research involving human participants.
7. My research involves no risk to human participants. Why does IRB approval need to be renewed every year?
All human subjects research potentially involves some risk to study participants. Even low risk studies involving innocuous surveys, for example, present a time burden to participants. Research involving record review presents the potential for loss of privacy. If your research qualifies as exempt, it does not require continuing review on a regular basis. However, if your research is non-exempt, requiring expedited or full IRB review, federal regulations require continuing review and re-approval at least annually at a schedule to be determined by the IRB. You must apply for continuing review, using the appropriate application form found HERE.
If your IRB approval expires, you must stop all study activities until you have received written documentation from the Human Studies Program that your project has been reapproved.
This depends on a number of factors, most importantly, the quality of the application and its attachments (e.g., consent forms, questionnaires, etc.).
In general, the turnaround time from start of review to decision is as follow:
- Exempt (2-3 weeks)
- Expedited (3-4 weeks)
- Full-Board (4-8 weeks)
Take note, that turnaround time may be longer during busy months (October-November, March-April) when the Human Studies Program receives higher volume of applications.
Yes, you can access the most current one HERE. The calendar also provides the deadline dates for submitting applications for full-board review.
Changes to IRB-approved research must have prior written approval by the IRB before implementation. This is federal law. For information on how to apply for approval to modify a research prject, see the Investigator's Handbook. You can also refer to the Human Studies Program SOP 103: Submitting Modification Requests to the IRB.
The Human Studies Program has training requirements for investigators and IRB members. For more information, see the "Get Training" section.
This will depend on a number of factors. Here are a few examples:
- Research to be performed in a Hawaii Department of Education (HIDOE) school or office requires prior approval by the State Superintendent. Check the HIDOE website at http://apps.hidoe.k12.hi.us/research for more information, application, and instructions.
- Research involving recombinant DNA requires review by the UH Institutional Biosafety Committee (IBC). For more information, check their website at https://manoa.hawaii.edu/researchcompliance/biological-safety.
- Research involving University of Hawaii institutional data requires review by the UH Data Governance Program. For more information, see http://www.hawaii.edu/uhdatagov/.
- If your research will be performed, in whole or in part, by a non-UH institution (e.g., a local hospital or other facility), you may need to apply for IRB approval by UH and at the other institution.
You can submit an email inquiry through https://manoa.hawaii.edu/researchcompliance/contact or call the Human Studies Program office directly at 808.956-5007. You can also visit the Human Studies Program office at the UH Manoa campus in the Sinclair Library, 2425 Campus Road, Sinclair 10.
- eProtocol™ is web-based software that promotes and facilitates protection of human research participants.
- eProtocol™ helps assure compliance with federal regulations for human research protections.
- eProtocol™ is used by researchers, management staff, technical teams, committee members, and reporting units.
- Intuitive, online interface with dynamic, question-based forms ("smart forms")
- Streamlined administrative processes (including the elimination of duplicative data entry for common compliance processes)
- Ability to modify and edit drafts, pause form completion and continue later
- Forms that can be completed by someone other than the form signatory
- Reporting and email notification features
Beginning April 15, 2016 all UH-affiliates will be able to access eProtocol. Non-UH affiliates will need to obtain a UH username and password to access the system.
At system launch (April 15, 2016), only new applications will be processed using eProtocol™. Active protocols initiated prior to the launch will continue to be processed using the existing submission mechanisms.
- Pick an internet browser (e.g., Safari, Firefox, Internet Explorer)
- Adjust that browser’s settings to allow popups
- Go to the URL https://uhmanoa.keyusa.net/
- Use your UH email username/password to log on
View the educational videos at: https://www.hawaii.edu/researchcompliance/eprotocol-learning-videos
For help navigating the IRB eProtocol™ application and submission process, contact the UH ORC Human Studies Program