should review the impact of the correctional setting on the procedures, with input from the IRB affiliated with the correctional setting. It should be done in an expedient manner (e.g., within 30 to 45 days) to allow for continuation of study participation.

Continuity of care is an important issue, especially for treatment studies. If terminating prisoner participation would adversely affect the health of the subject, participation may continue until the IRB review takes place. The custodial official receiving the prisoner should be informed that the prisoner is enrolled in a research protocol, provided information on the protocol, and explained the potential risks of not allowing continued participation. The researcher would have an obligation to advocate for providing the appropriate care while seeking to comply with regulations applicable to that setting.

Certain social or behavioral studies that, for example, examine health and risk behaviors over several years, may see some participants move into correctional settings. If the researchers wish to continue study involvement for those individuals, review would be necessary to weigh the risks and benefits within the new setting. If the risks remain low, continuation may be approvable. However, if new risks are foreseen, but they are still low, the consent may need to be updated for the participant’s continued involvement.

This need for review may not be an issue for many jailed detainees who are often incarcerated for just a few days if that short period does not affect participation in the protocol. In a related, but different situation, if a prisoner is participating in a study within a correctional setting and is transitorily confined to disciplinary segregation, the researcher will have to evaluate whether or not the potential interruption in access during the period of segregation would preclude continued participation.

Research studies lose participants for many reasons. There may be occasions in which participation in the study may not continue for the research participant who becomes incarcerated. For example:

  • The IRB may determine that the risks outweigh potential benefits to remaining in the study.

  • By statute, some states do not permit biomedical/clinical trials research in prisons.

  • By Department of Corrections policy, some states do not permit biomedical/clinical trials research in prisons.

REFERENCES

BJS (Bureau of Justice Statistics). 2001. Trends in State Parole, 2000. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/tsp00.pdf [accessed December 23, 2005].



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