These publications are available at no cost unless otherwise indicated.
Liu EC. Background and Legal Issues Related to Human Embryonic Stem Cell Research. Congressional Research Service. 2008-01-25: http://wikileaks.org/leak/crs/RS21044.pdf
Duffy DT. Background and Legal Issues Related to Stem Cell Research. Congressional Research Service. 2002-06-12: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RS21044.pdf
Johnson JA, Williams ED. Stem Cell Research. Congressional Research Service. 2004-08-13: http://www.fas.org/spp/civil/crs/RL31015.pdf
A Staff Report for the Use of the Subcommittee on Oversight and Investigations in Preparation for Its Hearing Human Tissue Samples: NIH Research Policies and Practices.
Majority and Minority Committee Staff, House Committee on Energy and Commerce. 2006-06-13 and 14: http://energycommerce.house.gov/108/home/staff%20report.pdf
Human Pesticide Experiments. United States House of Representatives, Committee on Government Reform—Minority Staff Special Investigations Division and United States Senate, Office of Senator Barbara Boxer, Environmental Staff. June 2005: http://www.democrats.reform.house.gov/Documents/20050627115401-68567.pdf
Viswanathan M, Ammerman A, Eng E, Gartlehner G, Lohr KN, Griffith D, Rhodes S, Samuel-Hodge C, Maty S, Lux, L, Webb L, Sutton SF, Swinson T, Jackman A, Whitener L. Community-Based Participatory Research: Assessing the Evidence. Evidence Report/Technology Assessment No. 99 (Prepared by RTI-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016). AHRQ Publication 04-E022-2. Rockville, MD: Agency for Healthcare Research and Quality. July 2004: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.44133
Moving Medical Innovations Forward — New Initiatives from HHS. January 2005: http://www.hhs.gov/reference/medicalinnovations.shtml
Department of Health and Human Services Regulatory Reform Initiative. Undated: http://regreform.hhs.gov/
OEI-05-07-00730: The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information. Department of Health and Human Services, Office of Inspector General. 2009-01: http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf
Department of Health and Human Services, Office of Inspector General. Work Plan Fiscal Year 2008. Accessed on 2007-10-09 at: http://oig.hhs.gov/publications/docs/workplan/2008/Work_Plan_FY_2008.pdf
OEI-01-06-00160: The Food and Drug Administration's Oversight of Clinical Trials. Department of Health and Human Services, Office of Inspector General. September 2007: http://oig.hhs.gov/oei/reports/oei-01-06-00160.pdf
OEI-01-97-00198: Clinical Trial Web Sites: A Promising Tool to Foster Informed Consent. Department of Health and Human Services, Office of Inspector General. May 2002: http://oig.hhs.gov/oei/reports/oei-01-97-00198.pdf
OEI-01-00-00190: The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Department of Health and Human Services, Office of Inspector General. September 2001: http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf
OEI-01-97-00195: Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research. Department of Health and Human Services, Office of Inspector General. June 2000: http://oig.hhs.gov/oei/reports/oei-01-97-00195.pdf
OEI-01-97-00196: Recruiting Human Subjects: Sample Guidelines for Practice. Department of Health and Human Services, Office of Inspector General. June 2000: http://oig.hhs.gov/oei/reports/oei-01-97-00196.pdf
OEI-05-99-00350: FDA Oversight of Clinical Investigators. Department of Health and Human Services, Office of Inspector General. June 2000: http://oig.hhs.gov/oei/reports/oei-05-99-00350.pdf
OEI-01-97-00197: Protecting Human Research Subjects: Status of Recommendations. Department of Health and Human Services, Office of Inspector General. April 2000: http://oig.hhs.gov/oei/reports/oei-01-97-00197.pdf
Testimony Before the Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources United States House of Representatives. Institutional Review Boards: A System of Protections Still in Need of Reform. Statement of Mark R. Yessian, Ph.D., Regional Inspector General for Evaluation and Inspections, Office of Inspector General Department of Health and Human Services. 1999-12-09: http://web.archive.org/web/20071116172554/http://oig.hhs.gov/reading/testimony/1999/finalirb.htm
OEI-01-97-00194: Low-Volume Institutional Review Boards. Department of Health and Human Services, Office of Inspector General. October 1998: http://oig.hhs.gov/oei/reports/oei-01-97-00194.pdf
OEI-01-97-00190: Institutional Review Boards: Their Role in Reviewing Approved Research. Department of Health and Human Services, Office of Inspector General. June 1998: http://oig.hhs.gov/oei/reports/oei-01-97-00190.pdf
OEI-01-97-00191: Institutional Review Boards: Promising Approaches. Department of Health and Human Services, Office of Inspector General. June 1998: http://oig.hhs.gov/oei/reports/oei-01-97-00191.pdf
OEI-01-97-00192: Institutional Review Boards: The Emergence of Independent Boards. Department of Health and Human Services, Office of Inspector General. June 1998: http://oig.hhs.gov/oei/reports/oei-01-97-00192.pdf
OEI-01-97-00193: Institutional Review Boards: A Time for Reform. Department of Health and Human Services, Office of Inspector General. June 1998: http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf
OEI-05-94-00100: Investigational Devices: Four Case Studies. Department of Health and Human Services, Office of Inspector General. April 1995: http://oig.hhs.gov/oei/reports/oei-05-94-00100.pdf
A-15-96-50001: Review of the Annual Reporting Process for Investigational New Drugs Regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research. Department of Health and Human Services, Office of Inspector General. July 17, 1998: http://oig.hhs.gov/oas/reports/phs/c9650001.pdf
A-15-95-50001: Review of the Food and Drug Administration's Processes to Review Medical Device Submissions Under the Pre-Market Approval and Investigational Device Exemption Programs. Department of Health and Human Services Office of Inspector General. March 6, 1996: http://oig.hhs.gov/oas/reports/phs/c9550001.pdf
OEI-01-04-00390: FDA's Monitoring of Postmarketing Study Commitments. Department of Health and Human Services Office of Inspector General. July 07, 2006: http://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf
Related Testimony
Institutional Review Boards: A System of Protections Still in Need of Reform. Yessian MR. Regional Inspector General for Evaluation and Inspections, Office of Inspector General, U.S. Department of Health and Human Services. Testimony Before the Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources, United States House of Representatives. 1999-12-09: http://web.archive.org/web/20071116172554/http://oig.hhs.gov/reading/testimony/1999/finalirb.htm
Protecting Human Subjects: Status of Recommendations. Grob G. Deputy Inspector General for Evaluation and Inspections, Office of Inspector General, U.S. Department of Health and Human Services. Testimony Before the House Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy, and Human Resources. 2000-05-03: http://web.archive.org/web/20071116172602/http://oig.hhs.gov/reading/testimony/2000/00503fin.htm
Related Reports
OEI-12-04-00310: HHS Agencies' Compliance With the National Practitioner Data Bank Malpractice Reporting Policy. Department of Health and Human Services, Office of Inspector General. October 11, 2005: http://oig.hhs.gov/oei/reports/oei-12-04-00310.pdf
OEI-05-00-00251: Enrollment and Certification Processes In the Clinical Laboratory Improvement Amendments Program. Department of Health and Human Services, Office of Inspector General. August 2001: http://oig.hhs.gov/oei/reports/oei-05-00-00251.pdf
OEI-05-00-00250: CLIA Regulation of Unestablished Laboratory Tests. Department of Health and Human Services, Office of Inspector General. June 2001: http://oig.hhs.gov/oei/reports/oei-05-00-00250.pdf
A-15-98-50001: Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports. Department of Health and Human Services, Office of Inspector General. December 14, 1999: http://oig.hhs.gov/oas/reports/phs/c9850001.pdf
A-03-92-00605: Follow-Up Review On Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510(k) Review Process. Department of Health and Human Services, Office of Inspector General. February 26, 1993: http://oig.hhs.gov/oas/reports/region3/39200605.pdf
OEI-09-90-00040: FDA Medical Device Regulation: From Premarket Review to Recall. Department of Health and Human Services, Office of Inspector General. February 1991: http://oig.hhs.gov/oei/reports/oei-09-90-00040.pdf
HHS Office of Inspector General Home Page
GAO-09-807 Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators. United States Government Accountability Office. 2009-10. Accessed on 2009-10-23 at: http://www.gao.gov/new.items/d09807.pdf
GAO-09-448T Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation. 2009-03-26: http://www.gao.gov/new.items/d09448t.pdf
Link to related house hearing and news coverage: http://www.circare.org/media/mediamarch2009.htm
GAO 09-190 Medical Devices FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. 2009-01. General Accountability Office Report. Accessed on 2009-02-03 at: http://www.gao.gov/new.items/d09190.pdf
GAO-06-320R Information on False Claims Act Litigation. General Accountability Office Report. 2006-01-31: http://www.gao.gov/new.items/d06320r.pdf
GAO-05-1042 Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications. General Accountability Office Report. 2005-09-30: http://www.gao.gov/new.items/d051042.pdf
GAO-05-191 Federal Research: NIH and EPA Need to Improve Conflict of Interest Reviews for Research Arrangements with Private Sector Entities. General Accountability Office Report. 2005-02-25: http://www.gao.gov/new.items/d05191.pdf
GAO-04-965 Health Information: First-Year Experiences under the Federal Privacy Rule. General Accountability Office Report. 2004-09-03: http://www.gao.gov/new.items/d04965.pdf
GAO-04-31 University Research: Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest. General Accounting Office Report. November, 2003-11-14: http://www.gao.gov/new.items/d0431.pdf
GAO-03-829 Technology Transfer: NIH-Private Sector Partnership in the Development of Taxol. General Accounting Office Report. 2003-06-04: http://www.gao.gov/new.items/d03829.pdf
GAO/HEHS-95-134 Health Research Misconduct: HHS' Handling of Cases Is Appropriate, but Timeliness Remains a Concern. General Accounting Office Report. 1995-08-03: http://www.gao.gov/archive/1995/he95134.pdf
HEHS-96-72 Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. 1996-03-08: http://www.gao.gov/archive/1996/he96072.pdf
HRD-88-100 FDA's Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies. General Accounting Office Report. 1988-09-12: http://archive.gao.gov/d17t6/137030.pdf
HRD-86-136FS Food and Drug Administration: Resources for Division of Scientific Investigations Have Been Reduced. General Accounting Office Report. 1986-08-28: http://archive.gao.gov/f0302/131183.pdf
HRD-76-96 Federal Control of New Drug Testing Is Not Adequately Protecting Human Test Subjects and the Public. General Accounting Office Report. 1976-07-15: http://archive.gao.gov/f0202/093704.pdf
MWD-75-71 Food and Drug Administration's Investigation of Defective Cardiac Pacemakers Recalled by the General Electric Company. General Accounting Office Report. 1975-03-10: http://archive.gao.gov/f0102/090415.pdf
B-164031(2) Supervision Over Investigational Use of Selected Drugs. General Accounting Office Report. 1973-07-23: http://archive.gao.gov/f0302/096136.pdf
U.S. General Accountability Office Reports and Testimony search by topic and date
U.S. General Accountability Office Home Page (On 2004-07-07 the General Accounting Office became the General Accountability Office.)
U.S. Congress, Office of Technology Assessment. New Developments in Biotechnology: Ownership of Human Tissues and Cells – Special Report OTA-BA-337. 1987-03: http://www.wws.princeton.edu/ota/disk2/1987/8719/8719.PDF
U.S. Congress, Office of Technology Assessment. Researching Health Risks OTA-BBS-570. 1993-01: http://www.wws.princeton.edu/ota/disk1/1993/9352/9352.PDF
U.S. Congress, Office of Technology Assessment. Biomedical Ethics in U.S. Public Policy OTA-BP-BBS-105. 1993-06: http://www.wws.princeton.edu/ota/disk1/1993/9312/9312.PDF
U.S. Congress, Office of Technology Assessment. Protecting Privacy in Computerized Medical Information OTA-TCT-576. 1993-09: http://www.wws.princeton.edu/ota/disk1/1993/9342/9342.PDF
U.S. Congress, Office of Technology Assessment. Index of Publications: http://www.wws.princeton.edu/~ota/ns20/pubs_f.html
Reports of the Office of Technology Assessment are hosted by the Woodrow Wilson School of Public and International Affairs at Princeton University on The OTA Legacy 1972-1995: http://www.wws.princeton.edu/ota/ns20/notes_f.html (Way to go Tigers!)
Summary Report of the Inspections of Clinical Trials Conducted in 2003 — 2004. Health Canada, Health Products and Food Branch Inspectorate. 2004-12-15: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/2003-2004_tc-tm_e.html
Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase. Health Canada, Health Products and Food Branch Inspectorate. 2003-07-11: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/gcp_insp_rep-rap_bpc_insp_tc-tm_e.html
Science and the public interest: communicating the results of new scientific research to the public. The Royal Society. 2006-04: http://www.royalsoc.ac.uk/downloaddoc.asp?id=2879
Milbank Memorial Fund Foundation. Milbank Memorial Fund Reports. Accessed 2006-02-28 at: http://www.milbank.org/reports/reportstest.html
Rand Corporation. Books and Publications, Rand Corporation Health and Health Care Documents Available Online. Accessed 2006-02-28 at: http://www.rand.org/publications/electronic/health.html
U.S. Department of Health and Human Services, Assistant Secretary for Legislation, Index of HHS Congressional Testimony (1996-): http://www.hhs.gov/asl/testimony.html
National Bioethics Advisory Commission Publications, Index of Publications: http://www.georgetown.edu/research/nrcbl/nbac/pubs.html
Last Updated: 2009-10-23
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