sections of the current regulations. For example, 45 C.F.R. § 46.305 (a)(2)– (7) includes the following regarding the issue of voluntariness to ensure that the subject’s participation in the research is not coerced:

  • any possible advantages accruing to the prisoner through his or her participation in research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison are not of such magnitude that his or her ability to weigh the risks of the research against the value of such advantages in a limited choice environment of the prison is impaired;

  • the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers; and

  • adequate assurance exists that parole boards will not take into account participation in making parole decisions, and prisoners will be informed that participation will have no effect on parole.

Institutional review boards (IRBs), however, have received guidance from the Office for Human Research Protections (OHRP) that suggests the definition may include parolees but not probationers. There is clearly confusion as to the parameters of the definition as it stands today. The important issue, as noted by the commission is that “prisoners are, as a consequence of being prisoners, more subject to coerced choice and more readily available for the imposition of burdens which others will not willingly bear” (NCPHSBRR, 1976).


Although this committee believes that research in correctional institutional settings should be subject to federal regulations, it also believes that the present emphasis on custodial detention is too narrow and results in depriving many other justice-involved individuals of human subjects protections appropriate to prisoner research participants. Several tables in Chapter 2 provide details relevant to this issue. Table 2-1 provides a broad snapshot of the number of individuals within the correctional population and notes that, as of December 2003, only 2.1 million of the 7 million total correctional population were in prisons and jails (Bureau of Justice Statistics [BJS], 2004). The rest had restricted liberties but outside the razor wire, in programs such as those listed in Table 4-1. These 4.9 million individuals (up from 1 million in 1978) require special protections when participating in research as well. Table 4-2 on pages 106–107 illustrates the vast array of incarceration options within the state of California and details a long list of alternatives to incarceration offered, including community service, electronic monitoring, and probation.

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