Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators
Introduction Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participati...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2017-04-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866116000212/type/journal_article |
| _version_ | 1811156872229552128 |
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| author | Rhonda G. Kost Stephen M. Poppel Barry S. Coller |
| author_facet | Rhonda G. Kost Stephen M. Poppel Barry S. Coller |
| author_sort | Rhonda G. Kost |
| collection | DOAJ |
| description |
Introduction
Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of “incidental” findings, in easy-to-understand language.
Methods and Results
After reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questions that she or he is encouraged to ask the investigator, and (2) a more detailed companion guide for investigators to help them develop simple-language answers to the questions. Both documents are available to use or modify.
Conclusions
We propose an approach to obtaining informed consent for NGS studies that encourages discussion of key issues without creating a complex, comprehensive document for participants; it also maximizes investigator flexibility. We also suggest mechanisms to return restricted information to participants.
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| first_indexed | 2024-04-10T04:58:18Z |
| format | Article |
| id | doaj.art-acde027e08e2427096f0ac30b5c85212 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:58:18Z |
| publishDate | 2017-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-acde027e08e2427096f0ac30b5c852122023-03-09T12:29:31ZengCambridge University PressJournal of Clinical and Translational Science2059-86612017-04-01111512010.1017/cts.2016.21Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigatorsRhonda G. Kost0Stephen M. Poppel1Barry S. Coller2The Rockefeller University, New York, NY, USAThe Rockefeller University, New York, NY, USAThe Rockefeller University, New York, NY, USA Introduction Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of “incidental” findings, in easy-to-understand language. Methods and Results After reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questions that she or he is encouraged to ask the investigator, and (2) a more detailed companion guide for investigators to help them develop simple-language answers to the questions. Both documents are available to use or modify. Conclusions We propose an approach to obtaining informed consent for NGS studies that encourages discussion of key issues without creating a complex, comprehensive document for participants; it also maximizes investigator flexibility. We also suggest mechanisms to return restricted information to participants. https://www.cambridge.org/core/product/identifier/S2059866116000212/type/journal_articleTranslational researchdesign and analysispatient-centered researchgenetic counseling |
| spellingShingle | Rhonda G. Kost Stephen M. Poppel Barry S. Coller Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators Journal of Clinical and Translational Science Translational research design and analysis patient-centered research genetic counseling |
| title | Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators |
| title_full | Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators |
| title_fullStr | Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators |
| title_full_unstemmed | Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators |
| title_short | Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators |
| title_sort | informed consent for next generation nucleotide sequencing studies aiding communication between participants and investigators |
| topic | Translational research design and analysis patient-centered research genetic counseling |
| url | https://www.cambridge.org/core/product/identifier/S2059866116000212/type/journal_article |
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