HRPP and IRB resources HRPP Listserv MU ICH-GCP Guidance Activities overseen by the IRB and our process Templates Consent Exempt Projects Only - Consent and Assent Templates Adult Consent – Exempt Project (Word Document) Child Assent – Exempt Project (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) FDA drug guidance 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 Federal regulations DHHS Regulations DHHS Guidance FDA Regulations FDA Guidance Department of Veterans Affairs Handbook External sources Understanding Health Privacy Laws (HIPAA) Clinical Trials Registration Genetic Information Nondiscrimination Act (GINA) Certificates of Confidentiality (COC) International Standards Belmont Report NIH Office of Science Policy Clinical Trial Resources 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 Human Subjects Research IRB Submission/Review Process Single IRB and Reliance Procedures Researcher resources Participant protection Participant outreach IRB Fees Policies and procedures Contact information Related Links eCompliance