Templates 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) HRPP and IRB guidance MU ICH-GCP Guidance Frequently Asked Questions FDA guidance – IND drug determinations 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 FDA guidance – IDE medical device determinations 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 Federal regulations and guidance 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 External sources Understanding Health Privacy Laws (HIPAA) Clinical Trials Registration Genetic Information Nondiscrimination Act (GINA) Certificates of Confidentiality (COC) International Standards Belmont Report Can’t find what you are looking for? Contact us. Contact the Human Subjects Research office 310 Jesse Hall Email: muresearchirb@missouri.edu Phone: 573-882-3181 Fax: 844-341-6544 Human Subjects Research IRB submission/review process Single IRB and reliance procedures Researcher resources Student researchers Education and training Participant protection Participant outreach ResearchMatch IRB fees Policies and procedures Frequently asked questions Contact information Related Links eCompliance