Quality Improvement Resources:
Checklists, Study Logs & Sample SOP
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Key Elements for Notes Describing the Informed Consent Process
- 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 consents to participate;
- 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]
Please note: These logs may not suit your protocol precisely, however, they may serve as a guide to get you started. Also, be mindful of HIPAA and when it might apply to data collected in pre-screen and enrollment logs.
(alphabetical order)
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Use this checklist to identify essential elements of informed consent for University of Kentucky human research. [PDF]
Basics for Easy-to-Read Informed Consent Documents
Use this document as a guide for developing an easy-to-read consent document. [PDF]
Investigational Device Accountability SOP Template
If you are conducting a study involving use of an investigational device, use this SOP as a guide for developing your own policies and procedures which can help ensure you are meeting the highest standards for human research protections. [PDF]