Index

A

Abuses.

See also Substance abuse intervening to curtail, 14

ACA. See American Correctional Association

Accountability, 7, 159160

Acquired immunodeficiency syndrome (AIDS), 12, 22, 24, 29, 43, 54, 119

Acres of Skin: Human Experiments at Holmesburg Prison, 54, 121

Addictions. See Substance abuse

Adoption of DHHS Human Subjects Protection Regulations, 7484

the Common Rule, 7678

Report of the SACHRP Subcommittee, 8184

Subpart C: Prisoners as Research Subjects, 7981

Adverse events (AE)

in reviewing prisoner research, 151

Agency head, defined, 211

Ages

of inmates, 4042

of research participants, 184, 186

AIDS. See Acquired immunodeficiency syndrome

Alternatives to comprehensive regulation, 99100

Alternatives to incarceration, 2324, 33

research settings, 185

that may be available to offenders, 104

Amendment review, of prisoner research, 151

American Correctional Association (ACA), 133

American Journal of Public Health, 37

American Psychiatric Association, 44

Animal Welfare Act, 64

Antiviral therapies, 43

Anxiety disorders, 45

Applicability, in Subpart C, 231

Applications lacking definite plans for involvement of human subjects, in Subpart A, 224

Assault. See Sexual assaults

Assent, defined, 235

B

Ballard v. Woodard, 58

Belmont Report, 10, 192

Beyond Consent: Seeking Justice in Research, 117, 132

Biologics, registry of clinical research on, 7

Biomedical research, 89, 67

distrust regarding, x

guidance on, 125127

interventions, 9



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 253
Index A Alternatives to incarceration, 23–24, 33 research settings, 185 Abuses. See also Substance abuse that may be available to offenders, 104 intervening to curtail, 14 Amendment review, of prisoner research, 151 ACA. See American Correctional American Correctional Association (ACA), Association 133 Accountability, 7, 159–160 American Journal of Public Health, 37 Acquired immunodeficiency syndrome American Psychiatric Association, 44 (AIDS), 1–2, 22, 24, 29, 43, 54, Animal Welfare Act, 64 119 Antiviral therapies, 43 Acres of Skin: Human Experiments at Anxiety disorders, 45 Holmesburg Prison, 54, 121 Applicability, in Subpart C, 231 Addictions. See Substance abuse Applications lacking definite plans for Adoption of DHHS Human Subjects involvement of human subjects, in Protection Regulations, 74–84 Subpart A, 224 the Common Rule, 76–78 Assault. See Sexual assaults Report of the SACHRP Subcommittee, Assent, defined, 235 81–84 Subpart C: Prisoners as Research B Subjects, 79–81 Adverse events (AE) Ballard v. Woodard, 58 in reviewing prisoner research, 151 Belmont Report, 10, 192 Agency head, defined, 211 Beyond Consent: Seeking Justice in Ages Research, 117, 132 of inmates, 40–42 Biologics, registry of clinical research on, 7 of research participants, 184, 186 Biomedical research, 8–9, 67 AIDS. See Acquired immunodeficiency distrust regarding, x syndrome guidance on, 125–127 Alternatives to comprehensive regulation, interventions, 9 99–100 253

OCR for page 253
254 INDEX BJS. See Bureau of Justice Statistics Subpart B: Additional Protections for Black prisoners, 38–39 Pregnant Women, Human Fetuses, BOP. See Bureau of Prisons and Neonates Involved in Research, BRRB. See Bureau Research Review Board 226–230 Bureau of Justice Statistics (BJS), 31, 33, Subpart C: Additional Protections 37–38, 44, 47–48, 89n, 105, 123 Pertaining to Biomedical and Bureau of Prisons (BOP), 6, 74, 85, 89–93, Behavioral Research Involving 99, 176, 202 Prisoners as Subjects, 23, 231–234 Bureau Research Review Board (BRRB), Subpart D: Additional Protections for 92–93 Children Involved as Subjects in Research, 234–238 Coleman v. Wilson, 30 C Collaborative research approach, 10–11, 16, 27, 127–130 California, 40, 42–43, 59 Commission of Correction v. Myers, 58 California Department of Corrections and Commissioned papers, 59, 176 Rehabilitation (CDCR), 51 Committee on Ethical Considerations (for California Medical Facility (CMF), 187 Revisions to the DHHS Regulations) California prison system medical care for Protection of Prisoners Involved system in receivership, 29–30, 51 in Research, ix, 22 Care. See Health-care services; Standards of individuals and organizations that care addressed, 177 CDC. See Centers for Disease Control and presentations before, 44 Prevention task and approach, 24–26 CDCR. See California Department of Common Rule, 2, 6, 24, 74, 76–78, 202. Corrections and Rehabilitation See also Code of Federal Regulations Centers for Disease Control and Prevention Title 45; Subpart A: Basic DHHS (CDC), 63, 66–67, 73 Policy for Protection of Human Central Intelligence Agency (CIA), 74, 79, Research Subjects 158 informed consent, 77–78 Certification, defined, 212–213 institutional assurances, 78 Cervical cancer, 37 IRBs, 77 Children, 3n Communicable diseases of inmates, 1–2, 24, defined, 235 29, 42–44, 53 excluded from study, 26n hepatitis, 42–43 requirements in Subpart D for assent by, HIV/AIDS, 43 237–238 of inmates, 42–44 of women under correctional tuberculosis, 43–44 supervision, 38 Communication skill levels, 38 Chronic diseases of inmates, 29, 44 Community service, 103 CIA. See Central Intelligence Agency Community settings, 4–6, 105–109 Clinical Investigations Using Human Compliance with policies, assuring, in all Subjects, 74 research conducted or supported by CMF. See California Medical Facility any federal department or agency, Code of Federal Regulations Title 45: Public 213–215 Welfare; Part 46: Protection of Conditions, in Subpart A, 9, 225–226 Human Subjects, xi, 2, 23, 27, 76, Confidentiality 88, 205–238 in DOJ regulations, 91 Subpart A: Basic DHHS Policy for of health information, 56 Protection of Human Research protecting, 25 Subjects, 23, 208–226

OCR for page 253
255 INDEX Congress, 14–15, 42, 115, 159 open sessions and workshops, 175–178 scope of spending power, 96–99 site visits, 187–188 Connecticut, 43 survey of state Departments of Consent. See Informed consent Corrections, 188–190 Consumer Product Safety Commission, 208 Decision making, autonomous, 15 Continuing review, of prisoner research, Declaration of Helsinki, 210 151 Definitions, 82–84, 211–213, 226–227, Continuity of care, 111 231–232, 235. See also individual Cooperative research, in Subpart A, 219– terms and acronyms 220 of minimal risk and benefit to Correctional population. See Prisoner participants, 83–84, 201 population of prisoner, 1, 21n, 27, 33, 65, 82–83, Correctional settings, 4–6, 101–112 105–109, 200, 231 current regulations pertinent to places of of prisoner research, 138–151 prisoner research, 102–103 Demographics delineation of settings, 109–110 ability of prisoners to provide ethically encompassing more than prisons and adequate informed consent, 56 jails, 103–105 barriers to privacy and right to consent ethical foundations of current research or refuse care, 56–58 regulations, 101–102 descriptions of prisons, jails, and other overcrowding of, 1–2 correctional settings, 30–31 when liberty status changes, 110–111 and the ethical conduct of research, 55– when proposed regulations should apply, 58 109–110 and health issues, 30–59 when proposed regulations should not implications for the ethical conduct of apply, 110 research on the prisoner population, Criminal justice system 55–58 agencies and facilities in California, prisoner population, 31–58 106–107 Department head, defined, 211 harm inflicted on those it punishes, 11– Department of Agriculture, 64, 208 12 Department of Commerce, 208 restrictions imposed by, 4–6, 30, 105– Department of Corrections (DOC), 111, 109 128, 142, 164. See also State Criteria for IRB approval of research, in Departments of Corrections Subpart A, 218–219 survey Cruzan v. Missouri Department of Health, Department of Defense, 86n, 208 57 Department of Education, 84n, 208 Current regulations pertinent to places of Department of Energy, 208 prisoner research, 102–103 Department of Health, Education, and Current research environment, 59–67 Welfare (DHEW), 191 Current status of prisoner research, 59 Department of Health and Human Services (DHHS), ix, xi, 1, 3, 4–10, 13–14, 22, 65–66, 105–109, 123–127, 138– D 139, 157–159, 199–202, 226, 234– 237 Data sources and methods, 175–190. See agencies of, 86–88 also Public database defined, 231 data retrieval needing improving, 64–66 regulations of, 59, 73–100 literature survey to assess general and Subpart A, 2 characteristics of research with Department of Housing and Urban prisoners, 178–187 Development, 208

OCR for page 253
256 INDEX Department of Justice (DOJ), 6–7, 47, 65– Environmental Protection Agency, 208 66, 74, 93, 202, 208 Estelle v. Gamble, 30, 50, 57 confidentiality, 91 Ethical considerations, for revisions to informed consent, 91–92 DHHS regulations for protection of regulations, 89–93 prisoners involved in research, 5 review of research protocols, 92–93 Ethical foundations, of current research statistics and trends, 31 regulations, 101–102 Department of Labor, 212 Ethical framework for research involving Department of Transportation, 208 prisoners, x, 7, 26, 113–135 Department of Veterans Affairs, 63, 208 1976 Commission’s ethical framework, Depression, major, 45 114–116 DHEW. See Department of Health, historical context, 114 Education, and Welfare justice, 115–116, 127–135 DHHS. See Department of Health and versus research involving nonprisoners, Human Services 25 Diabetes, 29 respect for persons, 115–127 Disadvantaged populations, 1–2. See also updated, 116–135 individual populations Ethical research, 11, 15 Dislocation of inmates, from local to distant prerequisites of, 1–2 jurisdictions, 49 European Convention for the Prevention of District of Columbia, 38 Torture and Inhuman or Degrading DOC. See Department of Corrections Treatment or Punishment, 153 Documentation of informed consent, in Evaluation and disposition of applications Subpart A, 223–224 and proposals for research to be DOJ. See Department of Justice conducted or supported by a federal Downsizing Prisons, 34 department or agency, in Subpart A, Drug rehabilitation programs, 37 224–225 Drugs Expedited review procedures for certain registry of clinical research on, 7 kinds of research involving no more war on, 23, 29, 33 than minimal risk and for minor changes in approved research, in Subpart A, 217–218 E E-mail survey, of state Departments of F Corrections (DOCs), 188 Early termination. See Termination of Facilities/locations, of research with research support—evaluation of prisoners, 60–61, 183–184 applications and proposals FBOP. See Federal Bureau of Prisons Education As Crime Prevention: Providing FDA. See Food and Drug Administration Education to Prisoners, 39 Federal Bureau of Prisons (FBOP), 52 Educational attainment Federal funds, use of in Subpart A, 225 for correctional populations and the Federal human subjects protections, 6–7, general population, 40 84–95 and reading skills of prisoners, 38–40 in the Report of the SACHRP Educational programs, participation in since Subcommittee, 202 most recent incarceration or sentence Federal-level review, 14 for state and federal prison inmates, Federal Register, 80, 85, 88, 167–168, 210– local jail inmates, and probationers, 211, 217, 233–234 41 Federal regulatory landscape, 73–100 Electronic monitoring programs, 24, 33, adoption of DHHS Human Subjects 103 Protection Regulations, 74–84

OCR for page 253
257 INDEX H alternatives to comprehensive regulation, 99–100 Halfway houses, 24 analysis, 94–100 Health-care services. See also Standards of DOJ regulations, 89–93 care existing authority for broader regulation, access to adequate, 2, 11, 133–134 95–96 potentially inadequate, 1–2, 22–23, 29 FDA regulations, 86–88 Health Insurance Portability and guaranteeing the DHHS broader Accountability Act (HIPAA), 150 authority, 96–99 Health status of inmates, 1, 12, 42–48 other DHHS agencies, 86–88 chronic diseases, 44 other federal human subjects communicable diseases, 42–44 protections, 84–93 gender factor in, 36 Subpart D, 85–86 injury, violence, rape, and suicide, 47–48 Federal Security Agency, 96 mental illness, 44–47 Federal-wide assurance (FWA), 78, 84–85, substance abuse, 47 138, 142, 201–202 Health Status of Soon-to-Be-Released Florida, 59 Inmates, The, 42 Food and Drug Administration (FDA), 8, Helvering v. Davis, 96 73, 85, 95, 125, 144, 170, 202, Hepatitis, 1–2, 22, 24, 29, 42–43, 128 212 High school completion, 39 regulations, 86–88, 99 HIPAA. See Health Insurance Portability For-profit prisons, 34, 49 and Accountability Act Former prisoners/prisoner advocates liaison Hispanic prisoners, 38–39 group, 176 History, of research with prisoners, 3, 54– Funding sources, 180–181 55 in the published literature of prisoner HIV. See Human immunodeficiency virus studies, 63 Holmesburg Prison, 54–55 FWA. See Federal-wide assurance HRPPP. See Human Research Participant Protection Program G HRW. See Human Rights Watch Human immunodeficiency virus (HIV), 1–2, GAO. See General Accounting Office 24, 29, 43, 114, 128, 144–145, 196 GED. See General Equivalency Development coinfections involving, 44 test gender factor in, 36 Gender of research participants, 184 Human research participant protection numbers of studies by, 186 programs (HRPPPs), 8, 10–11, 16, Gender-Responsive Strategies for Women 94n, 130, 133–134, 142, 149 Offenders, 36 creating a national resource for, 14 General Accounting Office (GAO), 36 Human Rights Watch (HRW), 34, 46, 49 General Equivalency Development (GED) Human subjects test, 39 defined, 212 Georgia, 43 protections for, 199–203 Gonzales v. Oregon, 97n, 99 Guardians I defined, 235 requirements in Subpart D for Incarcerated population permission by, 237–238 dislocation of, from local to distant Guidelines for human subjects research, jurisdictions, 49 establishing uniform, 6–7, 94–95 growing enormously, 31–33

OCR for page 253
258 INDEX J quality of health care provided, 50–54 services for, 49–54 Jackson State Prison, 121, 193 Incarceration Jacobson, Michael, 33 increased use of isolation in punishment Jacobson v. Massachusetts, 58 of inmates, 49–50 Jail inmates, numbers of, 32 purpose of, 11 Joint Commission on Accreditation of varieties of, 21 Healthcare Organizations (JCAHO), Incentives, 67, 228 133 Informed consent, 21, 122 JPI. See Justice Policy Institute ability of prisoners to provide ethically Justice, 27, 127–135 adequate, 56 collaborative responsibility, 127–130 in the Common Rule, 77–78 welfare of the prisoner population, 130– in DOJ regulations, 91–92 135 providing integrity to process of, 15 Justice Policy Institute (JPI), 31–32, 34 voluntary, 2, 15, 147–149 Juveniles, 26n, 108, 185 Initial review, of prisoner research, 150–151 Injury during incarceration. See also Sexual L assaults reasons for, 47–48 Legally authorized representative, defined, Institute of Medicine (IOM), ix, xi, 1, 3, 22, 211 176, 199 Liberty status, changes in, 110–111 Institution, defined, 211 Likelihood of injury, based on time in Institutional assurances, in the Common prison, 48 Rule, 78 Literature review of published prisoner Institutional review boards (IRBs), xi, 2, studies, 61–64 12–13, 30, 60, 103, 110–111, 123– facilities/locations, 183–184 124, 139–158, 161–170, 209, 212– funding sources, 63, 180–181 227 general characteristics of research with approval by, 12, 212 prisoners, 178–187 in the Common Rule, 77 locus of research activity, 61–62 composition of where prisoners are mechanisms of research approval, 63– involved, in Subpart C, 232 64, 180–182 considerations for independent ethical numbers and demographics of research review, modifying, 13, 156–157 participants, 184–187 defined, 212 results, 180–187 duties, in Subpart D, 235 study content/design, 62–63 functions and operations, in Subpart A, study design, 182 216 type of study, 62, 182–183 membership, in Subpart A, 215–216 Local research review board (LRRB), postapproval monitoring in oversight of 92–93 research with prisoners, 156–157 records, in Subpart A, 220 review of research, 3, 217 M International Development Cooperation Agency, Agency for International Maryland, 43 Development, 208 Mechanisms of research approval IOM. See Institute of Medicine in the published literature of prisoner IRBs. See Institutional review boards studies, 63–64 Isolation, in punishment of inmates, of research with prisoners, 180–182 increased use of, 49–50 Mental institutions, closing of large, 29

OCR for page 253
259 INDEX Mentally ill inmates, 1–2, 24, 44–47 Neonate excluded from study, 26n defined, 226 gender factor in, 36 nonviable, defined, 227 receiving mental health services while New Freedom Commission on Mental incarcerated, 30, 46 Health (NFCMH), 45 vulnerabilities of in prison, 12 New Jersey, 37 Michigan, 121, 193 New York, 59, 114, 195 Military personnel, 3n New York City excluded from study, 26n Department of Health and Mental Minimal risk, defined, 25, 124, 212, 232 Hygiene, 53 Minorities. See Race/ethnicity of research Departments of Correction and participants; individual minorities Probation, 34 New York Times, 42, 51–52 NFCMH. See New Freedom Commission N on Mental Health NIC. See National Institute of Corrections National Aeronautics and Space NIH. See National Institutes of Health Administration, 208 NIJ. See National Institute of Justice National Bioethics Advisory Commission Nonviable neonate, defined, 227 (NBAC), 75, 117 Nonwhite participants, numbers of studies National Center on Institutions and with, 187 Alternatives, 38 Nuremburg Code, 114, 194 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National O Commission) (NCPHSBBR), ix, xi, 22, 29, 66, 79, 101–102, 113, 191– Office for Human Research Protections 197 (OHRP), xi, 1, 3, 6, 8–9, 13–15, 22, deliberations, findings, and conclusions, 24, 73, 77, 83, 103, 123, 125, 156– 194–196 159, 175–176, 200–201, 211, 217 methodology, 193–194 enhancing capacity of, 13–14, 157–159 National Commission on Correctional prisoner certifications, 81–82 Health Care (NCCHC), 42, 44, 50– Office of Management and Budget, 217, 51, 133 219–220, 223–224 National Institute of Corrections (NIC), 36 Office of Research and Evaluation (ORE), National Institute of Justice (NIJ), 63 92–93 National Institute on Drug Abuse, 60 OHRP. See Office for Human Research National Institutes of Health (NIH), 63, Protections 66–67, 73–76 Ombudsman, 155 National Minority Conference on Human Open sessions and workshops, 175–178 Experimentations, 193 Open Society Institute (OSI), 34, 39 National oversight, of research with ORE. See Office of Research and Evaluation prisoners, 157–160 OSI. See Open Society Institute National Research Act, 115n, 117–118, Out of Sight: Super Maximum Security 191–192 Confinement in the United States, 49 Section 202(a)(2), 192 Oversight of research with prisoners, 151– National Science Foundation, 208 160 Nazi experiments, 114 IRB postapproval monitoring, 156–157 NBAC. See National Bioethics Advisory national oversight, 157–160 Commission Prison Research Subject Advocates, 153– NCCHC. See National Commission on 156 Correctional Health Care

OCR for page 253
260 INDEX P health status of, 42–48 history of research with, 3, 54–55 Parents implications of demographics for the defined, 235 ethical conduct of research, 55–58 requirements in Subpart D for injury, violence, rape, and suicide of, permission by, 237–238 47–48 Parole, 30–31 under jurisdiction of state or federal Pell Grants, 40 correctional authorities by gender, 35 Pennsylvania, 54–55 more women entering, 35–38 Permission, defined, 235 numbers of, 32 Permitted research involving prisoners, in obtaining input from, 10–11, 129–130 Subpart C, 233–234 racial and ethnic disparities, 38 Phases of human research, 131, 160 reentering society, 11–12, 134–135 Phase 3 testing, 9, 125 restrictions on liberty and autonomy, 1– PHR. See Physicians for Human Rights 2, 27 PHS. See Public Health Service subclasses of, 12 Physicians for Human Rights (PHR), 56 vulnerabilities of, 12, 21 Policies and procedures, for application welfare of, 130–135 review and study, 60–61 where incarcerated and how provided Policy makers, informing, 11–12, 134–135 with services, 49–54 PREA. See Prison Rape Elimination Act who is in prisons and jails, 35–42 Pregnancy Prisoner studies, published, literature review defined, 227 of, 61–64 high risk, 37 Prisons, jails, and other correctional settings Prejudicial information, 155 descriptions of, 30–31 Prison Health Services, Inc., 30, 52–53 everyday life in, 11 Prison Rape Elimination Act (PREA), 48, for-profit, 34, 49 98–99 Privacy Prison research subject advocate (PRSA), 12– absolute, difficulty guaranteeing, 16, 21– 13, 118, 137, 147, 154–156, 164–168 22 oversight of research with prisoners, barriers to, and the ethical conduct of 153–156 research, 1–2, 56–58 Prisoner IRB representatives, in the Report protection of, 2, 15–16, 25, 149–150 of the SACHRP Subcommittee, 83, Probation, 30–31, 103 200 Problems Prisoner Liaison Panel, xi, 50, 65, 120 investigating reports of possible, 14, 21– Prisoner population, 31–58. See also 22 Today’s prisoners—changing unexpected, in reviewing prisoner demographics, health issues, and the research, 151 current research environment Prohibited categories and types of research ages of inmates, 29, 40–42 involving prisoners, 170 causes of growth in, 23–24, 33–35 Proposals lacking definite plans for defined, 1, 21n, 27, 33, 65, 82–83, 105– involvement of human subjects, in 109, 200, 231 Subpart A, 224 echoes of Tuskegee and Retin-A, 22, 54– Proposed regulations, 109–110. See also 55 Recommendations educational level and reading skills of Protectionism, role of, 118–127 prisoners, 38–40 Protocols. See Research, protocols enormous growth in, 23, 29, 31–33 PRSA. See Prison research subject advocate findings on changing demographics and Public database, of all research involving health issues, 58–59 prisoners, 7, 65–66 by gender, 36

OCR for page 253
261 INDEX Public health implications, of inadequate Recommendations for further consideration health care for prisoners, 53–54 by the IOM, in the Report of the Public Health Service Act, 95 SACHRP Subcommittee, 84, 201– Public Health Service (PHS), 55, 74 202 Public meeting participants, 178–179 Registry of clinical research on drugs and Published prisoner studies, literature review biololgics, 7 of, 61–64 Registry of research involving prisoners, “Punishing decade,” 32 need for a national, 7, 14, 158 Purpose, in Subpart C, 231 Regulation, existing authority for broader, 95–96 Regulations for the protection of human Q subjects, 24 applicable even to research not federally Quality assurance (QA), 140 funded by any agency, 90 Quality improvement (QI), 140–141, 151, applicable to research involving human 155 subjects, 75 Quality of health care provided, 50–54 applicable to research involving public health implications of inadequate prisoners as subjects, independent of health care for prisoners, 53–54 funding source, 203 compliance with, 14 DOJ, 89–93 R Subpart A, 208–209 Subpart B, 226 RA. See Research assistant Subpart D, 234–235 Race/ethnicity of research participants, 1, Reiger, Darrel A., 44 38–39, 45, 187. See also individual Report and Recommendations: Research racial and ethnic groups Involving Prisoners, 2, 66, 79, 113 disparities among, 23, 38 Report of the SACHRP Subcommittee and numbers of studies by, 186 Human Subjects Protections, 27, 81– vulnerabilities of in prison, 12 84, 94, 199–203 Rape. See Sexual assaults defining minimal risk and benefit to Reading skill levels, 38 participants, 83–84, 201 Rearrest rates, 34 definition of prisoner, 82–83, 200 Recidivism prisoner IRB representatives, 83, 200 high rates of, 23, 34 recommendations for further reducing, 11–12, 39, 134–135 consideration by the IOM, 84, 201– Recommendations, 3–16, 196 202 data retrieval needing improving, 64–66 Requirements, for permission by parents or enhancing systematic oversight of guardians and for assent by children, research involving prisoners, xi, 1, 4, in Subpart D, 237–238 12–16, 159 Research ensuring universal, consistent ethical abuses in, 3 protection, xi, 1, 4, 6–7 categories of, 184 expanding definition of prisoner, xi, 1, involving, after delivery, the placenta, 4–6, 105–109 the dead fetus, or fetal material, in shifting from a category-based to a risk- Subpart B, 230 benefit approach to research review, involving greater than minimal risk and xi, 1, 4, 8–10 no prospect of direct benefit to updating the ethical framework to individual subjects, but likely to yield include collaborative responsibility, generalizable knowledge about the xi, 1, 4, 10–12 subject’s disorder or condition, in Subpart D, 236

OCR for page 253
262 INDEX involving greater than minimal risk but Respect for persons, 15, 27, 117–127, 192 presenting the prospect of direct expanded view of, 117–118 benefit to the individual subjects, in guidance on biomedical research, 125– Subpart D, 235–236 127 involving neonates, in Subpart B, 228– role of protectionism, 118–127 230 Responsible Research: A Systems Approach involving pregnant women or fetuses, in to Protecting Research Participants, Subpart B, 227–228 129 not involving greater than minimal risk, Results in Subpart D, 235 from Department of Corrections survey, not otherwise approvable which presents 189–190 an opportunity to understand, policies and procedures for application prevent review and study, 60–61 or alleviate a serious problem of research with prisoners, 180–187 affecting the health or welfare of from the surveys with key DOC children, in Subpart D, 236–237 personnel, 60–61 or alleviate a serious problem types of research permitted and research affecting the health or welfare of personnel, 60 pregnant women, fetuses, or Retin-A, echoes of among the prisoner neonates, in Subpart B, 230 population, 22, 54–55 protocols for, 10–11, 13, 22, 26, 92–93, Reviewing prisoner research, 138–151 129–130, 156–157 adverse events or unexpected problems, safeguards for particular kinds of, 160– 151 170 amendment review, 151 Research assistant (RA), 62n continuing review, 151 Research involving prisoners, 184–187 how reviews are conducted, 143–150 age, 140–142, 184, 186 initial review, 150–151 best practices gained from high-quality, by institution, in Subpart A, 219 12, 135 research protocols, in DOJ regulations, defined, 211 92–93 echoes of Tuskegee and Retin-A, 22, 54– what is reviewed, 139–141 55 when reviews are done, 150–151 establishing uniform guidelines for, 6–7, who reviews, 141–142 94–95 Rhode Island, 53n ethical framework for, 113–135 Right to consent or refuse care, and the gender, 184 ethical conduct of research, 56–58 government support needed for, 11–12, Risk 134–135 minimal, defined, 25, 124, 212 history of, 3, 54–55 threshold of, 26 monitoring, 12–13, 154–156 Risk-benefit framework, applying to numbers of, 185 research review, 8–10, 122–127 oversight of, 151–160 Rumsfeld v. Forum for Academic and priorities for, 25 Institutional Rights, 97n protecting privacy, 15–16, 149–150 race/ethnicity, 187 S settings delineated, 109–110 subject to regulation, defined, 212 SACHRP. See Secretary’s Advisory undertaken without the intention of Committee on Human Research involving human subjects, in Subpart Protections A, 224 Safeguards for particular kinds of research, 160–170

OCR for page 253
263 INDEX SAMHSA. See Substance Abuse and Mental definite plans for involvement of Health Services Administration human subjects, 224 Sample situations, 163–170 assuring compliance with this policy— San Quentin Prison, 187 research conducted or supported by Sanctions, for non-compliance, imposing, any federal department or agency, 14 213–215 Schloendorff v. Society of New York conditions, 225–226 Hospitals, 57 cooperative research, 219–220 Search terms, 179 criteria for IRB approval of research, Secretary of DHHS, 9 218–219 defined, 227, 231 documentation of informed consent, Secretary’s Advisory Committee on Human 223–224 Research Protections (SACHRP), 24, early termination of research support— 80–82, 199. See also Report of the evaluation of applications and SACHRP Subcommittee proposals, 225 Sentencing laws. See also The Sentencing evaluation and disposition of Project (TSP) applications and proposals for harsher, 23, 29 research to be conducted or mandatory minimums, 34 supported by a federal department or three-strike laws, 34 agency, 224–225 Sexual assaults, repeated, in incarcerated expedited review procedures for certain populations, 9, 37, 48 kinds of research involving no more Sexual offenders, 109 than minimal risk and for minor Sexually transmitted diseases (STDs), 42, changes in approved research, 217– 128 218 Single female heads of household, 37 general requirements for informed Site visits, 187–188 consent, 220–223 Social Security Administration (SSA), 74, IRB functions and operations, 216 79, 158 IRB membership, 215–216 South Dakota v. Dole, 96–97 IRB records, 220 Special study design, and PRSA monitoring IRB review of research, 217 safeguards, 162–163 research undertaken without the SSA. See Social Security Administration intention of involving human Stakeholders, 170–174 subjects, 224 obtaining input from, 10–11, 129–130 review by institution, 219 responsibilities of, 17–19, 170–174 suspension or termination of IRB Standards of care, ensuring adequate, 11, approval of research, 219 133–134 use of federal funds, 225 State Departments of Corrections (DOCs) to what this policy applies, 208–209 survey, 59, 140, 175, 188–190 Subpart A definitions, 211–213 e-mail survey, 59, 188 agency head, 211 telephone interviews, 59, 188 certification, 212–213 STDs. See Sexually transmitted diseases department head, 211 Study content/design of research with human subject, 212 prisoners, 182 institution, 211 in the published literature, 62–63 IRB, 212 Subjects, of reviews, 139–141 IRB approval, 212 Subpart A: Basic DHHS Policy for legally authorized representative, 211 Protection of Human Research minimal risk, 212 Subjects, 2, 208–226 research, 211 applications and proposals lacking research subject to regulation, 212

OCR for page 253
264 INDEX Subpart B: Additional Protections for Subpart D: Additional Protections for Pregnant Women, Human Fetuses, Children Involved as Subjects in and Neonates Involved in Research, Research, 8–9, 85–86, 234–238 226–230 framework, 87 duties of IRBs in connection with IRB duties, 235 research involving pregnant women, requirements for permission by parents fetuses, and neonates, 227 or guardians and for assent by research involving, after delivery, the children, 237–238 placenta, the dead fetus, or fetal research involving greater than minimal material, 230 risk and no prospect of direct benefit research involving neonates, 228–230 to individual subjects, but likely to research involving pregnant women or yield generalizable knowledge about fetuses, 227–228 the subject’s disorder or condition, research not otherwise approvable which 236 presents an opportunity to research involving greater than minimal understand, prevent, or alleviate a risk but presenting the prospect of serious problem affecting the health direct benefit to the individual or welfare of pregnant women, subjects, 235–236 fetuses, or neonates, 230 research not involving greater than to what these regulations apply, 226 minimal risk, 235 Subpart B definitions, 226–227 research not otherwise approvable which dead fetus, 226 presents an opportunity to delivery, 226 understand, prevent, or alleviate a fetus, 226 serious problem affecting the health neonate, 226 or welfare of children, 236–237 nonviable neonate, 227 wards, 238 pregnancy, 227 to what these regulations apply, 234– Secretary of DHHS, 227 235 viable, 227 Subpart D definitions, 235 Subpart C: Additional Protections assent, 235 Pertaining to Biomedical and children, 235 Behavioral Research Involving guardian, 235 Prisoners as Subjects, xi, 2–6, 66, parent, 235 79–81, 231–234 permission, 235 additional duties of the IRBs where Substance Abuse and Mental Health prisoners are involved, 232–233 Services Administration (SAMHSA), additional requirements for IRBs, 80–81 73 applicability, 231 Substance abuse of inmates, 37, 47 composition of IRBs where prisoners are Surveys with key DOC personnel, results involved, 232 from, 60–61 key definitions within Subpart C, 79–80 Suspension or termination of IRB approval OHRP certification, 81 of research, in Subpart A, 219 permitted research involving prisoners, Systems of oversight, safeguards, and 233–234 protections, 137–174 purpose, 231 applying safeguards for particular kinds rewriting, 24 of research, 160–170 Subpart C definitions, 231–232 defining and reviewing prisoner research, DHHS, 231 138–151 minimal risk, 232 impact of committee recommendations prisoners, 231 on stakeholder responsibilities, 170– Secretary of DHHS, 231 174

OCR for page 253
265 INDEX other prohibited categories and types of U.S. Patriot Act, 3n, 26n research involving prisoners, 170 U.S. Supreme Court, 30, 50, 56–57, 97 sample situations, 163–170 V T Viable, defined, 227 TB. See Tuberculosis Violent Crime Control and Law Telephone interviews, of state Departments Enforcement Act, 40 of Corrections (DOCs), 188 Viral diseases, 42–43 Termination of research support— antiviral therapies, 43 evaluation of applications and Virginia, 43 proposals, early, in Subpart A, 225 Voluntariness, in the prison setting, 25–26 Texas, 43, 52, 59 Voluntary informed consent, 2, 15, 147– The Sentencing Project (TSP), 34, 40 149 Therapeutic research, 116 Thompson v. City of Los Angeles, 58 W Three-strike laws, 34, 40, 42 Timing, 22–24 Wards, in Subpart D, 238 of reviews, 150–151 Washington State, 49 Today’s prisoners—changing demographics, Washington v. Harper, 58 health issues, and the current Weekend reporting programs, 33 research environment, 29–71 Welfare of the prisoner population, 130– changing demographics and health 135 issues, 30–59 White prisoners, 39, 45 current research environment, 59–67 White v. Napoleon, 57–58 current status of prisoner research, 59 Women data retrieval needing improving, 64–66 increasingly entering the correctional published literature—a review of selected system, 1–2, 23, 35–38 prisoner studies, 61–64 single female heads of household, 37–38 results from the surveys with key DOC vulnerabilities of in prison, 12, 36–38 personnel, 60–61 Women Offenders: Programming Needs summary of findings on current research and Promising Approaches, 37 environment, 66–67 Work-release programs, 24, 33 Transparency, 7, 26, 64, 159–160 World Medical Assembly Declaration, 210 TSP. See The Sentencing Project Tuberculosis (TB), 1–2, 24, 43–44 Tuskegee, echoes of among the prisoner Y population, 22, 54–55 Types of research with prisoners, 182–183 Young people, vulnerabilities of in prison, permitted, and research personnel, 60 12 in the published literature, 62 Z U Zaire v. Dalsheim, 58 U.S. Constitution Eighth Amendment, 23, 50, 57 role in guaranteeing the DHHS broader authority, 96

OCR for page 253