Journal article
Augmenting research consent: should large language models (LLMs) be used for informed consent to clinical research?
- Abstract:
- The integration of artificial intelligence (AI), particularly large language models (LLMs) like OpenAI’s ChatGPT, into clinical research could significantly enhance the informed consent process. This paper critically examines the ethical implications of employing LLMs to facilitate consent in clinical research. LLMs could offer considerable benefits, such as improving participant understanding and engagement, broadening participants’ access to the relevant information for informed consent and increasing the efficiency of consent procedures. However, these theoretical advantages are accompanied by ethical risks, including the potential for misinformation, coercion and challenges in accountability. Given the complex nature of consent in clinical research, which involves both written documentation (in the form of participant information sheets and informed consent forms) and in-person conversations with a researcher, the use of LLMs raises significant concerns about the adequacy of existing regulatory frameworks. Institutional Review Boards (IRBs) will need to consider substantial reforms to accommodate the integration of LLM-based consent processes. We explore five potential models for LLM implementation, ranging from supplementary roles to complete replacements of current consent processes, and offer recommendations for researchers and IRBs to navigate the ethical landscape. Thus, we aim to provide practical recommendations to facilitate the ethical introduction of LLM-based consent in research settings by considering factors such as participant understanding, information accuracy, human oversight and types of LLM applications in clinical research consent.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 311.5KB, Terms of use)
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- Publisher copy:
- 10.1177/17470161241298726
Authors
+ Wellcome Trust
More from this funder
- Funder identifier:
- https://ror.org/029chgv08
- Grant:
- 203132/Z/16/Z
- Publisher:
- SAGE Publications
- Journal:
- Research Ethics More from this journal
- Publication date:
- 2024-12-08
- Acceptance date:
- 2024-10-25
- DOI:
- EISSN:
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2047-6094
- ISSN:
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1747-0161
- Language:
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English
- Keywords:
- Pubs id:
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2042528
- Local pid:
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pubs:2042528
- Deposit date:
-
2024-10-25
Terms of use
- Copyright holder:
- Allen et al.
- Copyright date:
- 2024
- Rights statement:
- © The Author(s) 2024. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
- Notes:
- This research was funded in part, by the Wellcome Trust [203132/Z/16/Z]. The funders had no role in the preparation of this manuscript or the decision to submit for publication. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.
- Licence:
- CC Attribution (CC BY)
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