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Consent Document Preparation

Regulatory Knowledge & Support offers support for drafting, revising and finalizing consent documents

The consent document is integral to the process of informed consent as well as for a smooth IRB submission to approval timeline for any one protocol. Regulatory Knowledge & Support (RKS) offers support for drafting, revising and finalizing consent documents.

A library of template language for various study procedures and their respective risks has been created for access and use by the research community. These may be accessed below:

Consent template language

Procedures Risks
Biopsy (muscle, tissue) Missing Data
Cardiology Nephrology
Central Venous Catheter Neurology
CRC Bionutrition Studies OBGYN (Pregnancy, Pap smear, etc.)
Dentistry Psychological
Drug / Device (general) Pulmonary, Sleep, Critical Care
Endocrinology Radiology
Exercise Testing Sample Storage and Use
Genetic Testing Speciman Collection, Vitals, etc.
Immunology  

 

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