By Holly Fernandez Lynch By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight. Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of…
By Laura Stark Institutional Review Boards are in the top news at outlets such as the New York Times, as a research debacle unfolds. I looked through the documents that are publicly available to figure out what happened and what to expect. Researchers at 22 universities or hospitals in the US enrolled premature babies in…
By Laura Stark Working in private, the National Academy of Sciences’ panel on human-subjects regulations in social-behavioral sciences met this weekend to draft a final report. On Friday, the panel had wrapped up its public “Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences.” The workshop aimed to critique…
By Suzanne M. Rivera, Ph.D. Earlier this month, the American Association of University Professors (AAUP) recommended that researchers should be trusted with the ability to decide whether individual studies involving human subjects should be exempt from regulation. The AAUP’s report, which was prepared by a subcommittee of the Association’s Committee on Academic Freedom and Tenure,…
By Laura Stark Today and tomorrow, the National Academy of Sciences is hosting a workshop on revisions to the human-subjects regulations (the “Common Rule”), especially for rules on social and behavioral research. The workshop is being simulcast, and viewers can send in questions. Join us! The most provocative presentation this morning, from my perch in…
By Arthur Caplan Art Caplan has a new column responding to the latest report from the Presidential Commission for the Study of Bioethical Issues. Take a look: A top-level commission has just released a new report on the morality of studying the safety of an anthrax vaccine in children, with an eye toward treating kids…
By The Petrie-Flom Center A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard: Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions May 17, 2013, 8:00AM-5:00PM Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor) 1585 Massachusetts Ave.,…
By Suzanne M. Rivera, Ph.D. The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and…
By The Petrie-Flom Center
By Holly Fernandez Lynch Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.” You’ve really got to read the whole thing, but some of the provisions are pretty remarkable: “In the case of an injury occurring to the clinical trial subject, he or she shall…
