Frequently Asked Questions

Questions:

I developed my own research protocol and it is not funded by an outside party. Do I need permission of the IRB to perform it?

As required by law, the University of Hawaii follows government regulations on the protection of research subjects. These regulations apply to all research performed by UH faculty, staff or students or that uses UH facilities or resources (e.g., data, etc.). For help in determining whether your research requires IRB approval and oversight, and to determine the level of review, see the Review Categories section of this website.

Does research conducted by UH students require IRB approval?

By UH policy, master’s theses and doctoral dissertations that involve human subjects or use private identifiable information about living humans require IRB approval before research activities can be initiated.

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. For more information, see the Review Categories section of this website. If you still have questions about whether your project requires IRB approval, contact the Human Studies Program staff.

Can researchers who have no formal affiliation with UH submit applications to a UH IRB?

In general, researchers who have no formal affiliation with UH cannot submit applications 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 will be the contact person with the UH IRB.

UH has a formal agreement in place with a few unaffiliated institutions, under which research that does not involve UH can be reviewed by a UH IRB.

If am affiliated with UH, but my research project requires approval by another institution’s IRB. Do I also need approval by the UH IRB?

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 most research projects. There are other such agreements in place. If you have a question about this, contact the Human Studies Program Director.

Isn’t some research “exempt” from IRB approval?

Yes, there are two types of human subjects research: Exempt and Non-Exempt. These categories are defined by federal regulation. 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 a special application for approval of exempt research on this website. Completing this application will help you determine whether your study qualifies as exempt. For more information, see the Review Categories section of this website.

How do I apply for approval of my research project?

The Human Studies Program has developed application forms and guidance to help UH researchers apply for IRB approval. For more information, see the How to Apply for IRB Approval and the Forms and Documents sections of this website.

My research involves no risk to human subjects. Why does IRB approval need to be renewed  every year?

All human subjects research potentially involves some risk to study participants. 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. All IRB forms are posted on this website in the Forms and Documents section. 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.

How long will it take for the IRB to approve my study?

This depends on a number of factors, most importantly, the quality of the application and its attachments (e.g., consent forms, questionnaires, etc.). For more information, see the How to Apply for IRB Approval (Review Timelines) section of this website. There is other information on this website that will help you to develop a successful IRB application.

Is there a calendar listing IRB meetings?

Yes. You can access it here.

What if I want to change my study after the IRB has approved it?

Changes to IRB-approved research must have prior written approval by the IRB. This is federal law. For information on how to apply for approval to modify a research project, see the Requests for IRB Approval of a Study Modification section of this website. Also refer to Human Studies Program SOPP 103, Submitting Modification Requests to the IRB.

Are there special training requirements for conducting human subjects research at UH?

The UH Human Studies Program has training requirements for investigators and IRB members. For more information, see the Training Resources and Requirements section of this website.

Are approvals needed by departments other than the Human Studies Program?

This will depend on a number of factors. Here are a few examples:

How do I Contact the Human Studies Program?

You can submit an email inquiry to uhirb@hawaii.edu/irb or call the Human Studies Program office at 808.956.5007. Or you can stop by the Human Studies Program office on the UH Manoa campus at Biomed B-104.