Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement
Increasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Commit...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2020-04-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866119004059/type/journal_article |
| _version_ | 1811156873480503296 |
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| author | Rebecca Caruso Theodore Myatt Barbara E. Bierer |
| author_facet | Rebecca Caruso Theodore Myatt Barbara E. Bierer |
| author_sort | Rebecca Caruso |
| collection | DOAJ |
| description | Increasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Committee (IBC) review is generally required at each separate site. Duplicative review may result in both administrative costs and delays, without evidence of increased safety or protections, and investigator frustration. To address these inefficiencies, IBC leaders drafted a collaborative IBC Reliance Authorization Agreement. The Agreement allows one or more institutions to cede IBC review to a reviewing IBC that accepts the responsibility. The ability to cede IBC review, and the ability to rely on one decision on behalf of all collaborating institutions for a given protocol, removes delays in approval of multi-center protocols, and collaborating principal investigators are able to focus on research rather than administrative tasks. In the process, we found promotion of this collaborative model led to stronger connections among institutions and among IBC members. The requirement for IBC member representation from the local community, however, limits its broader dissemination; we make several recommendations to mitigate this challenge. |
| first_indexed | 2024-04-10T04:57:18Z |
| format | Article |
| id | doaj.art-b304e7a6d067444c849d92d9de8fc6cc |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:57:18Z |
| publishDate | 2020-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-b304e7a6d067444c849d92d9de8fc6cc2023-03-09T12:29:53ZengCambridge University PressJournal of Clinical and Translational Science2059-86612020-04-014909510.1017/cts.2019.405Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization AgreementRebecca Caruso0Theodore Myatt1Barbara E. Bierer2https://orcid.org/0000-0001-6448-8170Harvard Medical School, Boston, MA, USABrigham and Women’s Hospital, Boston, MA, USAHarvard Medical School, Boston, MA, USA Brigham and Women’s Hospital, Boston, MA, USA Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USAIncreasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Committee (IBC) review is generally required at each separate site. Duplicative review may result in both administrative costs and delays, without evidence of increased safety or protections, and investigator frustration. To address these inefficiencies, IBC leaders drafted a collaborative IBC Reliance Authorization Agreement. The Agreement allows one or more institutions to cede IBC review to a reviewing IBC that accepts the responsibility. The ability to cede IBC review, and the ability to rely on one decision on behalf of all collaborating institutions for a given protocol, removes delays in approval of multi-center protocols, and collaborating principal investigators are able to focus on research rather than administrative tasks. In the process, we found promotion of this collaborative model led to stronger connections among institutions and among IBC members. The requirement for IBC member representation from the local community, however, limits its broader dissemination; we make several recommendations to mitigate this challenge.https://www.cambridge.org/core/product/identifier/S2059866119004059/type/journal_articleBiosafetyInstitutional Biosafety Committeecompliancerecombinant DNAmulti-institutional reliance |
| spellingShingle | Rebecca Caruso Theodore Myatt Barbara E. Bierer Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement Journal of Clinical and Translational Science Biosafety Institutional Biosafety Committee compliance recombinant DNA multi-institutional reliance |
| title | Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement |
| title_full | Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement |
| title_fullStr | Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement |
| title_full_unstemmed | Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement |
| title_short | Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement |
| title_sort | innovation in biosafety oversight the harvard catalyst common reciprocal ibc reliance authorization agreement |
| topic | Biosafety Institutional Biosafety Committee compliance recombinant DNA multi-institutional reliance |
| url | https://www.cambridge.org/core/product/identifier/S2059866119004059/type/journal_article |
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