Quality Assurance/Improvement Resources: Checklists, Study Logs & Sample SOP

Use the "Consent/Assent Checklist: Quality Improvement Review" [PDF] to identify essential elements of informed consent for University of Kentucky human research.

Informed Consent/Assent [HTML]

• Federal Plain Language Guidelines (plainlanguage.gov)
  • Use Simple Words and Phrases
• Glossary of Lay Terms for Use in Preparing Consent Documents [PDF]
• “Basics for Easy-to-Read Informed Consent Documents” Checklist [O11.0000] [PDF]
• Lay Terms & Alternative Words
  • Everyday Words for Public Health Communication (Centers for Disease Control and Prevention (CDC))
  • Informed Consent Language (ICL) Database (National Comprehensive Cancer Network (NCCN))
  • Simplified Assent Form Language Toolkit (Quorum)
  • Standard Drug Risk Language Library (Dana Farber/Harvard Cancer Center Office of Human Research Studies)
  • Standard Risk Language Database (Dana Farber/Harvard Cancer Center Office of Human Research Studies)
  • Suggested Consent Language (Northwestern Office for Research Institutional Review Board (IRB))
  • Tables of Possible Side Effects for Commonly-Used Oncology Regimens (National Institutes of Health (NIH) National Cancer Institute (NCI))
  • Talking Glossary of Genetic Terms (National Institutes of Health (NIH))
• Readability Toolkit (Kaiser Permanente Washington Research Institute Program for Readability & Science in Medicine (PRISM))
  • Alternative Wording Suggestions
  • Quick Reference Guide for Improving Readability
  • Health Literacy and Guidance for Improving Readability of Informed Consent Forms
• Sample Informed Consent Language Library: Describing Technologies Used in Research [PDF] (Harvard Catalyst: The Harvard Clinical and Translational Science Center)

If you are conducting a study involving use of an investigational device, use the Sample Policy/Procedure Template: Investigational Device Accountability [WORD]  and log [WORD] as a guide for developing your own policies and procedures which can help ensure you are meeting the highest standards for human research protections.

• Statement that “eligibility criteria met” (or completed eligibility checklist attached);
• Date;
• Details of who involved/present;
• Description of process;
• Discussion items;
• Questions & clarifications;
• Any assessment used to document understanding;
• Statement that subject voluntarily consented to participate prior to participating;
• Copy of signed consent given to subject;
• Any other pertinent information (witness, LAR, supplemental materials); 
• PI contact information;
• IRB number;
• Protocol title;
• Version of the consent document signed.

Samples (Please note: These may not suit your protocol precisely, however, they may serve as a guide to get you started):

• Template for History/Progress Note in Medical Record (UK) [PDF]
• Researcher's Certification of Consent and Authorization (AHRQ) [PDF]