University of Hawai‘i
Research Compliance

About Human Studies

Mandatory changes must be made to the Informed Consent Form for all new studies approved on or after January 21, 2019! Please click here for information on several important changes to the federal regulations governing human research, known as the Common Rule. Among these changes are improvements to the informed consent process, resulting in revisions to the UH Model consent forms.

Final Revisions to the Common Rule

What is the Human Studies Program?

The Human Research Protection Program (HRPP) is an institutional-wide program administered by the UH Human Studies Program (HSP) under the Office of Research Compliance. The HSP works together with the UH research community to ensure the health, welfare, rights, and dignity of people who participate in UH research. The HSP provides guidance and administrative support to its three UH Institutional Review Boards.

UH Institutional Review Boards (IRBs)

As part of the HRPP, the primary goal of the UH IRBs is to protect the rights and welfare of individuals recruited to participate in research activities conducted under the auspices of the University of Hawai‘i.

Researcher Responsibilities

As a UH investigator or research staff working on a human research study, you are expected to follow the federal, state, and university policies regarding the protection of research participants. The Investigator’s Handbook will help guide you through the policies and procedures related to the ethical conduct of human research.

HSP Program Information

The UH HRPP is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Grant application information:
The UH HRPP has filed an Assurance with the U.S. Health and Human Services (HHS) Office of Human Research Protections (OHRP). Assurance number FWA3526. Expiration date: February 2, 2022

HSP Updates

Now Available: 2020 IRB Meeting and Deadline Calendar

Revised Common Rule Update: Posting Clinical Trial Consent Forms
Federal websites have been identified that will satisfy the revised Common Rule (also known as the “2018 Rule”) requirement to publicly post clinical trial consent forms (45 CFR 46.116(h)). More information may be found here.

UH Receives Human Research Protection Accreditation
The University of Hawaiʻi is now recognized as a top research institution that follows rigorous standards for ethics, quality and protections while conducting human research—and becomes the first research organization in the state to be awarded this highly regarded status.