61 See Irving, "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at: http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html. See also Irving, "Historic roots of human genetic engineering: REASON, Duke, and parahuman reproduction - 1972" (July 11, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_34winstonduke.html. [Back]
63 Testimony of Lori Andrews, J.D., before President's Bioethics Council; PCBE: Transcripts (July 24, 3003): Session 4: "Stem Cell Research: Current Law and Policy with Emphasis on the States", (emphases added), http://www.bioethics.gov/transcripts/july03/session4.html. [Back]
64 See, e.g., Kischer, "The corruption of the science of Human Embryology", http://www.lifeissues.net/writers/kisc/kisc_01humanembryology.html. See also many of the articles listed in note 25, supra. [Back]
65 For an extensive history of the "birth" of bioethics, an evaluation of its principles, with extensive scientific, philosophical and historical references, see Irving, "What is 'bioethics'?", UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.: University Faculty For Life, 2002), pp. 1-84, at: http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html; and at http://www.uffl.org/irving/irvwhatisbio.htm. For a shorter version, see "The bioethics mess", Crisis Magazine, Vol. 19, No. 5, May 2001, at: http://www.catholic.net/rcc/Periodicals/Crisis/2001-05/irving.html, and at http://www.lifeissues.net/writers/irv/irv_37bioethicsmess.html. [Back]
66 For a detailed exploration of the use of such erroneous scientific definitions, and how they could impact applications of the OHRP federal regulations, see Irving, "'New age' embryology text books: 'Pre-embryo', 'pregnancy' and abortion counseling: Implications for fetal research", Linacre Quarterly (May 1994), 61(2):42-62, at: http://www.lifeissues.net/writers/irv/irv_50newagetextbook1.html. [Back]
67 In 1981 the OPRR (now, OHRP) federal regulations were established, requiring that the use of federal funds in research be monitored by "institutional review boards" (IRB's), and they were to follow the "IRB Guidebooks" issued by DHHS. [It is this same OPRR that scientifically mis-defines both "pregnancy" and "fetus" as beginning at implantation!).
Since that time the malfunctioning of and abuses of these IRB's have grown to epidemic proportions, resulting in numerous private, governmental and Congressional oversight hearings on these abuses. For example, in 1997 the National Bioethics Advisory Commission's Human Subjects Subcommittee held hearings. Also in 1997 Rep. Christopher Shays chaired a series of hearings, "Oversight of HHS (Department of Health and Human Services): Bioethics and the Adequacy of Informed Consent," conducted by the House Government Reform and Oversight Committee's Human Resources subcommittee. Senators Frist and Kennedy held similar hearings in 2002, i.e., the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, "Protecting Human Subjects in Research: Are Current Safeguards Adequate?"
The literature on IRB's is enormous, but the following selection might help those unfamiliar with it at least get into the "ballpark". See, e.g., various testimonies by Alliance for Human Research Protection: Sharav, "Testimony before the National Bioethics Advisory Commission, Human Subjects Subcommittee", Sept. 18, 1997, http://www.ahrp.org/testimonypresentations/NBAC1997/sharav.html; Sharav, "Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research", Submitted To U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing Feb. 2, 2000, http://www.ahrp.org/testimonypresentations/InducedPsychosis.html; Sharav and Cassidy, "Testimony Submitted to the Office of Human Research Protection (OHRP)", April, 2001, http://www.ahrp.org/testimonypresentations/sharavCassidyOHRP.html; Sharav and Noble, "Testimony before the Subcommittee on Public Health, Committee on Health, Education, Labor, & Pensions, United States Senate at Hearing", "Protecting Human Subjects in Research: Are Current Safeguards Adequate?" on April 23, 2002, http://www.ahrp.org/testimonypresentations/childrenApril02.html; Sharav, "Human Experiments: A Chronology of Human Research".
See also Sue McGreevey, "Almost half of all faculty on Institutional Review Boards have ties to industry", study by Harvard and Partners, Aug. 14, 2003, http://www.boston.com/dailyglobe2/084/nation/System_for_protecting_humans_in _research_faulted+.shtml; Michael Kranish, "System for protecting humans in research faulted", Boston Globe, Mar. 25, 2002, http://www.boston.com/dailyglobe2/084/nation/System_for_protecting_humans_in _research_faulted+.shtml; Dr. Angela J. Bowen, Institute for Health Freedom, "Testimony before "Institutional Review Boards: A System in Jeopardy?"", June 11, 1998, http://forhealthfreedom.org/Publications/Children/hr61198/bowen.html; Sidney M. Wolfe and Peter Lurie "Comments before 'Institutional Review Boards: A System in Jeopardy'", June 11, 1998, http://www.comite.bioetica.org/biblio8.htm; "IRBs Come Under Scrutiny of Congressional Subcommittee", Psychiatric News, http://www.psych.org/pnews/98-08-07/irb.html; National Patient Safety Foundation, "Accountability in Clinical Research: Balancing Risk & Benefit Forum Report", April 24-26, 2002 http://www.researchsafety.org/download/2002ForumReport.pdf; a helpful mini-summary can be found by WashingtonFAX, "Protecting human research subjects", http://www.washingtonfax.com/samples/docs/bioethics/patients/index.html. [Back]
68 The relevant current federal regulations are found in Title 45 Code of Federal Regulations Part 46 Protection of Human Subjects (revised June 18, 1991), 45 CFRpart46, Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Revised November 13, 2001, Effective December 13, 2001 [[Source: Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and Regulations, Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13no01-9] ]], http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html. [Back]
69 Federal Policy for the Protection of Human Subjects (56 FR 28003), http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html. [Back]
70 Joseph Palca, "A Word to the Wise", Hastings Center Report, March-April 1994, p. 5. [Back]
71 Public Law 103-43, as amended; June 10, 1993; National Institutes of Health Revitalization Act of 1993; Title I - General Provisions Regarding Title IV of Public Health Service Act; Subtitle A - Research Freedom; Part II - Research on Transplantation of Fetal Tissue; Sec. 111. Establishment of Authorities, http://ohrp.osophs.dhhs.gov/humansubjects/guidance/publiclaw103-43.htm. [Back]
74 H.J.Res. 2, Public Law 108-7, signed February 20, 2003, http://www.doleta.gov/budget/PL108-7%20ETA.pdf. [Back]
75 See, e.g., publications in PubMed, Irving, "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at: http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html. [Back]
76 "Cloning is possible by nucleus transplantation and by embryo splitting. Nucleus transplantation does not result in a genetically completely identical individual because the mitochondrial DNA originates from the ovum donor. Embryo splitting may be regarded as the artificial production of a monozygotic multiplet.", Geraedts JP, de Wert GM, "Cloning: applications in humans 1. Technical aspects", Ned Tijdschr Tandheelkd. 2001 Apr;108(4):145-50; PMID: 11383357, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11383357. [Back]
77 For PubMed, see: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed. See also Irving, "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at: http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html. See also Irving, "Historic roots of human genetic engineering: REASON, Duke, and parahuman reproduction - 1972" (July 11, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_34winstonduke.html. [Back]
78 See, http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm. [Back]
79 See, http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm. [Back]
81 Office for Human Research Protections, Department of Health and Human Services: Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles (March 19, 2002), http://ohrp.osophs.dhhs.gov/humansubjects/guidance/stemcell.pdf. [Back]
Ibid.86 FDA Title 21 CFR Part 312, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=1. Also, FDA Title 21 CFR Part 812, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812&showFR=1. [Back]
87 White House press release, "Embryonic Stem Cell Research", August 9, 2001, at: http://www.whitehouse.gov/news/releases/2001/08/print/20010809-1.html. [Back]
88 See, e.g., Irving: "Individual testimony before the NIH Human Embryo Research Panel" (March 14, 1994); reprinted in Linacre Quarterly, 61(4):82-89 (Nov. 1994), at: http://www.lifeissues.net/writers/irv/irv_32individualtestimony.html; "NIH Human Embryo Research Panel revisited: What is wrong with this picture?", Linacre Quarterly (May 2000), at: http://www.lifeissues.net/writers/irv/irv_31nih_and_her1.html; "UFL submission to NBAC Report: Research Involving Human Biological Materials: Ethical Issues and Policy Guidance"; VOLUME I Report and Recommendations of the National Bioethics Advisory Commission Rockville, Maryland August 1999 The National Bioethics Advisory Commission (NBAC), acknowledged Appendix E, p. 111, at: http://govinfo.library.unt.edu/nbac/hbm.pdf; "Affidavit in support of petition for injunction of the NIH Human Embryo Research Panel, Mary Doe v. Donna Shalala, et al," U.S. Dist. Ct. MD, No. PJM-94-1703, filed Aug. 1994, cert denied; at: http://www.lifeissues.net/writers/irv/irv_47affidavit.html. [Back]
89 See, e.g., Irving, "Human Embryonic Stem Cell Research: Are official positions based on scientific fraud?" (July 1999), at: http://www.lifeissues.net/writers/irv/irv_18stemcell.html, and at http://www.unspun.info/. [Back]
90 See analysis of both Weissman's and West's "theories" in Irving, "Analysis: Stearns' Congressional Human Cloning Fairy Tale 'Ban'; New Age and Transhumanist Legislation for 'Converging Technologies'?" (Sept. 8, 2004), at: http://www.lifeissues.net/writers/irv/irv_77stearncloningtale1.html. [Back]
91 See Irving, "Stem cells that could become embryos: Implications for the NIH Guidelines on stem cell research, the NIH stem cell report, informed consent, and patient safety in clinical trials" (July 22, 2001); written as consultant on human embryology and human embryo research as Fellow of The Linacre Institute (CMA), The Catholic Medical Association (USA), and The International Federation of Catholic Medical Associations (FIAMC), at: http://www.lifeissues.net/writers/irv/irv_39anlystemcel1.html. [Back]
92 "Group urges review of statin drug advice" (Sept. 24, 2004), CNN.com, at: http://www.cnn.com/2004/HEALTH/09/24/statins.reut/index.html; "Drugmakers Blackmail the Public'; Author Marica Angell says her research shows their huge influence over Congress, the FDA, and doctors is harming Americans" (Aug. 18, 2004), Business Week Online, at: http://www.businessweek.com/technology/content/aug2004/tc20040818_7567_tc121.htm; Irving comments on "A prescription for full disclosure: The results of clinical trials of many drugs are going unreported or unnoticed, which flies in the fact of science and may even harm patients" (Aug. 16, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_36nytimesprescription.html. [Back]
93 State Children's Health Insurance Program; Eligibility for Prenatal Care and Other Health Services for Unborn Children [42 CFR Part 457]; Final Rule [Federal Register: October 2, 2002 (Volume 67, Number 191), at http://frwebgate6.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=340071244152+0+0+0&WAISaction=retrieve]. [Back]
94 Jerad G. Seurer, "Can I patent that clone?", Wyatt Newsletter, Intellectual Property Report (no date), at: http://www.wyattfirm.com/clone.html. [Back]
95 H.R.2673, FY 2004 Consolidated Appropriations Bill, 1/23/2004 Became Public Law No: 108-199, United States Patent and Trademark Office [http://thomas.loc.gov/cgi-bin/query/D?c108:6:./temp/~c108830u57:e308591:]. [Back]
96 President's Bioethics Council, "Staff Working Paper, Patenting Human Organisms" (June 21, 2002), at: http://www.bioethics.gov/background/workpaper8.html. [Back]
97 BIO (Biotechnology Industry Organization, "Cloning Patent Fact Sheet: New Patent Legislation Sets Dangerous Precedent And Stifles Research" (Sept. 2, 2003), at: http://www.bio.org/ip/action/cloningfactsheet.asp. See also, Jim Abrams, "Lawmakers weigh human organism patent ban", Seattle Post-Intelligencer, at: http://www.gene.ch/genet/2003/Nov/msg00082.html. [Back]
98 Congressional Record, at: http://frwebgate.access.gpo.gov/cgibin/getpage.cgi?dbname=2003_record&page=H7274&position=all. See also Douglas Johnson, "Biotechnology Lobby Opposes Weldon Amendment, Seeks Open Door to Patents on Human Embryos", at: http://www.nrlc.org/Killing_Embryos/Human_Patenting/NRLCstatementWeldon111103.html. [Back]
99 The President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Chapter Three: "Patenting Human Organisms", at: http://www.bioethics.gov/reports/reproductionandresponsibility/chapter6.html. [Back]
101 For an extensive historical and scientific analysis of the "birth" of bioethics, see Irving, ""What is 'bioethics'?", UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.: University Faculty For Life, 2002), pp. 1-84, at: http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html, and http://www.uffl.org/irving/irvwhatisbio.htm. See also, Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998); and David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: BasicBooks; a subsidiary of Perseus Books, L.L.C., 1991). [Back]
102 Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnolog, Information Technology and Cognitive Science, NSF/DOC-sponsored report, edited by Mihail C. Roco and William Sims Bainbridge, National Science Foundation (June 2002), at: http://wtec.org/ConvergingTechnologies/Report/NBIC_report.pdf. [Back]
103 See Irving analyses: "Analysis: Stearns' Congressional Human Cloning Fairy Tale 'Ban'; New Age and Transhumanist Legislation for 'Converging Technologies'?" (Sept. 8, 2004), at: http://www.lifeissues.net/writers/irv/irv_77stearncloningtale1.html; "University Faculty for Life: Letter of Concern to Sen. Brownback and Congressman Weldon Re the 'Human Cloning Bill 2001'"; written as UFL Board Member on behalf of UFL; submitted to Sen. Brownback and Cong. Weldon, U.S. Congress, Washington, D.C. (May 27, 2001), at: http://www.uffl.org/irving/irvbrownback.htm, and at http://www.lifeissues.net/writers/irv/irv_52weldonbrownback1.html. [Back]
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,