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Subject:   The Lack of Representation by Human Subjects, Their Families, and Advocacy Organizations in Advisory Bodies Entrusted with Ensuring Public Safety in Human Research
Date:   2005-04-14

The Secretary of Health and Human Services and the Office for Human Research Protections (OHRP) has advisory bodies to assist in its mission to protect human subjects. Chief among them is the Secretary's Advisory Committee on Human Research Protections (SACHRP), specifically charged with advising the Secretary regarding issues for protecting human subjects, especially concerned with vulnerable populations. Currently research, business, medical and academic interests are represented on these committees and/or have been invited many times to present their views, but not any persons who have been research subjects, their families or advocacy groups expressly concerned with the subject of human research safety. This situation demands immediate redress if the mission to obtain the highest possible level of public safety in the arena of human subject research is to be achieved.

Recently a subcommittee was appointed to examine Sub-Part A of 45 CFR 46 – the main body of the research code. CIRCARE asked to present its views to this subcommittee by becoming part of the committee but was denied and then invited to present any views during the occasional ten- or fifteen-minute public forums that SACHRP holds. We plan to present our views and the problem of lack of representation at this coming April 18, 2005 meeting.

CIRCARE is the oldest organization advocating for the protection of human subjects and long advocating a coherent view of human research subject safety. We believe that human subjects, their families, or their advocacy groups should have the same rights as industry, academic medical centers, or other institutional interests to bring sustained input to these advisory bodies. Our citizens are better served and their safety more likely to be protected when all responsible views are heard in such advisory bodies.

Michael A. Susko, President, CIRCARE
Paul Gelsinger, Vice President, CIRCARE


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Last Updated: 2005-12-11

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