Informed consent and investigational new drug abuses in the U.S. Military

Accountability in Research

Volumn 9, Issue 2, 2002, Pages 93-103

  Cummings, Mary L ^a  

^a University of Virginia   (United States)

Author keywords

Anthrax; Gulf War; Informed consent; Investigational drugs; Military

Indexed keywords

NEW DRUG;

ANTHRAX; ARTICLE; BIOLOGICAL WARFARE; BIOMEDICAL AND BEHAVIORAL RESEARCH; DEPARTMENT OF DEFENSE; EMPIRICAL APPROACH; ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; POLICY; PROFESSIONAL STANDARD; SOLDIER; UNITED STATES; VACCINATION; WAR;

BIOMEDICAL AND BEHAVIORAL RESEARCH; DEPARTMENT OF DEFENSE; EMPIRICAL APPROACH;

ANTHRAX; BIOLOGICAL WARFARE; DRUGS, INVESTIGATIONAL; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; GULF WAR; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MILITARY PERSONNEL; PUBLIC POLICY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINATION;

EID: 0036557168     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620212967     Document Type: Article

References (21)

1. 55 Federal Register at 52,187. 1990: codified at 21 CFR 50.23(d).
2. 64 Federal Register 54,180. 1999.
3. CBS television (1996). "The Pill, " 60 Minutes, September 29.
4. Code of Federal Regulations (1999). Title 45, 46.116(c).
5. Code of Federal Regulations (2000). Title 21, 312.35.
6. Code of Federal Regulations (2001). Title 21, 312.2.b.1.
7. Fleisher-Black, M., and Voris, B. V. (2001). Anthrax vaccine's liability issue, National Law Journal, p. A1.
8. General Accounting Office (2001). Anthrax Vaccine: Changes to the Manufacturing Process, p. 10.
9. Havrilak, G. T. (1999). The Pentagon's Anthrax Vaccination Immunization Program. December 2, Military Readiness Project.
10. Milner, C. A. (1996). Gulf War guinea pigs: Is informed consent optional during war? The Catholic University of America Journal of Contemporary Health Law & Policy, Fall, 13:199-232.
11. Myers, S. L. (1999). Drug May Be Cause of Veterans' Illnesses, New York Times, Oct. 18, p. A18, col. 4.
12. Nass, Meryl (1999). Written testimony before the Subcommittee on National Security, Veterans' Affairs, and International Relations, U.S. House of Representatives, April 19.
13. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publication (OS) 78-0011.
14. Office of the Surgeon General (1990). Memorandum SGRD-HR (15-1a). October 11, Department of the Army: Falls Church, VA.
15. Ornstein, C. (2002). Response to Terror, Los Angeles Times, February 1, p. A24.
16. Rempfer, T. L. (2000). Why Am I Resisting the Vaccine? The Military Trained Me To, Washington Post, January 3, p. B01.
17. Ryan, R. P. (1997). Should combat troops be given the option of refusing investigational drug treatment? The Food and Drug Law Institute Food and Drug Law Journal, 52(4):377-400.
18. Tuthill, K. A. (1997). Human experimentation: Protecting patient autonomy through informed consent, The Journal of Legal Medicine, June, 18:221-250.
19. United States District Court, District of Columbia (2001a). Bates v. Rumsfeld.
20. United States District Court, District of Columbia (2001b). Bates v. Rumsfeld, Memorandum in Support of Federal Defendants' Motion to Dismiss.
21. U.S. Army Medical Research Institute of Infectious Diseases (1990). Memorandum SGRD-UIZ-H. October 5, Department of the Army: Fort Detrick, MD.