Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies
Abstract 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 nov...
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| Format: | Article |
| Language: | English |
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BMC
2021-10-01
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| Series: | BMC Medical Ethics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12910-021-00708-1 |
| _version_ | 1818890275420897280 |
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| author | Jaime Fons-Martinez Cristina Ferrer-Albero Javier Diez-Domingo |
| author_facet | Jaime Fons-Martinez Cristina Ferrer-Albero Javier Diez-Domingo |
| author_sort | Jaime Fons-Martinez |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-19T17:22:20Z |
| format | Article |
| id | doaj.art-7ab50c75090d441c954a3afcb5cd445a |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-12-19T17:22:20Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-7ab50c75090d441c954a3afcb5cd445a2022-12-21T20:12:38ZengBMCBMC Medical Ethics1472-69392021-10-0122111210.1186/s12910-021-00708-1Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studiesJaime Fons-Martinez0Cristina Ferrer-Albero1Javier Diez-Domingo2Vaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIOFacultad de Medicina y Ciencias de la Salud, Universidad Católica de Valencia San Vicente MártirVaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIOAbstract 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.https://doi.org/10.1186/s12910-021-00708-1Informed consent processi-CONSENTRAND/UCLA methodEthical guidelinesEthical recommendations |
| spellingShingle | Jaime Fons-Martinez Cristina Ferrer-Albero Javier Diez-Domingo Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies BMC Medical Ethics Informed consent process i-CONSENT RAND/UCLA method Ethical guidelines Ethical recommendations |
| title | Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| title_full | Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| title_fullStr | Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| title_full_unstemmed | Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| title_short | Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| title_sort | assessment of the appropriateness of the i consent guidelines recommendations for improving understanding of the informed consent process in clinical studies |
| topic | Informed consent process i-CONSENT RAND/UCLA method Ethical guidelines Ethical recommendations |
| url | https://doi.org/10.1186/s12910-021-00708-1 |
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