Forms & Templates
New Protocol Submission review requests, including Human Research Determinations, Exemptions, HUDs and Emergency Use requests must be submitted for review in the SpartaIRB System (https://spartairb.case.edu).
In SpartaIRB, much of the information about your study will be submitted to the IRB in a protocol template document that is a Microsoft Word file. When submitting in SpartaIRB, the use of one of these templates is REQUIRED.
Please use these documents to prepare your study for submission to the UH IRB.
- HRP-503BIO: Biomedical Protocol template
- HRP-503DATA: Chart Review Data + Specimens Protocol template
- HRP-503NHR: Non-Human or Non-Research Protocol template
- HRP-503SUPP: Supplemental Form
The protocol templates can be found on the SpartalRB Library under the Templates tab (login required).
“Becoming a Research Volunteer” Brochure: This brochure, created by the Office of Human Research Protection (OHRP), explains what research is. It is recommended that this brochure is given to potential participants.
When using email or letters as part of your recruitment plan, use of the respective “Form, Templates and Tutorial” below is REQUIRED.
The form templates can be found on the SpartalRB Library under the Templates tab (login required).
Waiver of Hipaa Authorization Form
Under the federal HIPAA privacy rule, research use or disclosure of an individual’s protected health information (PHI) requires the individual’s authorization unless the IRB determines the use or disclosure qualifies for a waiver. If requesting to waive HIPAA Authorization the completion of the “Request for Waiver of HIPAA Authorization Form” is REQUIRED.
The form can be found on the SpartalRB Library under the Templates tab (login required).
Templates for Consent Documents
- HRP-506ASSENTUH – TEMPLATE – UH Assent
- HRP-506BIO – TEMPLATE- UH BIO Consent Template
- Please note this is a new/revised version of our consent tutorial. We have updated this template to include the changes to the common rule.
- HRP-506CANCER – TEMPLATE – UH Cancer Informed Consent Document Template
The consent and assent templates can be found on the SpartaIRB Library under the Templates tab (login required).
Adverse Event Reporting Forms and Information
Please refer to the Investigator Manual for IRB Submissions for reporting requirements.