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Pages 253-266

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From page 253...
... , 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.
From page 254...
... 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
From page 255...
... 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)
From page 256...
... 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)
From page 257...
... , 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)
From page 258...
... , 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)
From page 259...
... 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)
From page 260...
... , 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.
From page 261...
... 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
From page 262...
... 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
From page 263...
... 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)
From page 264...
... 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
From page 265...
... 265 INDEX other prohibited categories and types of U.S. Patriot Act, 3n, 26n research involving prisoners, 170 U.S.


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