Forms

Preparatory to Research

Submission Requirements

• Submission Requirements
• New Study Approval Process (Flow Chart) (PDF, 93KB)
• Oncology New Study Submission Checklist (Word, 35KB)
• Next Steps After a Study is Approved (Flow Chart) (PDF, 83KB)

Initial Review

• New Project Application (Word, 307KB)
• Exempt Research and Not Human Subjects Research Determination Form (Word, 399KB)
• Additional Signatures Page (Word, 17KB)
• Permission for Emergency Use of Test Article, Biologic, Device (PDF, 2053KB)
• Request for Creation of a Specimen Repository (Word, 66KB)
• Not Human Subjects Research IRB Submission Form (PDF, 188KB)

Sample Protocol Templates

• A3 Quality Project Template (Word, 78KB) – for quality improvement projects only.
• Clinical Trail Protocol Template (Word, 700KB)
• Minimal Risk Protocol Template (Word, 153KB)

Consent Waivers

• Waiver of Informed Consent (Word, 96KB)

Templates

• Informed Consent Template – Medical – Michigan AA (Word, 165KB) For drug, device, investigational treatment research
• Trinity Health Michigan Minimal Risk Consent (Word, 54KB)
• Children's Assent (Female) (Word, 34KB)
• Short Form Consent - English (PDF, 12KB)
• Short Form Consent - Romanian (PDF, 64KB)
• Short Form Consent - Spanish (PDF, 12KB)
• Short Form Consent - Arabic (PDF, 100KB)
• Short Form Consent - Russian (PDF, 107KB)
• Short Form Consent - Somali (PDF, 132KB)
• Short Form Consent - Burmese (PDF, 237KB)
• Short Form Consent - Bosnian (PDF, 161KB)
• Short Form Consent - Chinese (PDF, 254KB)
• HIPAA authorization - Spanish (PDF 137KB)
• Addendum to the Consent for All Participants (Word, 22KB)

HIPAA

• Waiver or Alteration of HIPAA (Word, 251KB)

Conflict of Interest

• Significant Financial Interest Disclosure Form (PDF, 356KB)
• Conflict Avoidance Statement (Word, 49KB)

Adverse Events and Unexpected Problems

• Internal AE and UP Reporting Form (Word, 166KB)
• Chart for Reporting AE and Ups to the IRB (PDF, 43KB)
• Flow Chart- AE and UP reporting (PDF, 425KB)

Deviations

• Sample Deviation Tracking and Reporting Template (Word, 35KB)

Amendments to Research

• Revisions to Research (Word, 137KB)
• Change in Research Team (Word, 131KB)

Continuing the Research

• Continuing Review Form (Word, 268KB)

Closing the Research

• Study Close-Out Form (Word, 76KB)