BOX 7.2
Examples of What Might Be Included in a Quality Assurance Database Related to Studies Involving Infants, Children, and Adolescents

  • Resources allocated to the human research protection program (e.g., budget, full-time equivalent employees, and space) and resources dedicated to pediatric issues specifically

  • Number and percentage of ongoing protocols that include children

  • Target sample size for each protocol that includes children and the number of participants of different ages actually enrolled

  • Types of studies being conducted (e.g., a clinical trial, observational study, or survey)

  • Numbers and types of adverse events involving children and any related protocol modifications

  • Sentinel events (not only deaths but also injuries and serious procedural errors) that raise safety concerns

  • Duration of studies

  • Dates of protocol submission, approval, and continuing review for each study

  • Expertise in child health represented on the IRB(s) or sought through consultation by the IRB(s) for studies involving children

  • Dates of data safety monitoring board or data monitoring committee actions, as relevant

  • Principal investigators and collaborators

  • Research staff profiles and delegated responsibilities

  • Documentation of training in research ethics and regulations related to research involving children

SOURCE: Adapted from IOM (2003a, Box 6.3)

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). The rationale was to promote voluntary quality assurance and improvement efforts; direct greater attention to outcome measures; and encourage an evolving and cooperative process of identifying deficiencies, providing feedback on performance, and recognizing excellent performance. Since publication of that report, efforts to develop and implement accreditation programs have moved well along, and some organizations have won accreditation.

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