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Pages 209-216

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From page 209... ... certification, 43 collecting data on and assessing impacts of, beginning now, 19-20, 90 91 effect on performance, 61-62 establishing nongovernmental organizations for, 11, 56-57 of human research participant protection programs, 5 initiating federal studies evaluating, 20, 91-93 to insure compliance with AAALAC standards, 47 209 issues not addressed by, 57~1 as a mark of excellence, 86 need for wide acceptance of, 16 pursuing through pilot testing, 10-11, 5356 substituting private for public regulation, 46 as a supplement to governmental regulations, 45-46 Accreditation bodies, 49-50 Association for the Accreditation of Human Research Protection Programs, 10,47,49-50 Accreditation Outcome Table, 137-140 Accreditation process, elements of, 48-53 Accreditation programs accommodating distinct research methods and models within, 13-15, 69-70 appeals process, 53 coverage of, 7 data produced by, 89 development of, 22 directly involving research participants in, 18, 73-75 eligibility criteria for, 51 evaluating pilot, 89 and external evaluation, 52 failures of, 54n Read the entire page →
From page 210... ... A-119, 17, 56 original intention of, 56n Cline, Martin, 58 Clinical research, shutdowns at academic and VA medical centers, 29-31 Clinical trials, rise of, 38-39 Collecting data, on accreditation, beginning now, 19-20, 90-91 Committee on Assessing the System for Protecting Human Research Subjects, 1-2 findings of, 6-10 task of, 5-6 Committee on National Statistics, 40 "Common Rule" governing human research, 80 origin of, 26, 62 signatories to, 16, 55n Community Clinical Oncology Program, 38 Comparisons, between draft NCQA and PRIM&R accreditation standards, 8 Compliance with standards, assessing, 7677 Concerns, 115 Confidentiality issues, in the draft standards for accreditation of VA Medical Centers, 136, 180-182 Consent informed, 25, 36, 38, 183-194 monitoring, 74 Consortium of Social Science Associations (COSSA) , 50 Consumer organizations, 74 Costs, of institutional review boards, 92n Council for International Organizations of Medical Sciences (CIOMS) Read the entire page →
From page 211... ... See Data safety and monitoring boards Duke University, shutdowns at, 29 EEducating investigators, 59, 154-155 Eligibility criteria, for accreditation programs, 51 Ethics-based standards, establishing for accreditation, 12-13, 66-67 Evaluation of research protocols, systematic, by IRBs, 160-167 Evaluation process for accreditation development of, 22 external, 52 initiating federal studies for, 20, 91-93 pilot programs, 89 self, 51-52 Excellence, accreditation as a mark of, 86 Existing regulatory requirements base standards for, 15-17, 71-72 relation of standards to, 71-72 External evaluation, accreditation programs and, 52 F FDA. See Food and Drug Administration FDA Form 3454, 141 Federal Policy for the Protection of Human Subjects in Research, 26 Federal regulations. Read the entire page →
From page 212... ... See Investigational Device Exemption Identifying violations, 57-59 Impacts of accreditation, beginning now, 19-20, 90-91 Implementing Human Research Regulations, 26 IND. See Investigational New Drug Application Independent IRBs, 14, 40-41 Indian Council of Medical Research, 27 Individual IRBs, structure and operations of, in the draft standards for accreditation of VAMedicalCenters, 136, 156-170 Informed consent, 25 as an "exception" to protection, 190-194 centrality of, 36, 38 in the draft standards for accreditation of VA Medical Centers, 136, 183-194 measuring, 38 Institute for Human Gene Therapy, 58n Institute of Medicine (IOM) Read the entire page →
From page 213... ... , 51n Multi-center clinic trials, 61 Multiple project assurances (MPAs) , 30n, 143 N National Association of IRB Managers, 43 National Association of State Universities and Land Grant Colleges, 50 National Bioethics Advisory Commission (NBAC) Read the entire page →
From page 214... ... See Public Responsibility in Medicine and Research Principles for ethics-based standards, establishing for accreditation, 12-13, 16, 66-67 underlying protection of humans studied in research, PRIM&A, 116-133 Privacy issues, in the draft standards for accreditation of VA Medical Centers, 136, 180-182 Private organizations, role of, 74 Privately funded research, rise of, 38-39 Read the entire page →
From page 215... ... mechanisms, 143 Risks, 171-175 incorporating continuously into stan dards, 17, 72 R Recommendations, 10-20 for initial standards to begin pilot testing, 84-87 Recruiting research participants, in the draft standards for accreditation of VAMCs, 136, 176-179 Registration process, 52n Regulatory requirements base standards for, 15-17, 71-72 governmental, 45-46, 71 relation of standards to existing, 71-72 rigidity of existing, 55n Remedial action, draft accreditation outcomes and, 138-140 Repeat accreditation, 53 Research inherent risks of, 4 nonbiomedical, 39-40 rise of privately funded, 38-39 Research infrastructures, 118, 143 accommodating a variety of, 13-15, 6970 215 Research methods and models, accommodating within accreditation programs, 13-15, 69-70 Research monitoring, 42-43 improving, 6~61 Research participants/subjects/individuals studiedin research, An, 118, 142 directly involving in accreditation programs, 18, 73-75 in the draft standards for accreditation of VA Medical Centers, 136, 176-179 naming of, 33-34 role of, 41-42 selecting and recruiting, 176-179 vulnerability of, 144 Research personnel, in proposed standards, 131-133 Research protocol files, 5 In, 143 Research protocols, 51 n, 143 conflicts over, 66n IRBs evaluating each systematically, considerations of, in the draft standards for accreditation of VA Medical Centers, 136, 171-175 minimal, 143 S SAEs. See Serious adverse events Safety reports (IND/IDE) Read the entire page →
From page 216... ... , 144 Standards for accreditation, 63-87. See also Draft standards; Proposed standards; Appendix B and Appendix C articulating sound goals within, 12, 65-66 assessing compliance with, 7~77, 81-82 to begin pilot testing, recommendation for initial, 84-87 comparison of, 78-79 development of, 22 to encompass multiple research settings and methods, need for, 69-70 to enhance the role of research participants, need for, 73-75 establishing standards for the standards, 64 67 flexible, ethics-based, and meaningful, 12-13, 66-67 hortatory, 81 incorporating quality improvement mechanisms continuously into, 17, 72 international conference on harmonization guideline for good clinical practice, 83 measures to accompany, 67~8 NCQA, modifying to initiate pilot programs, 18-19, 84, 86-87 for quality improvement and self-study, 72 regarding roles and responsibilities of research sponsors, need for, 75-76 in relation to existing regulatory requirements, 15-17, 71-72 review of available drafts, 76-83 Statement of task, 32 Subjects. Read the entire page →

From page 209...

... certification, 43 collecting data on and assessing impacts of, beginning now, 19-20, 90 91 effect on performance, 61-62 establishing nongovernmental organizations for, 11, 56-57 of human research participant protection programs, 5 initiating federal studies evaluating, 20, 91-93 to insure compliance with AAALAC standards, 47 209 issues not addressed by, 57~1 as a mark of excellence, 86 need for wide acceptance of, 16 pursuing through pilot testing, 10-11, 5356 substituting private for public regulation, 46 as a supplement to governmental regulations, 45-46 Accreditation bodies, 49-50 Association for the Accreditation of Human Research Protection Programs, 10,47,49-50 Accreditation Outcome Table, 137-140 Accreditation process, elements of, 48-53 Accreditation programs accommodating distinct research methods and models within, 13-15, 69-70 appeals process, 53 coverage of, 7 data produced by, 89 development of, 22 directly involving research participants in, 18, 73-75 eligibility criteria for, 51 evaluating pilot, 89 and external evaluation, 52 failures of, 54n

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From page 210...

... A-119, 17, 56 original intention of, 56n Cline, Martin, 58 Clinical research, shutdowns at academic and VA medical centers, 29-31 Clinical trials, rise of, 38-39 Collecting data, on accreditation, beginning now, 19-20, 90-91 Committee on Assessing the System for Protecting Human Research Subjects, 1-2 findings of, 6-10 task of, 5-6 Committee on National Statistics, 40 "Common Rule" governing human research, 80 origin of, 26, 62 signatories to, 16, 55n Community Clinical Oncology Program, 38 Comparisons, between draft NCQA and PRIM&R accreditation standards, 8 Compliance with standards, assessing, 7677 Concerns, 115 Confidentiality issues, in the draft standards for accreditation of VA Medical Centers, 136, 180-182 Consent informed, 25, 36, 38, 183-194 monitoring, 74 Consortium of Social Science Associations (COSSA) , 50 Consumer organizations, 74 Costs, of institutional review boards, 92n Council for International Organizations of Medical Sciences (CIOMS)

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From page 211...

... See Data safety and monitoring boards Duke University, shutdowns at, 29 EEducating investigators, 59, 154-155 Eligibility criteria, for accreditation programs, 51 Ethics-based standards, establishing for accreditation, 12-13, 66-67 Evaluation of research protocols, systematic, by IRBs, 160-167 Evaluation process for accreditation development of, 22 external, 52 initiating federal studies for, 20, 91-93 pilot programs, 89 self, 51-52 Excellence, accreditation as a mark of, 86 Existing regulatory requirements base standards for, 15-17, 71-72 relation of standards to, 71-72 External evaluation, accreditation programs and, 52 F FDA. See Food and Drug Administration FDA Form 3454, 141 Federal Policy for the Protection of Human Subjects in Research, 26 Federal regulations.

Read the entire page →

From page 212...

... See Investigational Device Exemption Identifying violations, 57-59 Impacts of accreditation, beginning now, 19-20, 90-91 Implementing Human Research Regulations, 26 IND. See Investigational New Drug Application Independent IRBs, 14, 40-41 Indian Council of Medical Research, 27 Individual IRBs, structure and operations of, in the draft standards for accreditation of VAMedicalCenters, 136, 156-170 Informed consent, 25 as an "exception" to protection, 190-194 centrality of, 36, 38 in the draft standards for accreditation of VA Medical Centers, 136, 183-194 measuring, 38 Institute for Human Gene Therapy, 58n Institute of Medicine (IOM)

Read the entire page →

From page 213...

... , 51n Multi-center clinic trials, 61 Multiple project assurances (MPAs) , 30n, 143 N National Association of IRB Managers, 43 National Association of State Universities and Land Grant Colleges, 50 National Bioethics Advisory Commission (NBAC)

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From page 214...

... See Public Responsibility in Medicine and Research Principles for ethics-based standards, establishing for accreditation, 12-13, 16, 66-67 underlying protection of humans studied in research, PRIM&A, 116-133 Privacy issues, in the draft standards for accreditation of VA Medical Centers, 136, 180-182 Private organizations, role of, 74 Privately funded research, rise of, 38-39

Read the entire page →

From page 215...

... mechanisms, 143 Risks, 171-175 incorporating continuously into stan dards, 17, 72 R Recommendations, 10-20 for initial standards to begin pilot testing, 84-87 Recruiting research participants, in the draft standards for accreditation of VAMCs, 136, 176-179 Registration process, 52n Regulatory requirements base standards for, 15-17, 71-72 governmental, 45-46, 71 relation of standards to existing, 71-72 rigidity of existing, 55n Remedial action, draft accreditation outcomes and, 138-140 Repeat accreditation, 53 Research inherent risks of, 4 nonbiomedical, 39-40 rise of privately funded, 38-39 Research infrastructures, 118, 143 accommodating a variety of, 13-15, 6970 215 Research methods and models, accommodating within accreditation programs, 13-15, 69-70 Research monitoring, 42-43 improving, 6~61 Research participants/subjects/individuals studiedin research, An, 118, 142 directly involving in accreditation programs, 18, 73-75 in the draft standards for accreditation of VA Medical Centers, 136, 176-179 naming of, 33-34 role of, 41-42 selecting and recruiting, 176-179 vulnerability of, 144 Research personnel, in proposed standards, 131-133 Research protocol files, 5 In, 143 Research protocols, 51 n, 143 conflicts over, 66n IRBs evaluating each systematically, considerations of, in the draft standards for accreditation of VA Medical Centers, 136, 171-175 minimal, 143 S SAEs. See Serious adverse events Safety reports (IND/IDE)

Read the entire page →

From page 216...

... , 144 Standards for accreditation, 63-87. See also Draft standards; Proposed standards; Appendix B and Appendix C articulating sound goals within, 12, 65-66 assessing compliance with, 7~77, 81-82 to begin pilot testing, recommendation for initial, 84-87 comparison of, 78-79 development of, 22 to encompass multiple research settings and methods, need for, 69-70 to enhance the role of research participants, need for, 73-75 establishing standards for the standards, 64 67 flexible, ethics-based, and meaningful, 12-13, 66-67 hortatory, 81 incorporating quality improvement mechanisms continuously into, 17, 72 international conference on harmonization guideline for good clinical practice, 83 measures to accompany, 67~8 NCQA, modifying to initiate pilot programs, 18-19, 84, 86-87 for quality improvement and self-study, 72 regarding roles and responsibilities of research sponsors, need for, 75-76 in relation to existing regulatory requirements, 15-17, 71-72 review of available drafts, 76-83 Statement of task, 32 Subjects.

Read the entire page →

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Index Pages 209-216

Index
Pages 209-216