IRB Review and Public Health Biobanking: A Case Study of the Michigan Bio Trust for Health
The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the individuals from whom the materials were obtained would be harmed by the research. Because of the deidentification process, the possibility of identify...
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Published in | IRB Vol. 34; no. 3; p. 11 |
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Main Authors | , |
Format | Journal Article |
Language | English |
Published |
Garrison
The Hastings Center
01.05.2012
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Subjects | |
Online Access | Get full text |
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Abstract | The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the individuals from whom the materials were obtained would be harmed by the research. Because of the deidentification process, the possibility of identifying individuals whose biospecimens were stored was deemed negligible. Up to this point, blood had been collected and stored for purposes related to newborn screening and for possible personal use.\n Within Michigan, some participants in the citizen engagement sessions had expressed concerns that various social groups might be differentially benefited or burdened by BioTrust research. [...]the IRB felt that the spirit of respect for persons demands going beyond the "letter" of regulatory requirements that focus on individual risk to consider potential group harms. |
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AbstractList | The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the individuals from whom the materials were obtained would be harmed by the research. Because of the deidentification process, the possibility of identifying individuals whose biospecimens were stored was deemed negligible. Up to this point, blood had been collected and stored for purposes related to newborn screening and for possible personal use.\n Within Michigan, some participants in the citizen engagement sessions had expressed concerns that various social groups might be differentially benefited or burdened by BioTrust research. [...]the IRB felt that the spirit of respect for persons demands going beyond the "letter" of regulatory requirements that focus on individual risk to consider potential group harms. |
Author | McGee, Harry Mongoven, Ann |
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Copyright | Copyright The Hastings Center May/Jun 2012 |
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Snippet | The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the... |
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SubjectTerms | Blood Children & youth Consent Decision making Ethics Fiduciary responsibility Medical screening Nonprofit organizations Parental rights R&D Research & development |
Title | IRB Review and Public Health Biobanking: A Case Study of the Michigan Bio Trust for Health |
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