The Texas Medical Board approved controversial regulations last Friday which are claimed to guarantee safe clinical use of stem cells and other “investigational agents”.

The Texas Medical Board approved controversial regulations last Friday which are claimed to guarantee safe clinical use of stem cells and other “investigational agents”. Critics say the regulations are too permissive and open the door to dubious future treatments. Even stem cell scientists – who usually criticise attempts to use stem cells in clinics without clinical evidence – are confused as to whether the regulations aim to rein in rogue clinicians or open the door to increased use.

The regulations require those who seek to provide stem cells to patients to get approval from the US Food and Drug Administration (FDA). The FDA considers most stem cell treatments to be inside its jurisdiction and requires they be clinically verified, or approved by an institutional review board (IRB).

Leigh Turner, a bioethicist at the University of Minneapolis, told New Scientist: “They seem to have taken experimental research and swept it into the practice of medicine.” The regulations say IRBs “can be affiliated with an academic setting or a Texas licensed hospital, be accredited by the Association for the Accreditation of Human Research Protections Programs, Inc. (AAHRPP), be register by the US Departments of Health and Human Services Office for Human Research Protection… or have received national accreditation by an organization acceptable to the TMB (Texas Medical Board)”.

Turner pointed out in an 8 April letter to the TMB that this broad and ill-defined characterisation could include non-profit boards, create financial conflicts of interest and cause researchers rejected by an IRB to keep “searching for an IRB until they find one that approves whatever studies they wish to conduct”. ~ Nature News, Apr 16; New Scientist, Apr 17

Texas passes stem cell regulations
Jared Yee
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stem cells
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