Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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7 Regulatory Compliance, Accreditation, and Quality Improvement
7 Regulatory Compliance, Accreditation, and Quality Improvement
Pages 229-245
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From page 229... ...
Chapter 1 summarized some of the consequences, which included the reorganizing and refocusing of federal government units responsible for regulatory oversight and the wellpublicized, temporary suspensions of federally supported human research in a number of prominent universities for deficiencies in their programs for protecting research participants. By the time that Greg Koski (outgoing director of the Office for Human Research Protections)
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Many research institutions have gone further to establish the regulations as the standard for all human research. One of the recommendations in the final chapter of this report is that all clinical research involving children should occur under the umbrella of a formal human research protection program regardless of source of funding or regulation under the Federal Food, Drug, and Cosmetic Act.
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A series of reports have noted progress in human research protections but have also described deficiencies in their implementation and have made recommendations for improvement. No report has, however, focused explicitly on problems in implementing the federal regulations protecting child participants in research.
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now undertakes occasional "not-for-cause" evaluations.) The 2001 NBAC report noted the failure of all federal agencies that conduct or fund research involving children to adopt the special protections application to children found in Subpart D of the DHHS regulations.
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. The DHHS report did not include explicit findings on IRB or investigator implementation of or compliance with the regulations but observed that "problems and concerns related to research involving children generally have resulted from a failure to implement the existing regulations appropriately and consistently, not from fundamental deficiencies of the regulations" (DHHS, 2001, p.
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OHRP was able to provide some data on compliance problems related to clinical research involving children, but FDA could not. As described in Chapter 1, both DHHS and FDA have reorganized their human research protection programs following the above-cited criticisms of the oversight of human research protections and the widely publicized instances of questionable or deficient research conduct.
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Oversight by the Office for Human Research Protections Even when regulators necessarily rely on voluntary compliance with regulations and adopt a quality improvement perspective that encourages excellence and not merely compliance, regulators must still have methods suitable for monitoring and enforcing adherence to the regulations for which they are responsible. The OHRP strategy for compliance oversight relies primarily on the investigation of allegations of institutional noncompliance or other problems (Koski, 2000)
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Of the 155 institutions receiving letters of determination, more than 80 percent conducted research involving children. One-fifth of the institutions were cited for an IRB's failure to make the required findings for research involving children (e.g., whether the research involved minimal risk or a prospect of direct benefit)
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As with OHRP, most problems identified are resolved through voluntary actions, without penalties or sanctions. FDA could not readily provide information on inspection findings or problems found during the review of written materials that involved pediatric studies, its rules on pediatric trials, or ICH guidelines on pediatric studies.
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Improving Data on Federal Oversight of Pediatric Research, Regulatory Protections, and Safety in Clinical Trials The dearth of information about human research and human research protections in general and about pediatric research and research protections for children in particular makes it impossible to describe adequately the application of these regulations, much less evaluate compliance. As one of its recommendations for strengthening the system for protecting human participants in research, the IOM report Responsible Research proposed
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Nonetheless, in calling for this study, Congress has already recognized the particular concerns presented by research involving children and the regulations applicable to this research. If necessary, it should be prepared to direct the collection of baseline data on research that includes children and the implementation of research protections for children.
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· The types and numbers of serious and unanticipated adverse events attrib utable to studies involving children and the types and numbers of research injuries attributable to such studies or to failures of participant protection by age of the child. SOURCE: Adapted from IOM (2003a, Box 6.1)
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that ask about research involving children. Question 51: Does your IRB include awareness of, through consulta tion or representation on the IRB as appropriate, the additional con cerns or issues of research involving vulnerable populations (such as, children, prisoners, women who are pregnant, persons with mental disabilities, or persons who are economically or educationally disad vantaged)
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When organizations that sponsor or conduct pediatric studies develop quality improvement plans for programs to protect human research participants, they should identify priorities related to research involving infants, children, and adolescents. Organizations that are not involved with significant amounts of pediatric research should still include such research in their quality improvement plans even if such research would not be otherwise identified by priority-setting exercises aimed at high-volume or high-risk studies.
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Compliance and Voluntary Accreditation In 2001, the IOM report Preserving Public Trust recommended the implementation of pilot projects to test programs of nongovernmental accreditation for programs to protect human participants in research (IOM, 2001)
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(The organization does not directly assess the expertise required to review research involving children.) Consistent with the 2001 IOM report, this committee supports the further development and systematic evaluation of accreditation for human research participant protection programs.
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Recommendation 7.2: Organizations that accredit human research pro tection programs should · provide for expertise in child health in their own activities; · develop explicit provisions for evaluating whether institutional review boards are appropriately constituted and are prepared to review research involving children; and · involve parents, children, and adolescents who have experience with pediatric clinical research in discussions to identify their concerns with the conduct of research. In addition, if they are not already doing so, accreditation organizations should examine samples of approved pediatric protocols and protocols that include both adults and children as part of their process of assessing organizations that review pediatric studies.
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