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Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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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

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

BJS. See Bureau of Justice Statistics

Black prisoners, 3839

BOP. See Bureau of Prisons

BRRB. See Bureau Research Review Board

Bureau of Justice Statistics (BJS), 31, 33, 3738, 44, 4748, 89n, 105, 123

Bureau of Prisons (BOP), 6, 74, 85, 8993, 99, 176, 202

Bureau Research Review Board (BRRB), 9293

C

California, 40, 4243, 59

California Department of Corrections and Rehabilitation (CDCR), 51

California Medical Facility (CMF), 187

California prison system medical care system in receivership, 2930, 51

Care. See Health-care services;

Standards of care

CDC. See Centers for Disease Control and Prevention

CDCR. See California Department of Corrections and Rehabilitation

Centers for Disease Control and Prevention (CDC), 63, 6667, 73

Central Intelligence Agency (CIA), 74, 79, 158

Certification, defined, 212213

Cervical cancer, 37

Children, 3n

defined, 235

excluded from study, 26n

requirements in Subpart D for assent by, 237238

of women under correctional supervision, 38

Chronic diseases of inmates, 29, 44

CIA. See Central Intelligence Agency

Clinical Investigations Using Human Subjects, 74

CMF. See California Medical Facility

Code of Federal Regulations Title 45: Public Welfare; Part 46: Protection of Human Subjects, xi, 2, 23, 27, 76, 88, 205238

Subpart A: Basic DHHS Policy for Protection of Human Research Subjects, 23, 208226

Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, 226230

Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, 23, 231234

Subpart D: Additional Protections for Children Involved as Subjects in Research, 234238

Coleman v. Wilson, 30

Collaborative research approach, 1011, 16, 27, 127130

Commission of Correction v. Myers, 58

Commissioned papers, 59, 176

Committee on Ethical Considerations (for Revisions to the DHHS Regulations) for Protection of Prisoners Involved in Research, ix, 22

individuals and organizations that addressed, 177

presentations before, 44

task and approach, 2426

Common Rule, 2, 6, 24, 74, 7678, 202.

See also Code of Federal Regulations Title 45;

Subpart A: Basic DHHS Policy for Protection of Human Research Subjects

informed consent, 7778

institutional assurances, 78

IRBs, 77

Communicable diseases of inmates, 12, 24, 29, 4244, 53

hepatitis, 4243

HIV/AIDS, 43

of inmates, 4244

tuberculosis, 4344

Communication skill levels, 38

Community service, 103

Community settings, 46, 105109

Compliance with policies, assuring, in all research conducted or supported by any federal department or agency, 213215

Conditions, in Subpart A, 9, 225226

Confidentiality

in DOJ regulations, 91

of health information, 56

protecting, 25

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Congress, 1415, 42, 115, 159

scope of spending power, 9699

Connecticut, 43

Consent. See Informed consent

Consumer Product Safety Commission, 208

Continuing review, of prisoner research, 151

Continuity of care, 111

Cooperative research, in Subpart A, 219220

Correctional population. See Prisoner population

Correctional settings, 46, 101112

current regulations pertinent to places of prisoner research, 102103

delineation of settings, 109110

encompassing more than prisons and jails, 103105

ethical foundations of current research regulations, 101102

overcrowding of, 12

when liberty status changes, 110111

when proposed regulations should apply, 109110

when proposed regulations should not apply, 110

Criminal justice system

agencies and facilities in California, 106107

harm inflicted on those it punishes, 1112

restrictions imposed by, 46, 30, 105109

Criteria for IRB approval of research, in Subpart A, 218219

Cruzan v. Missouri Department of Health, 57

Current regulations pertinent to places of prisoner research, 102103

Current research environment, 5967

Current status of prisoner research, 59

D

Data sources and methods, 175190.

See also Public database

data retrieval needing improving, 6466

literature survey to assess general characteristics of research with prisoners, 178187

open sessions and workshops, 175178

site visits, 187188

survey of state Departments of Corrections, 188190

Decision making, autonomous, 15

Declaration of Helsinki, 210

Definitions, 8284, 211213, 226227, 231232, 235.

See also individual terms and acronyms

of minimal risk and benefit to participants, 8384, 201

of prisoner, 1, 21n, 27, 33, 65, 8283, 105109, 200, 231

of prisoner research, 138151

Demographics

ability of prisoners to provide ethically adequate informed consent, 56

barriers to privacy and right to consent or refuse care, 5658

descriptions of prisons, jails, and other correctional settings, 3031

and the ethical conduct of research, 5558

and health issues, 3059

implications for the ethical conduct of research on the prisoner population, 5558

prisoner population, 3158

Department head, defined, 211

Department of Agriculture, 64, 208

Department of Commerce, 208

Department of Corrections (DOC), 111, 128, 142, 164.

See also State Departments of Corrections survey

Department of Defense, 86n, 208

Department of Education, 84n, 208

Department of Energy, 208

Department of Health, Education, and Welfare (DHEW), 191

Department of Health and Human Services (DHHS), ix, xi, 1, 3, 410, 1314, 22, 6566, 105109, 123127, 138139, 157159, 199202, 226, 234237

agencies of, 8688

defined, 231

regulations of, 59, 73100

and Subpart A, 2

Department of Housing and Urban Development, 208

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Department of Justice (DOJ), 67, 47, 6566, 74, 93, 202, 208

confidentiality, 91

informed consent, 9192

regulations, 8993

review of research protocols, 9293

statistics and trends, 31

Department of Labor, 212

Department of Transportation, 208

Department of Veterans Affairs, 63, 208

Depression, major, 45

DHEW. See Department of Health, Education, and Welfare

DHHS. See Department of Health and Human Services

Diabetes, 29

Disadvantaged populations, 12.

See also individual populations

Dislocation of inmates, from local to distant jurisdictions, 49

District of Columbia, 38

DOC. See Department of Corrections

Documentation of informed consent, in Subpart A, 223224

DOJ. See Department of Justice

Downsizing Prisons, 34

Drug rehabilitation programs, 37

Drugs

registry of clinical research on, 7

war on, 23, 29, 33

E

E-mail survey, of state Departments of Corrections (DOCs), 188

Early termination. See Termination of research support—evaluation of applications and proposals

Education As Crime Prevention: Providing Education to Prisoners, 39

Educational attainment

for correctional populations and the general population, 40

and reading skills of prisoners, 3840

Educational programs, participation in since most recent incarceration or sentence for state and federal prison inmates, local jail inmates, and probationers, 41

Electronic monitoring programs, 24, 33, 103

Environmental Protection Agency, 208

Estelle v. Gamble, 30, 50, 57

Ethical considerations, for revisions to DHHS regulations for protection of prisoners involved in research, 5

Ethical foundations, of current research regulations, 101102

Ethical framework for research involving prisoners, x, 7, 26, 113135

1976 Commission’s ethical framework, 114116

historical context, 114

justice, 115116, 127135

versus research involving nonprisoners, 25

respect for persons, 115127

updated, 116135

Ethical research, 11, 15

prerequisites of, 12

European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment, 153

Evaluation and disposition of applications and proposals for research to be conducted or supported by a federal department or agency, in Subpart A, 224225

Expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research, in Subpart A, 217218

F

Facilities/locations, of research with prisoners, 6061, 183184

FBOP. See Federal Bureau of Prisons

FDA. See Food and Drug Administration

Federal Bureau of Prisons (FBOP), 52

Federal funds, use of in Subpart A, 225

Federal human subjects protections, 67, 8495

in the Report of the SACHRP Subcommittee, 202

Federal-level review, 14

Federal Register, 80, 85, 88, 167168, 210211, 217, 233234

Federal regulatory landscape, 73100

adoption of DHHS Human Subjects Protection Regulations, 7484

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

alternatives to comprehensive regulation, 99100

analysis, 94100

DOJ regulations, 8993

existing authority for broader regulation, 9596

FDA regulations, 8688

guaranteeing the DHHS broader authority, 9699

other DHHS agencies, 8688

other federal human subjects protections, 8493

Subpart D, 8586

Federal Security Agency, 96

Federal-wide assurance (FWA), 78, 8485, 138, 142, 201202

Florida, 59

Food and Drug Administration (FDA), 8, 73, 85, 95, 125, 144, 170, 202, 212

regulations, 8688, 99

For-profit prisons, 34, 49

Former prisoners/prisoner advocates liaison group, 176

Funding sources, 180181

in the published literature of prisoner studies, 63

FWA. See Federal-wide assurance

G

GAO. See General Accounting Office

GED. See General Equivalency Development test

Gender of research participants, 184

numbers of studies by, 186

Gender-Responsive Strategies for Women Offenders, 36

General Accounting Office (GAO), 36

General Equivalency Development (GED) test, 39

Georgia, 43

Gonzales v. Oregon, 97n, 99

Guardians

defined, 235

requirements in Subpart D for permission by, 237238

Guidelines for human subjects research, establishing uniform, 67, 9495

H

Halfway houses, 24

Health-care services.

See also Standards of care

access to adequate, 2, 11, 133134

potentially inadequate, 12, 2223, 29

Health Insurance Portability and Accountability Act (HIPAA), 150

Health status of inmates, 1, 12, 4248

chronic diseases, 44

communicable diseases, 4244

gender factor in, 36

injury, violence, rape, and suicide, 4748

mental illness, 4447

substance abuse, 47

Health Status of Soon-to-Be-Released Inmates, The, 42

Helvering v. Davis, 96

Hepatitis, 12, 22, 24, 29, 4243, 128

High school completion, 39

HIPAA. See Health Insurance Portability and Accountability Act

Hispanic prisoners, 3839

History, of research with prisoners, 3, 5455

HIV. See Human immunodeficiency virus

Holmesburg Prison, 5455

HRPPP. See Human Research Participant Protection Program

HRW. See Human Rights Watch

Human immunodeficiency virus (HIV), 12, 24, 29, 43, 114, 128, 144145, 196

coinfections involving, 44

gender factor in, 36

Human research participant protection programs (HRPPPs), 8, 1011, 16, 94n, 130, 133134, 142, 149

creating a national resource for, 14

Human Rights Watch (HRW), 34, 46, 49

Human subjects

defined, 212

protections for, 199203

I

Incarcerated population

dislocation of, from local to distant jurisdictions, 49

growing enormously, 3133

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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quality of health care provided, 5054

services for, 4954

Incarceration

increased use of isolation in punishment of inmates, 4950

purpose of, 11

varieties of, 21

Incentives, 67, 228

Informed consent, 21, 122

ability of prisoners to provide ethically adequate, 56

in the Common Rule, 7778

in DOJ regulations, 9192

providing integrity to process of, 15

voluntary, 2, 15, 147149

Initial review, of prisoner research, 150151

Injury during incarceration.

See also Sexual assaults

reasons for, 4748

Institute of Medicine (IOM), ix, xi, 1, 3, 22, 176, 199

Institution, defined, 211

Institutional assurances, in the Common Rule, 78

Institutional review boards (IRBs), xi, 2, 1213, 30, 60, 103, 110111, 123124, 139158, 161170, 209, 212227

approval by, 12, 212

in the Common Rule, 77

composition of where prisoners are involved, in Subpart C, 232

considerations for independent ethical review, modifying, 13, 156157

defined, 212

duties, in Subpart D, 235

functions and operations, in Subpart A, 216

membership, in Subpart A, 215216

postapproval monitoring in oversight of research with prisoners, 156157

records, in Subpart A, 220

review of research, 3, 217

International Development Cooperation Agency, Agency for International Development, 208

IOM. See Institute of Medicine

IRBs. See Institutional review boards

Isolation, in punishment of inmates, increased use of, 4950

J

Jackson State Prison, 121, 193

Jacobson, Michael, 33

Jacobson v. Massachusetts, 58

Jail inmates, numbers of, 32

Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 133

JPI. See Justice Policy Institute

Justice, 27, 127135

collaborative responsibility, 127130

welfare of the prisoner population, 130135

Justice Policy Institute (JPI), 3132, 34

Juveniles, 26n, 108, 185

L

Legally authorized representative, defined, 211

Liberty status, changes in, 110111

Likelihood of injury, based on time in prison, 48

Literature review of published prisoner studies, 6164

facilities/locations, 183184

funding sources, 63, 180181

general characteristics of research with prisoners, 178187

locus of research activity, 6162

mechanisms of research approval, 6364, 180182

numbers and demographics of research participants, 184187

results, 180187

study content/design, 6263

study design, 182

type of study, 62, 182183

Local research review board (LRRB), 9293

M

Maryland, 43

Mechanisms of research approval

in the published literature of prisoner studies, 6364

of research with prisoners, 180182

Mental institutions, closing of large, 29

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Mentally ill inmates, 12, 24, 4447

excluded from study, 26n

gender factor in, 36

receiving mental health services while incarcerated, 30, 46

vulnerabilities of in prison, 12

Michigan, 121, 193

Military personnel, 3n

excluded from study, 26n

Minimal risk, defined, 25, 124, 212, 232

Minorities. See Race/ethnicity of research participants;

individual minorities

N

National Aeronautics and Space Administration, 208

National Bioethics Advisory Commission (NBAC), 75, 117

National Center on Institutions and Alternatives, 38

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) (NCPHSBBR), ix, xi, 22, 29, 66, 79, 101102, 113, 191197

deliberations, findings, and conclusions, 194196

methodology, 193194

National Commission on Correctional Health Care (NCCHC), 42, 44, 5051, 133

National Institute of Corrections (NIC), 36

National Institute of Justice (NIJ), 63

National Institute on Drug Abuse, 60

National Institutes of Health (NIH), 63, 6667, 7376

National Minority Conference on Human Experimentations, 193

National oversight, of research with prisoners, 157160

National Research Act, 115n, 117118, 191192

Section 202(a)(2), 192

National Science Foundation, 208

Nazi experiments, 114

NBAC. See National Bioethics Advisory Commission

NCCHC. See National Commission on Correctional Health Care

Neonate

defined, 226

nonviable, defined, 227

New Freedom Commission on Mental Health (NFCMH), 45

New Jersey, 37

New York, 59, 114, 195

New York City

Department of Health and Mental Hygiene, 53

Departments of Correction and Probation, 34

New York Times, 42, 5152

NFCMH. See New Freedom Commission on Mental Health

NIC. See National Institute of Corrections

NIH. See National Institutes of Health

NIJ. See National Institute of Justice

Nonviable neonate, defined, 227

Nonwhite participants, numbers of studies with, 187

Nuremburg Code, 114, 194

O

Office for Human Research Protections (OHRP), xi, 1, 3, 6, 89, 1315, 22, 24, 73, 77, 83, 103, 123, 125, 156159, 175176, 200201, 211, 217

enhancing capacity of, 1314, 157159

prisoner certifications, 8182

Office of Management and Budget, 217, 219220, 223224

Office of Research and Evaluation (ORE), 9293

OHRP. See Office for Human Research Protections

Ombudsman, 155

Open sessions and workshops, 175178

Open Society Institute (OSI), 34, 39

ORE. See Office of Research and Evaluation

OSI. See Open Society Institute

Out of Sight: Super Maximum Security Confinement in the United States, 49

Oversight of research with prisoners, 151160

IRB postapproval monitoring, 156157

national oversight, 157160

Prison Research Subject Advocates, 153156

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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P

Parents

defined, 235

requirements in Subpart D for permission by, 237238

Parole, 3031

Pell Grants, 40

Pennsylvania, 5455

Permission, defined, 235

Permitted research involving prisoners, in Subpart C, 233234

Phases of human research, 131, 160

Phase 3 testing, 9, 125

PHR. See Physicians for Human Rights

PHS. See Public Health Service

Physicians for Human Rights (PHR), 56

Policies and procedures, for application review and study, 6061

Policy makers, informing, 1112, 134135

PREA. See Prison Rape Elimination Act

Pregnancy

defined, 227

high risk, 37

Prejudicial information, 155

Prison Health Services, Inc., 30, 5253

Prison Rape Elimination Act (PREA), 48, 9899

Prison research subject advocate (PRSA), 1213, 118, 137, 147, 154156, 164168

oversight of research with prisoners, 153156

Prisoner IRB representatives, in the Report of the SACHRP Subcommittee, 83, 200

Prisoner Liaison Panel, xi, 50, 65, 120

Prisoner population, 3158.

See also Today’s prisoners—changing demographics, health issues, and the current research environment

ages of inmates, 29, 4042

causes of growth in, 2324, 3335

defined, 1, 21n, 27, 33, 65, 8283, 105109, 200, 231

echoes of Tuskegee and Retin-A, 22, 5455

educational level and reading skills of prisoners, 3840

enormous growth in, 23, 29, 3133

findings on changing demographics and health issues, 5859

by gender, 36

health status of, 4248

history of research with, 3, 5455

implications of demographics for the ethical conduct of research, 5558

injury, violence, rape, and suicide of, 4748

under jurisdiction of state or federal correctional authorities by gender, 35

more women entering, 3538

numbers of, 32

obtaining input from, 1011, 129130

racial and ethnic disparities, 38

reentering society, 1112, 134135

restrictions on liberty and autonomy, 12, 27

subclasses of, 12

vulnerabilities of, 12, 21

welfare of, 130135

where incarcerated and how provided with services, 4954

who is in prisons and jails, 3542

Prisoner studies, published, literature review of, 6164

Prisons, jails, and other correctional settings

descriptions of, 3031

everyday life in, 11

for-profit, 34, 49

Privacy

absolute, difficulty guaranteeing, 16, 2122

barriers to, and the ethical conduct of research, 12, 5658

protection of, 2, 1516, 25, 149150

Probation, 3031, 103

Problems

investigating reports of possible, 14, 2122

unexpected, in reviewing prisoner research, 151

Prohibited categories and types of research involving prisoners, 170

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

Proposed regulations, 109110.

See also Recommendations

Protectionism, role of, 118127

Protocols. See Research, protocols

PRSA. See Prison research subject advocate

Public database, of all research involving prisoners, 7, 6566

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Public health implications, of inadequate health care for prisoners, 5354

Public Health Service Act, 95

Public Health Service (PHS), 55, 74

Public meeting participants, 178179

Published prisoner studies, literature review of, 6164

“Punishing decade,” 32

Purpose, in Subpart C, 231

Q

Quality assurance (QA), 140

Quality improvement (QI), 140141, 151, 155

Quality of health care provided, 5054

public health implications of inadequate health care for prisoners, 5354

R

RA. See Research assistant

Race/ethnicity of research participants, 1, 3839, 45, 187.

See also individual racial and ethnic groups

disparities among, 23, 38

numbers of studies by, 186

vulnerabilities of in prison, 12

Rape. See Sexual assaults

Reading skill levels, 38

Rearrest rates, 34

Recidivism

high rates of, 23, 34

reducing, 1112, 39, 134135

Recommendations, 316, 196

data retrieval needing improving, 6466

enhancing systematic oversight of research involving prisoners, xi, 1, 4, 1216, 159

ensuring universal, consistent ethical protection, xi, 1, 4, 67

expanding definition of prisoner, xi, 1, 46, 105109

shifting from a category-based to a risk-benefit approach to research review, xi, 1, 4, 810

updating the ethical framework to include collaborative responsibility, xi, 1, 4, 1012

Recommendations for further consideration by the IOM, in the Report of the SACHRP Subcommittee, 84, 201202

Registry of clinical research on drugs and biololgics, 7

Registry of research involving prisoners, need for a national, 7, 14, 158

Regulation, existing authority for broader, 9596

Regulations for the protection of human subjects, 24

applicable even to research not federally funded by any agency, 90

applicable to research involving human subjects, 75

applicable to research involving prisoners as subjects, independent of funding source, 203

compliance with, 14

DOJ, 8993

Subpart A, 208209

Subpart B, 226

Subpart D, 234235

Reiger, Darrel A., 44

Report and Recommendations: Research Involving Prisoners, 2, 66, 79, 113

Report of the SACHRP Subcommittee and Human Subjects Protections, 27, 8184, 94, 199203

defining minimal risk and benefit to participants, 8384, 201

definition of prisoner, 8283, 200

prisoner IRB representatives, 83, 200

recommendations for further consideration by the IOM, 84, 201202

Requirements, for permission by parents or guardians and for assent by children, in Subpart D, 237238

Research

abuses in, 3

categories of, 184

involving, after delivery, the placenta, the dead fetus, or fetal material, in Subpart B, 230

involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition, in Subpart D, 236

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, in Subpart D, 235236

involving neonates, in Subpart B, 228230

involving pregnant women or fetuses, in Subpart B, 227228

not involving greater than minimal risk, in Subpart D, 235

not otherwise approvable which presents an opportunity to understand, prevent

or alleviate a serious problem affecting the health or welfare of children, in Subpart D, 236237

or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, in Subpart B, 230

protocols for, 1011, 13, 22, 26, 9293, 129130, 156157

safeguards for particular kinds of, 160170

Research assistant (RA), 62n

Research involving prisoners, 184187

age, 140142, 184, 186

best practices gained from high-quality, 12, 135

defined, 211

echoes of Tuskegee and Retin-A, 22, 5455

establishing uniform guidelines for, 67, 9495

ethical framework for, 113135

gender, 184

government support needed for, 1112, 134135

history of, 3, 5455

monitoring, 1213, 154156

numbers of, 185

oversight of, 151160

priorities for, 25

protecting privacy, 1516, 149150

race/ethnicity, 187

settings delineated, 109110

subject to regulation, defined, 212

undertaken without the intention of involving human subjects, in Subpart A, 224

Respect for persons, 15, 27, 117127, 192

expanded view of, 117118

guidance on biomedical research, 125127

role of protectionism, 118127

Responsible Research: A Systems Approach to Protecting Research Participants, 129

Results

from Department of Corrections survey, 189190

policies and procedures for application review and study, 6061

of research with prisoners, 180187

from the surveys with key DOC personnel, 6061

types of research permitted and research personnel, 60

Retin-A, echoes of among the prisoner population, 22, 5455

Reviewing prisoner research, 138151

adverse events or unexpected problems, 151

amendment review, 151

continuing review, 151

how reviews are conducted, 143150

initial review, 150151

by institution, in Subpart A, 219

research protocols, in DOJ regulations, 9293

what is reviewed, 139141

when reviews are done, 150151

who reviews, 141142

Rhode Island, 53n

Right to consent or refuse care, and the ethical conduct of research, 5658

Risk

minimal, defined, 25, 124, 212

threshold of, 26

Risk-benefit framework, applying to research review, 810, 122127

Rumsfeld v. Forum for Academic and Institutional Rights, 97n

S

SACHRP. See Secretary’s Advisory Committee on Human Research Protections

Safeguards for particular kinds of research, 160170

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

SAMHSA. See Substance Abuse and Mental Health Services Administration

Sample situations, 163170

San Quentin Prison, 187

Sanctions, for non-compliance, imposing, 14

Schloendorff v. Society of New York Hospitals, 57

Search terms, 179

Secretary of DHHS, 9

defined, 227, 231

Secretary’s Advisory Committee on Human Research Protections (SACHRP), 24, 8082, 199.

See also Report of the SACHRP Subcommittee

Sentencing laws.

See also The Sentencing Project (TSP)

harsher, 23, 29

mandatory minimums, 34

three-strike laws, 34

Sexual assaults, repeated, in incarcerated populations, 9, 37, 48

Sexual offenders, 109

Sexually transmitted diseases (STDs), 42, 128

Single female heads of household, 37

Site visits, 187188

Social Security Administration (SSA), 74, 79, 158

South Dakota v. Dole, 9697

Special study design, and PRSA monitoring safeguards, 162163

SSA. See Social Security Administration

Stakeholders, 170174

obtaining input from, 1011, 129130

responsibilities of, 1719, 170174

Standards of care, ensuring adequate, 11, 133134

State Departments of Corrections (DOCs) survey, 59, 140, 175, 188190

e-mail survey, 59, 188

telephone interviews, 59, 188

STDs. See Sexually transmitted diseases

Study content/design of research with prisoners, 182

in the published literature, 6263

Subjects, of reviews, 139141

Subpart A: Basic DHHS Policy for Protection of Human Research Subjects, 2, 208226

applications and proposals lacking definite plans for involvement of human subjects, 224

assuring compliance with this policy—research conducted or supported by any federal department or agency, 213215

conditions, 225226

cooperative research, 219220

criteria for IRB approval of research, 218219

documentation of informed consent, 223224

early termination of research support—evaluation of applications and proposals, 225

evaluation and disposition of applications and proposals for research to be conducted or supported by a federal department or agency, 224225

expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research, 217218

general requirements for informed consent, 220223

IRB functions and operations, 216

IRB membership, 215216

IRB records, 220

IRB review of research, 217

research undertaken without the intention of involving human subjects, 224

review by institution, 219

suspension or termination of IRB approval of research, 219

use of federal funds, 225

to what this policy applies, 208209

Subpart A definitions, 211213

agency head, 211

certification, 212213

department head, 211

human subject, 212

institution, 211

IRB, 212

IRB approval, 212

legally authorized representative, 211

minimal risk, 212

research, 211

research subject to regulation, 212

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, 226230

duties of IRBs in connection with research involving pregnant women, fetuses, and neonates, 227

research involving, after delivery, the placenta, the dead fetus, or fetal material, 230

research involving neonates, 228230

research involving pregnant women or fetuses, 227228

research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, 230

to what these regulations apply, 226

Subpart B definitions, 226227

dead fetus, 226

delivery, 226

fetus, 226

neonate, 226

nonviable neonate, 227

pregnancy, 227

Secretary of DHHS, 227

viable, 227

Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, xi, 26, 66, 7981, 231234

additional duties of the IRBs where prisoners are involved, 232233

additional requirements for IRBs, 8081

applicability, 231

composition of IRBs where prisoners are involved, 232

key definitions within Subpart C, 7980

OHRP certification, 81

permitted research involving prisoners, 233234

purpose, 231

rewriting, 24

Subpart C definitions, 231232

DHHS, 231

minimal risk, 232

prisoners, 231

Secretary of DHHS, 231

Subpart D: Additional Protections for Children Involved as Subjects in Research, 89, 8586, 234238

framework, 87

IRB duties, 235

requirements for permission by parents or guardians and for assent by children, 237238

research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition, 236

research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, 235236

research not involving greater than minimal risk, 235

research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, 236237

wards, 238

to what these regulations apply, 234235

Subpart D definitions, 235

assent, 235

children, 235

guardian, 235

parent, 235

permission, 235

Substance Abuse and Mental Health Services Administration (SAMHSA), 73

Substance abuse of inmates, 37, 47

Surveys with key DOC personnel, results from, 6061

Suspension or termination of IRB approval of research, in Subpart A, 219

Systems of oversight, safeguards, and protections, 137174

applying safeguards for particular kinds of research, 160170

defining and reviewing prisoner research, 138151

impact of committee recommendations on stakeholder responsibilities, 170174

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

other prohibited categories and types of research involving prisoners, 170

sample situations, 163170

T

TB. See Tuberculosis

Telephone interviews, of state Departments of Corrections (DOCs), 188

Termination of research support—evaluation of applications and proposals, early, in Subpart A, 225

Texas, 43, 52, 59

The Sentencing Project (TSP), 34, 40

Therapeutic research, 116

Thompson v. City of Los Angeles, 58

Three-strike laws, 34, 40, 42

Timing, 2224

of reviews, 150151

Today’s prisoners—changing demographics, health issues, and the current research environment, 2971

changing demographics and health issues, 3059

current research environment, 5967

current status of prisoner research, 59

data retrieval needing improving, 6466

published literature—a review of selected prisoner studies, 6164

results from the surveys with key DOC personnel, 6061

summary of findings on current research environment, 6667

Transparency, 7, 26, 64, 159160

TSP. See The Sentencing Project

Tuberculosis (TB), 12, 24, 4344

Tuskegee, echoes of among the prisoner population, 22, 5455

Types of research with prisoners, 182183

permitted, and research personnel, 60

in the published literature, 62

U

U.S. Constitution

Eighth Amendment, 23, 50, 57

role in guaranteeing the DHHS broader authority, 96

U.S. Patriot Act, 3n, 26n

U.S. Supreme Court, 30, 50, 5657, 97

V

Viable, defined, 227

Violent Crime Control and Law Enforcement Act, 40

Viral diseases, 4243

antiviral therapies, 43

Virginia, 43

Voluntariness, in the prison setting, 2526

Voluntary informed consent, 2, 15, 147149

W

Wards, in Subpart D, 238

Washington State, 49

Washington v. Harper, 58

Weekend reporting programs, 33

Welfare of the prisoner population, 130135

White prisoners, 39, 45

White v. Napoleon, 5758

Women

increasingly entering the correctional system, 12, 23, 3538

single female heads of household, 3738

vulnerabilities of in prison, 12, 3638

Women Offenders: Programming Needs and Promising Approaches, 37

Work-release programs, 24, 33

World Medical Assembly Declaration, 210

Y

Young people, vulnerabilities of in prison, 12

Z

Zaire v. Dalsheim, 58

Suggested Citation:"Index." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Ethical Considerations for Research Involving Prisoners Get This Book
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In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision.

Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners.

The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections:

• expand the definition of "prisoner";

• ensure universally and consistently applied standards of protection;

• shift from a category-based to a risk-benefit approach to research review;

• update the ethical framework to include collaborative responsibility; and

• enhance systematic oversight of research involving prisoners.

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