BOX S-1

Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research

Recommendations

Redefine the term prisoner to expand the reach of human subjects protections. (4.1)

Ensure Universal, Consistent Ethical Protection

  • Establish uniform guidelines for all human subjects research involving prisoners. (3.1)

  • Maintain a public database of all research involving prisoners. (2.1)

  • Ensure transparency and accountability in the research enterprise. (6.7)

Shift from a Category-Based to a Risk-Benefit Approach to Research Review

  • Apply a risk-benefit framework to research review. (5.1)

Update the Ethical Framework to Include Collaborative Responsibility

  • Use a collaborative research approach. (5.2)

  • Ensure adequate standards of care. (5.3)

  • Support critical areas of correctional research. (5.4)

Enhance Systematic Oversight of Research Involving Prisoners

  • Strengthen monitoring of research involving prisoners. (6.3)

  • Modify institutional review board considerations for independent ethical review of research protocols. (6.4)

  • Enhance the Office for Human Research Protections’s capacity to provide systematic oversight of research involving prisoners. (6.5)

  • Establish systematic oversight of all research with prisoners. (6.6)

  • Ensure voluntary informed consent. (6.1)

  • Protect the privacy of prisoners engaged in research. (6.2)

tional institution or a community setting, in which a person’s liberty is restricted by the criminal justice system. (Recommendation 4.1)

The goal of this recommendation is to expand the reach of the regulatory procedures and oversight mechanisms recommended in this report to the fuller population of individuals whose liberty is restricted by the criminal justice system. These individuals face greater risks than those in the general population. The freedom of a prisoner to make a choice as well as the ability to protect his or her privacy can be hampered in any of the correctional settings that restrict liberty. Throughout this report, the term prisoner is used with this expanded meaning in mind. An exclusion, however, was provided by the committee so that prisoners living in a noncusto-



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