Health and Medical News and Resources

General interest items edited by Janice Flahiff

Report On Human Subjects Protection Released By President’s Bioethics Commission

Presidential Commission for the Study of Bioethical Issues

From the 19 December 2011 Medical News Today article

The Presidential Commission for the Study of Bioethical Issues has issued its report concerning federally-sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk. In its report, “Moral Science: Protecting Participants in Human Subjects Research,” the Commission also recommended 14 changes to current practices to better protect research subjects, and called on the federal government to improve its tracking of research programs supported with taxpayer dollars. …

….

Key Findings:

In the report’s central finding, the Commission found that the “U.S. system provides substantial protections for the health, rights, and welfare of research subjects.”

In assessing the current regulations that protect human subjects, the Commission learned that there is no central source with information about the overall size, scope, and cost of the government’s research involving human subjects. [Flahiff’s emphasis]The Commission requested information from 18 individual agencies that conduct most federal human subjects research, but discovered that many federal offices could not provide basic data about the research they support.[Flahiff ‘s emphasis]…

Recommendations:

The Commission recommended several areas where improvements could be made to current rules and procedures. “Immediate changes can be made to increase accountability and thereby reduce the likelihood of harm or unethical treatment,” Gutmann said.

The Commission recommends that each federal department or agency supporting research with human subjects maintain a core set of data for their research programs that includes the title and lead investigator of each project, the location of each study, and the amount appropriated for the research. Each office should aid the public in learning more about the government’s research efforts by developing or improving publicly available electronic systems or releasing information through a government-wide system. To support these efforts, the Commission suggested that the Office for Human Research Protections or another office should administer a central web-based portal that links to each individual department or agency system. In addition, the government should consider developing a unified federal research database, which may ultimately be more cost-effective and efficient. ….

 

Related Resources

December 19, 2011 - Posted by | Medical and Health Research News | , , ,

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