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Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Diane Hoffmann
This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.
Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry
Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry
Leslie Meltzer Henry
The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the …
Revising The Common Rule: Prospects And Challenges, Leslie Henry
Revising The Common Rule: Prospects And Challenges, Leslie Henry
Leslie Meltzer Henry
The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address "Human Subjects Research Regulations: Proposals for Reform." This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule.
Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns
Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns
Maxwell L. Stearns
Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.
Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns
Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns
Leslie Meltzer Henry
Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.