№ files_lp_4_process_3_104446
Administrative regulatory language document defining mandatory clauses and instructions for inserting financial, legal, medical risk, genetic nondiscrimination, and health information privacy statements into informed consent forms used in research studies conducted under West Virginia University oversight.
Institution: West Virginia University
Related Institution: West Virginia University Health System (WVUHS)
Organization: Advarra
Document Type: Research compliance language document
Document Purpose: Standard language insertion for informed consent forms
Subject Area: Human subjects research regulation and consent documentation
Applicable Sections: Financial Considerations; Radiation Risk; Compensation for Injury; GINA Law; HIPAA Authorization
Relevant Law: Genetic Information Nondiscrimination Act (GINA)
Relevant Regulation: Health Insurance Portability and Accountability Act (HIPAA)
Regulatory Bodies Mentioned: U.S. Department of Health and Human Services; Food and Drug Administration; National Institutes of Health
Applicable Institution Offices: WVU Office of Human Research Protections; WVU Office of Sponsored Programs; WVU Tax Services Office
Geographic Scope: West Virginia, United States
Related Parties: Research sponsors; principal investigators; research staff; institutional review boards
Primary Users: Advarra staff preparing consent documents for WVU research studies
Content Components: billing disclosure; taxable compensation notice; commercial use of research data and specimens; radiation exposure disclosure; injury compensation language options; genetic nondiscrimination notice; protected health information authorization
Price: 8 / 10 USD
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