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Research Article
Jaime Fons-Martínez
Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO
Corresponding Author
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This work is licensed under a CC BY 4.0 License. Read Full License
Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.
Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.
Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).
The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating.
The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.
Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.
Keywords
informed consent process, i-CONSENT, RAND/UCLA method, ethical guidelines, ethical recommendations
Figure 1
Figure 2
Figure 3
No competing interests reported.
This is a list of supplementary files associated with this preprint. Click to download.
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On 05 Apr, 2021
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Medical Ethics
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A new preprint design is coming!
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This preprint is under consideration at BMC Medical Ethics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Jaime Fons-Martínez
Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 05 Apr, 2021
No community comments so far
Editorial decision: Major revision
On 02 Jul, 2021
Reviewers agreed
On 12 Jun, 2021
Reviews received
Received 13 May, 2021
Reviews received
Received 06 May, 2021
Reviewers agreed
On 21 Apr, 2021
Reviewers agreed
On 05 Apr, 2021
Reviewers invited
Invitations sent on 05 Apr, 2021
Editor assigned
On 05 Apr, 2021
Editor invited
On 02 Apr, 2021
Submission checks complete
On 02 Apr, 2021
First submitted
On 26 Mar, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Medical Ethics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.
Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.
Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).
The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating.
The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.
Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.
Figure 1
Figure 2
Figure 3
No competing interests reported.
This is a list of supplementary files associated with this preprint. Click to download.
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