Informed Consent

Model Consent and Parental Permission Forms

• Instructions for Preparing a Consent Form or Parental Permission Form Instructions
• Informed Consent Form
• Parental Permission Form
• Summary Explanation for Research
  • Summary Explanation for Exempt Research
  • Summary Explanation for Verbal or Implied Consent (waived signed consent)
  • Summary Explanation for Verbal or Implied Consent for Research Using PHI 
• Addendum to Consent - To provide additional information to current participants
• Addendum for Emancipated Minors -  Investigators must obtain informed consent to continue in the research from participants who were enrolled as minors and are now 18 or newly emancipated and able to consent for themselves.
• Notice of Participation -  To inform participants enrolled while decisionally compromised for medical reasons.
• Witness Form -  For participants not able to read or requiring oral explanations
• Pregnant Partner Consent Form

Consent Form Header and Approval Stamp Box

• Steps to Update a Consent Form Header and Approval Stamp Box

Suggested Wording for Consent Forms

• Suggested Consent Wording - Example wording for specific situations, such as conflict of interest, Certificates of Confidentiality, discomfort and risk examples, etc.
• Lay Terms for Consent Forms - Links to glossaries

 

Consent for Participants with Limited English Proficiency

• Instruction - Documentation of Informed Consent for Participants with Limited English Proficiency
• Template - Short Form Consent Document - (For limited English proficiency participants)
• Certification of Translation Form
• Hospital Policies and Resources:
  • PSHMC policy - Interpretation Services for Patients with Limited English Proficiency
  • For information about Interpreters and written translation services, contact Care Coordination (531-8306)
  • The HSPO (531-5687) may also have information about translation services recently used

 

Translations Ready for Use:

• Spanish Short Form Consent
• Russian Short Form Consent
• French Short Form Consent
• Vietnamese Short Form Consent
• Italian Short Form Consent

 

Waivers

• Request for Waiver or Alteration of Consent
  • Fill-in Version
  • Print Version
• Request for Waiver of a Signed Consent Form
  • Fill-in Version
  • Print Version