Research, Innovation & Impact

Consent

Exempt Projects Only - Consent and Assent Templates

• Adult Consent – Exempt Project (Word Document)

• Child Assent – Exempt Project (Word Document)

• Exempt Project Consent with HIPAA (Word Document)

Expedited and Full Board Consent and Assent Templates

• Written Consent – Social Behavioral Educational (Word Document)

• Parental/Guardian Written Consent - Social Behavioral Educational (Word Document)

• Written Consent - Biomedical (Word Document)

• Parental/Guardian Written Consent - Biomedical (Word Document)

• Consent with Waiver of Documentation (Word Document)

• Written Child Assent (Word Document)

• Example Consent Text for Study-Specific Items (Word Document)

HIPAA

• HIPAA Authorization Form (Word Document)

• Waiver of Authorization Form - This is now a subform embedded within the eCompliance forms.

Protocol

• Biomedical Protocol Template (Word Document)

• NIH New Clinical Trial Protocol Template Writing Tool

• Social-Behavioral-Educational Protocol Template (Word Document)

VA

The Truman VA Hospital research office maintains the copies of their templates. Please contact Jennifer Hegerfeld at 573-814-6000 ext. 56550 or Jennifer.Hegerfeld@va.gov.

Other Templates

• Debriefing Form (Word Document)

• Permission Letter (Word Document)

• MU ICH-GCP Guidance
• Frequently Asked Questions
• eCompliance IRB form edit function - overview

• Drugs/Other Products FAQs
• Expanded Access to Investigational Drugs for Treatment Use
• Emergency Use of an Investigational Drug or Biologic
• FDA's Expanded Access Contact Information
• FDA IND/IDE Contacts
• "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
• Determining Whether Human Research Studies Can be Conducted without an IND
• Charging for Investigational Drugs under an IND
• Drug Study Designs
• Instructions for Filling out an IND – Form 1571
• IND Application Reporting: Protocol Amendments
• Form FDA 1572 FAQs
• Combination Product Definitions and Types

• Medical Devices FAQs
• Significant Risk and Nonsignificant Risk Medical Device Studies
• FAQs about Medical Devices (including HUDs)
• Policy for Device Software Functions and Mobile Medical Applications
• Device Software Functions Including Mobile Medical Devices
• Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are not Individually Identifiable
• In Vitro Diagnostic Device Studies - FAQs

• Clinical trials guidance documents
• Department of Veterans Affairs Handbook
• DHHS Regulations
• DHHS Guidance
• FDA Regulations:
  • 21 CFR 50 Protection of Human Subjects
  • 21 CFR 56 Institutional Review Boards
  • 21 CFR 812 Investigational Device Exemptions
  • 21 CFR 814 Premarket Approval of Medical Devices
  • 21 CFR 312 Investigational New Drug Application
  • Regulations: Good Clinical Practice and Clinical Trials

• Understanding Health Privacy Laws (HIPAA)
• Clinical Trials Registration
• Genetic Information Nondiscrimination Act (GINA)
• Certificates of Confidentiality (COC)
• International Standards 
• Belmont Report