Policies, Procedures, and Guidance

About These Documents
Federal regulations require the Human Studies Program to have written policies and procedures that describe how it will comply with applicable laws. We are continually developing and updating these documents. In order to assist investigators and their staffs in understanding and complying with IRB requirements, we have also developed several guidance documents and forms.

Human Studies Program general policies and procedures as well as standard operating policies and procedures (SOPPs) addressing specific topics are posted on this page.

Form fillable application forms that have been created to implement these policies and procedures are posted on the Forms page of this website.

Standard Policies and Procedures
SOPP 101: Reporting and Reviewing Unanticipated Problems SOPP_101_UP_Reporting.pdf
SOPP 102: Avoiding IRB Member Conflicts of Interest SOPP_102.2_IRB_Member_Conflicts_of_Interest-1.pdf
SOPP 103: Submitting Modification Requests to the IRB SOPP_103.2_Submitting_Modification_Requests_to_the_IRB.pdf
SOPP 104: Reporting Protocol Violations to the IRB SOPP_104.3 Reporting Protocol Violations to the IRB.pdf
SOPP 105: IRB Approval of Research with Stipulations SOPP_105.2_IRB_Approval_with_Stipulations.pdf
SOPP 106: Performing Expedited Review of Human Subjects Research SOPP_106.1_Expedited_Review.pdf
SOPP 108: Reporting Ceded Research to the UH Human Studies Program SOPP_108_Reporting_Ceded_Research_to_the_Human_Studies_Program.pdf
Policy on Submitting Investigator Brochures to the IRB Policy on Submitting Investigator Brochures.pdf
Policy on Creating and Approving IRB Authorization Agreements IRB Authorization Agreement Procedures.pdf

Guidance
Required Training for Investigators and Key Personnel UH Investigator and Key Personnel Training Requirements 5-1-12.pdf
Guidelines for Developing an IRB Application Guidelines_for_Developing_an_IRB_Application.pdf
Guidelines for Consent Forms Consent_Form_Guidance.pdf
Guidelines for Recruitment Flyers Recruitment_Flyer_Guidelines.doc
Guidelines for Hawaii Dept. of Education Sites HIDOE_instructions.pdf
Guidelines for Developing a Clinical Research Protocol Guidelines for Developing a Clinical Research Protocol.pdf
Guidelines for Investigator Brochures
Single Patient Use of Investigational Drugs Guidelines for Single Patient Use Tutorial.pdf