Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study
Abstract Introduction: Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed an...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2021-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866121008074/type/journal_article |
| _version_ | 1811156612099866624 |
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| author | Erin D. Solomon Jessica Mozersky Kari Baldwin Matthew P. Wroblewski Meredith V. Parsons Melody Goodman James M. DuBois |
| author_facet | Erin D. Solomon Jessica Mozersky Kari Baldwin Matthew P. Wroblewski Meredith V. Parsons Melody Goodman James M. DuBois |
| author_sort | Erin D. Solomon |
| collection | DOAJ |
| description |
Abstract
Introduction:
Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown.
Methods:
We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60).
Results:
We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice.
Conclusions:
Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.
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| first_indexed | 2024-04-10T04:54:16Z |
| format | Article |
| id | doaj.art-e9e3627287f44a808743d9f922bed314 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:54:16Z |
| publishDate | 2021-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-e9e3627287f44a808743d9f922bed3142023-03-09T12:31:02ZengCambridge University PressJournal of Clinical and Translational Science2059-86612021-01-01510.1017/cts.2021.807Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method studyErin D. Solomon0https://orcid.org/0000-0002-3295-0698Jessica Mozersky1https://orcid.org/0000-0002-4942-4571Kari Baldwin2Matthew P. Wroblewski3https://orcid.org/0000-0002-5256-2414Meredith V. Parsons4https://orcid.org/0000-0002-8869-3766Melody Goodman5https://orcid.org/0000-0001-8932-624XJames M. DuBois6https://orcid.org/0000-0002-3712-7051Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USABioethics Research Center, Washington University School of Medicine, St. Louis, MO, USABioethics Research Center, Washington University School of Medicine, St. Louis, MO, USABioethics Research Center, Washington University School of Medicine, St. Louis, MO, USABioethics Research Center, Washington University School of Medicine, St. Louis, MO, USASchool of Global Public Health, New York University, New York, NY, USABioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA Abstract Introduction: Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown. Methods: We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60). Results: We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice. Conclusions: Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments. https://www.cambridge.org/core/product/identifier/S2059866121008074/type/journal_articleInformed consentassessmentvalidated assessmentsresearch ethicsimplementation science |
| spellingShingle | Erin D. Solomon Jessica Mozersky Kari Baldwin Matthew P. Wroblewski Meredith V. Parsons Melody Goodman James M. DuBois Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study Journal of Clinical and Translational Science Informed consent assessment validated assessments research ethics implementation science |
| title | Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study |
| title_full | Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study |
| title_fullStr | Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study |
| title_full_unstemmed | Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study |
| title_short | Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study |
| title_sort | perceived barriers to assessing understanding and appreciation of informed consent in clinical trials a mixed method study |
| topic | Informed consent assessment validated assessments research ethics implementation science |
| url | https://www.cambridge.org/core/product/identifier/S2059866121008074/type/journal_article |
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