Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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Appendix A Data Sources and Methods
Appendix A Data Sources and Methods
Pages 175-190
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From page 175... ...
. The committee organized two meetings with the liaison panel to receive their expert advice and guidance in framing the issues, identifying important sources of information, and ensuring a comprehensive analysis.
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This public workshop focused on the ethical, legal, regulatory frameworks that underlie research involving prisoners. The committee also heard from representatives of the corrections industry about the practicalities of conducting research in correctional settings.
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Regier, M.D., M.P.H., American Psychiatric Association Bernard Schwetz, DVM, Ph.D., Department of Health and Human Services Vera Hassner Sharav, M.L.S., Alliance for Human Research Protection Christopher Slobogin, J.D., LL.M., University of Florida School of Law Susan Sniderman, M.D., IRB Chair, UCSF Irene Stith-Coleman, Office for Human Research Protections T Howard Stone, J.D., LL.M., University of Louisville David Thomas, M.D., Nova Southeastern University College of Medicine Dan Wikler, Ph.D., Harvard University Gary Zajac, Ph.D., Pennsylvania Department of Corrections former prisoners and prisoner advocates talked about needed protections for research involving prisoners.
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Patricia El-Hinnawy, Office for Human Research Protections Julie Falk, CorrectHELP Christine Fornwalt, Johns Hopkins Bloomberg School of Public Health Gerald Gaes, National Institute of Justice Doreen Geiger, Washington State Department of Corrections Harold Goldstein, American Psychiatric Institute for Research and Education Te Guerra Erica Hall, KPFT Pacifica Radio, Houston News Shirley Hicks, Office for Human Research Protections addition, many other individuals attended and participated in the three public meetings (Box A-4)
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Sandra Sanford, George Mason University Jeffrey Schomisch, Guide to Good Clinical Practice Angela Sharpe, Consortium of Social Science Associations Barbara Solt, Institute for the Advancement of Social Work Research Anne Spaulding, Medical College of Georgia/ Georgia Correctional Health Care, Infectious Disease Mary Sylla, Centerforce Sara Tobin, Stanford University Center for Biomedical Ethics Christie Visher, The Urban Institute Cheryl Crawford Watson, National Institute of Justice Donna Willmott, Legal Services for Prisoners with Children Information Center, National Technical Information Service, and Excerpta Medica Database. Search terms used included IRB composition, multisite study/studies, risk-benefit, informed consent, undue influence, vulnerable populations, payment, biomedical research, behavioral research, environment, clinical trials, medication development, FDA, data storage, record keeping, privacy, placebo-control trials, standard of care, follow-up care, follow-up monitoring, data monitoring, HIV/AIDS, tuberculosis, infectious diseases, substance abuse, mental health, women, females, juveniles, adolescents, and mental illness.
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. Fifteen percent indicated institutional review board approval; other entity review was 19 percent.
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7 6 6 5 4 3 2 Number of Studies 1 1 1 1 1 1 1 1 1 1 0 t t s s n ty rant ress ward isons Gran ciate ge G ota P Gran inistratio Affair nd Quali hool m ersity rch A au of Pr Colle Asso eterans innes esea rch a al Sc re ABT s Ad V Univ ic sea ice of M Med Serv e Re ilot R deral Bu illy P ersity Fe hcar Eli L s and Univ Healt urce iatry/ eso ych y for lth R nt Ps genc A ce Hea doles nd A hild a of C emy Acad ican r Ame FIGURE A-2 Number of studies with other or other federal sources of funding.
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, Behavioral 39% Outcome, 14% Correlational Study, 27% FIGURE A-4 Study design. Type of Study Most of the studies (41 percent)
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study; any medical therapeutic study (regardless of the existence of a standard of care) ; any social/behavioral therapeutic study; and any nontherapeutic study involving a manipulation that the research assistant judged to involve potentially serious physical or emotional stress (e.g., long sleep deprivation)
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Number and Demographics of Research Participants The number of participants in a published article ranged from 1 to 336,668. Most studies (272)
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Juvenile detention centers were included in this analysis because the committee decided to limit its focus to adults after this literature assessment was conducted. 6 >100,000 Number of Participants 10 10,001-100,000 39 1,001-10,000 182 101-1,000 90 <100 0 50 100 150 200 Number of Studies FIGURE A-9 Number of research participants.
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300 242 250 229 Number of Studies 191 200 161 150 100 50 0 Black/African White/Euro Latino/Hispanic Other American American FIGURE A-12 Number of studies by race/ethnicity of research participants.
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187 APPENDIX A 140 122 120 100 Number of Studies 80 60 51 50 40 20 5 2 2 2 1 1 1 1 1 1 0 ab n er e an an a n an al te l r ia e ia iv tin tia in hi nd th ac Ar ic ic di at As ig La ai -w /O er er In la tir N or H on Am Am Is ify ul ka Ab M N ec fic as e an ci Sp iv Al Pa ic at ex ot N N M id D FIGURE A-13 Number of studies with participants of "other" race/ethnicity. 5 4 Number of Studies 4 3 3 2 2 2 1 1 1 1 0 Bi-racial Minority Multi- Mixed Non- Bi- Mulatto racial black cultural FIGURE A-14 Number of studies with nonwhite participants.
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Telephone Interviews The committee collected information from DOCs in six states via telephone interviews: New York, California, Iowa, Texas, Florida, and Utah. The interviews covered the following: • types of research that are conducted, • number of studies that have been undertaken in recent years, • requirements for informed consent, • degree of risk to which research subjects are subjected, • procedures for processing research proposals, • credentials and qualifications of the people charged with the responsibility of approving research, • problems or concerns that have arisen in connection with such research, and • impact of laws and regulations on proposed or actual research projects.
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or correlational studies (e.g., association of prisoner characteristics with type of index crime, number/type of disciplinary infractions) based on information routinely gathered by the DOC outside the framework of a specific research protocol 2.
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Answer the following questions only if at least one of the types of research described above is permitted in your DOC. To ensure the safety of research subjects, in many research settings any study that involves human beings as research participants must be evaluated and approved by an institutional review board (IRB)
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