Ethical, Legal, and Policy Issues Surrounding Biospecimen Research Conducted or Supported in the USA

Rapid and dramatic advances in molecular sequencing technology, as well as medical discoveries from genome-wide association and other precision medicine studies, have highlighted the longstanding ethical and legal challenges research biobanks consistently face. Whose authority is needed to conduct research with excised tissue, and how that authority may be exercised with respect and transparency, are central questions. This review article explores how scholars have addressed ethical and legal controversies such as the proper breadth and scope of consent for collection and future research use of biological specimens and data, the importance of disclosing individual research results and secondary findings, and collecting cadaver tissue from deceased persons. This article focuses on the legal and regulatory environment for conducting and/or supporting biospecimen research in the United States of America. It takes the position that proper biobank governance strategies, which ensure accountability and model respect toward biospecimen contributors, as well as transparency in communications between participants and researchers, reduce the likelihood of downstream legal disputes.