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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"References." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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REFERENCES 95 References Accrediting Body for Human Subjects Research Nears Reality. 2001. Science and Government Report XXXI(6):1–2. AAMC (American Association of Medical Colleges). 2000. Clinical Research: A Reaffirmation of Trust Between Medical Science and the Public. [Online]. Available http://www.aamc.org/ newsroom/pressrel/000608b.htm [accessed February 1, 2001]. AAPP (American Academy of Pharmaceutical Physicians). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. AAU (Association of American Universities) Task Force on Research Accountability. 2000. Report on University Protections of Human Beings Who Are the Subjects of Research. Washington, DC: AAU. (See also http://www.aau.edu/HumSubRpt06.28.00.pdf). AAU (Association of American Universities), COGR (Council on Governmental Relations), and NASULGC (National Association of State Universities and Land-Grant Colleges). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. AAUP (American Association of University Professors). Forthcoming. Protecting Human Beings: Institutional Review Boards and Social Science Research. Draft. Washington, DC: AAUP. ACHRE (Advisory Committee on Human Radiation Experiments). 1995. Advisory Committee on Human Radiation Experiments, Final Report. Washington, DC: U.S. Government Printing Office. (See also http://tis.eh.doe.gov/ohre/roadmap/achre/index.html). AMA (American Medical Association) Judicial Council. 1946. Supplementary Report of the Judicial Council of the American Medical Association. Journal of the American Medical Association 132:1090.

REFERENCES 96 Amdur, R. J. 2000. Improving the Protection of Human Research Subjects. Academic Medicine 75:718–720. Ashe, Warren T. (Associate Dean for Research, Howard University School of Medicine). 2001. Statement at the January 22, 2001, public forum of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Batt, Sharon. 1994. Patient No More: The Politics of Breast Cancer. Charlottetown, Prince Edward Island, Canada: Gynergy Books. Bazell, Robert. 1998. HER-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer. New York: Random House. Beecher, Henry K. 1966. Ethics and Clinical Research. The New England Journal of Medicine 274:1354–1360. Bell, James, Whiton, John, and Connelly, Sharon. James Bell Associates. 1998. Prepared for the Office of Extramural Research, NIH. Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects. Alexandria, VA: James Bell and Associates. BNA (Bureau of National Affairs). 1996, December 11. AMA House of Delegate Approves Physician Accreditation Program. BNA Health Care Daily, p. d4. BNA. 2000, April 6. Accreditation Failing to Receive Payer/Provider Support: AMA to Discontinue Accreditation Program. BNA Health Care Daily. p. d14. Case Western Reserve University. 2001. Office of Research Administration: Human Subjects Protection. [Online]. Available: http://ora.ra.cwru.edu/ main_human_subjects_protection_page.htm [accessed February 15, 2001]. CECHR (Central Ethics Committee on Human Research), Indian Council of Medical Research. 2000. Ethical Guidelines for Biomedical Research on Human Subjects. [Online]. Available: http://www.icmr.nic.in/vsicmr/ethical.pdf [accessed January 24, 2001]. Chadwick, Gary, and Liders, Gunta J. 2000. Re: New Educational Requirements for Human Subject Researchers. [Online]. Available: http://www.rochester.edu/ORPA/ORPA-L/hsed.html [accessed February 5, 2001]. Chodosh, Sanford (President, Public Responsibility in Medicine and Research). 2000. Statement at the December 18, 2000, meeting of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. CIOMS (Council for International Organizations of Medical Sciences). In: Bankowski, Z. and Howard Jones N., eds. 1982. Human Experimentation and Medical Ethics. Geneva: CIOMS. CIOMS. 1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS. Clinton, William J. 1995. Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission. Executive Order 12975. Federal Register 60(193):52063–52065. Cook-Deegan, Robert Mullan. 1997. Do Research Moratoria Work? In: Cloning Human Beings, Vol. II. Commissioned Papers. Rockville, MD: National Bioethics Advisory Commission. Pp. H-1–H-52. (See also www.bioethics.gov/pubs/cloning2/cc8.pdf). Cornblath, David R (Johns Hopkins Medicine). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects.

REFERENCES 97 DHHS (U.S: Department of Health and Human Services). 2000. HHS News: New Office for Human Research Protections Created, Dr. Koski Named Director. [Online]. Available: http:// www.hhs.gov/news/press/2000pres/20000606.html [accessed January 15, 2001]. DHHS OIG (U.S. Department of Health and Human Service, Office of Inspector General). 1998a. Low-Volume Institutional Review Boards. Publication No. OEI-01-97-00194. (See also http://www.dhhs.gov/progorg/oei/reports/a308.pdf). DHHS OIG. 1998b. Institutional Review Boards: A Time for Reform. Publication No. OEI-01-97-00193. (See also http://www.dhhs.gov/progorg/oei/reports/a276.pdf). DHHS OIG. 1998c. Institutional Review Boards: The Emergence of Independent Boards. Publication No. OEI-01-97-00192. (See also http://www.dhhs.gov/progorg/oei/reports/a275.pdf). DHHS OIG. 1998d. Institutional Review Boards: Promising Approaches. Publication No. OEI-01-97-00191. (See also http://www.dhhs.gov/progorg/oei/reports/a274.pdf). DHHS OIG. 1998e. Institutional Review Boards: Their Role in Reviewing Approved Research. Publication No. OEI-01-97-00190. (See also http://www.dhhs.gov/progorg/oei/reports/ a273.pdf). DHHS OIG. 1999a. The External Review of Hospital Quality: A Call for Greater Accountability. Publication No. OEI-01-97-00050. (See also http://www.dhhs.gov/progorg/oei/reports/ a381.pdf). DHHS OIG. 1999b. The External Review of Hospital Quality: The Role of Accreditation. Publication No. OEI-01-97-00051. (See also http://www.dhhs.gov/progorg/oei/reports/a382.pdf). DHHS OIG. 2000a. FDA Oversight of Clinical Investigators. Publication No. OEI-05-99-00350. (See also http://www.hhs.gov/oig/oei/reports/a457.pdf). DHHS OIG. 2000b. Protecting Human Research Subjects: Status of Recommendations. Publication No. OEI-01-97-00197. (See also http://www.dhhs.gov/progorg/oei/reports/a447.pdf). DHHS OIG. 2000c. Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research. Publication No. OEI-01-97-00195. (See also http://www.hhs.gov/oig/oei/reports/a459.pdf). DHHS OIG. 2000d. Recruiting Human Subjects: Sample Guidelines for Practice. Publication No. OEI-01-97-00196. (See also http://www.hhs.gov/oig/oei/reports/a458.pdf). Dimmit, Barbara Sande. 1995. Accreditation: What's the Big Deal? Business and Health 13:38–44. Epstein, Steven. 1996. Impure Science: AIDS, Activism, and the Politics of Knowledge. Berkeley: University of California Press. Erickson, Stephen (Director, Office of Research Administration, Boston College). 2001. Statement at the January 22, 2001, hearing of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Faden, Ruth R., and Beauchamp, Tom L. 1986. A History and Theory of Informed Consent. New York: Oxford University Press. Fletcher, John C. Forthcoming. Location of OPRR Within the NIH: Problems of Status and Independent Authority. Draft report, the National Bioethics Advisory Commission (NBAC). Rockville, MD: NBAC.

REFERENCES 98 Flexner, Abraham. 1910. Medical Education in the United States and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching, Bulletin No. 4. New York: Carnegie Foundation for the Advancement of Teaching. Gamble, V. N. 1997. Under the Shadow of Tuskegee: African Americans and Health Care. American Journal of Public Health 87:1773–1778. GAO (General Accounting Office). 1996. Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. Washington, DC: GAO. GAO. 2000. VA Research: Protections for Human Subjects Need to Be Strengthened. Washington, DC: GAO. Gelsinger, Paul. 2000. Jesse's Intent. Guinea Pig Zero 8:7–17. Goldschmidt, Peter (President, Medical Care Management Corporation). 2001. Statement at the January 22, 2001, hearing of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Grob, George (Deputy Inspector General for Evaluation and Inspections, Office of Inspector General, U. S. Department of Health and Human Services). 2000. Testimony on Protecting Human Subjects: Status of Recommendations. Statement at the May 3, 2000, hearing of the Subcommittee on Criminal Justice, Drug Policy and Human Resources, Committee on Government Reform, U.S. House of Representatives. (See also http://www.house.gov/ reform/cj/hearings/00.05.03/Grob.htm). Gunsalus, C. K. Forthcoming. An Examination of Issues Presented by Proposal to Unify and Expand Federal Oversight of Human Subject Research. Draft report for the National Bioethics Advisory Commission (NBAC). Rockville, MD: NBAC. Hamm, Michael. 1997. The Fundamentals of Accreditation. Washington, DC: American Society of Association Executives. Hanna, K. E. 2000. Research Ethics: Reports, Scandals, Calls for Change. The Hastings Center Report 30(6):6. Heller, J. 1972. Syphilis Victims in U.S. Study Went Untreated for 40 Years. The New York Times. p. A1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1996. Therapeutic Products Directorate Guidelines: ICH Harmonised Tripartite Guideline: General Considerations for Clinical Trials. Ottawa, Canada: Health Canada. (See also http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/ english/guides/ich/efficacy/gclintr_e.html) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997. Therapeutic Products Directorate Guidelines: ICH Harmonised Tripartite Guideline: Good Clinical Practice:Consolidated Guideline. Ottawa, Canada: Health Canada. (See also http://www.hc-sc.gc.ca/hpbdgps/therapeut/zfiles/english/ guides/ich/efficacy/goodclin_e.html) International Conference on Harmonisation. 1998. International Conference on Harmonisation Structure. [Online], Available: http://www.ifpma.org/ich2.html [accessed February 22, 2001]. IOM (Institute of Medicine). 1994. In: Mastroianni, Anna C., Faden, Ruth, and Federman, Daniel, ed. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. Washington, DC: National Academy Press. IOM. 1999. The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved. Washington, DC: National Academy Press.

REFERENCES 99 IOM. 2001. Public forum of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. January 22, 2001. Isidor, John (CEO, Shulman and Associates IRB, Inc.). 2001. Statement at the January 22, 2001, hearing of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. JCAHO (Joint Commission on Accreditation of Healthcare Organizations). 2000. Joint Commission Standards. [Online]. Available: www.jcaho.org/standard/jcstandards.html [accessed February 13, 2001]. Jones, J. H. 1981. Bad Blood: The Tuskegee Syphilis Experiment. New York: The Free Press. Jost, Timothy. 1994. Medicare and the Joint Commission on Accreditation of Healthcare Organizations: A Healthy Relationship? Law and Contemporary Problems 57:15–46. Kant, Immanuel. 1999. The Good Will. In: Feinberg, J., and Shafer-Landau, R., ed. Reason and Responsibility. Belmont, CA: Wadsworth Publishing Company, pp. 558–570. Kulakowski, Elliott C. (President, Society of Research Administrators International). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Lehrman, Sally. 2000a. The Gelsinger Story. [Online]. GeneLetter. Available: http://www.geneletter. com/05-01-00/features/gelsinger1.html [accessed February 20, 2001]. Lehrman, Sally. 2000b. The Gelsinger Story: Aftermath. [Online]. GeneLetter. Available: http:// www.geneletter.com/06-01-00/features/gelsinger2.html [accessed February 20, 2001]. Levine, Felice J. (American Sociological Association and Consortium of Social Science Associations). 2001. Statement at the January 22, 2001, hearing of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Lewin Group. Prepared for the Center for Substance Abuse Treatment. 1998. Profiling Regulatory Models. Fairfax, Virginia: The Lewin Group, Inc. Love, Susan M. 1995. Dr. Susan Love's Breast Book. 2nd ed. Reading, MA: Perseus Books. Marshall, Patricia A. Forthcoming. The Relevance of Culture for Informed Consent in U.S. Funded International Health Research. Draft Report for the National Bioethics Advisory Commission (NBAC), Rockville, MD: NBAC. Mastroianni, Anna C., and Kahn, Jeffrey P. 1998. The Importance of Expanding Current Training in the Responsible Conduct of Research. Academic Medicine 73:1249–1254. McCarthy, Charles R. Forthcoming. Reflections on the Organizational Locus of the Office for Protection from Research Risks. Draft Report for the National Bioethics Advisory Commission (NBAC). Rockville, MD: NBAC. Merkatz, Ruth B., and Summers, Elyse I. 1997. Including Women in Clinical Trials: Policy Changes at the Food and Drug Administration. In: Haseltine, Florence P., Greenberg Jacobson, Beverly, and Society for the Advancement of Women's Health Research, ed. Women's Health Research: A Medical and Policy Primer. Washington, DC: Health Press International. National Association of IRB Managers. 2001. About the Program. [Online]. Available: www.naim.org/cert.htm [accessed March 27, 2001]. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government Printing Office.

REFERENCES 100 NBAC (National Bioethics Advisory Commission). 1997. Cloning Human Beings, Volume I. Rockville, MD: U.S. Government Printing Office. (See also http://bioethics. gov/pubs/ cloning1/cloning.pdf). NBAC. 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Rockville, MD: U.S. Government Printing Office. (See also http://bioethics.gov/ capacity/TOC.htm). NBAC. 1999a. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. Rockville, MD: U.S. Government Printing Office. (See also http://bioethics.gov/hbm.pdf). NBAC. 1999b. Ethical Issues in Human Stem Cell Research. Rockville, MD: U.S. Government Printing Office. (See also http://bioethics.gov/stemcell.pdf). NBAC. Forthcoming-a. Ethical and Policy Issues in International Research. Draft. Rockville, MD: U.S. Government Printing Office. (See also http://bioethics.gov/ toc_pdf). NBAC. Forthcoming-b. Ethical and Policy Issues in Research Involving Human Participants. Draft. (See also http://bioethics.gov/human/human_comment.html). NCI (National Cancer Institute). 1997. Report of the National Cancer Institute Clinical Trials Program Review Group (The Armitage Report). [Online]. Available: http:// deainfo.nci.nih.gov/advisory/bsa/bsa_program/2a [accessed February 5, 2001]. NCI. 1999. Monitoring of Clinical Trials. [Online]. NIH Guide for Grants and Contracts: Notices. Available: http://grants.nih.gov/grants/guide/notice-files/not99-140.html [accessed February 5, 2001]. NCI. 2001. Cancer Clinical Trials: A New National System. [Online]. Available: http:// cancertrials.nci.nih.gov/system/html/newsystem.html [accessed February 5, 2001]. NCQA (National Committee for Quality Assurance). 2001a. MCO Accreditation Information. [Online]. Available: http://www.ncqa.org/Pages/Programs/Accreditation/mco/accred.htm [accessed February 1, 2001]. NCQA. 2001b. VA Human Research Accreditation Program. [Online]. Available: http:// www.ncqa.org/Pages/Programs/QSG/vahrpap.htm [accessed January 11, 2001]. NIH (National Institutes of Health). 2000. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. [Online]. Available: http://grants.nih. gov/grants/guide/notice- files/NOT-OD-00-038.html [accessed February 2, 2001]. Nishimi, Robyn Y. (Senior Associate, Office of Technology Assessment). 1994. Statement at the September 28, 1994, hearing of the Subcommittee on Legislation and National Security, Committee on Government Operations, U.S. House of Representatives. NRC (National Research Council). 1996. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press. NSERC (Natural Sciences and Engineering Research Council of Canada). 2000. NSERC-Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans. [Online]. Available: http://www.nserc.ca/programs/ethics/english. [accessed February 22, 2001]. Nuremberg Code. 1949. In: Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, DC: U.S. Government Printing Office. Oakes, David D. (Chair, Administrative Panel on Human Subjects in Medical Research, Stanford University), 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects.

REFERENCES 101 Office for Protection from Research Risks Review Panel. 1999. Report to the Advisory Committee to the Director, NIH from the Office for Protection from Research Risks Review Panel. Rockville, MD: National Institutes of Health. (See also http://www.nih.gov/about/ director/060399b.htm.) Office of Human Subjects Research, National Institutes of Health. 2001. Protection of Human Research Subjects Computer-Based Training for Researchers. [Online]. Available: http:// ohsr.od.nih.gov/cbt [accessed February 5, 2001]. OHRP. 2000a. Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC): C.2. [Online]. Available: http://ohrp.osophs.dhhs.gov/ humansubjects/assurance/ INTL [accessed February 22, 2001]. OHRP. 2000b. Procedures for Registering Institutional Review Boards (IRBs) and Filing Federalwide Assurances of Protection for Human Subjects. [Online]. Available: http:// ohrp.osophs.dhhs.gov/irbasur.htm [accessed January 31, 2001]. OMB (Office of Management and Budget). 1998. Circular No. A-119, Revised. [Online]. Available: www.whitehouse.gov/omb/circulars/a119/a119.html [accessed February 28, 2001]. OTA (Office of Technology Assessment), U.S. Congress. 1993. Biomedical Ethics in U.S. Public Policy—Background Paper. Washington, DC: U.S. Government Printing Office. (See also http://www.wws.princeton.edu/cgi-bin/byteserv.prl/`ota/disk1/1993/9312/9312.pdf.) Overbey, Mary Margaret (Director of Government Relations, American Anthropological Association). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. PHS (U.S. Public Health Service). 1966. Clinical Investigations Using Human Subjects. In: Final Report: Advisory Committee on Human Radiation Experiments, Supplemental Volume I. Washington, DC: U.S. Government Printing Office. Pp. 475–476. President's Commission (President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research). 1981. Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation. Washington, DC: U.S. Government Printing Office. President's Commission. 1983. Implementing Human Research Regulations: The Adequacy and Uniformity of Federal Rules and of Their Implementation. Washington, DC: U.S. Government Printing Office. PRIM&R (Public Responsibility in Medicine and Research). 2001a. IRB Professional Certification Exam. [Online]. Available: http://www.primr.org/certification.html [accessed February 13, 2001]. PRIM&R. 2001b. AAAHRP Update. [Online]. Available: http://www.primr.org/aahrppupdate.html [accessed February 19, 2001]. Rettig, Richard A. 2000. The Industrialization of Clinical Research. Health Affairs 19:129–146. Rothman, David J. 1991. Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making. New York: Basic Books. Rubin, Philip (Director, Division of Behavioral and Cognitive Sciences, National Science Foundation). 2001. Statement at the January 22, 2001, hearing of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects.

REFERENCES 102 Rudder, Catherine (Executive Director, American Political Science Association). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Ryan, Stephen J. (Dean, Keck School of Medicine, University of Southern California). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Shalala, Donna. 2000. Sounding Board: Protecting Research Subjects—What Must Be Done. New England Journal of Medicine 343:808–810. Shopes, Linda (Historian, Pennsylvania Historical and Museum Commission). 2001. Written comments to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects. Snyderman, R., and Holmes E. W. 2000. Oversight Mechanisms for Clinical Research. Science 287:595–597. Starr, Paul. 1982. Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry. New York: Basic Books. Sugarman, J. 2000. The Role of Institutional Support in Protecting Human Research Subjects. Academic Medicine 75:687–692. Thompson, Larry. 1994. Correcting the Code: Inventing the Genetic Cure for the Human Body. New York: Simon and Schuster. Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973. Final Report. Washington, DC: U.S. Department of Health, Education, and Welfare. United States v. Karl Brandt et al. 1949. In: The Medical Case, Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10. Washington, DC: U.S. Government Printing Office. U.S. House of Representatives, Committee on Veterans Affairs. 1999. Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical Facilities and Informed Consent and Patient Safety in VA Medical Research: Hearing of the Committee on Veterans Affairs. 106th Cong. April 21, 1999. U.S. Senate, Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions. 2000. Gene Therapy: Is There Oversight for Patient Safety?: Hearing of the Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions. 106th Congress. February 2, 2000. VA (U.S. Department of Veterans Affairs). 2000. Press Release: VA Raises Standard for Protecting Human Research Participants. [Online]. Available: http://www.va.gov/opa [accessed February 20, 2001]. Weiss, R. and Nelson, D. 1999, December 8. Methods Faulted in Fatal Gene Therapy. The Washington Post. p. A1. World Medical Association. 1964. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Ferney-Voltaire, France: World Medical Association. World Medical Association. 2000. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, revised. Ferney-Voltaire, France: World Medical Association. Young, Kenneth E., Chamber, Charles M., Kells, H. R., and Associates. 1983. Understanding Accreditation. San Francisco: Jossey-Bank, Inc.

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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