Massachusetts laws
MGL c.111L Biotechnology
Law says, in part, "it shall be the policy of the Commonwealth to actively foster research and therapies in the life sciences and regenerative medicine by permitting research and clinical applications involving the derivation and use of human embryonic stem cells..."
Massachusetts regulations
105 CMR 960 Biotechnology
Federal laws
Dickey-Wicker Amendment, P.L. 104-99, sec.128
Prohibits use of Federal funds for "(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero..."
21st Century Cures Act, P.L. 114-255
Includes sections requiring timely regulatory review of regenerative therapies, including therapies enabled by stem cell therapy research. See also 21 USC 356g, Standards for regenerative medicine and regenerative advanced therapies,
Federal executive orders and guidelines
Executive Order 13505: Removing barriers to responsible scientific research involving human stem cells, March 9, 2009.
"For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry."
National Institutes of Health guidelines for human stem cell research, Effective 2009. Guidelines and FAQs.
Selected cases
Sherley v. Sebelius, 689 F.3d 776 (2012), cert. den. 133 S.Ct. 847 (2012)
The last in a series of cases on federal funding of embryonic stem cells. Affirms the decision of the US District Court (see below) which granted summary judgment to the government and allows the federal funding to go forward. "NIH may not simply disregard an Executive Order.... Bound as it is to carry out the President's directives, NIH thus reasonably limited the scope of its Guidelines to implement the Executive Order. And because the Executive Order's entire thrust was aimed at expanding support of stem-cell research, it was not arbitrary or capricious for NIH to disregard comments that instead called for termination of all ESC research (including research that the executive branch has permitted since 2001)." Lower court cases: Sherley v. Sebelius, 776 F.Supp.2d 1 (July 2011), Sherley v. Sebelius, 644 F.3d 388 (April 2011), 704 F.Supp.2d 63 (2010).
Web sources
International Society for Stem Cell Research
Links to cutting edge articles regarding advances in research from around the world, policies and position statements of the Global membership, and their Stem Cells in focus blog. It also has a search feature to narrow down to specific diseases.
Stem cell information, National Institutes for Health.
Includes links to basic information, federal policy, research topics and information for researchers.
Print sources
College and university law manual, 2nd ed., MCLE, loose-leaf, Chapter 7.
Massachusetts health and hospital law manual, 3rd ed., MCLE, loose-leaf, 2022. Chapter 10: Biomedical research.
Contact
Online
| Last updated: | May 23, 2023 |
|---|