Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations

• Published in: JAMA : the journal of the American Medical Association Vol. 317; no. 15; pp. 1521 - 1522
• Main Authors: Hodge, James G, Gostin, Lawrence O
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 18.04.2017
• Subjects: Ethics Committees, Research - legislation & jurisprudence; Genetic research; Human Experimentation - ethics; Human Experimentation - legislation & jurisprudence; Human subjects; Humans; Informed Consent - legislation & jurisprudence; Modernization; Public Health Practice; Research Subjects - classification; Research Subjects - legislation & jurisprudence; Rules; Specimen Handling - methods; United States; United States Office of Research Integrity
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2017.1633

Hodge and Gostin discuss a final rule to modernize the Federal Policy for the Protection of Human Subjects, known as the Common Rule. Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research. Research enterprises now encompass vast multi-center trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.