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Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
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Pages 277-290

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From page 277...
... ; Liability and 277 compensation; Research Ethics Review Boards (Research ERBs) academic research, 50, 54-55, 56-57, 58, 250-252 ethical research culture, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167-168 human research participant protection programs (HRPPPs)
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From page 278...
... , 69, 73 Research Ethics Review Boards (Research ERBs) , 138 Award for Excellence in Human Research Protection, 142 B Bayh-Dole Act, 185 Beaumont, William, 33 Behavioral and social research, see Nonbiomedical research Belmont Report, 70, 74-75, 92, 119, 181, 238 Best practices, 61, 106, 107, 163-164, 166, 171, 198 see also Good Clinical Practice (GCP)
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From page 279...
... , 159160, 179, 181-182, 205, 207-211 informed consent and, 119 non-biomedical research, 238, 239-240, 243-244 regulatory issues, general, 159-160, 205211, 215-216 Research Ethics Review Boards (Research ERBs) , 87, 100, 153, 160, 209-211 template form to document, 261 Conflicts of interest, 11, 17-18, 38, 41, 46, 53, 117-118, 132, 162-163, 182-187, 197 accreditation issues, 174 committee study methodology, 41, 42, 232, 235 financial, 2, 6, 10-11, 17, 24, 42, 46, 50, 55, 65, 72, 73-74, 82-83, 117118, 183-186, 255-256 fraud, 179, 180 human research participant protection programs (HRPPPs)
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From page 280...
... basic principles, 31-32, 56 committee study methodology, 2, 30, 31, 42-43, 235 cultural context of research, 7-8, 18, 23 38, 54, 60, 61, 69, 117-118, 134, 167-168 historical perspectives, 29-30, 31, 33-34, 45, 99, 100 participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135 European Convention on Human Rights liability and compensation issues, 188 non-biomedical research, 245 Office of Research Compliance and Assurance (ORCA) , 166-168 professional education, 114 111 112 quality control, 166-168, 171, 172-173 Dignity of participants, 29, 31, 46, 165, 193-194, 238 see also Confidentiality and privacy; Informed consent Drugs, see Pharmaceuticals industry and Biomedicine, 188 Experimental studies, 32, 34, 36 see also Radiation experiments oversight and data and safety monitoring, 139 participant-investigator interactions, F False Claims Act, 179, 181 FDA, see Food and Drug Administration
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From page 281...
... , 139, 140, 157, 213 professional education, 114, 181 registries, clinical trials, 14, 201-202 Research Ethics Review Boards (Research ERBs) , 73, 78, 79, 86, 87, 100, 103, 145-146, 152 Food and Drug Administration Modernization Act of 1997, 14(n.17)
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From page 282...
... ; Research Ethics Review Boards (Research ERBs) accountability, 6, 7-8, 30, 44, 48, 50, 54-57, 249-262 accreditation issues, 3, 30, 116, 174, 175, 176-177, 193 committee recommendations, 6, 9, 11, 12, 19-28, 44, 47, 54, 197-216 committee study at hand, methodology, 1, 3, 4, 30, 42, 231-236 conflicts of interest, 46, 50, 53, 55, 65, 76 data safety and monitoring plans, 49, 136, 141, 151, 160 definitional issues, 48-52 ethical research culture, 7-8, 18, 23, 38, 54, 60, 61, 69, 117-118, 134, 167168 funding, 23, 44, 52, 53, 54, 57-60 participant-investigator interactions, 2, 6, 13, 32, 42, 46, 48, 49, 67-68, 103, 108-135, 157 protocols, 1-2, 6, 46, 49-51, 53, 56, 59, 65, 66-67, 68, 69, 76, 108-109, 136, 151, 162, 249-262 quality improvement, 17, 163, 168-171 Research Ethics Review Boards (Research ERBs)
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From page 283...
... , 2, 3, 5, 6, 8-9, 36-37, 39-40, 48, 53, 70-74, monitoring, 151 103, 141, 142, 184, 209, 215, 236 see also Accreditation; Research Ethics Review Boards (Research ERBs) academic research, 81, 84, 232 committee recommendations, 8-12, 60, 71, 110(n.3)
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From page 284...
... , 158, 258 Investigational New Drug Applications (IND) , 112, 140, 146, 152, 157, 158, 201, 212, 251, 253, 255 IRBs, see Institutional Review Boards J Journal articles, 158, 163, 168, 197, 203, 206-207, 235 L Legal issues, see also Confidentiality and privacy; Conflicts of interest; Informed consent; Legislation; Liability and compensation; Regulatory issues fraud, 179, 180 Legislation, 20-22, 47-48 see also Regulatory issues Bayh-Dole Act, 185 False Claims Act, 179, 181 Food and Drug Administration Modernization Act, 14(n.17)
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From page 285...
... , 260-261 defined, 140 historical perspectives, 141 informed consent, 137, 152, 154 inspections, 69, 144, 145, 148, 150 internal, 16, 48, 78, 138, 149, 163 protocols, 5, 40, 137, 152, 154 Research Ethics Review Boards (Research ERBs) , 74, 88, 99, 100, 101, 144, 152-154, 251-252, 254, 256 template forms to document, 260-261 Multicenter Academic Clinical Research Organization (MACRO )
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From page 286...
... , 238 observational studies, 32, 35, 36, 237 regulatory issues, general, 43, 242-244 Nuremburg Code, 32, 33, 62 o Observational studies, 32, 35, 36, 237 see also Non-biomedical research Office for Good Clinical Practice, 39 Office for Human Research Protections (OHRP) , 7, 12, 18-19, 20-22, 37, 38, 39, 50, 57, 198 committee study methodology, 215, 232, 234 financial conflicts of interest, 86 informed consent, 141-142 non-biomedical research, 238-246 (passim)
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From page 287...
... , 99, 114 non-biomedical research, 246 participant-investigator interactions, 108, 110, 112-117, 133 informed consent, 108-109, 119-120 pathophysiology and pharmacology, 150 quality monitoring, 170, 172 recruitment and enrollment of participants, 108-109 regulatory issues, general, 61, 62, 114, 115 Research Ethics Review Boards (Research ERBs) , 88, 99-101, 106, 115-116, 133, 134, 150, 181 computer applications, 99 template form to document, 261 Project LEAD, 101, 134, 232 Protocols, 1-2, 6, 25, 32, 40, 41, 42, 46, 68, 70, 72-107, 154, 170, 251, 255-256 see also Scientific review access to, stakeholders, 13-14 conflicts of interest, 10-11, 66-6 7, 78, 117, 255-256 definitional issues, 49-51 financial conflicts of interest, 10-11 human research participant protection programs (HRPPPs)
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From page 288...
... , 72-77, 78, 79, 8284, 87, 93, 95, 98, 100, 101-104, 110, 112, 118, 128, 135, 152-153, 253-254 standard operating procedures, 139, 140, 152, 154 template forms to document, 258-261 Psychological effects, 165, 193-194 see also Attitudes and beliefs dignity of participants, 29, 31, 46, 165, 193-194 genetics research, 35-36 non-biomedical research, 237 Public education, 13-14, 23, 64, 131, 200204 see also Participant/patient education committee study methodology, access to, 234-235 mass media, 3, 15, 37 registries, clinical trials, 14, 22, 197, 201-204 transparency, 7, 13-14, 52, 64-66, 69, 127-128, 234-235 Public Health Service, 79-80 conflicts of interest, 118, 184 Public Health Service Act, 4(n.7) Public opinion, 14-15, 39, 215 mass media, 3, 15, 37 .
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From page 289...
... , 5 confidentiality and privacy, 159-160, 205-211, 215-216 continuing review of research, 139, 143 exempt research and expedited review, 43, 90, 91, 112, 160, 176, 209, 238, 242-244 Federal Demonstration Partnership, 198 informed consent, 94-95, 121, 141-142 non-biomedical research, 43, 242-244 professional education about, 61, 62, 114, 115 risk-appropriate safety monitoring, 11, 68, 89 Religious factors, 97 Research Ethics Review Boards (Research ERBs) , 9-12, 23-28, 70-88, 91-107, 176, 177-178, 179, 196, 201 academic research, 81, 84, 86, 251-252 accreditation, 104-105, 107 audits, 138 certification of members, 101, 115 commercial, 79, 80, 85-86, 88 committee recommendations, 9, 11, 2328, 71, 72, 96, 98, 102, 106, 138, 144, 162, 182 confidentiality and privacy, 87, 100, 153, 160, 209-211 conflicts of interest, 10-11, 18, 24, 72, 74-75, 82-87, 100, 101-102, 105, 118, 162-163, 182, 185-186, 187, 205 cost factors, 104-105 financial conflicts of interest, 10-11, 7475, 82-83, 85-86 289 Food and Drug Administration (FDA)
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From page 290...
... , 49, 68, 77, 82, 87, 91, 139, 147, 151, 152, 154-157, 158-159, 161, 170, 195, 235, 254, INDEX Spanish, 189 Standard operating procedures, 139, 140, 152, 154 Standards, 2, 17, 46-47, 79-80, 88, 161, 163, 168-169 see also Accreditation; Good Clinical Practice (GCP) ; Protocols; Quality control; Regulatory issues academic research, 50 best practices, 61, 106, 107, 163-164, 166, 171, 198 certification of professionals, 63, 96, 101, 113-114, 115-117, 133 conflicts of interest, 18 cost factors, 236 256, 260-261 Project LEAD, 101, 134, 232 informed consent and, 93, 94, 122, 123 reporting, 148, 149-150 participant-investigator interactions, 110 State government, 47-48, 65 regulatory issues, general, 11, 68, 89 Research Ethics Review Boards (Research ERBs)
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Key Terms

  • human research
  • research ethics
  • ethics review
  • informed consent
  • research erbs

  • safety monitoring
  • professional education
  • institutional review
  • research participant
  • protection programs

  • committee study
  • participant protection
  • research protections
  • regulatory issues
  • clinical practice

  • financial conflicts
  • study methodology
  • genetics research
  • research protection
  • continuing review

  • human subjects
  • research participants
  • common rule
  • decisionally impaired
  • education efforts

  • monitoring committees
  • impaired persons
  • human radiation
  • participant protections
  • personal data


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