Consent, Assent, and Screening Templates

Minimal Risk Research Consent Templates (Expedited or Exempt)

These templates are appropriate for social, behavioral, and educational ("SBER") research that does not include any biomedical procedures.

• Study Information Sheet (no signature)
• Consent Form (includes signature)
• Consent Form for Federally Funded Research
• Parent Permission Form (parents provide permission for child to participate)
• Parent Consent Form (parents complete research procedures themselves)
• Oral Consent Script Outline
• Sample Debriefing Script

Biomedical Research Informed Consent Templates

• Biomedical Research Consent Template
• Consent Template for Expanded Access Research
• Right to Try Consent Template
• Humanitarian Use Device Consent Template

Child and Adolescent Assent Templates

• Child Assent Template (Age 7-12)
• Adolescent Assent Template for Non-Treatment Studies (Age 13-17)

Addendum Consent Templates

• Addendum Consent Template for Non-Treatment Studies (for new procedures, risks)
• Addendum Consent Template for Treatment Studies (for new procedures, risks)

Screening Scripts

• Screening Script for non-Treatment Studies
• Screening Script for Treatment Studies

Consent Standards and Sample Language

• Social, Behavioral & Educational ("SBER") Consent form Standards and Template Language
• Biomedical Research Consent Form Standards and Sample Language

Comprehension Tools

• PRISM Readability Tool Kit
• Self-Certification of Surrogate Decision Makers for Potential Research Subject's Participation in UC Research (For use only in studies the IRB has reviewed and explicitly approved for surrogate consent)
• Decision-Making Capacity Assessment Tool (for potential subjects who may have cognitive impairments)

Other References

• Research Participant Bill of Rights/Experimental Subjects Bill of Rights - available in 34 languages
• Conducting Risk-Benefit Assessments
• Obtaining and Documenting Informed Consent (v. 07-28-11)
• Requesting Waivers and Exceptions to Informed Consent (v. 07-28-11)
• Child Assent and Permission by Parents or Guardians (v. 09-06-11)
• The Use of Legally Authorized Representatives or Surrogate Consent (v. 06-21-10)
• Recruitment and Screening Methods and Materials (v. 09-05-11)

Feedback

We appreciate your suggestions for improving templates and/or adding sample language to the standards documents. Please email OHRPPEQI@research.ucla.edu to provide your feedback.