Stem Cell Research Laws

  • Post author:
  • Post category:Uncategorized

For the purposes of these guidelines, `human embryonic stem cells (hES cells) are cells derived from the inner cell mass of human blastocyst embryos, capable of dividing over a prolonged culture period without differentiation and known to develop into cells and tissues of the three primary germ layers. Although hES cells are derived from embryos, these stem cells are not themselves human embryos. All processes and procedures for verifying the eligibility of hES cells are centralized at the NIH as follows: But if a state defines a person from the moment of conception, it would effectively ban research with embryos, R. Alta Charo, who leads stem cell policy for national academies, President Barack Obama`s transition team, and stem cell research institutes in Wisconsin and California. said in an interview. Respondents were concerned that donors are clearly “informed in advance by all researchers that there may be a financial gain to be gained from the donation and that the donor(s) should know in advance whether they will share the financial gain.” The guidelines address these concerns by requiring that the donor(s) have been informed during the consent process that the donation was made without restrictions or instructions regarding the person(s) who may receive medical benefits from the use of stem cells, such as cell transplant recipients. The guidelines also require that the donor(s) receive information indicating that the research was not intended to provide a direct medical benefit to the donor(s); that the results of research using hES cells could have commercial potential and that the donor(s) would not derive any financial or other benefit from such commercial development. By executive order on March 9, 2009, President Barack Obama lifted certain restrictions on federal funding for research into new human embryonic stem cell lines. [9] Prior to President Obama`s executive order, federal funding was limited to non-embryonic stem cell research and embryonic stem cell based on embryonic stem cell lines that existed prior to August 9, 2001. Federal funding from current funding to the Department of Health and Human Services (including the National Institutes of Health) under the Omnibus Appropriations Act of 2009 remains prohibited under the Dickey-Wicker Amendment for (1) the creation of a human embryo for research purposes; or (2) research in which one or more human embryos are destroyed, disposed of, or knowingly exposed to a greater risk of injury or death than is permitted for in utero fetal research. The Massachusetts legislature overwhelmingly approves Senate Bill 2039, which clarifies the state`s human embryonic stem cell research and therapeutic cloning law and ensures that such research is permitted within a regulatory framework. Johns Hopkins University`s John Gearhart is the first to derive human embryonic germlines from aborted fetuses. Stem cells have been used in medicine since the 1950s.

Congressional involvement in stem cell policy began as early as 1974. This timeline provides policy milestones that influence the course of stem cell research in the United States. If states grant personality to embryos without specific exemptions to obtain stem cells from embryos, then there can be no stem cells on which to conduct research or develop therapeutic products, said Mark Barnes, a research attorney at Ropes & Gray LLP. The Senate and House of Representatives approve a bill that would dramatically increase government support for embryonic stem cell research. In 2005, Canada passed legislation authorizing research on embryos discarded from in vitro fertilization procedures. However, it prohibits the creation of human embryos for research purposes. [1] “Part of the challenge is that it happens so quickly,” she said. “In a way, things that were once considered sacred may no longer be sacred. And even federal laws that would protect research or certain activities or procedures can be vulnerable to the courts when these types of proceedings are challenged. “Embryonic stem cells hold promise for health and medicine because they can transform into any cell in the human body and offer the potential to repair and regenerate tissue damaged by various diseases. They can also be used to test drug candidates for toxicity. But embryos must be destroyed when creating stem cell lines for research.

It is illegal to create embryos specifically for research, but American researchers can use embryos from in vitro fertilization that would otherwise be discarded and donated for research. Respondents also sought clarification on the statement contained in the draft directive, which states that “although human embryonic stem cells originate from embryos, these stem cells themselves are not human embryos”. For NIH funding purposes, an embryo is defined in Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09, also known as the Dickey Amendment, as any organism that is not protected as a human subject under 45 C.F.R. Part 46 and that is obtained by fertilization, parthenogenesis, cloning, or other means from one or more human gametes or diploid cells. Since 1999, the Department of Health and Social Services (HHS) has consistently interpreted this provision as not applying to research involving hES cells, as hES cells are not embryos within the meaning of Section 509. This longstanding interpretation has been left unchanged by Congress, which enacts the Dickey Amendment every year, fully aware that HHS has funded hESC research since 2001. These guidelines therefore recognize the distinction accepted by Congress between obtaining stem cells from an embryo that results in the destruction of the embryo for which federal funding is prohibited, and research involving hES cells that does not involve an embryo or results in the destruction of an embryo for which federal funding is authorized. The political positions of various political leaders in the United States on stem cell research have not always been predictable. HHS argues that the current embryonic research law does not cover embryonic stem cell research because the law only protects the embryo, which is an “organism” – and a stem cell obtained by destroying an embryo is not an “organism”. HHS even cites my December 2 statement for the thesis that a stem cell is not an organism — but the authors overlook other parts of my statement.

More importantly, they ignore two important aspects of the applicable law. Several studies have examined the impact of changing funding policies on scientific research in the United States and the development of new cell therapies by industry.