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Ethical Considerations for Research Involving Prisoners
2
Today’s Prisoners: Changing Demographics, Health Issues, and the Current Research Environment
The conditions of confinement in today’s prisons and jails have many of the same characteristics that were of concern to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR) some 30 years ago (see Appendix B). Yet important new factors have emerged that require consideration. The correctional population has expanded more than 4.5 fold between 1978 and 2004—from 1.5 million to almost 7 million as a result of tougher sentencing laws and the war on drugs (Bureau of Justice Statistics [BJS], 1997, 2005a,f,g,h; Human Rights Watch [HRW], 2003; Jacobson, 2005). Just within prisons and jails, the population grew from 454,444 to 2.1 million (BJS, 2005a,f). The rest of the expansion occurred among probationers and parolees (BJS, 2005g,h).
In addition, with the closing of large state mental institutions, prisons have effectively become the new mental illness asylums. Prisoners suffer higher rates of communicable diseases, such as human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) and hepatitis, than the general population, and chronic diseases such as diabetes are on the rise, especially among the growing older population of prisoners (National Commission on Correctional Health Care [NCCHC], 2002). Health care within some prison systems is less than satisfactory. Through class actions over the inadequacies of state prison health-care systems, the most serious problems were largely addressed and health-care delivery systems were put in place (Metzner, 2002; Sturm, 1993). However, problems remain. Most recently, a federal district court judge placed California’s entire prison medical health-care system into federal receivership, taking it out of
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control of the state and placing it under the control of a trustee appointed by the court.1 In addition, the entire state prison mental health system is being monitored by another federal court after being found to be providing constitutionally inadequate mental health services to inmates with serious mental illnesses (Coleman v. Wilson, 912 F.Supp. 1282 [E.D.Cal 1995]). And New York regulators have faulted the private firm Prison Health Services in several deaths within the state’s prison system (Von Zielbauer, 2005d). This follows by 30 years the case of Estelle v. Gamble, in which the U.S. Supreme Court articulated a constitutionally protected right to health care in prisons and jails (U.S. Supreme Court, 1976).
The committee’s review of current research indicated that the majority of research involving prisoners is happening outside the purview of Subpart C, and many prisoner studies are being conducted without review or approval by an institutional review board (IRB). Prison research committees that may serve some type of proxy IRB role only infrequently include prisoners or prisoner representatives among their membership. All of these factors point to a population of prisoners who may be more vulnerable and require stronger protections than those inspired by the commission in the 1970s.
CHANGING DEMOGRAPHICS AND HEALTH ISSUES
Descriptions of Prisons, Jails, and Other Correctional Settings
Within the United States, correctional settings, which constrain liberty, entail more than prisons. Local jails, usually county or city facilities, house prisoners from arraignment through conviction and for sentences usually no longer than one year. State and federal prisons incarcerate those sentenced for longer periods. About 6 percent, or close to 99,000 prisoners, are held in privately operated facilities that incarcerate the state and federal overflow (BJS, 2005a,c). In six states, all in the West, at least one-quarter of all persons in prisons are in private facilities (BJS, 2005a). Several other alternatives to prisons and jails that constrain liberty, including restitution centers, camps, treatment facilities, and electronic monitoring programs, are listed in Table 4-1 (see Chapter 4); specific options within the state of California are provided in Table 4-2 (see Chapter 4). Parole and probation are two other settings in which individuals have restricted liberties by virtue of involvement in the criminal justice system. Parole is used for offenders
1
U.S. District Court for the Northern District of California. Findings of Fact and Conclusions of Law Re Appointment of Receiver, Marciano Plata, et al. vs. Arnold Schwarzenegger, et al., October 3, 2005, page 2.
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who are conditionally released from prison to community supervision. An offender is required to observe the conditions of parole and is under the supervision of a parole agency. Parole differs from probation, which is determined by judicial authority and is usually an alternative to initial confinement.
The Prisoner Population
The Incarcerated Population Has Grown Enormously
The total estimated correctional population in the United States in 2004 was very close to 7 million, according to the Bureau of Justice Statistics (2005a). Table 2-1 indicates that the majority of these individuals were on probation (4 million), followed by confinement in prison (1.4 million), on parole (765,355), and confinement in jail (713,990). Overall, the population in 2004 was more than 4.5 times larger than it was in 1978.
By the end of 2004, the nation’s prisons and jails incarcerated 2.1 million persons (BJS, 2005a) compared with 216,000 in 1974 (BJS, 2003a). Today, two-thirds of inmates are housed in federal and state prisons, and the other third are in local jails.
The numbers in Table 2-1 are point-in-time figures. Annual flow in and out of jail, where incarceration time is comparatively short, provides a useful picture as well. Nearly a quarter (23 percent) of all jail inmates spend 14 days or less in jail, 29 percent are held from 2 to 6 months, 7 percent are held for a year or more (BJS, 2004c). The transitory nature of jail confinement can have an impact on research participation, as discussed in Chapter 4.
Using Department of Justice statistics and trends, the Justice Policy
TABLE 2-1 Persons Under Adult Correctional Supervision, 1978–2004 Total Estimated
Year
Correctional Population
Probation
Parole
Jail
Prison
1978
1,531,596
899,305
177,847
158,394
296,050
1980*
1,840,400
1,118,097
220,438
82,288
319,598
1995
5,342,900
3,077,861
679,421
507,044
1,078,542
2000
6,445,100
3,826,209
723,898
621,149
1,316,333
2001
6,581,700
3,931,731
732,333
631,240
1,330,007
2002
6,758,800
4,024,067
750,934
665,475
1,367,547
2003
6,936,600
4,144,782
745,125
691,301
1,392,796
2004
6,996,500
4,151,125
765,355
713,990
1,421,911
*1980 figures from BJS, 2003c.
SOURCES: U.S. Census, 1998, 1994; BJS, 1997, 2000a, 2003c, 2004b, 2005a,f,g,h.
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FIGURE 2-1 The punishing decade: number of prison and jail inmates, 1910– 2000.
SOURCE: JPI (2002).
Institute (JPI) based in Washington, D.C., estimated in 2000 that the United States had the world’s largest incarcerated population and highest incarceration rate. Just 6 weeks into the new millennium, America had one-quarter of the world’s prison population, despite having less than 5 percent of the world’s population (JPI, 2002). The U.S. incarceration rate was highest, with 686 per 100,000 of the national population (Walmsley, 2003), followed by the Cayman Islands (664), Russia (638), Belarus (554), Kazakhstan (522), Turkmenistan (489), and Belize (459). More than 62 percent of countries worldwide have rates below 150 per 100,000. By 2004, the U.S. rate had risen to 724 per 100,000 (BJS, 2005a).
Calling the 1990s “the punishing decade,” JPI noted that the imprisoned population grew at a faster rate during the 1990s than during any decade in recorded history (see Figure 2-1). The prison growth during the 1990s dwarfed the growth in any previous decade; it exceeded the prison growth of the 1980s by 61 percent and is nearly 30 times the average prison population growth of any decade before the 1970s (JPI, 2002). This growth has led to serious overcrowding. According to BJS data for 2004 (BJS, 2005a), 24 state departments of corrections and the federal prison system are operating above capacity. The federal prison system is operating at 40 percent above capacity.
The population of prisoners under jail supervision who are confined in
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TABLE 2-2 Persons Under Jail Supervision, by Confinement Status and Type of Program, Midyear 1995, 2000, and 2002–2004
Confinement Status and Type of Program
Number of Persons Under Jail Supervision
1995
2000
2002
2003
2004
Total
541,913
687,033
737,912
762,672
784,538
Held in jail
507,044
621,149
665,475
691,301
713,990
Supervised outside of jail facilitya
34,869
65,884
72,437
71,371
70,548
Weekender programs
1,909
14,523
17,955
12,111
11,589
Electronic monitoring
6,788
10,782
9,706
12,678
11,689
Home detentionb
1,376
332
1,037
594
1,173
Day reporting
1,283
3,969
5,010
7,965
6,627
Community service
10,253
13,592
13,918
17,102
13,171
Other pretrial supervision
3,229
6,279
8,702
11,452
14,370
Other work programsc
9,144
8,011
5,190
4,498
7,208
Treatment programsd
NA
5,714
1,256
1,891
2,208
Other/unspecified
887
2,682
9,663
3,080
2,513
NOTE: NA, not available.
aExcludes persons supervised by a probation or parole agency.
bIncludes only those without electronic monitoring.
cIncludes persons in work-release programs, work gangs, and other work alternative programs.
dIncludes persons under drug, alcohol, mental health, and other medical treatment.
SOURCE: BJS, 2005c.
settings outside of a jail facility has doubled since 1995 (see Table 2-2). This point is important for the Chapter 4 discussion regarding the definition of the term prisoner. In 2004, jail authorities supervised 70,548 men and women in the community in work-release, weekend reporting, electronic monitoring, and other alternative programs.
Why Has the Prisoner Population Grown?
The exponential growth of prison and jail populations in the last two decades has many causes. Some relate to changes in federal and state sentencing policies, and some reflect the actions of American society in those years as it engaged in a war against drugs. BJS reports that, in 1997, 21 percent of state prisoners and more than 60 percent of federal prisoners were incarcerated for drug offenses (BJS, 1999c). Between 1995 and 2003, 49 percent of the total growth in the federal prison population was from drug offenses (BJS, 2005a). Michael Jacobson, former Commissioner of the
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New York City Departments of Correction and Probation, argues in his book, Downsizing Prisons (2005), that mandatory minimum sentencing, parole agencies intent on sending people back to prison, three-strike laws (defined below), for-profit prisons, and other changes in the legal system have contributed to the spectacular rise of the general prison population. The Sentencing Project (TSP) came to the same conclusion, stating that rigid sentencing formulas such as mandatory sentencing and truth in sentencing often result in lengthy incarceration (TSP, 2001). According to Human Rights Watch (2003), the U.S. rate of incarceration soared to the highest in the world for the reasons stated previously: “Championed as protecting the public from serious and violent offenders, the new criminal justice policies in fact yielded high rates of confinement for nonviolent offenders. Nationwide, nonviolent offenders account for 72 percent of all new state prison admissions.”
Three-strikes laws impose mandatory life terms or extremely long prison terms without parole for criminals who have been convicted of three felonies involving violence, rape, use of a deadly weapon, or molestation. In some states, such as California, the third felony does not even have to be a violent crime. California’s three-strikes law is considered the toughest in the country, because it can be invoked when a third felony conviction is for a nonviolent crime—even one that could have been charged as a misdemeanor if the prosecutor had wanted to [JPI, 2004; TSP, 2001].) Nationally, half of the states have enacted some form of three-strikes legislation, but only a handful have convicted more than 100 individuals using the statute, led by a wide margin by California, according to the Justice Policy Institute and the Sentencing Project (JPI, 2004; TSP, 2001). “As of mid 1998, only California (40,511 individuals), Georgia (942), South Carolina (825), Nevada (304), Washington, (121), and Florida (116) had been using the three-strikes legislation to any significant extent” (TSP, 2001). Moving into 2004, three strikes was most heavily used in three states, with 42,322 persons incarcerated under the three-strikes law in California, 7,631 in Georgia, and 1,628 in Florida (JPI, 2004).
Reported rates of recidivism for adult offenders in the United States are extraordinarily high, as noted in a report by the Open Society Institute (OSI, 1997): “The national rearrest rate is around 63 percent, and the reimprisonment rate averages around 41 percent.” Among probationers and parolees, recidivism is lower but still occurs. In 2003, 16 percent of probationers were incarcerated because of a rule violation or a new offense (BJS, 2004b). That same year, 38 percent of parolees were incarcerated because of violations of parole conditions (26 percent) or committing a new crime (11 percent) (BJS, 2004b). Parole officers are spending more time on policing whether conditions are violated (with more drug tests, more track-
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TABLE 2-3 Prisoners Under the Jurisdiction of State or Federal Correctional Authorities, by Gender, 1995, 2003, and 2004
Variable
Men
Women
All inmates
1995
1,057,406
68,468
2003
1,363,813
100,384
2004
1,391,781
104,848
Average annual change, 1995–2004
3.1%
4.8%
Sentenced to > 1 year
2003
1,315,790
92,571
2004
1,337,668
96,125
Percent change, 2003–2004
1.7%
3.8%
Incarceration ratea
1995
789
47
2004
920
64
aTotal number of prisoners with a sentence of more than 1 year per 100,000 U.S. residents on December 31.
SOURCE: BJS, 2005a.
ing of movement, and so on) and less on promoting reintegration (Petersilia, 2000).
Finally, admissions to state and federal prisons are outpacing releases (BJS, 2005c). There was also a large increase in parole violators returning to prison between 1990 and 1998. The number of returned parole violators increased 54 percent between 1990 and 1998 (from 133,870 to 206,152) and has since slowed to a 2 percent annual increase (BJS, 2005a,c).
Who Is in Prison and Jail?
Men far outnumber women in prisons and jails. Men make up 93 percent of all inmates (BJS, 2005a). By the end of 2004, 104,848 women and 1,391,781 men were in state or federal prisons. The female prisoner population has been rising at a faster rate than the male prisoner population (Table 2-3). The overall increase since 1995 for male prisoners is 32 percent and for female prisoners, 53 percent (BJS, 2005a).
More women are entering the correctional system Between 1980 and 1998, the number of female inmates under the jurisdiction of federal and state correctional authorities increased more than 500 percent, from about 13,400 in 1980 to roughly 84,400 by the end of 1998, according to the U.S.
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TABLE 2-4 Jail Populations by Gender, 1990– 2004 (1-Day Count)
Year
Adult Males
Adult Females
1990
365,821
37,190
1991
384,628
39,501
1992
401,106
40,674
1993
411,500
44,100
1994
431,300
48,500
1995
448,000
51,300
1996
454,700
55,700
1997
498,678
59,296
1998
520,581
63,791
1999
528,998
67,487
2000
543,120
70,414
2001
551,007
72,621
2002
581,411
76,817
2003
602,781
81,650
2004
619,908
86,999
SOURCE: BJS, 2005e.
General Accounting Office (GAO, 1999). In 2004 (BJS, 2005a), that number had risen to 104,848 (Table 2-3). A large percentage of these women (85 percent) were on parole or probation (BJS, 1999b).
Within jails specifically (Table 2-4), between 1990 and 2004, the female inmate population grew 134 percent, whereas the male inmate population grew by 70 percent.
Not only is the female population becoming larger, but it is also becoming more diverse. Increasingly, incarcerated women are older and more likely minority and drug abusers than earlier populations of women prisoners (BJS, 2005a; GAO, 1999, 2000).
In Gender-Responsive Strategies for Women Offenders (2005), the National Institute of Corrections (NIC) staff characterize women in the criminal justice system: “Women offenders typically have low incomes and are undereducated and unskilled. They have sporadic employment histories and are disproportionately women of color. They are less likely than men to have committed violent offenses and more likely to have been convicted of crimes involving drugs or property. Often, their property offenses are economically driven, motivated by poverty and by the abuse of alcohol and other drugs.” Women prisoners in general have poorer health than men, with higher rates of mental illness (BJS, 1999a) and HIV infection (BJS, 1999b). Women prisoners also are more likely to report medical problems after admission than men (BJS, 2001b). These data and the rising rates of
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incarceration among women make health care for women in prison a pressing issue (Young and Reviere, 2001).
Women offenders have needs that are different from those of men, stemming in part from their disproportionate victimization from sexual and physical abuse and their responsibility for children, according to the authors of Women Offenders: Programming Needs and Promising Approaches (BJS, 1998b). In an American Journal of Public Health editorial, Braithwaite et al. (2005) noted that the diverse needs of women are forgotten and neglected in the criminal justice system. Medical concerns that relate to reproductive health and to the psychosocial matters that surround imprisonment of single female heads of households are often overlooked. The authors state that “Women in prison complain of a lack of regular gynecological and breast examinations and say their medical concerns are often dismissed.” They also note the poor physical health of women as they enter the correctional system, with higher than average risk for high-risk pregnancies, HIV/AIDS, hepatitis C, and human papillomavirus infection, a risk factor for cervical cancer. Nearly 6 in 10 women in state prisons had experienced physical or sexual abuse in the past (BJS, 1999b).
“Women have more severe substance abuse histories by the time they come to the attention of the criminal justice system,” said Nena P. Messina, Ph.D., a criminologist at University of California, Los Angeles Integrated Substance Abuse Programs. “That means they are using drugs on a daily basis. They are more likely to be injecting drugs, using multiple drugs, and trading sex for drugs and money. Their histories and their paths to substance abuse and crime are very different than men’s.” Messina described her experience with women prisoners at the July 2005 meeting of this Institute of Medicine (IOM) committee.
In a survey of prisoners in New Jersey (Blitz et al., 2005), researchers found that women were more likely to be classified as special needs inmates (those with behavioral health disorders) than men (37 percent versus 16 percent). An active addiction disorder was present in one-half to three-quarters of women with behavioral health disorders. National data collected by the BJS in 1998 also showed more women than men (20 percent versus 16 percent) are diagnosed with mental disorders (BJS, 1999a).
Although substance abuse is common, drug rehabilitation programs are not common in these institutions (Braithwaite et al., 2005). Consequently, when women prisoners are released, they are at high risk of falling
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Ethical Considerations for Research Involving Prisoners
TABLE 2-5 Children of Women Under Correctional Supervision, 1998
Variable
Women Offenders
Women Offenders with Minor Children
Minor Children
Total
869,600
615,500
1,300,800
Probation
721,400
516,200
1,067,200
Jail
63,800
44,700
105,300
State prisons
75,200
49,200
117,100
Federal prisons
9,200
5,400
11,200
NOTE: Only children under age 18 are counted.
SOURCE: BJS, 1999b.
back into addiction with exposure to the environmental pressures that led them there in the first place.
Women are also more likely than men to be solely responsible for their children. Two-thirds of incarcerated women have children younger than 18 years (BJS, 1999b). Approximately 1.3 million children in the United States have mothers under correctional supervision (Table 2-5). Just under a quarter million children have mothers who are serving time in prison or jail (BJS, 1999b).
Racial and ethnic disparities Blacks and Hispanics are disproportionately represented in prison and jail populations. At midyear 2004, an estimated 12.6 percent of all black males in their late 20s were in prisons or jails compared with 3.6 percent of Hispanic males and 1.7 percent of white males (BJS, 2005c). Young black men are particularly hit hard. One in eight black men in their late 20s is incarcerated on any given day (Mauer & King, 2004). A report of the National Center on Institutions and Alternatives (Lotke, 1997) indicated that in the District of Columbia, 50 percent of young black men ages 18 to 35 were under criminal justice supervision (in prison, jail, probation, parole, out on bond, or being sought on a warrant). Table 2-6 shows jail incarceration rates by race and ethnicity from 1990 through 2004.
Educational level and reading skills of prisoners Often individuals come into the correctional system with little education and, therefore, poor reading, writing, math, and oral communication skills (Haigler et al., 1994; Spangenberg, 2004). Poor reading and communication skills pose a challenge to informed consent, which is often handled through written documents, and points to the importance of ensuring that informed consent procedures are monitored to determine that prisoners truly understand what they are consenting to. The BJS (2003b) reported on the poor educa-
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TABLE 2-6 Jail Incarceration Rates by Race and Ethnicity, 1990–2004a
Year
White Non-Hispanic
Black Non-Hispanic
Hispanic of Any Race
1990
89
560
245
1991
92
594
247
1992
93
618
251
1993
94
633
262
1994
98
656
274
1995
104
670
263
1996
111
640
276
1997
117
706
293
1998
125
716
292
1999
127
730
288
2000
132
736
280
2001
138
703
263
2002
147
740
256
2003
151
748
269
2004
160
765
262
NOTE: U.S. resident population estimates for sex, race, and Hispanic origin were made using a U.S. Census Bureau Internet release, December 23, 1999, with adjustments for census undercount. Estimates for 2000–2004 are based on the 2000 Census and then estimated for July 1 of each year.
aPer 100,000 U.S. residents.
SOURCE: BJS, 2005a.
tion level of prisoners. Forty-one percent of inmates in the nation’s state and federal prisons and local jails and 31 percent of probationers had not completed high school or its equivalent (Table 2-7). In comparison, 18 percent of the general population age 18 or older had not finished the twelfth grade. Minority prisoners had lower education levels than whites (53 percent of Hispanics, 44 percent of blacks, and 27 percent of whites had no diploma or general equivalency diploma). The same report indicates that less educated prisoners were less likely to have jobs before they entered prison and more likely to have a prior sentence, to be sentenced as juveniles, and to return to prison after release.
Prisoners tend to leave the system poorly educated as well. According to a 1997 report by the OSI, Education As Crime Prevention: Providing Education to Prisoners, in the shift from rehabilitation to punishment and the exponential population growth, educational and vocational programs, which, OSI notes, correlate positively with the ability to remain out of prison, have been substantially reduced. Despite evidence supporting the connection between higher education and lowered levels of recidivism, the
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probation, residential drug treatment programs, parole, mental health facilities, community corrections, home confinement, and boot camps.
Types of research Very little research in the published literature involves medical clinical trials or other biomedical studies (see Figure 2-3). The majority of published studies were minimal risk, nontherapeutic social and behavioral studies (41 percent), DOC program evaluations (26 percent), administrative records review (21 percent), or social or behavioral therapeutic studies (6 percent).
Study content/design Prisoner research is dominated by epidemiological studies (e.g., surveys, 39 percent) and correlational designs (27 percent).
FIGURE 2-3 Type of study.
NOTE: Greater than minimal risk included any biomedical (nontherapeutic) study; any medical therapeutic study (regardless of the existence of a standard of care); any social/behavioral therapeutic study; and any nontherapeutic study involving a manipulation that the research assistant (RA) judged to involve potentially serious physical or emotional stress (e.g., long sleep deprivation). Not greater than minimal risk included any study based on review of administrative records; any program evaluation study; any nontherapeutic social/behavioral study that involved either no manipulation (e.g., innocuous questionnaires and surveys) or involved a manipulation that the RA judged not to involve potentially serious physical or emotional stress (e.g., long sleep deprivation).
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FIGURE 2-4 Source of funding.
Other studies are described as examining behavioral issues (14 percent), medical outcomes (5 percent), case studies (6 percent), nonmedical experiments (1 percent), or “other” (8 percent). An alternative classification of study content reveals that health status questions (43 percent) and personality characteristics (19 percent) are the focus of most research. Other studies deal with aspects of being confined (10 percent) or reentry into the community (11 percent) or bear no clear relationship to prisoner status (9 percent).
Sources of funding It was sometimes challenging to determine or to categorize the source of funding for prisoner research from published reports. Approximately 20 percent of the studies reviewed did not indicate the source of support (see Figure 2-4), and another 29 percent fit the “other” coding category (e.g., a medical school grant; university small grants; a study supported by a Veterans Affairs office). Prisoner research is funded by a wide variety of state and federal entities. Federal resources cited in the present sample included two DHHS agencies (NIH, 8 percent and CDC, 3 percent), National Institute of Justice (5 percent), and “other” federal (10 percent). Also mentioned were state funds (11 percent), foundation grants (5 percent), and prison system funding (4 percent).
Mechanisms of research approval For 15 percent of the studies, a statement in the report indicated that the investigators had obtained IRB approval for the research; for another 19 percent of studies, the approval of some other reviewing body (e.g., a research committee) was referenced. For
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most studies (66 percent), the reports did not indicate whether, or by whom, the research was approved (in terms of human subjects protections).21
A review of 10 years of correctional and scientific literature on HIV/ AIDS studies involving prisoners (Farley, unpublished, 2005) yielded similar findings. The studies reviewed lacked transparency. Fewer than one-third of the studies mentioned review by an IRB, and nearly one-half made no mention of informed consent.
Data Retrieval Needs Improving
“[Prisoners’] only single armor against being subjected to experimental abuse hangs on a single thread, on a single federal regulation in federally funded research only,” said Vera Hassner Sharav, founder and president of the Alliance for Human Research Protection. “Chimpanzees, by contrast, are protected by mandatory rules, oversight, and enforcement mechanisms since the Animal Welfare Act of 1966. The U.S. Department of Agriculture (USDA) must submit annual reports to Congress documenting the disposition of every chimp, dog, rabbit, and hamster. No one keeps track of how many human beings have died or been harmed in clinical research.” Sharav painted this stark comparison of protections for prisoners with protections for animals in research at the committee’s July 2005 meeting.
The dearth of information regarding the contemporary landscape of prisoner research led the committee to gather systematic information concerning the frequency and types of prisoner research currently being conducted and the research-related policies and procedures of state agencies that house large numbers of prisoners. It was conceded at the outset that the scope of the committee’s efforts in this regard would be limited. For example, the surveys of key personnel in prisons were limited to state DOCs and did not include the federal prison system or the myriad city, county, and municipal jails in which offenders may be at least temporarily
21
This does not necessarily mean, however, that human subjects reviews were not conducted or that appropriate approvals were not obtained. Journals and journal editors vary considerably in their requirements for reporting (or not) that the research had prior IRB or other human subjects review and approval.
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Jeffrey Ian Ross, an associate professor in the Division of Criminology, Criminal Justice, and Social Policy at the University of Baltimore, and a member of the committee’s Prisoner Liaison Panel, agreed at the committee’s October 2005 meeting that a registry is needed. “I would make it a point to have some sort of clearinghouse that actually tracks this kind of research on a regular basis so we know if it is increasing, decreasing, and whether it is more behavioral, social science, criminologic, or medical.”
housed. Similarly, the review of published literature was of limited scope and was not supplemented with efforts to uncover, sample, and review unpublished reports in the possession of state, federal, or private agencies or research institutions.
There is no central repository of information about the amount and type of research involving prisoners. For the same reason that registries of clinical research on drugs and biologics exist and have recently garnered strong support (DeAngelis et al., 2004; IOM, 2006), a national database would bring clarity to the currently murky landscape of research involving prisoners.
Recommendation 2.1: Maintain a public database of all research involving prisoners. The Department of Health and Human Services, in cooperation with the Department of Justice, should systematically and comprehensively document all human subjects research with prisoners.22
The establishment of a national registry of research involving prisoners should include data, such as who is conducting research, with what support, what kind of research, on what populations, and the nature and extent of ethical oversight provided. There is currently no central repository of information about the amount and type of research involving prisoners, however a government-run registry of clinical research does exist (www.Clinicaltrials.gov) and could be a starting point and leveraging mechanism to make this endeavor feasible and not cost prohibitive. A national registry would shed light on the totality of research taking place on prisoners and the quality of ethical oversight provided for each protocol. To enable consideration of questions of justice, it could be used to examine
22
The term prisoner is defined by the Committee in Chapter 4 and used throughout this report in a broader way that it is commonly used. In this report, the term prisoner refers to all persons, including parolees and probationers, whose liberty has been restricted by decisions of the criminal justice system.
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the magnitude and volume of prisoners in different types of research to determine the allocation of benefits and burdens of research among prisoners. A registry would also enhance the application of research findings to prisoner populations. In the absence of such a registry, the committee was unable to accurately determine the nature and extent of prisoners’ participation as subjects of research.
Cost is always a consideration when suggesting a database be developed. The director of Clinicaltrials.gov, the federal government’s public database of clinical research, indicated that the annual costs for that database, which is maintained at the National Library of Medicine, is $3.2 million per year (Deborah Zarin, personal communication, May 17, 2006). She noted, however, that there may not be a reason to start a new registry for research involving prisoners. The existing clinicaltrials.gov could add a field that indicated if prisoners were included in a study, and then users could customize the view to see only those studies. At present, clinicaltrials. gov does not include social/behavioral research, but it could be a starting point and leveraging mechanism to make Recommendation 2.1 feasible and not cost prohibitive.
Summary of Findings on Current Research Environment
Findings from the surveys of DOC personnel and the literature review shed light on the possible impact of the national commission’s Report and Recommendations—Research Involving Prisoners (NCPHSBBR, 1976) and indicate practical and political complexities that may hamper efforts to create a uniform and comprehensive system of protections for prisoners as research participants. Findings and implications from these data include the following:
The reach of the Subpart C regulations to protect prisoners involved in research does not extend to the vast majority of prisoner research participants. The current regulations are binding only with respect to research supported by DHHS or in those institutions that voluntarily extend the regulations to non-DHHS funded studies involving prisoners (currently the Central Intelligence Administration and Social Security Administration; see Chapter 3). Survey responses from key DOC personnel reveal that a significant amount of research with prisoners is initiated and conducted internally, and that extramural research applications come from a wide variety of investigators, some (perhaps many) of whom may not be supported by DHHS funding, and thus not bound by the regulations. Similarly, the review of published prison research studies indicates that only about 11 percent of studies are DHHS funded, through NIH and the CDC (the
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percentage may be slightly higher given that NIH and CDC may jointly fund some studies coded as having multiple funding sources).
It is not clear that all studies involving prisoners are being conducted with IRB review and approval. Also, prison research committees, which may serve some type of proxy IRB role, only infrequently include prisoners or prisoner representatives among their membership.
Biomedical research involving prisoners, particularly that of a nontherapeutic nature, is rare, perhaps as a consequence of the national commission’s 1976 report. Across the two surveys, one-third of respondents indicated that therapeutic medical studies might be permissible, and only 5 percent (two states) indicated that nontherapeutic biomedical research might be permissible. Several DOCs report that biomedical research, including potentially therapeutic research, is prohibited by state law or DOC policy. Further, medical studies with the potential for therapeutic outcome make up only 2 percent of the published prisoner research studies. Although the current regulations permit therapeutic medical studies with prisoners under certain circumstances, little such research appears to be taking place.
Some DOC research implementation policies may preclude potential remedies that some have suggested to ensure fair and equitable research participation by prisoners. For example, some have suggested the prisoner participants be allowed to receive incentives that, if not equal, are at least proportional to those available to nonprisoner participants in the community. Five of the six state DOCs interviewed in depth prohibit prisoner participants from receiving financial or other incentives for research participation.
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Representative terms from entire chapter:
involving prisoners