Forum on prisoners' access to clinical trials: Summary of recommendations

AIDS and Public Policy Journal

Volumn 11, Issue 1, 1996, Pages 3-20

  Stein, Gary L ^a   Headley, Linda D ^b  

^a NEW YORK ACADEMY OF MEDICINE   (United States)

^b New Jersey Protect Advocacy Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ETHICS; HEALTH CARE ACCESS; HEALTH CARE POLICY; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICAL RESEARCH; PATIENT CARE; PRISONER; REVIEW;

BIOMEDICAL AND BEHAVIORAL RESEARCH; CONTROL GROUPS; DEPARTMENT OF HEALTH AND HUMAN SERVICES; FEDERAL GOVERNMENT; FEMALES; FORUM ON PRISONER ACCESS TO CLINICAL TRIALS (NJ); GOVERNMENT REGULATION; HEALTH CARE; HEALTH CARE AND PUBLIC HEALTH; MALES; NATIONAL INSTITUTES OF HEALTH; NEW JERSEY; NORTH JERSEY COMMUNITY RESEARCH INITIATIVE; SELECTION OF SUBJECTS; STANDARDS; THERAPEUTIC RESEARCH; UNITED STATES;

CLINICAL TRIALS; CONTROL GROUPS; DRUGS, INVESTIGATIONAL; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; ETHICS, MEDICAL; FEDERAL GOVERNMENT; FEMALE; GOVERNMENT REGULATION; GUIDELINES; HEALTH SERVICES ACCESSIBILITY; HIV INFECTIONS; HUMANS; MALE; NEW JERSEY; PATIENT SELECTION; PRISONERS; RESEARCH SUBJECTS; THERAPEUTIC HUMAN EXPERIMENTATION;

EID: 0029892767     PISSN: 08873852     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (121)

1. N.N. Dubler and V.W. Sidel, "On Research on HIV Infection and AIDS in Correctional Institutions," Milbank Quarterly 67 (1989): 174.
2. World Health Organization Global Programme on AIDS, WHO Guidelines on HIV Infection and AIDS in Prisons (Geneva: World Health Organization, 1993), § F(38) reads: Prisoners should have the same access as people living in the community to clinical trials of treatments for all HIV/AIDS-related diseases. Prisoners should not be placed under pressure to participate in clinical trials, taking into account the principle that individuals deprived of their liberty may not be the subjects of medical research unless they freely consent to it and it is expected to produce a direct and significant benefit to their health; National Commission on Acquired Immune Deficiency Syndrome (hereafter National Commission on AIDS), HIV Disease in Correctional Facilities (Washington, D.C.: National Commission on AIDS, 1991), 14-15.
3. World Health Organization Global Programme on AIDS, WHO Guidelines on HIV Infection and AIDS in Prisons (Geneva: World Health Organization, 1993), § F(38) reads: Prisoners should have the same access as people living in the community to clinical trials of treatments for all HIV/AIDS-related diseases. Prisoners should not be placed under pressure to participate in clinical trials, taking into account the principle that individuals deprived of their liberty may not be the subjects of medical research unless they freely consent to it and it is expected to produce a direct and significant benefit to their health; National Commission on Acquired Immune Deficiency Syndrome (hereafter National Commission on AIDS), HIV Disease in Correctional Facilities (Washington, D.C.: National Commission on AIDS, 1991), 14-15.
4. K. Duke, "Achieving Balance: Biomedical Research and Inmates," Corhealth (Fall 1993): 2.
5. T.M. Hammett et al., 1992 Update: HIV/ AIDS in Correctional Facilities: Issues and Options (Washington, D.C.: National Institute of Justice, 1994), 14-28.
6. R. Altman, Medical Director, New Jersey Department of Health, Division of AIDS Prevention and Control, telephone communication with the authors, 5 May 1995.
7. J. Mikl, P.F. Smith, and R.B. Greifinger, "HIV Seroprevalence among New York State Prison Entrants," (Paper presented at the Ninth International Conference on AIDS, Berlin, 6-11 June 1993), abstract no. PO-C21-3108, 735.
8. Estelle v. Gamble, 429 U.S. 91, 103-104 (1976).
9. The Eighth Amendment to the U.S. Constitution states: "Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted [emphasis added]."
10. In its March 1991 report on correctional facilities, the National Commission on AIDS reaffirmed the position of its predecessor, the Presidential Commission on the Human Immunodeficiency Virus Epidemic, which concluded that "care and treatment available to HIV-infected inmates in correctional facilities should be equal to that available to HIV-infected individuals in the general community." National Commission on AIDS, HIV Disease in Correctional Facilities, 12; Presidential Commission on Human Immunodeficiency Virus 1988: 135 (Recommendation 9-82). See also J.M. Quinlin and K. Moritsugu, "AIDS in Prison: The Federal Experience," Judges' Journal (Summer 1990): 28 ("Prison administrators must provide health care that is commensurate with national community standards").
11. In its March 1991 report on correctional facilities, the National Commission on AIDS reaffirmed the position of its predecessor, the Presidential Commission on the Human Immunodeficiency Virus Epidemic, which concluded that "care and treatment available to HIV-infected inmates in correctional facilities should be equal to that available to HIV-infected individuals in the general community." National Commission on AIDS, HIV Disease in Correctional Facilities, 12; Presidential Commission on Human Immunodeficiency Virus 1988: 135 (Recommendation 9-82). See also J.M. Quinlin and K. Moritsugu, "AIDS in Prison: The Federal Experience," Judges' Journal (Summer 1990): 28 ("Prison administrators must provide health care that is commensurate with national community standards").
12. See note 4, p. 67.
13. Ibid., 68.
14. Ibid., table 21, 70. At this time, these drugs may be more widely available.
15. Harris v. Thigpen, 727 F.Supp. 1564 (M.D.Alabama 1990); Consent Decree, Roe et al. v. Fauver et al., C.A. No. 88-1225-AET (D. New Jersey, 3 March 1992); Inmates of New York with Human Immunodeficiency Virus v. Cuomo, No. 90-CV-252 (N.D. New York), cited in Hammett et al., HIV/AIDS in Correctional Facilities, 83.
16. Fitzhugh v. Wyoming Board of Charities and Reform, No. 91-CV-0106-B (D. Wyoming 1991), cited in Hammett et al., HIV/AIDS in Correctional Facilities, 84.
17. Hammett, et al., HIV/AIDS in Correctional Facilities, 71.
18. The FDA's drug approval process, including the implementation of clinical trials, is regulated under 21 Code of Federal Regulations, Parts 312 and 314.
19. B. Kerness, "The Inmate Perspective," (Paper presented at meeting of the Forum on Prisoner Access to Clinical Trials, Newark, N.J., October 1994).
20. The abbreviation "IND" is synonymous with notice of claimed investigational exemption for a new drug. 21 Code of Federal Regulations § 312.3(b).
21. 21 Code of Federal Regulations (hereafter, CFR) § 312.35(a).
22. Ibid., § 312.34(b)(1).
23. Ibid., § 312.35(b).
24. D.A. Kessler, "The Regulation of Investigational Drugs," New England Journal of Medicine 320 (1989): 285.
25. 57 Federal Register 13248, 13250 (15 April 1992).
26. National Commission on AIDS, HIV Disease in Correctional Facilities.
27. Ibid. In its report, the commission noted two cases that illustrate the magnitude of the clinical trial issue for prisoners with HIV. In one case, an inmate's cytomegalovirus (CMV) retinitis, which causes blindness when untreated, stopped responding to gancyclovir, the approved treatment for this infection; foscarnet, the only existing alternative, was available solely through a clinical trial. In another case, a 30-year-old man with cryptococcal meningitis became severely intolerant to amphotericin B, a treatment of this condition approved by the FDA at the time. Although cryptococcal meningitis is fatal if untreated, the prisoner had no access to fluconazole, the alternative therapy, because it was available only through a clinical trial.
28. The primary source of protection for participants of clinical research is contained in the 1974 DHHS regulations (45 CFR, Part 46). (Since 18 June 1991, the regulations of all federal agencies have been made uniform, and are now called "Federal Policy for the Protection of Human Subjects.") In addition, the DHHS regulations were amended in 1978 to include special guidelines for research on prisoners (45 CFR § 46.301 and forward). Parallel regulations promulgated by the FDA (21 CFR, Parts 50 and 56) have been the subject of litigation and have never been in effect.
29. The primary source of protection for participants of clinical research is contained in the 1974 DHHS regulations (45 CFR, Part 46). (Since 18 June 1991, the regulations of all federal agencies have been made uniform, and are now called "Federal Policy for the Protection of Human Subjects.") In addition, the DHHS regulations were amended in 1978 to include special guidelines for research on prisoners (45 CFR § 46.301 and forward). Parallel regulations promulgated by the FDA (21 CFR, Parts 50 and 56) have been the subject of litigation and have never been in effect.
30. The primary source of protection for participants of clinical research is contained in the 1974 DHHS regulations (45 CFR, Part 46). (Since 18 June 1991, the regulations of all federal agencies have been made uniform, and are now called "Federal Policy for the Protection of Human Subjects.") In addition, the DHHS regulations were amended in 1978 to include special guidelines for research on prisoners (45 CFR § 46.301 and forward). Parallel regulations promulgated by the FDA (21 CFR, Parts 50 and 56) have been the subject of litigation and have never been in effect.
31. 45 CFR § 46.306(a)(1).
32. Ibid., § 46.306(a)(2). These provisions are described in part and are modified by additional regulatory requirements.
33. Although federal regulations permit prisoners to enroll in clinical trials, the Federal Bureau of Prisons has not generally allowed inmates to participate. H. Lebowitz, Senior Research Analyst, U.S. Department of Justice, Federal Bureau of Prisons, telephone communication with the authors, September 1994.
34. For further discussion of this topic, see Recommendation 7 on use of placebo-control arms.
35. M. Linde, R.N., Clinical Research Specialist, Pharmaceutical and Regulatory Affairs Branch, National Institutes of Health, personal communication with the authors, 24 March 1995.
36. J. Meschino, PhD, Chief, Pharmaceutical and Regulatory Affairs Branch, NIH, personal communication with the authors, 1 June 1995; M. Linde, R.N., Clinical Research Specialist, Pharmaceutical and Regulatory Affairs Branch, NIH, personal communication with the authors, 6 June 1995; and F.W. Dommel, Esq., Director, Division of Human Subjects Protection, OPRR, NIH, telephone communication with the authors, 9 May 1995.
37. J. Meschino, PhD, Chief, Pharmaceutical and Regulatory Affairs Branch, NIH, personal communication with the authors, 1 June 1995; M. Linde, R.N., Clinical Research Specialist, Pharmaceutical and Regulatory Affairs Branch, NIH, personal communication with the authors, 6 June 1995; and F.W. Dommel, Esq., Director, Division of Human Subjects Protection, OPRR, NIH, telephone communication with the authors, 9 May 1995.
38. New Jersey Administrative Code (hereafter, NJAC), 10A:16-2.20(a),(b).
39. Ibid., 10A:1-10.1(a).
40. Consent Decree, Roe v. Fauver, C.A. No. 88-1225-AET (D. New Jersey, 3 March 1992), 15-16.
41. F. DeVesa, Attorney General of New Jersey, Opinion Letter to Commissioner W.H. Fauver, New Jersey Department of Corrections, 30 November 1993.
42. National Commission for the Protection of Human Subjects, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D.C: National Commission for the Protection of Human Subjects, 1978).
43. 45 CFR Part 46.
44. 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook (Bethesda, Md.: NIH, 1993), xxi, xxii.
45. Ibid.
46. Ibid.
47. 45 CFR §§ 46.107, 46.304.
48. Ibid., § 46.103(b)(4).
49. Ibid., § 46.108(b).
50. Ibid., § 46.109(a).
51. Ibid., § 46.109(d).
52. Ibid., § 46.109(e).
53. Ibid., § 46.111.
54. Kelly identifies the public policy objectives of these regulations to be "to prevent two closely related unethical results: First, that due to their powerlessness and deprived condition, prisoners will be coerced into accepting risks they would not accept if they were free; second, that researchers will use a 'captive' population to undergo experiments that involve a level of risk which civilian populations would find unacceptable." E. Kelly, "Expanding Prisoners' Access to AIDS-related Clinical Trials: An Ethical and Clinical Imperative," Prison Journal 75 (1995): 57.
55. 45 CFR § 46.306.
56. Ibid., § 46.305(a)(3).
57. Ibid., § 46.305(a)(2).
58. Ibid., § 46.305(a)(4).
59. Ibid., §§ 46.305(a)(6),(7).
60. Ibid., § 46.305(a)(5).
61. See note 1, p. 185.
62. Ibid., 195.
63. Ibid., 197.
64. V.L. Sharp, "Inmates as Clinical Trial Participants: Ethics and Implementation," (Paper presented at the Forum on Prisoner Access to Clinical Trials, Newark, N.J., January 1995).
65. 45 CFR §§ 46.116(a)(1), (8).
66. Ibid., § 46.116(b).
67. G. Siegel, "The Effect of Literacy and General Education Development Programs on Adult Offenders on Probation," Perspectives (Winter 1994): 38. Substantial numbers of these individuals can be expected to have learning disabilities that require accommodation under federal and state laws.
68. See note 1, p. 196.
69. The federal regulations also permit waiver of the documentation requirement in limited circumstances that would not apply to clinical trials. See 45 CFR §46.117(c). It should also be noted that the New Jersey Department of Corrections regulations, discussed in note 69, require written consent from inmates or parolees participating in research activities.
70. 45 CFR § 46.117(b)(1).
71. This will fulfill the obligations of prison officials and investigators under the Americans with Disabilities Act, 42 USC §§ 12101 and forward, and in New Jersey, the State Law Against Discrimination, NJSA 10:5-1 and forward, to meet the needs of individuals with disabilities and to ensure effective communication.
72. This will fulfill the obligations of prison officials and investigators under the Americans with Disabilities Act, 42 USC §§ 12101 and forward, and in New Jersey, the State Law Against Discrimination, NJSA 10:5-1 and forward, to meet the needs of individuals with disabilities and to ensure effective communication.
73. 45 CFR § 46.117(b)(2).
74. There was considerable discussion about this recommendation. Several FPA members believed that a prisoner or former prisoner should be the representative of choice. One member felt strongly that administrative and security difficulties could be minimized, given the IRB's willingness to meet inside the correctional facility and depending on the security level of the inmate or inmates involved. Another member suggested that the administrative problems could be overcome by having two members represent the interests of prisoners, one of whom would be a prisoner; presumably, at least one of the two would be able to attend each meeting.
75. The DOC regulations governing research activities involving inmates or parolees require a multi-level review of any research request, with the ultimate authority to approve or disapprove the request residing within the commissioner. The panel believed that these measures, in addition to the research institution's IRB, are adequate. See NJAC 10A:1-10.1 and forward.
76. Their experience contrasts with the perception on a national level that prisoners are "desperate" to have the opportunity to participate in HIV-related clinical trials. J. Walker, AIDS Information Coordinator, ACLU National Prison Project, telephone communication with L. Headley, 20 June 1995.
77. See note 59.
78. National Commission on AIDS, HIV Disease in Correctional Facilities, Recommendation Five.
79. F. Rocco, Coordinator of Health Education and Training, the Spellman Center for HIV-related Disease, St. Clare's Hospital and Health Center, telephone communication with L. Headley, 24 February 1995.
80. A few correctional systems are attempting to develop peer education programs; these, too, are essentially targeted toward prevention, especially where the peer educators are trained by the correctional system. Prisoners are generally suspicious of the information conveyed in such programs. By contrast, inmate-organized and inmate-controlled peer education by those living with HIV disease (who are usually self-taught), in the few places where it exists, is an effective means of distributing information. J. Walker, AIDS Information Coordinator, ACLU National Prison Project, telephone communication with L. Headley, 20 June 1995.
81. R. Jacobs, Executive Director, the Hyacinth Foundation, and former Director of Public Policy of the New Jersey Association on Corrections, telephone communication with L. Headley, 24 February 1995; D. Morgan, Assistant Commissioner, New Jersey Department of Health, Division of AIDS Prevention and Control, telephone communication with L. Headley, 16 March 1995.
82. See note 24; see also Management of HIV Infection in New York State Prisons (New York: New York State Department of Health AIDS Institute, 1989), 7.
83. One member of the forum has noted that it is unacceptable for staff who have had no medical training to be involved, in any way, in a triage process. In her experience, inmates fill out request slips when they wish to make an appointment with medical staff, with a carbon copy retained by the inmate. Such a system allows requests to be submitted in a way that preserves confidentiality; for instance, preaddressed envelopes could be available in all housing areas, or nursing staff who must visit each area on a daily basis to distribute medications could be responsible for collecting medical requests. C. Hanssens, AIDS Project Director, Lambda Legal Defense Fund, memorandum to the authors, 28 April 1995.
84. NJSA, 26:5C-5 and forward, generally prohibits the disclosure of records that contain identifying information about a person who has, or is suspected of having, HIV disease without the prior written consent of that person, except in certain limited circumstances, and creates a private right of action for violations of the statute.
85. T.D. Farrell, Supervisor, Health Services Unit, New Jersey Department of Corrections, (statement made during meeting of the Forum on Prisoner Access, Newark, N.J., January 1995). It should be noted, however, that the administrative regulations controlling the disclosure of medical information to DOC personnel generally permit the release of information to nonmedical personnel to the extent "necessary to permit proper exercise of discretion" where the "information is relevant in connection with the staff person's need to make a decision concerning the inmate, such as job placement, discipline, and parole." NJAC 10A:22-2.5. The regulations also generally permit the release of adult inmate records to law enforcement agencies or individuals in the course of their public duties. NJAC 10A:22-2.4. The regulations should be amended to incorporate the special protection afforded to HIV-related records under NJSA 26:5C-5 and forward.
86. T.D. Farrell, Supervisor, Health Services Unit, New Jersey Department of Corrections, (statement made during meeting of the Forum on Prisoner Access, Newark, N.J., January 1995). It should be noted, however, that the administrative regulations controlling the disclosure of medical information to DOC personnel generally permit the release of information to nonmedical personnel to the extent "necessary to permit proper exercise of discretion" where the "information is relevant in connection with the staff person's need to make a decision concerning the inmate, such as job placement, discipline, and parole." NJAC 10A:22-2.5. The regulations also generally permit the release of adult inmate records to law enforcement agencies or individuals in the course of their public duties. NJAC 10A:22-2.4. The regulations should be amended to incorporate the special protection afforded to HIV-related records under NJSA 26:5C-5 and forward.
87. T.D. Farrell, Supervisor, Health Services Unit, New Jersey Department of Corrections, (statement made during meeting of the Forum on Prisoner Access, Newark, N.J., January 1995). It should be noted, however, that the administrative regulations controlling the disclosure of medical information to DOC personnel generally permit the release of information to nonmedical personnel to the extent "necessary to permit proper exercise of discretion" where the "information is relevant in connection with the staff person's need to make a decision concerning the inmate, such as job placement, discipline, and parole." NJAC 10A:22-2.5. The regulations also generally permit the release of adult inmate records to law enforcement agencies or individuals in the course of their public duties. NJAC 10A:22-2.4. The regulations should be amended to incorporate the special protection afforded to HIV-related records under NJSA 26:5C-5 and forward.
88. T.D. Farrell, Supervisor, Health Services Unit, New Jersey Department of Corrections, (statement made during meeting of the Forum on Prisoner Access, Newark, N.J., January 1995). It should be noted, however, that the administrative regulations controlling the disclosure of medical information to DOC personnel generally permit the release of information to nonmedical personnel to the extent "necessary to permit proper exercise of discretion" where the "information is relevant in connection with the staff person's need to make a decision concerning the inmate, such as job placement, discipline, and parole." NJAC 10A:22-2.5. The regulations also generally permit the release of adult inmate records to law enforcement agencies or individuals in the course of their public duties. NJAC 10A:22-2.4. The regulations should be amended to incorporate the special protection afforded to HIV-related records under NJSA 26:5C-5 and forward.
89. This recommendation is in accord with the conclusions of the AIDS in Prison Project that "where a trial occurs at a healthcare site which generally serves the HIV-infected inmate population, the confidentiality of an inmate's HIV status is at least no more threatened by that inmate's participation in a trial than by the inmate's use of that site's other services." See note 49, p. 21.
90. "Prisoners in Clinical Trials," AIDS in Prison Project Newsletter, November 1993, 5.
91. Ibid., 4.
92. Division of Health Sciences Policy, IOM, National Academy of Sciences, Issues in the Inclusion of Women in Clinical Trials (Washington, D.C.: National Academy of Sciences, 1991).
93. General Considerations for the Clinical Evaluation of Drugs (Washington, D.C.: DHEW Publication No. FDA 77-3040).
94. NIH, Opportunities for Research on Women's Health (1991) (Bethesda, Md.: NIH publication no. 92-3457A, 1992), ix.
95. Ibid., 67.
96. "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," 58 Federal Register 39,407 (22 July 1993). The guideline has been effective since its publication. P. Goebel, Chief, Institutional Review Branch, Center for Drug Evaluation and Research, Division of Scientific Investigations, Food and Drug Administration, telephone communication with L. Headley, 23 June 1995.
97. "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," 59 Federal Register 14,508 (28 March 1994).
98. Ibid., 14,508.
99. See note 5.
100. See note 24, "Executive Summary."
101. L. Kummer, Infection Control Nurse, Maryland Department of Public Safety and Correctional Services, Division of Corrections (statement made during meeting of the Forum on Prisoner Access, Newark, N.J., January 1995).
102. N.M. Kendig, "Implementing Clinical Trials in Correctional Facilities," (Paper presented at meeting of the Forum on Prisoner Access, Newark, N.J., October 1994).
103. See note 92.
104. See note 79.
105. See note 24.
106. See note 1, p. 174; C. Potler, V.L. Sharp, and S. Remick, "Prisoners Access to HIV Experimental Trials: Legal, Ethical, and Practical Considerations," Journal of Acquired Immune Deficiency Syndrome 7 (1994): 1093.
107. See note 59.
108. M. Linde, Clinical Research Specialist, Pharmaceutical and Regulatory Affairs Branch, NIH, telephone communication with the authors, 6 June 1995.
109. 45 CFR §46.306(a)(2)(D).
110. J. Porter, D.P.A., M.P.H., Senior Policy Analyst, Office for Protection from Research Risks, telephone communication with the authors, April 1995.
111. R.J. Levine, Ethics and Regulation of Clinical Research, 2nd ed. (Baltimore, Md.: Urban & Schwarzenberg, 1986), 202-207.
112. A.R. Fleischman, Senior Vice President, New York Academy of Medicine, personal letter to the authors, 14 April 1995.
113. Potler, Sharp, and Remick, "Prisoners' Access to HIV Experimental Trials," 1092.
114. See note 49, p. 20.
115. See note 59.
116. See note 93.
117. R. Gottula, Medical Director, Colorado Department of Corrections, personal communication with the authors, 25 July 1994.
118. C. Smith, Clinical Administrator, Colorado Department of Corrections, personal communication with the authors, 1 March 1995.
119. See note 104; see note 59.
120. See note 79; Jacobs, personal communication with the authors.
121. See note 1, p. 204.