GENETIC RESEARCH
No TL;DR found
Abstract
Federal regulations, primarily the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, govern the collection, storage, and use of biological specimens for genetic research using banked biological specimens. Despite some prescriptive requirements, the federal law fails to adequately protect individuals’ interests from unwanted collection and use of their tissues for genetic research as a result of ambiguity and limiting the applicability of federal regulation to situations of direct identifiability. Several state legislatures have magnified these loopholes in federal regulation, codifying sweeping unregulated exceptions to promote medical and scientific research advancements. Despite the importance of genetic research and its lucrative promises of research partnerships, evading consent and authorization is not sustainable and undermines the purpose of the federal regulations, severely compromising individual autonomy and dignity. Section I of this article reviews the relevant federal regulatory framework and section II describes state statutory provisions governing biobanking and genetic research. These federal and state regulations are then applied in section III. Section IV discusses research partnerships and human subjects protections, while consent and public benefit are considered in the ensuing