With more than half of individuals incarcerated having serious mental health concerns, correctional settings offer excellent opportunities for epidemiological, prevention, and intervention research. However, due to unique ethical and structural challenges, these settings create risks and vulnerabilities for participants not typically encountered in research populations. We surveyed 1,224 researchers, Institutional Review Board members, and IRB prisoner representatives to assess their perceptions of risks and vulnerabilities associated with mental health research conducted in correctional settings. Highest ranked risks were related to privacy, (...) stigma, and confidentiality; lowest ranked risks were related to prisoners’ loss of privileges or becoming targets of violence due to having participated in research. Cognitive impairment, mental illness, lack of autonomy, and limited access to services emerged as the greatest sources of vulnerability; being male, being female, being older than age 60, being a minority, and being pregnant were the lowest ranked sources of vulnerability. Researchers with corrections experience perceived lower risks and vulnerabilities than all other groups, raising the question whether these researchers accurately appraise risk and vulnerability based on experience, or if their lower risk and vulnerability perceptions reflect potential bias due to their vested interests. By identifying areas of particular risk and vulnerability, this study provides important information for researchers and research reviewers alike. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Following press disclosures in 1993 that U.S. government agencies had been using human subjects in tests and trials involving radioactive isotopes since the mid-1940s, a major national initiative to locate and declassify records concerning these tests was initiated. The U.S. Department of Energy, which led the declassification effort, pledged that a new “culture of openness” would attend the management of classified documents in the future. Following the attacks on the United States in September 2001, this momentum was reversed. Declassification initiatives (...) were delayed or terminated, and a significant portion of the many thousands of records about “human radiation experiments” during the 1940s and 1950s were removed from both online access, which had been in place since the mid-1990s, and from the public domain altogether. (shrink)