Ethical Considerations for Research Involving Prisoners (2007)
Chapter: Index
Index
A
Abuses.
See also Substance abuse intervening to curtail, 14
ACA. See American Correctional Association
Acquired immunodeficiency syndrome (AIDS), 1–2, 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, 74–84
Report of the SACHRP Subcommittee, 81–84
Subpart C: Prisoners as Research Subjects, 79–81
Adverse events (AE)
in reviewing prisoner research, 151
Agency head, defined, 211
Ages
of research participants, 184, 186
AIDS. See Acquired immunodeficiency syndrome
Alternatives to comprehensive regulation, 99–100
Alternatives to incarceration, 23–24, 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
Beyond Consent: Seeking Justice in Research, 117, 132
Biologics, registry of clinical research on, 7
distrust regarding, x
interventions, 9
BJS. See Bureau of Justice Statistics
BOP. See Bureau of Prisons
BRRB. See Bureau Research Review Board
Bureau of Justice Statistics (BJS), 31, 33, 37–38, 44, 47–48, 89n, 105, 123
Bureau of Prisons (BOP), 6, 74, 85, 89–93, 99, 176, 202
Bureau Research Review Board (BRRB), 92–93
C
California Department of Corrections and Rehabilitation (CDCR), 51
California Medical Facility (CMF), 187
California prison system medical care system in receivership, 29–30, 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, 66–67, 73
Central Intelligence Agency (CIA), 74, 79, 158
Certification, defined, 212–213
Cervical cancer, 37
Children, 3n
defined, 235
excluded from study, 26n
requirements in Subpart D for assent by, 237–238
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, 205–238
Subpart A: Basic DHHS Policy for Protection of Human Research Subjects, 23, 208–226
Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, 226–230
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, 23, 231–234
Subpart D: Additional Protections for Children Involved as Subjects in Research, 234–238
Coleman v. Wilson, 30
Collaborative research approach, 10–11, 16, 27, 127–130
Commission of Correction v. Myers, 58
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
Common Rule, 2, 6, 24, 74, 76–78, 202.
See also Code of Federal Regulations Title 45;
Subpart A: Basic DHHS Policy for Protection of Human Research Subjects
institutional assurances, 78
IRBs, 77
Communicable diseases of inmates, 1–2, 24, 29, 42–44, 53
HIV/AIDS, 43
Communication skill levels, 38
Community service, 103
Community settings, 4–6, 105–109
Compliance with policies, assuring, in all research conducted or supported by any federal department or agency, 213–215
Conditions, in Subpart A, 9, 225–226
Confidentiality
in DOJ regulations, 91
of health information, 56
protecting, 25
scope of spending power, 96–99
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, 219–220
Correctional population. See Prisoner population
Correctional settings, 4–6, 101–112
current regulations pertinent to places of prisoner research, 102–103
delineation of settings, 109–110
encompassing more than prisons and jails, 103–105
ethical foundations of current research regulations, 101–102
when liberty status changes, 110–111
when proposed regulations should apply, 109–110
when proposed regulations should not apply, 110
Criminal justice system
agencies and facilities in California, 106–107
harm inflicted on those it punishes, 11–12
restrictions imposed by, 4–6, 30, 105–109
Criteria for IRB approval of research, in Subpart A, 218–219
Cruzan v. Missouri Department of Health, 57
Current regulations pertinent to places of prisoner research, 102–103
Current research environment, 59–67
Current status of prisoner research, 59
D
Data sources and methods, 175–190.
See also Public database
data retrieval needing improving, 64–66
literature survey to assess general characteristics of research with prisoners, 178–187
open sessions and workshops, 175–178
survey of state Departments of Corrections, 188–190
Decision making, autonomous, 15
Declaration of Helsinki, 210
Definitions, 82–84, 211–213, 226–227, 231–232, 235.
See also individual terms and acronyms
of minimal risk and benefit to participants, 83–84, 201
of prisoner, 1, 21n, 27, 33, 65, 82–83, 105–109, 200, 231
Demographics
ability of prisoners to provide ethically adequate informed consent, 56
barriers to privacy and right to consent or refuse care, 56–58
descriptions of prisons, jails, and other correctional settings, 30–31
and the ethical conduct of research, 55–58
implications for the ethical conduct of research on the prisoner population, 55–58
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, 4–10, 13–14, 22, 65–66, 105–109, 123–127, 138–139, 157–159, 199–202, 226, 234–237
defined, 231
and Subpart A, 2
Department of Housing and Urban Development, 208
Department of Justice (DOJ), 6–7, 47, 65–66, 74, 93, 202, 208
confidentiality, 91
review of research protocols, 92–93
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, 1–2.
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, 223–224
DOJ. See Department of Justice
Downsizing Prisons, 34
Drug rehabilitation programs, 37
Drugs
registry of clinical research on, 7
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, 38–40
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
Ethical considerations, for revisions to DHHS regulations for protection of prisoners involved in research, 5
Ethical foundations, of current research regulations, 101–102
Ethical framework for research involving prisoners, x, 7, 26, 113–135
1976 Commission’s ethical framework, 114–116
historical context, 114
versus research involving nonprisoners, 25
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, 224–225
Expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research, in Subpart A, 217–218
F
Facilities/locations, of research with prisoners, 60–61, 183–184
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, 6–7, 84–95
in the Report of the SACHRP Subcommittee, 202
Federal-level review, 14
Federal Register, 80, 85, 88, 167–168, 210–211, 217, 233–234
Federal regulatory landscape, 73–100
adoption of DHHS Human Subjects Protection Regulations, 74–84
alternatives to comprehensive regulation, 99–100
existing authority for broader regulation, 95–96
guaranteeing the DHHS broader authority, 96–99
other federal human subjects protections, 84–93
Federal Security Agency, 96
Federal-wide assurance (FWA), 78, 84–85, 138, 142, 201–202
Florida, 59
Food and Drug Administration (FDA), 8, 73, 85, 95, 125, 144, 170, 202, 212
Former prisoners/prisoner advocates liaison group, 176
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
Guardians
defined, 235
requirements in Subpart D for permission by, 237–238
Guidelines for human subjects research, establishing uniform, 6–7, 94–95
H
Halfway houses, 24
Health-care services.
See also Standards of care
access to adequate, 2, 11, 133–134
potentially inadequate, 1–2, 22–23, 29
Health Insurance Portability and Accountability Act (HIPAA), 150
Health status of inmates, 1, 12, 42–48
chronic diseases, 44
gender factor in, 36
injury, violence, rape, and suicide, 47–48
substance abuse, 47
Health Status of Soon-to-Be-Released Inmates, The, 42
Helvering v. Davis, 96
Hepatitis, 1–2, 22, 24, 29, 42–43, 128
High school completion, 39
HIPAA. See Health Insurance Portability and Accountability Act
History, of research with prisoners, 3, 54–55
HIV. See Human immunodeficiency virus
HRPPP. See Human Research Participant Protection Program
HRW. See Human Rights Watch
Human immunodeficiency virus (HIV), 1–2, 24, 29, 43, 114, 128, 144–145, 196
coinfections involving, 44
gender factor in, 36
Human research participant protection programs (HRPPPs), 8, 10–11, 16, 94n, 130, 133–134, 142, 149
creating a national resource for, 14
Human Rights Watch (HRW), 34, 46, 49
Human subjects
defined, 212
I
Incarcerated population
dislocation of, from local to distant jurisdictions, 49
quality of health care provided, 50–54
Incarceration
increased use of isolation in punishment of inmates, 49–50
purpose of, 11
varieties of, 21
ability of prisoners to provide ethically adequate, 56
providing integrity to process of, 15
Initial review, of prisoner research, 150–151
Injury during incarceration.
See also Sexual assaults
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, 12–13, 30, 60, 103, 110–111, 123–124, 139–158, 161–170, 209, 212–227
in the Common Rule, 77
composition of where prisoners are involved, in Subpart C, 232
considerations for independent ethical review, modifying, 13, 156–157
defined, 212
duties, in Subpart D, 235
functions and operations, in Subpart A, 216
membership, in Subpart A, 215–216
postapproval monitoring in oversight of research with prisoners, 156–157
records, in Subpart A, 220
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, 49–50
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
collaborative responsibility, 127–130
welfare of the prisoner population, 130–135
Justice Policy Institute (JPI), 31–32, 34
L
Legally authorized representative, defined, 211
Liberty status, changes in, 110–111
Likelihood of injury, based on time in prison, 48
Literature review of published prisoner studies, 61–64
general characteristics of research with prisoners, 178–187
locus of research activity, 61–62
mechanisms of research approval, 63–64, 180–182
numbers and demographics of research participants, 184–187
study design, 182
Local research review board (LRRB), 92–93
M
Maryland, 43
Mechanisms of research approval
in the published literature of prisoner studies, 63–64
of research with prisoners, 180–182
Mental institutions, closing of large, 29
Mentally ill inmates, 1–2, 24, 44–47
excluded from study, 26n
gender factor in, 36
receiving mental health services while incarcerated, 30, 46
vulnerabilities of in prison, 12
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, 101–102, 113, 191–197
deliberations, findings, and conclusions, 194–196
National Commission on Correctional Health Care (NCCHC), 42, 44, 50–51, 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, 66–67, 73–76
National Minority Conference on Human Experimentations, 193
National oversight, of research with prisoners, 157–160
National Research Act, 115n, 117–118, 191–192
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 City
Department of Health and Mental Hygiene, 53
Departments of Correction and Probation, 34
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
O
Office for Human Research Protections (OHRP), xi, 1, 3, 6, 8–9, 13–15, 22, 24, 73, 77, 83, 103, 123, 125, 156–159, 175–176, 200–201, 211, 217
enhancing capacity of, 13–14, 157–159
prisoner certifications, 81–82
Office of Management and Budget, 217, 219–220, 223–224
Office of Research and Evaluation (ORE), 92–93
OHRP. See Office for Human Research Protections
Ombudsman, 155
Open sessions and workshops, 175–178
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, 151–160
P
Parents
defined, 235
requirements in Subpart D for permission by, 237–238
Pell Grants, 40
Permission, defined, 235
Permitted research involving prisoners, in Subpart C, 233–234
Phases of human research, 131, 160
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, 60–61
Policy makers, informing, 11–12, 134–135
PREA. See Prison Rape Elimination Act
Pregnancy
defined, 227
high risk, 37
Prejudicial information, 155
Prison Health Services, Inc., 30, 52–53
Prison Rape Elimination Act (PREA), 48, 98–99
Prison research subject advocate (PRSA), 12–13, 118, 137, 147, 154–156, 164–168
oversight of research with prisoners, 153–156
Prisoner IRB representatives, in the Report of the SACHRP Subcommittee, 83, 200
Prisoner Liaison Panel, xi, 50, 65, 120
See also Today’s prisoners—changing demographics, health issues, and the current research environment
causes of growth in, 23–24, 33–35
defined, 1, 21n, 27, 33, 65, 82–83, 105–109, 200, 231
echoes of Tuskegee and Retin-A, 22, 54–55
educational level and reading skills of prisoners, 38–40
enormous growth in, 23, 29, 31–33
findings on changing demographics and health issues, 58–59
by gender, 36
history of research with, 3, 54–55
implications of demographics for the ethical conduct of research, 55–58
injury, violence, rape, and suicide of, 47–48
under jurisdiction of state or federal correctional authorities by gender, 35
numbers of, 32
obtaining input from, 10–11, 129–130
racial and ethnic disparities, 38
reentering society, 11–12, 134–135
restrictions on liberty and autonomy, 1–2, 27
subclasses of, 12
where incarcerated and how provided with services, 49–54
who is in prisons and jails, 35–42
Prisoner studies, published, literature review of, 61–64
Prisons, jails, and other correctional settings
everyday life in, 11
Privacy
absolute, difficulty guaranteeing, 16, 21–22
barriers to, and the ethical conduct of research, 1–2, 56–58
protection of, 2, 15–16, 25, 149–150
Problems
investigating reports of possible, 14, 21–22
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, 109–110.
See also Recommendations
Protectionism, role of, 118–127
Protocols. See Research, protocols
PRSA. See Prison research subject advocate
Public database, of all research involving prisoners, 7, 65–66
Public health implications, of inadequate health care for prisoners, 53–54
Public Health Service Act, 95
Public Health Service (PHS), 55, 74
Public meeting participants, 178–179
Published prisoner studies, literature review of, 61–64
“Punishing decade,” 32
Purpose, in Subpart C, 231
Q
Quality assurance (QA), 140
Quality improvement (QI), 140–141, 151, 155
Quality of health care provided, 50–54
public health implications of inadequate health care for prisoners, 53–54
R
RA. See Research assistant
Race/ethnicity of research participants, 1, 38–39, 45, 187.
See also individual racial and ethnic groups
numbers of studies by, 186
vulnerabilities of in prison, 12
Rape. See Sexual assaults
Reading skill levels, 38
Rearrest rates, 34
Recidivism
data retrieval needing improving, 64–66
enhancing systematic oversight of research involving prisoners, xi, 1, 4, 12–16, 159
ensuring universal, consistent ethical protection, xi, 1, 4, 6–7
expanding definition of prisoner, xi, 1, 4–6, 105–109
shifting from a category-based to a risk-benefit approach to research review, xi, 1, 4, 8–10
updating the ethical framework to include collaborative responsibility, xi, 1, 4, 10–12
Recommendations for further consideration by the IOM, in the Report of the SACHRP Subcommittee, 84, 201–202
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, 95–96
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
Subpart B, 226
Reiger, Darrel A., 44
Report and Recommendations: Research Involving Prisoners, 2, 66, 79, 113
Report of the SACHRP Subcommittee and Human Subjects Protections, 27, 81–84, 94, 199–203
defining minimal risk and benefit to participants, 83–84, 201
definition of prisoner, 82–83, 200
prisoner IRB representatives, 83, 200
recommendations for further consideration by the IOM, 84, 201–202
Requirements, for permission by parents or guardians and for assent by children, in Subpart D, 237–238
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
involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, in Subpart D, 235–236
involving neonates, in Subpart B, 228–230
involving pregnant women or fetuses, in Subpart B, 227–228
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, 236–237
or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, in Subpart B, 230
protocols for, 10–11, 13, 22, 26, 92–93, 129–130, 156–157
safeguards for particular kinds of, 160–170
Research assistant (RA), 62n
Research involving prisoners, 184–187
best practices gained from high-quality, 12, 135
defined, 211
echoes of Tuskegee and Retin-A, 22, 54–55
establishing uniform guidelines for, 6–7, 94–95
ethical framework for, 113–135
gender, 184
government support needed for, 11–12, 134–135
numbers of, 185
priorities for, 25
protecting privacy, 15–16, 149–150
race/ethnicity, 187
subject to regulation, defined, 212
undertaken without the intention of involving human subjects, in Subpart A, 224
Respect for persons, 15, 27, 117–127, 192
guidance on biomedical research, 125–127
role of protectionism, 118–127
Responsible Research: A Systems Approach to Protecting Research Participants, 129
Results
from Department of Corrections survey, 189–190
policies and procedures for application review and study, 60–61
of research with prisoners, 180–187
from the surveys with key DOC personnel, 60–61
types of research permitted and research personnel, 60
Retin-A, echoes of among the prisoner population, 22, 54–55
Reviewing prisoner research, 138–151
adverse events or unexpected problems, 151
amendment review, 151
continuing review, 151
how reviews are conducted, 143–150
by institution, in Subpart A, 219
research protocols, in DOJ regulations, 92–93
when reviews are done, 150–151
Rhode Island, 53n
Right to consent or refuse care, and the ethical conduct of research, 56–58
Risk
minimal, defined, 25, 124, 212
threshold of, 26
Risk-benefit framework, applying to research review, 8–10, 122–127
Rumsfeld v. Forum for Academic and Institutional Rights, 97n
S
SACHRP. See Secretary’s Advisory Committee on Human Research Protections
SAMHSA. See Substance Abuse and Mental Health Services Administration
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
Secretary’s Advisory Committee on Human Research Protections (SACHRP), 24, 80–82, 199.
See also Report of the SACHRP Subcommittee
Sentencing laws.
See also The Sentencing Project (TSP)
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
Social Security Administration (SSA), 74, 79, 158
Special study design, and PRSA monitoring safeguards, 162–163
SSA. See Social Security Administration
obtaining input from, 10–11, 129–130
responsibilities of, 17–19, 170–174
Standards of care, ensuring adequate, 11, 133–134
State Departments of Corrections (DOCs) survey, 59, 140, 175, 188–190
STDs. See Sexually transmitted diseases
Study content/design of research with prisoners, 182
in the published literature, 62–63
Subpart A: Basic DHHS Policy for Protection of Human Research Subjects, 2, 208–226
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, 213–215
criteria for IRB approval of research, 218–219
documentation of informed consent, 223–224
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, 224–225
expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research, 217–218
general requirements for informed consent, 220–223
IRB functions and operations, 216
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, 208–209
Subpart A definitions, 211–213
agency head, 211
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
Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, 226–230
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, 228–230
research involving pregnant women or fetuses, 227–228
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, 226–227
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, 2–6, 66, 79–81, 231–234
additional duties of the IRBs where prisoners are involved, 232–233
additional requirements for IRBs, 80–81
applicability, 231
composition of IRBs where prisoners are involved, 232
key definitions within Subpart C, 79–80
OHRP certification, 81
permitted research involving prisoners, 233–234
purpose, 231
rewriting, 24
Subpart C definitions, 231–232
DHHS, 231
minimal risk, 232
prisoners, 231
Secretary of DHHS, 231
Subpart D: Additional Protections for Children Involved as Subjects in Research, 8–9, 85–86, 234–238
framework, 87
IRB duties, 235
requirements for permission by parents or guardians and for assent by children, 237–238
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, 235–236
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, 236–237
wards, 238
to what these regulations apply, 234–235
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, 60–61
Suspension or termination of IRB approval of research, in Subpart A, 219
Systems of oversight, safeguards, and protections, 137–174
applying safeguards for particular kinds of research, 160–170
defining and reviewing prisoner research, 138–151
impact of committee recommendations on stakeholder responsibilities, 170–174
other prohibited categories and types of research involving prisoners, 170
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
The Sentencing Project (TSP), 34, 40
Therapeutic research, 116
Thompson v. City of Los Angeles, 58
Today’s prisoners—changing demographics, health issues, and the current research environment, 29–71
changing demographics and health issues, 30–59
current research environment, 59–67
current status of prisoner research, 59
data retrieval needing improving, 64–66
published literature—a review of selected prisoner studies, 61–64
results from the surveys with key DOC personnel, 60–61
summary of findings on current research environment, 66–67
Transparency, 7, 26, 64, 159–160
TSP. See The Sentencing Project
Tuberculosis (TB), 1–2, 24, 43–44
Tuskegee, echoes of among the prisoner population, 22, 54–55
Types of research with prisoners, 182–183
permitted, and research personnel, 60
in the published literature, 62
U
U.S. Constitution
role in guaranteeing the DHHS broader authority, 96
U.S. Supreme Court, 30, 50, 56–57, 97
V
Viable, defined, 227
Violent Crime Control and Law Enforcement Act, 40
antiviral therapies, 43
Virginia, 43
Voluntariness, in the prison setting, 25–26
Voluntary informed consent, 2, 15, 147–149
W
Wards, in Subpart D, 238
Washington State, 49
Washington v. Harper, 58
Weekend reporting programs, 33
Welfare of the prisoner population, 130–135
Women
increasingly entering the correctional system, 1–2, 23, 35–38
single female heads of household, 37–38
vulnerabilities of in prison, 12, 36–38
Women Offenders: Programming Needs and Promising Approaches, 37
World Medical Assembly Declaration, 210
Y
Young people, vulnerabilities of in prison, 12
Z
Zaire v. Dalsheim, 58
