Forms & Templates

Checklists/Forms

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).

Protocol Templates

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-503SBER: SBER Protocol template
  • HRP-503DATA: Chart Review Data + Specimens Protocol template
  • HRP-503NHR: Non-Human or Non-Research Protocol template
  • HRP-503RLY: Relying Institution Protocol template
  • HRP-503SUPP: Supplement for Biomedical Clinical Sponsored Protocols template

Download the protocol templates from the SpartalRB Library under the Templates tab (login required)

Recruitment

“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.

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.

Templates for Consent Documents

Download the consent and assent templates from 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.

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