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 102: Avoiding IRB Member Conflicts of Interest | |
| SOPP 103: Submitting Modification Requests to the IRB | |
| SOPP 104: Reporting Protocol Violations to the IRB | |
| SOPP 105: IRB Approval of Research with Stipulations | |
| SOPP 106: Performing Expedited Review of Human Subjects Research | |
| SOPP 108: Reporting Ceded Research to the UH Human Studies Program | |
| Policy on Submitting Investigator Brochures to the IRB | |
| Policy on Creating and Approving IRB Authorization Agreements | |
| Guidance | |
|---|---|
| Required Training for Investigators and Key Personnel | |
| Guidelines for Developing an IRB Application | |
| Guidelines for Consent Forms | |
| Guidelines for Recruitment Flyers | |
| Guidelines for Hawaii Dept. of Education Sites | |
| Guidelines for Developing a Clinical Research Protocol | |
| Guidelines for Investigator Brochures | |
| Single Patient Use of Investigational Drugs | |