A major ethical concern in research with prisoners (and other incarcerated populations) is the potential for abuse due to coercive influences (and, to a lesser degree, undue incentives) in prison settings that may adversely affect offenders' capacity to give voluntary consent to research participation. A recent study by a committee of the Institute of Medicine (National Academy of Sciences) concluded that this concern extends to offenders in a variety of settings (e.g., in community corrections programs, on parole or probation) and made several recommendations regarding additional safeguards that might provide greater human subjects protections to offenders across a variety of settings, thus leading to more ethical practices in research with these populations. Numerous factors that may adversely affect individual autonomy in the prisoner/offender context have been identified; however, there have been no systematic empirical investigations of the extent to which offenders view these factors as salient or as likely to coercively influence their decisions about research participation. The primary objective of this research is to identify -- from the perspective of prisoner/offenders -- factors that may adversely affect the ability of these individuals to give voluntary consent to research participation.
Specific aims within this objective include assessing offenders' views about (1) research as a social enterprise, (2) the differential salience and perceived coercive influence of specific factors, and (3) the recommendations of the IOM/NAC Committee that were proposed to provide additional human subjects protections to prisoner/offender subjects.
These aims will be accomplished using questionnaire/survey methods that solicit subjects' self-reports about these issues. This research will provide the first, large-sample data regarding prisoner/offender views of the pervasiveness and coerciveness of factors that (putatively) may undermine voluntary consent. This information may be of considerable value to agencies that draft, implement, and enforce guidelines for research with offenders and to Institutional Review Boards that must pass judgment on the adequacy of human subjects research protections in protocols involving prisoners as research participants.

Public Health Relevance

This study will solicit views from offenders in various settings concerning the likelihood and impact of threats to autonomous decision-making in relation to participating in research. These data will be the first of their kind and will inform policy makers and IRB boards about offender groups' views of potential threats to voluntary research participation in these settings. ? ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
1R01MH081069-01A1
Application #
7526888
Study Section
Special Emphasis Panel (ZRG1-HOP-E (90))
Program Officer
Juliano-Bult, Denise M
Project Start
2008-09-18
Project End
2011-06-30
Budget Start
2008-09-18
Budget End
2009-06-30
Support Year
1
Fiscal Year
2008
Total Cost
$398,469
Indirect Cost
Name
Texas A&M University
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
078592789
City
College Station
State
TX
Country
United States
Zip Code
77845
Stiles, Paul G; Epstein, Monica; Poythress, Norman et al. (2012) Protecting people who decline to participate in research: an example from a prison setting. IRB 34:15-8
Magyar, Melissa S; Edens, John F; Epstein, Monica et al. (2012) Examining attitudes about and influences on research participation among forensic psychiatric inpatients. Behav Sci Law 30:69-86
Stiles, Paul G; Epstein, Monica K; Poythress, Norman G et al. (2011) Formal assessment of voluntariness with a three-part consent process. Psychiatr Serv 62:87-9
Poythress, Norman; Epstein, Monica; Stiles, Paul et al. (2011) Awareness of the Tuskegee syphilis study: impact on offenders' decisions to decline research participation. Behav Sci Law 29:821-8
Edens, John F; Epstein, Monica; Stiles, Paul G et al. (2011) Voluntary consent in correctional settings: do offenders feel coerced to participate in research? Behav Sci Law 29:771-95