A
Data Sources and Methods

To comprehensively address the committee’s overarching task of reviewing ethical considerations for protection of prisoners involved in research, the committee cast a broad net for the collection and assessment of information. These sources included commissioned papers (Box A-1), open sessions and workshops, telephone interviews and e-mail surveys to the state departments of corrections (DOCs), a survey of recent literature (to assess basic characteristics of research with prisoners), and two site visits to the correctional facilities.

In addition, a liaison panel of former prisoners and prisoner advocates was assembled for the committee to consult with throughout the project (Box A-2). 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. A summary description of the committee’s evidence gathering activities and results follows.

OPEN SESSIONS AND WORKSHOPS

Over the course of the study, the committee sought and received input from former prisoners, representatives of the prisoner advocacy community, bioethics researchers, health professionals, prison services researchers, and other organizations involved with research in prisons. To help accomplish this, the committee held three open meetings. The first was part of the first committee meeting on March 16, 2005. Staff from the Office for



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 175
A Data Sources and Methods To comprehensively address the committee’s overarching task of re- viewing ethical considerations for protection of prisoners involved in re- search, the committee cast a broad net for the collection and assessment of information. These sources included commissioned papers (Box A-1), open sessions and workshops, telephone interviews and e-mail surveys to the state departments of corrections (DOCs), a survey of recent literature (to assess basic characteristics of research with prisoners), and two site visits to the correctional facilities. In addition, a liaison panel of former prisoners and prisoner advocates was assembled for the committee to consult with throughout the project (Box A-2). 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. A summary description of the committee’s evidence gathering activities and results follows. OPEN SESSIONS AND WORKSHOPS Over the course of the study, the committee sought and received input from former prisoners, representatives of the prisoner advocacy commu- nity, bioethics researchers, health professionals, prison services researchers, and other organizations involved with research in prisons. To help accom- plish this, the committee held three open meetings. The first was part of the first committee meeting on March 16, 2005. Staff from the Office for 175

OCR for page 175
176 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS BOX A-1 Commissioned Papers Ethical Issues Regarding HIV/AIDS Research Among Prisoners Theodore M. Hammett, Ph.D., Abt Associates, Inc. 10 Years of HIV/AIDS Research Behind Bars: Time for Change Jason Farley, Ph.D.(c), MPH, CRNP, The Johns Hopkins University Rethinking the Ethics of Research Involving Prisoners Alex London, Ph.D., Carnegie Mellon University Research with Prisoners: A Reexamination of Ethical Foundations Mary Anderlik Majumder, J.D., Ph.D., Center for Medical Ethics and Health Policy Current Status of the Process of Mental Health Research and Substance Abuse Research with Prisoners: Practical Burdens and Benefits of the Current System Robert Trestman, Ph.D., M.D., University of Connecticut Health Center BOX A-2 Former Prisoners/Prisoner Advocates Liaison Group Edward Anthony, Philadelphia, PA Jack Beck, Esq., Correctional Association of New York Debra Breuklander, MECCA James J. Dahl, Ph.D., Phoenix House Allen Hornblum, M.A., M.P.A., Temple University Daniel S. Murphy, Ph.D., Appalachian State University Barry Nakell, Esq., North Carolina Prisoner Legal Services, Inc. Osvaldo Rivera, LADC I, Span, Inc. Jeffrey Ian Ross, Ph.D., University of Baltimore Jean Scott, Phoenix House Human Research Protections (OHRP) discussed the current federal regula- tions and their goals for this Institute of Medicine (IOM) project. Perspec- tives on the current federal regulation and needed changes were also pro- vided by representatives of the prisoner advocacy community, bioethics researchers, prison services researcher, and a representative from the fed- eral Bureau of Prisons (BOP). The second was a workshop in Washington, D.C., on May 4, 2005. This public workshop focused on the ethical, legal, regulatory frameworks that underlie research involving prisoners. The com- mittee also heard from representatives of the corrections industry about the practicalities of conducting research in correctional settings. A panel of

OCR for page 175
177 APPENDIX A BOX A-3 Individuals and Organizations that Addressed the Committee Elizabeth Alexander, J.D., National Prisoner Project of the American Civil Liberties Union (ACLU) Edward Anthony, Philadelphia, PA Larry Bench, Ph.D., Utah Department of Corrections Jessica Berg, J.D., Case Western Reserve University Joseph Bick, M.D., California Medical Facility Debra Breuklander, MECCA Alvin J. Bronstein, J.D., ABA Task Force on Legal Status of Prisoners, ACLU National Prison Project James Childress, Ph.D., University of Virginia Gwendolyn C. Chunn, M.A., American Correctional Association Hazel D. Dean, Sc.D., M.P.H., Centers for Disease Control and Prevention Nancy Dubler, LL.B., Montefiore Medical Center Bernice Elger, Ph.D., Timothy Harding University of Geneva, Switzerland Gerald Gaes, Ph.D., National Institute of Justice Julia Gorey, J.D., Office for Human Research Protections Olga Grinstead, Ph.D., M.P.H., University of California, San Francisco (UCSF) Alison Hardy, J.D., Prison Law Office Edward Harrison, CCHP, National Commission on Correctional Health Care Allen Hornblum, M.A., M.P.H., Temple University Doris J. James, M.A., Bureau of Justice Statistics Denise Johnston, M.D., Center for Children of Incarcerated Parents Patricia King, J.D., Georgetown University Peter Leone, Ph.D., University of Maryland at College Park Phillip Lyons, J.D., Ph.D., Sam Houston State University Philip Magaletta, Ph.D., Federal Bureau of Prisons Monika Markowitz, MSN, RN, M.A., Virginia Commonwealth University Mary Faith Marshall, Ph.D., University of Minnesota Nena Messina Ph.D., University of California, Los Angeles Daniel S. Murphy, Ph.D., Appalachian State University David Paar, M.D., University of Texas Medical Branch, Galveston Darrel A. 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. The third workshop was held in San Fran- cisco on July 18, 2005. This workshop focused on topical research areas and methodological issues related to conducting research with correctional populations. Former prisoners and prisoner advocates also presented their views of needed protections. The organizations and individuals that ad- dressed the committee in these open sessions are listed in Box A-3. In

OCR for page 175
178 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS BOX A-4 Public Meeting Participants Sue Allison, Federal Bureau of Prisons Susan Bankowski, Johns Hopkins School of Public Health Jessica Baumann, Bureau of National Affairs Francis Beylotte, American Psychological Association Laura Bishop, Kennedy Institute of Ethics Kristina Borror, Office for Human Research Protections Bret Bucklen, Pennsylvania Department of Corrections Scott Camp, Federal Bureau of Prisons Michael Carome, Office for Human Research Protections Erika Check, Nature Michael D. Cohen, New York State Office of Children and Family Services Jennifer Couzin, Science Joyce Cutler, Bureau of National Affairs Pamela Diamond, University of Texas School of Public Health Erik Dietz, Federal Bureau of Prisons Glen Drew, Office for Human Research Protections Jessica Ebert, Nature David Egilman, Brown University Bernice Elger, University of Geneva and National Institutes of Health (NIH) 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). LITERATURE SURVEY TO ASSESS GENERAL CHARACTERISTICS OF RESEARCH WITH PRISONERS To help characterize the landscape of published research with prisoners (i.e., who is doing what type of research in what type of prisoner settings), the committee conducted an assessment of prisoner research published in peer-reviewed journals. The preliminary search consisted of English lan- guage articles published since 1990, using the following databases: MedLine, PsychLit, Sociological Abstracts, Cumulative Index to Nursing & Allied Health Literature, Criminal Justice Abstracts, Education Resources

OCR for page 175
179 APPENDIX A Terry Hill, Lumetra Sally Hillsman, American Sociological Association Bill Holman, Gilead Sciences, Inc. Craig Hutchinson, UCSF Center for AIDS Prevention Studies Victoria Joseph, Bureau of Prisons Julie Kaneshiro, Office for Human Research Protections Alexa Kasdan, San Francisco AIDS Foundation Steven Krosnick, NIH/Center for Scientific Review Dan Landrigan, Report on Research Compliance Molly Lang, The Blue Sheet, F-D-C Reports Elizabeth Mendelsohn, UCSF Office of Research Leah Mendelsohn, Johns Hopkins Bloomberg School of Public Health Virginia Morrison, Health Care Mediations, Inc. Janet Myers, UCSF Medicine Edward Opton, Jr. Sangeeta Panicker, American Psychological Association Kevin Prohaska, Office for Human Research Protections Mercedes Rubio, American Sociological Association William Ruby, Gilead Sciences, Inc. 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, environ- ment, 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, ado- lescents, and mental illness. These search terms were cross-matched with the following subject terms: inmate(s), prisoner(s), incarcerate(d), jail(s). The preliminary search resulted in more than 14,000 articles. The search was then limited to the past 5 years, which resulted in a selection of 1,870 articles.

OCR for page 175
180 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS A random sampling of 20 percent of the 1,870 articles was selected as the final sample. Of these 374 studies, a total of 327 were studies that included human subjects. The remaining 47 included the following types of articles: review articles, commentaries, introductions to special editions, letters to the editor, position pieces, editorials, theory articles, news articles, legal reviews, opinion pieces, discussion pieces, and news type articles. All of the articles were reviewed and coded using the standard criteria. The results follow. Results The results of the survey to assess the general characteristics of pub- lished research with prisoners are summarized in the following figures. Funding Sources Funding stemmed from a variety of sources, including the federal govern- ment, state agencies, universities, and the private sector (Figures A-1, A-2). Mechanism of Approval Most studies (66 percent) did not report the mechanism by which they were approved (Figure A-3). Fifteen percent indicated institutional review board approval; other entity review was 19 percent. Prison System, Joint, 4% Foundation, Meta Analysis 4% 5% National Institute (No Funding), of Justice, 1% 5% Other, 29% Centers for Disease Control, 3% National Institutes of Health, 8% Did Not Specify, Other, Federal, 20% 10% State, 11% FIGURE A-1 Source of funding.

OCR for page 175
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. 181

OCR for page 175
182 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Institutional Review Board, 15% Other Entity Review, No Approval 19% Mentioned, 66% FIGURE A-3 Mechanism of approval. Study Design As shown in Figure A-4, epidemiological studies were the most com- mon (39 percent). Other common study designs included correlational stud- ies (27 percent) and those assessing behavioral outcomes (14 percent). Medical Outcome, 5% Case Study, Non-medical 6% Experiment, 1% Other, 8% Epidemiological (e.g., surveys), Behavioral 39% Outcome, 14% Correlational Study, 27% FIGURE A-4 Study design. Type of Study Most of the studies (41 percent) in the sample had a sociobehavioral focus, lacked a therapeutic purpose, and had minimal risk to participants (Figure A-5). Program evaluations (26 percent) and record reviews (21 percent) were also common.

OCR for page 175
183 APPENDIX A Medical, Therapeutic, No Standard of Care, Medical, Therapeutic, Biomedical, 1% Standard of Care Exists, Nontherapeutic, 2% 1% Other, 2% Social/Behavioral, Non- therapeutic, Greater than Social/Behavioral, Minimal Risk, Therapeutic, 0% 6% Social/Behavioral, Non- Administrative therapeutic, Minimal Risk, Records Review, 41% 21% Department of Corrections Program Evaluation, 26% FIGURE A-5 Type of study. (Same as Figure 2-3). NOTE: Greater than minimal risk included any biomedical (nontherapeutic) 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 phys- ical or emotional stress (e.g., long sleep deprivation). Not greater than minimal risk included any study based on review of administrative records; any program evalua- tion study; any nontherapeutic social/behavioral study that either involved no ma- nipulation (e.g., innocuous questionnaires/surveys) or involved a manipulation that the research assistant judged did not involve potentially serious physical or emo- tional stress (e.g., long sleep deprivation). Studies were largely focused on health status (43 percent) and personal- ity characteristics (19 percent) (Figure A-6). Facilities/Locations More than half of the studies (53 percent) were conducted in prisons or jails (Figure A-7). Another large proportion of the studies (37 percent) were conducted in alternate settings, such as treatment programs or postincarceration settings (Figures A-7, A-8).

OCR for page 175
184 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Other, 8% No Relationship Being Confined, with Being in 10% Prision, 9% Personality Health Status, Characteristics, 43% 19% Re-Entry, 11% FIGURE A-6 Categories of research. Other, 10% Alternatives to Incarceration, 37% Prisons, Jails, 53% FIGURE A-7 Facilities/location of studies. Number and Demographics of Research Participants The number of participants in a published article ranged from 1 to 336,668. Most studies (272) included 1,000 or fewer participants (Figure A-9). Gender More studies included male participants than female participants (Figure A-10). Age Most studies included adult participants; few included participants younger than 18 years (Figure A-11).

OCR for page 175
185 APPENDIX A Boot Camps, 1% Home Day Treatment, 0% Confinement, 1% Residential Drug Halfway Treatment, 4% Houses, 0% Community Juvenile Corrections, Detention 4% Center, 12% Mental Health Probation, Facilities, 7% 4% Parole, 4% FIGURE A-8 Alternatives to incarceration research settings. NOTE: This graph corresponds to the “Alternatives to Incarceration” slice in Fig- ure A-7. Juvenile detention centers were included in this analysis because the com- mittee decided to limit its focus to adults after this literature assessment was con- ducted. 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.

OCR for page 175
186 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS 300 262 250 227 Number of Studies 200 150 100 43 50 0 Did Not Specify Male Female FIGURE A-10 Number of studies by gender of participants. 188 200 Number of Studies 150 101 100 85 50 15 0 Under 18 Years Over 18 Years Did Not Specify Other of Age of Age FIGURE A-11 Number of studies by age of participants. 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.

OCR for page 175
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. Race/Ethnicity Most studies included Caucasians, closely followed by Af- rican Americans, and Latinos/Hispanics (Figure A-12). Other racial and ethnic groups were represented to a lesser extent (Figures A-13, A-14). SITE VISITS The committee conducted two site visits to correctional facilities. On July 20, 2005, the committee visited San Quentin Prison in San Francisco and the California Medical Facility (CMF) at Vacaville, California. During their site visits, the committee had guided tours of both facilities and un-

OCR for page 175
188 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS structured discussions with peer educators (i.e., inmates who are trained to be peer educators) about research experiences and needed protections when participating in research. SURVEY OF STATE DEPARTMENTS OF CORRECTIONS As part of its data collection activities, the committee collected infor- mation from state DOCs regarding research policies and practices. The committee conducted telephone interviews with six states and sent a survey to the remaining states and District of Columbia by e-mail. Telephone Interviews The committee collected information from DOCs in six states via tele- phone 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 respon- sibility of approving research, • problems or concerns that have arisen in connection with such re- search, and • impact of laws and regulations on proposed or actual research projects. Chapter 2 includes summary results of those telephone interviews. E-Mail Survey In the interest of reaching all 50 states and the District of Columbia, similar information to that which was collected by telephone interviews was requested from the DOCs of the remaining 44 states and Washington, D.C., in an e-mail survey. The purpose of this survey was to poll the states’ DOCs about their research activities and practices. All but three (Delaware, Illinois, Wyoming) DOCs responded, bringing to 48 the total number of DOCs about which the committee had information (6 from telephone inter- views, 42 from e-mail survey). Table A-1 presents the survey questions and a summary of DOC responses.

OCR for page 175
TABLE A-1 Summary of Results from Department of Corrections (DOC) Survey Question Yes No Other For questions 1–8, is this type of research permitted in your DOC? 40 2 1. Purely DOC records review, typically descriptive studies (e.g., demographics of prison population) 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. Evaluation studies of DOC programs that evaluate the process or outcomes of an internal DOC program 40 2 such as an educational program (e.g., impactof new classroom technique on GED test performance), or health or mental program (e.g., drug/substance abuse education; sex offender treatment) 3. Nontherapeutic social/behavioral studies involving minimal risk such as administration of interviews 30 10 1/case by case and/or questionnaires to assess personality features and personal history for development of a risk 1/yes–noa assessment measure; reaction time studies (e.g., how quickly inmates respond to different visual stimuli presented on a computer screen) 4. Nontherapeutic social/behaviors studies involving greater than minimal risk (e.g., evaluate the effects of 4 34 1/not likely prolonged sleep deprivation) 2/case by case 1/yes–nob 5. Evaluation of behavioral clinical interventions developed and administered by outside agencies (e.g., 20 19 2/case by case university researchers implement and evaluate a group therapy treatment protocol for PTSD that is not 1/yes–noa part of DOC standard services). 6. Medical research–therapeutic studies (e.g., AIDS, hepatitis C, breast/prostate cancer, reproductive 13 27 1/case by case medicines/devices) in which study involvement permits inmates to have access to experimental 1/yes–noa treatments that would not be otherwise available continued 189

OCR for page 175
TABLE A-1 Continued 190 Question Yes No Other 7. Medical research–therapeutic studies of diseases for which there is an established standard of care (e.g., 14 26 1/case by case new asthma medications) 1/yes–noa 8. Biomedical studies of a nontherapeutic nature, including studies that involve exposure to a biological 3 38 1/not likely or chemical agent to assess the effects on and reactions of humans (e.g., effects of cosmetic or cleaning agents on skin) 9. If you answered “no” to any of the questions above, is it the case that some of these types of research are 31 8 3/NA explicitly prohibited by your DOC policy or by legislation? 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) before the study can commence. Please answer each of the questions below regarding IRB nvolvement in research at your organization. 10. Does your DOC require IRB approval before research can commence? 29 10 3/NA 11a. Does your DOC have its own IRB within the organization? 13 26 3/NA 11b. If you answered yes to Question 11a, are there prisoner representatives on the DOC’s IRB? 5 13 24/NA 12. Does your DOC have an adverse events reporting process or procedure? 18 20 4/NA NOTE: DOC, Department of Corrections; IRB, institutional review board; NA, not applicable; GED, General Education Development (tests); PTSD, post-traumatic stress disorder. aVermont stated that the DOC is part of an umbrella Agency of Human Services (AHS). The AHS operates an IRB for review of all research, including DOC-related studies. No research involving minimal or greater risk to participants may proceed without IRB approval. bOnly with IRB approval.