Forms and Documents

The following provides a checklist, tips, forms and template documents for PPHS:

E-Submission Checklist

  • HRP-430 Checklist—Investigator QI Assessment
    The HRP-430 Checklist covers what must be stored in the regulatory (study) binder, study records, PI responsibilities when holding an IND or IDE, and other requirements that must be met for each study.

HRP forms are not required for Ideate submissions.

This form accompanies changes to add personnel or to the Appendices. The Principal Investigator must sign the form. The Department Chair or designee must sign the attestation on modifications that include the addition of study personnel. If personnel are being added from multiple departments, the chairs of each department involved in the research must sign.

Below are standalone sections of Form HRP-211: These can be used if multiple of same sections of the Application for Human Research form are needed (e.g. multiple "drug/biologic" Appendix B):

For Forms and Templates related to relying on an external IRB, please visit the Request to Rely (R2R) page.

All applications submitted to for IRB review require a Protocol Template. Please refer to the Template Protocol with Instructions (HRP-503) in order to see what information the IRB needs in order to evaluate each section. You can use this for your Template and delete the instructions as you go or use this as a reference document and type directly into HRP-503a, which contains only section headings without detailed instructions.

The template you will use depends on how your submission will be made to the PPHS. Our electronic submission system, Ideate, is in use for all new submissions and requires use of the Ideate template versions below.

Ideate Consent Templates

***The new consent template incorporates new elements of consent required under the Revised Common Rule, which goes into effect on January 21, 2019. All new projects must utilize the new template. The new template has been revised and reorganized, so please start from stratch with this document rather than trying to cut and paste whole sections from old templates.***

Additional template versions (additional translations) will be forthcoming. If you need a specific version, or a copy of the old template, please contact the IRB Office directly at

Spanish Templates:

PROJECTS APPROVED PRIOR TO JANUARY 21, 2019 SHOULD NOT TRANSITION THE CONSENT FORMS TO THE NEW TEMPLATE. Because these projects were approved under the old rule and will continue to be reviewed under those regulations, they should remain on the old consent template.

ADULT EMERGENCY USE/TREATMENT CONSENT - this consent should not be used without prior authorization from the FDA and IDS.

For SOPS, Worksheets & Checklists IRB Uses to Make Determinations