Book Summary:
The new HIPAA regulations will substantially impact clinical research activity - most notably the informed consent process. This new guidebook from CenterWatch is designed to assist clinical research professionals in complying with the new and final HIPAA regulations. Ensuring a HIPAA-Compliant Informed Consent Process - both an instruction manual and reference resource -- provides detailed guidelines on how to manage and conduct a HIPAA compliant and IRB-acceptable informed consent process. The guide includes sample language and templates for the HIPAA Authorization Form and informed consent forms for use in a variety of clinical research studies including genetic testing, tissue banking and assent. An extensive glossary of terms for use in preparing informed consent documents and convenient and easy-to-reference regulatory guidelines are also included. Book features:
- Practical approaches to incorporating HIPAA language into a wide variety of informed consent forms
- Discussion of Common Rule requirements and GCP-ICH recommendations
- Sample HIPAA-compliant language and useful templates
- How to examine whether the consent language puts your institution at risk
- Ways to avoid unnecessary IRB objections |