The Human Studies Program is the department established by the University of Hawaii (UH) that is responsible for the federally-mandated program that ensures UH compliance with government regulations and institutional policies written to protect the safety, welfare and rights of human subjects who participate in research. The Human Studies Program is administratively placed within the UH Office of Research Compliance, a component of the Office of the Vice Chancellor for Research and Graduate Education at UH Manoa. Despite its placement on the Manoa campus, the Human Studies Program has authority to review, approve and oversee human subjects research on all UH campuses, including the community colleges.

Research subject to approval and oversight by the Human Studies Program includes studies performed by UH faculty, staff or students and/or using UH facilities or other resources (e.g., data). Both funded and unfunded research may require Human Subjects Program review and oversight. This website provides information to help you decide if your research requires review by the Human Studies Program and how to work with the IRB.

There are three levels of human subjects review, all of which are determined by federal regulation.

• Some human subjects research qualifies as exempt from IRB approval and from most of the federal human subjects regulations. Exempt research does require approval by the Human Studies Program.

• Human subjects research that does not qualify as exempt (meaning it is non-exempt ) may qualify for review under an expedited review procedure. The Human Studies Program staff determines whether an application will be reviewed under an expedited procedure.

• Non-exempt research that does not qualify for expedited review requires review and approval by the convened IRB at a scheduled meeting with a quorum present. This level of review is often referred to as full IRB review .

An IRB is a formally-established compliance committee that is mandated and governed by federal regulations and institutional policies. Its purpose is to review and provide initial and continuing approval and ongoing oversight to research involving human subjects. Three Institutional Review Board(s) currently operate under the authority of the UH Human Studies Program.

• The Biomedical IRB reviews, approves, and provides continuing oversight to clinical research protocols and related research projects, including clinical trials that evaluate investigational drugs and devices or medical procedures.

• The Social and Behavioral Sciences IRB reviews, approves, and provides continuing oversight to research protocols in the fields of psychological, education, sociology, etc. or that involve behavioral interventions.

• The Cooperative IRB reviews, approves, and provides continuing oversight to federally-funded research that is performed by two or more members of a cooperative of local institutions. Members of the cooperative include the University of Hawaii, The Queen’s Medical Center, Hawaii Pacific Health, and Castle Medical Center.

If you have questions about these review processes, contact the Human Studies Program by phone at 808.956.5007 or by email at uhirb@hawaii.edu