Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval
| Autor: | Patricia S. Gordon, Adam J. Mrdjenovich, R. Alexander Blackwood, Ted A. Hamilton, Terry M. VandenBosch, Ronald F. Maio, Emily L. Shipman |
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| Rok vydání: | 2015 |
| Předmět: |
Medical education
Biomedical Research Informed Consent business.industry Informed Consent Document Documentation General Medicine Library and Information Sciences Public relations Institutional review board United States Education law.invention Consent Forms IRB Approval Human Experimentation Informed consent law CLARITY Humans Human research business Psychology Ethics Committees Research |
| Zdroj: | Accountability in Research. 22:237-245 |
| ISSN: | 1545-5815 0898-9621 |
| DOI: | 10.1080/08989621.2014.956866 |
| Popis: | The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. "Omissions" in documentation (40%) and "better clarity" (24%) accounted for the majority, while "word-smithing" accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging "word-smithing" on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process. |
| Databáze: | OpenAIRE |
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