THAA Informed Consent Form (ICF) Template

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1

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THAA ICF Template.doc (156.5 KB)

Purpose

  • Provides required language and structure for obtaining informed consent for research at Trinity Health Ann Arbor.
  • Includes HIPAA authorization for use/disclosure of Protected Health Information (PHI).

Main Sections

  1. Header Information

    • Study Title, Study Number, PI, Sponsor, NCT Number.

  2. Introduction

    • Voluntary participation, rights, and general principles.

  3. Study Details

    • Purpose of the study.
    • Why the participant is eligible.
    • What participation involves (procedures, randomization, duration).

  4. Risks and Discomforts

    • Categorized by frequency and severity.
    • Includes pregnancy precautions if applicable.

  5. Benefits

    • Possible personal and societal benefits.

  6. Alternatives

    • Options if participant declines.

  7. Rights and Responsibilities

    • Withdrawal, new information, incidental findings.

  8. Compensation and Costs

    • Payment details and potential costs.

  9. Special Considerations

    • Genetic testing, GINA protections.
    • HIV, substance use, mental health disclosures.

  10. Confidentiality

    • Who will access records, PHI handling, legal reporting obligations.

  11. Injury and Emergency

    • Care for research-related injuries and reporting.

  12. Withdrawal and Removal

    • Conditions for participant or investigator-initiated withdrawal.

  13. Financial Conflict of Interest

    • Disclosure of PI’s financial ties.

  14. Contacts

    • PI, study coordinator, IRB contact info.

  15. Optional Sections

    • Companion studies (e.g., Quality of Life, Tissue Use).
    • Future contact for research.

  16. HIPAA Authorization

    • Details on PHI use/disclosure, expiration, participant rights.