Universal and uniform protections of human subjects in research

American Journal of Bioethics

Volumn 7, Issue 12, 2007, Pages 7-9

  Shamoo, Adil E ^a   Schwartz, Jack ^b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b Maryland Attorney General's Office

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BENEFICENCE; ETHICS; FINANCIAL MANAGEMENT; GOVERNMENT; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; LEGAL ASPECT; RESEARCH ETHICS; RESEARCH SUBJECT; UNITED STATES;

ADVISORY COMMITTEES; BENEFICENCE; ETHICS, RESEARCH; FINANCING, GOVERNMENT; GOVERNMENT AGENCIES; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MARYLAND; RESEARCH SUBJECTS; UNITED STATES;

EID: 37549033920     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160701795825     Document Type: Article

References (17)

1. Animal Welfare Act. 1966. PL 89-544. Amended in PL 91-579 (1970) and in PL 94-279 (1976).
2. Advisory Committee on Human Radiation Experiments. 1995. Final report. Washington, DC: U.S. Government Printing Office.
3. Beauchamp, T. L., and J.F. Childress. 1994. Principles of biomedical ethics, 4th edition. New York, NY: Oxford University Press.
4. Code of Federal Regulations. 2006b. Title 45 Part 46.
5. Code of Federal Regulations. 2006a. Title 21 Part 56.
6. Maryland Laws. 2002. Chapter 552, Enacting Health-General Article Title 13, Subtitle 20.
7. National Bioethics Advisory Commission. 2001. Ethical and policy issues in research involving human participants, Vol. 1, Report and recommendations. Bethesda, MD: National Bioethics Advisory Commission.
8. Rawls, J. 1971. A theory of justice. Cambridge, MA: Belknap Press.
9. Schwartz, J. 2001. Oversight of human subject research: The role of the states. In National Bioethics Advisory Commission, 2001. Ethical and policy issues in research involving human participants, Vol. 2, commissioned papers and staff analysis, NBAC, Bethesda, MD: NBAC.
10. Slater, E. 2002. IRB reform. New England Journal of Medicine 346: 1402-1404.
11. Shamoo, A. E. (ed). 1997. Ethics in neurobiological research with human subjects. Amsterdam, NED: Gordon and Breach Publishers OPA.
12. Shamoo, A. E. 1999. Unregulated research with human subjects. Accountability in Research 6: 205-214.
13. Shamoo, A. E. 2001. Adverse events reporting - the tip of an iceberg, Accountability in Research 8:197-218.
14. Shamoo, A. E., and V.H. Sharav. 1997. Unethical use of persons with mental illness in high risk research experiments. BioLaw 2: S23-S31.
15. Shamoo, A. E., and L. Strause. 2004. Closing the gap in regulations for the protection of human subjects in research. Monitor Spring: 15-18.
16. United States Department of Health and Human Services. 1979. Belmont Report. Available online at http://ohrp.osophs.gov/humansubjects/guidance/ belmont.htm. (accessed June 12, 2006).
17. United States Food and Drug Administration. 2003. Warning letter. Available online at http://www.fda.gov/foi/warning_letters/g3936d.pdf (accessed on 11/12/03).