Inclusion of residual tissue in biobanks: opt-in or opt-out?
Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2012-01-01
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| Series: | PLoS Biology |
| Online Access: | http://europepmc.org/articles/PMC3415320?pdf=render |
| _version_ | 1818367443177832448 |
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| author | Noor A A Giesbertz Annelien L Bredenoord Johannes J M van Delden |
| author_facet | Noor A A Giesbertz Annelien L Bredenoord Johannes J M van Delden |
| author_sort | Noor A A Giesbertz |
| collection | DOAJ |
| description | Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a "thick" opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out. |
| first_indexed | 2024-12-13T22:52:08Z |
| format | Article |
| id | doaj.art-2e29d956c4814ff09af7b3af0875b344 |
| institution | Directory Open Access Journal |
| issn | 1544-9173 1545-7885 |
| language | English |
| last_indexed | 2024-12-13T22:52:08Z |
| publishDate | 2012-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Biology |
| spelling | doaj.art-2e29d956c4814ff09af7b3af0875b3442022-12-21T23:28:35ZengPublic Library of Science (PLoS)PLoS Biology1544-91731545-78852012-01-01108e100137310.1371/journal.pbio.1001373Inclusion of residual tissue in biobanks: opt-in or opt-out?Noor A A GiesbertzAnnelien L BredenoordJohannes J M van DeldenResidual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a "thick" opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.http://europepmc.org/articles/PMC3415320?pdf=render |
| spellingShingle | Noor A A Giesbertz Annelien L Bredenoord Johannes J M van Delden Inclusion of residual tissue in biobanks: opt-in or opt-out? PLoS Biology |
| title | Inclusion of residual tissue in biobanks: opt-in or opt-out? |
| title_full | Inclusion of residual tissue in biobanks: opt-in or opt-out? |
| title_fullStr | Inclusion of residual tissue in biobanks: opt-in or opt-out? |
| title_full_unstemmed | Inclusion of residual tissue in biobanks: opt-in or opt-out? |
| title_short | Inclusion of residual tissue in biobanks: opt-in or opt-out? |
| title_sort | inclusion of residual tissue in biobanks opt in or opt out |
| url | http://europepmc.org/articles/PMC3415320?pdf=render |
| work_keys_str_mv | AT nooraagiesbertz inclusionofresidualtissueinbiobanksoptinoroptout AT annelienlbredenoord inclusionofresidualtissueinbiobanksoptinoroptout AT johannesjmvandelden inclusionofresidualtissueinbiobanksoptinoroptout |