Posts in category: Uncategorized
Compensating Participants Injured in Pediatric Medical Countermeasure Research
In its recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) revisited the issue of compensation for research-related injury—an issue first addressed in its December 2010 report, Moral Science: Protecting Participants in Human Subjects Research. In Safeguarding Children, the Bioethics Commission reaffirmed the conclusion [...]
Bioethics Commission Develops Ethical Framework—Guidance for National-Level Review of Higher Risk Pediatric Research Protocols
The central tenet of pediatric research ethics is that it should not pose greater than minimal risk (or the risks of daily life) to participants, and, when greater risk cannot be avoided in research, there must be a commensurate potential for direct benefit to pediatric participants or benefit to an identifiable class of children. Only [...]
What’s next for the Commission?
The Presidential Commission for the Study of Bioethical Issues published a report on whole genome sequencing, Privacy and Progress in Whole Genome Sequencing, in October 2012. At its January meeting in Miami, Fla. the Commission finalized its work on a report on the ethics of medical countermeasures research with children, which will be released soon. [...]
The Commission’s at ASBH
The Bioethics Commission is at the American Society of Bioethics and Humanities (ASBH) 14th Annual Meeting in Washington, D.C. October 18-21. The theme of this year’s meeting is “Representing Bioethics.” Between staff, Members, and advisors, the Commission will be represented at several different sessions at ASBH. For example, on Friday, October 19 at 8 a.m. Executive Director [...]
Commission builds database of scientific trials
One basic issue in today’s federally funded research involving human subjects around the world: There’s no single database. Dr. Amy Gutmann, President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues, noted the absence of a database during the second day of meetings, which are examining the [...]
Panel recommends compensation for research injuries
An international expert panel today issued five recommendations to the Presidential Commission for the Study of Bioethical Issues on the effectiveness of current federal rules and international standards for research involving human subjects. One of the five was a recommendation that the U.S. government should implement a system to compensate research subjects for research-related injuries. [...]
Questions and answers on Guatemala research
During today’s meeting of the Presidential Commission for the Study of Bioethical Issues, several key questions were answered about the investigation into the U.S. Public Health Service’s studies in Guatemala from 1946 to 1948 that exposed and infected vulnerable populations to sexually transmitted diseases. Here are some of the questions: Why were they studying sexually [...]
Quotes on Guatemala investigation
Here are some notable quotes from members of the Presidential Commission for the Study of Bioethical Issues. The Commission today focused on the historical investigation of a U.S. Public Health Service research in Guatemala from 1946 to 1948 in which researchers deliberately exposed and infected participants with sexually transmitted diseases. Lonnie Ali, the wife of [...]
The story of Berta
It was just one woman’s story, and that was more than enough for a Commission member to find moral blame. During the Presidential Commission for the Study of Bioethical Issues’ meeting today on the investigation of US researchers deliberately exposing and infecting Guatemalans with sexually transmitted diseases from 1946 to 1948, one member raised the [...]
Commission discusses ethical conclusions in Guatemala investigation
For nine months, the Presidential Commission for the Study of Bioethical Issues has investigated a US-funded research project in Guatemala from 1946 to 1948 that deliberately exposed and infected vulnerable people with sexually transmitted diseases. Today, it unveiled some of its findings. While the Commission will not release its complete findings until next month when [...]
