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Federal Regulations for Prison-Based Research: An Overview for Nurse Researchers

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The National Institutes of Health (NIH) deems prisoners to be a vulnerable population because prisoners “may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research.” (NIH, 1978, ยง46.302). Stringent federal regulations have been instituted to protect prisoners from coercion or abuse. This article was borne from my experiences in implementing a mental health research project in a state prison system. The extent of the regulations at the project outset was underestimated, thus causing logistical challenges and delays. Familiarity with these regulations will facilitate the completion of prison-based research projects for other nurse researchers.


Document Type: Research Article


Publication date: 2011-03-01

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