Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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4 Current Regulation of Human Embryonic Stem Cell Research
4 Current Regulation of Human Embryonic Stem Cell Research
Pages 63-80
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From page 63... ...
• Safety reviews of laboratory work that involves genetic alteration of hES cell lines. • Animal care committee reviews of hES cell research that uses nonhuman animals.
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From page 64... ...
REGULATION OF PROCUREMENT OF GAMETES, SOMATIC CELLS, AND BLASTOCYSTS Whether it involves receiving donated blastocysts that would otherwise be dis carded after infertility treatment or procuring gametes and somatic cells to make blastocysts specifically for research purposes, the procurement process often re quires oversight by an Institutional Review Board (IRB) , whose membership and functions are described in Department of Health and Human Service (DHHS)
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From page 65... ...
has made it clear that hES cell research "that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research [and therefore] IRB review is not required for such research."4 According to OHRP, merely asking couples whether they wish to donate their surplus blastocysts for research does not render them "human subjects of research" if no data on them are being gathered and there is no substantive interaction with them other than gaining their consent.5 On the other hand, where physical interaction is needed to obtain biological materials, such as in the case of donors whose sperm, oocytes, or somatic cells are used to make blastocysts for research, the interaction brings them under the purview of the human subjects protections system and IRB review is required, even though the donors are not themselves the subjects of scientific study.
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From page 66... ...
Recommendation 8: Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from in vitro fertilization clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells do nated for development of hES cell lines derived through nuclear transfer. Recommendation 9: Institutional Review Boards may not waive the requirement for obtaining in formed consent from any person whose somatic cells, gametes, or blastocysts are used in hES research.
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From page 67... ...
When investigators wish to work with existing lines rather than obtain materials to derive new lines, those lines may be accompanied by medical or other information about the donors. Work with hES cell lines whose identifiers render identity of the original donors readily ascertainable to the investigators would be a form of human subjects research that requires IRB review because the work might well reveal information about the donors.
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From page 68... ...
, human subjects protections are triggered unless the infor mation is carefully coded and managed. In addition to human subjects protections, if donor health information is at tached to hES cell lines, federal privacy protections under the Health Insurance Portability and Accountability Act of 1996 (HIPAA; PL 104-191)
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From page 69... ...
Recommendation 10: Investigators, institutions, Institutional Review Boards, and privacy boards should ensure that authorizations are received from donors, as appropriate and required by federal human subjects protections and the Health Insurance Port ability and Accountability Act, for the confidential transmission of personal health information to repositories or to investigators who are using hES cell lines derived from donated materials. REGULATION OF IN VITRO AND ANIMAL STUDIES THAT USE hES CELL LINES In general, state law does not affect the practice of in vitro or animal studies with hES cells.
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From page 70... ...
To the extent possible, review of individual recombinant DNA research proposals has been delegated to local IBCs, and they remain as the guardians of public safety with regard to all recombinant DNA research and other potentially biohazardous research. They focus their review on safety, not on compliance with human subjects protections or other aspects of state and federal law governing the ethical conduct of scientific research.
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From page 71... ...
These do not include basic exploratory studies performed to determine whether a test article has any potential utility or to determine its physical or chemical characteristics but they do encompass in vivo or in vitro experiments in which test articles are studied to determine their safety -- an activity that would be characteristic of the preclinical phase of hES cell research. Failure to conform to GLP regulations, although not itself a violation of law, would render any hES cells less useful in the future if they were considered for clinical trials of tissue transplantation or other cell-based therapies.13 Recommendation 11: Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care.
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From page 72... ...
But failure to follow FDA's tissue transplantation regulations may result in FDA's re fusal to use materials from the laboratories in question in later clinical trials. If so, investigators might have to derive new cell lines in accordance with the regulations if their materials are to be acceptable for development into transplantable tissue.
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From page 73... ...
Tissue transplantation from cell lines grown on nonhuman feeder cells would be considered xenotransplantation and would require additional FDA review.17 For hES cell investigators who plan to obtain cell lines from outside the United States, it is worth noting that FDA's new tissue regulations also govern the importation of cell lines and derived tissues for use in clinical transplantation, and importation must be approved by FDA, whose regulations pursuant to Section 361 of the Public Health Service Act are designed to prevent the transmission of communicable diseases. Also of relevance to researchers working with cell lines from other countries, there are medical privacy requirements in other countries that must be considered whenever transnational collaborations are contemplated.18 For collaborations with 16See § 1271.55 of the new regulations, as presented in "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products", Federal Register Vol.
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From page 74... ...
Many forms of hES cell research, however, can be exempted from the rules, provided that the data are rendered anonymous. Under the ISO guidelines, anonymization means rendering data "nonpersonal," that is, the codes do not directly or indirectly reveal the identity of the donors.21 Given the varied ways in which anonymous is interpreted under HIPAA, ISO guidelines, and federal human subjects research rules, investigators and institutions need to be attentive to the concerns of all appropriate bodies before working with cell lines that are under stood to be anonymized.
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From page 75... ...
A number of states, such as Louisiana, Maine, Massachusetts, Minnesota, New Hampshire, North Dakota, Pennsylvania, and Rhode Island, have enacted legislation to prohibit or limit research with human embryos,24 with the definition of embryo occasionally merged with the definition of fetus.25 In some cases, these state laws restricting embryo research have been challenged successfully in court, on grounds such as unconstitutional vagueness.26 But most U.S. states have no laws or regulations specifically addressing hES cell research.
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From page 76... ...
Investigators working with NT or hES cell lines are well advised to seek advice on the latest rules applicable in their states. REGULATION OF hES CELL AND NT RESEARCH IN OTHER COUNTRIES There is no international consensus yet on whether and how to pursue hES cell research.
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From page 77... ...
As of early 2005, HFEA had granted 28 research licenses, including 10 related to hES cells and two related to parthenogenesis.37 Two licenses were granted for work with NT blastocysts.38 The United Kingdom also has created a Stem Cell Bank, launched by the Medical Research Council in September 2002. The bank exists to establish fully characterized and quality-controlled cell lines (see Chapter 5 for a discussion on banking)
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From page 78... ...
Under the guidelines issued by the Canadian Institute for Health Research,42 review and approval by the central Stem Cell Oversight Committee, by local research ethics boards (REBs) , and, where appropriate, by animal care committees is required for all research involving the derivation, in vitro study, and clinical trial of hES cell lines.
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From page 79... ...
government (but unlike that of New Jersey or California) , the Canadian guidelines prohibit public financial support for making embryos solely for research or of research in which hES cells are combined with a nonhuman embryo.43 CONCLUSION Despite the lack of federal funding for most hES cell research underway in the United States, several sets of federal regulations govern various aspects of hES cell research -- human subjects protections for oocyte and some blastocyst donors, medical privacy protections, laboratory and safety standards, animal welfare requirements, and rules governing the importation of biological materials or the transfer of medical data from other countries.
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