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Regulation and Ethics Questions1. Is stem cell research regulated? 1. Is stem cell research regulated? Regulation for ALL research exists at international, national, state, university and institutional levels. Regulation protects society by establishing ethical practices, protecting patient safety and ensuring medical effectiveness, while allowing science to proceed with appropriate oversight. The following is a list of just some of the regulations and guidelines that are in place for research involving human subjects. It is by no means intended to be exhaustive, but only a representative sampling. The Nuremberg Code is an example of international regulation on general research involving human subjects. It was established in1946, after the atrocities of WWII and requires that subjects’ consent for research must be voluntary, competent, informed and comprehensive. Specific to stem cell research, the International Society of Stem Cell Researchers (ISSCR) first wrote guidelines in 2006 and revised them in 2008. ISSCR guidelines give researchers and doctors direction for moving stem cells from promising research to practical, ethical application. Examples of general research guidelines on a national level include the Belmont Report (1978), which identifies basic ethical principles for conducting research involving human subjects. Under these guidelines, research must have:
Additional federal law governing research comes from the Dept. of Health and Human Services Code of Federal Regulations…for Protection of Human Subjects, which allows research to occur only if it follows stringent regulations about consent and scientific merit (45 CFR 46). Specific to stem cell research are the National Academies’ Guidelines for Human Embryonic Stem Cell Research (2005), which address both ethical and scientific concerns for the conduct of embryonic stem cell research. These guidelines are intended to enhance the integrity of embryonic stem cell research by encouraging responsible practices in the conduct of that research. Most recently, the National Institutes of Health developed Guidelines for Human Stem Cell Research. The NIH drafted the guidelines in response to President Barack Obama’s Executive Order 13505, issued March 9, 2009, which allowed government funding to flow to embryonic stem cell research using all ethically derived stem cell lines. The guidelines, finalized on July 7, 2009, “establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy and conducted in accordance with applicable law.” (http://stemcells.nih.gov/policy/2009guidelines.htm) Learn more about the Office of Human Research Protection at http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf; http://www.hhs.gov/ohrp/policy/ and http://grants.nih.gov/grants/policy/hs/ohrp_fda.htm. Review the Institute of Medicine guidelines at http://www.iom.edu/CMS/3740/22140/26661.aspx. The FDA’s stem cell research regulations can be found at http://content.nejm.org/cgi/content/full/355/16/1730 Regarding Michigan and local institutional regulation, on Nov. 4, 2008, Michigan voters approved Proposal 2 which amended the state constitution, overturning a 1978 Michigan law that prohibited the use of human embryos for research, even if those embryos were to be discarded. The law change enables Michigan researchers to derive new embryonic stem lines, using procedures already employed in laboratories around the world.The new state law allows the use of human embryos for research that is already permitted under federal law, provided that the embryos:
The new law makes Michigan one of three states that protect stem cell research in the state constitution. Michigan’s ban on human (reproductive) cloning was not altered by Proposal 2 and remains in full effect. In addition, the federal government requires that any institution or organization that conducts any research using human subjects must have an Internal Review Board (IRB) to review, approve and monitor all research projects to ensure ethical requirements are met. The IRB rules and regulations are precise and do not allow exploitation As an added layer of regulation for embryonic stem cell research, the National Academies require research centers including universities to establish local Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committees to
These groups were originally called Embryonic Stem Cell Research Oversight (ESCRO) Committees, but progress in the iPS field resulted in the change in name to Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committees. 3. Is the National Food & Drug Administration (FDA) involved in this research? The FDA is responsible for protecting public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. All treatments must be approved by the FDA. Bioethics is the study of the moral and ethical issues in the fields of scientific research, medical treatment and the life sciences. While advances in technology introduce both new and exciting insights into scientific processes and diseases, they also bring about new ethical issues that must be examined and evaluated. 5. What do researchers say to those who believe that life begins at conception, and anything that interferes with the embryo’s development is morally wrong? Using microscopic embryos that will otherwise be destroyed to create stem cell lines that will potentially help patients with debilitating and deadly diseases is a humane course of action. Most Americans, regardless of their religious or political affiliation, support moving forward with this work. Many people believe that stem cell research – including embryonic stem cell research – represents the best hope for relieving the suffering caused by many diseases that still have no treatments. In fact, some religious faiths consider it immoral not to pursue medical research that has the potential to reduce human suffering. New research and treatments often brings new fears -- fear of the “slippery slope.” Change is almost always hard and radical new medical discoveries and treatments often receive a mixed reception from people because of their fears. With stem cell research, people have visions of armies of clones or of part animal, part human creatures and other images from science fiction. But, there was fear with many new discoveries that have made our lives so much better, including the use of live vaccines (polio, flu) or blood transfusions; even the first X-rays were frightening. Ethical, regulated research needs to continue so scientists can pursue new avenues which could result in new knowledge and new cures. Science advances by exploring the unknown and research, with appropriate regulation and oversight, is necessary for the benefit of humankind. 6. Is there any form of stem cell research that the science community agrees should stay off limits? Yes. The scientific community has reached broad agreement on guidelines and limitations, and those guidelines have been spelled out clearly. The guidelines developed by the National Academy of Sciences are detailed and comprehensive, but the main points are:
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Copyright © 2006, 2009 Michigan Citizens For Stem Cell Research & Cures