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

• Activities overseen by the IRB and our process

• Education and training

• Student researchers

• 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

• 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