Posts in category: Human Subjects Protection
When an Incidental Finding Saves a Life
During today’s meeting of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), a panel of experts discussed the ethical considerations associated with incidental findings that arise during research. Alex John London, M.A., Ph.D., Professor of Philosophy at Carnegie Mellon began by noting “The researcher may have a duty to act in [...]
Multiple steps must be taken before ethical pediatric anthrax vaccine trials can be considered
Today the Presidential Commission for the Study of Bioethical Issues concluded that the federal government would have to take multiple steps, including additional research in adults, before anthrax vaccine trials with children could be ethically considered by the U.S. government. In its report released today, Safeguarding Children: Pediatric Medical Countermeasure Research, the Bioethics Commission responded to [...]
Commission’s “Moral Science” Report Making an Impact
Less than a year after its release, the Commission’s report, Moral Science: Protecting Participants in Human Subjects Research, is having a noteworthy impact in the research community. Recently, stakeholders have taken concrete steps to implement two of the Commission’s recommendations, namely, those concerning accountability through public access and promoting community engagement. As part of its [...]
Compensation Expert Addresses Commission
In the course of its review of current human subjects research protections, the Presidential Commission for the Study of Bioethical Issues asked an international panel of experts to advise them on how the current system might be improved. One of the recommendations of the international panel was that the U.S. government “should implement a system [...]
Commission Calls for Transparency in U.S. Government-Funded Research
As the Presidential Commission for the Study of Bioethical Issues continued its assessment of current protections for human subjects in research at its public meeting in Boston this afternoon, Commission member, Christine Grady, proposed that the Commission recommend improving transparency in U.S. Government-funded research. Grady said that federal agencies could develop systems – or improve [...]
Commission Work Will Dovetail Nicely with HHS’ ANPRM
The Presidential Commission for the Study of Bioethical Issues today discussed how its current work assessing the contemporary rules and regulations that protect human subjects in research will nicely dovetail with the Department of Health and Human Service’s Advanced Notice of Proposed Rulemaking (ANPRM), which was released last summer. The ANPRM is entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects [...]
Putting Ethics in Action – What Role do Professional Standards Play?
Following the revelation that the U.S. Public Health Service conducted unethical research on STDs in Guatemala in the 1940s, President Obama charged the Presidential Commission for the Study of Bioethical Issues to conduct “a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of [...]
Ethically Impossible
From 1946-1948, a team of medical researchers in the United States Public Health Service intentionally infected more than 1,300 Guatemalan prison inmates, psychiatric patients, commercial sex workers and soldiers with sexually transmitted diseases. The team also used children in diagnostic testing. Done completely without consent, their experiments resulted in a living hell for many of [...]
The scars of research done poorly
For much of the meeting, a discussion around protection of human subjects in scientific research was abstract. It became tangible today when Carletta Tilousi, member of the Havasupai Tribal Council in Supai, Arizona, told the story of a diabetes research study involving her tribe to the Presidential Commission for the Study of Bioethical Issues. The [...]
