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Consent Templates and Resources

Listed below are several resources to assist you in composing and documenting informed consent for your research study.

If you are using consent template other than ones provided below (i.e., provided by an external sponsor or department), ensure all institutionally required language is inserted. This language can be found in the USA Local Context Language document.

Consent Templates

While these templates are not strictly required by the USA IRB, utilizing them offers several significant advantages:

  • Ensure Compliance: They provide a solid structure that guarantees all federal and institutional required elements are included.
  • Improve Clarity: The templates include specific guidance and suggestions to help you write consents that ensure participant understanding.
  • Speed Up Approval: Using these standardized forms can help reduce the time spent on revisions, ultimately speeding up the IRB approval process.
  1. Biomedical Research Consent Template
  2. Social, Behavioral, and Education Research (SBER) Consent Template
  3. Assent Template, for children ages 7-11
  4. Assent Template
  5. Information Sheet Template

Consent Documentation

Beyond simply obtaining a signature on the consent form, best practices dictate that you must conduct an appropriate consent process. The following templates are available to assist with following and documenting a structured, compliant consent process. These should be adapted to fit your specific research needs. 

  1. Consent Process Checklist
  2. Biomedical Consent Process Documentation 
  3. Biomedical Consent Assent Process Documentation
  4. Participant Comprehension Assessment

Additional Consent Resources

  1. Readability Toolkit
  2. 18 PHI Identifiers
  3. Informed Consent Form Element Checklist