Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium
Abstract Background In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s trans...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-03-01
|
| Series: | BMC Medical Ethics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12910-021-00592-9 |
| _version_ | 1818577024033226752 |
|---|---|
| author | Elise Jacquier Pierre Laurent-Puig Cécile Badoual Anita Burgun Marie-France Mamzer |
| author_facet | Elise Jacquier Pierre Laurent-Puig Cécile Badoual Anita Burgun Marie-France Mamzer |
| author_sort | Elise Jacquier |
| collection | DOAJ |
| description | Abstract Background In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights. Methods Informed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”. Results 29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs. Conclusions Our review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested. |
| first_indexed | 2024-12-16T06:23:20Z |
| format | Article |
| id | doaj.art-7f780c4530d14c8ab8385f0a8eac99ef |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-12-16T06:23:20Z |
| publishDate | 2021-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-7f780c4530d14c8ab8385f0a8eac99ef2022-12-21T22:41:05ZengBMCBMC Medical Ethics1472-69392021-03-0122111310.1186/s12910-021-00592-9Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortiumElise Jacquier0Pierre Laurent-Puig1Cécile Badoual2Anita Burgun3Marie-France Mamzer4Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de ParisCentre de Recherche Des Cordeliers (UMRS 1138), Team Personalized Medicine, INSERM, Sorbonne Université, Université de Paris, Pharmacogenomics and Therapeutic OptimizationCentre de Ressources Biologiques, Service d’anatomo-pathologie, Hôpital Européen Georges Pompidou, Assistance publique – Hôpitaux de ParisDépartement D’informatique Médicale, de Biostatistique Et de Santé Publique, Hôpital Européen Georges Pompidou, Assistance publique – Hôpitaux de ParisCentre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de ParisAbstract Background In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights. Methods Informed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”. Results 29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs. Conclusions Our review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested.https://doi.org/10.1186/s12910-021-00592-9Dynamic consentInformed consentTranslational researchBiobank researchPatient participationPartnership in research |
| spellingShingle | Elise Jacquier Pierre Laurent-Puig Cécile Badoual Anita Burgun Marie-France Mamzer Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium BMC Medical Ethics Dynamic consent Informed consent Translational research Biobank research Patient participation Partnership in research |
| title | Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium |
| title_full | Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium |
| title_fullStr | Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium |
| title_full_unstemmed | Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium |
| title_short | Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium |
| title_sort | facing new challenges to informed consent processes in the context of translational research the case in carpem consortium |
| topic | Dynamic consent Informed consent Translational research Biobank research Patient participation Partnership in research |
| url | https://doi.org/10.1186/s12910-021-00592-9 |
| work_keys_str_mv | AT elisejacquier facingnewchallengestoinformedconsentprocessesinthecontextoftranslationalresearchthecaseincarpemconsortium AT pierrelaurentpuig facingnewchallengestoinformedconsentprocessesinthecontextoftranslationalresearchthecaseincarpemconsortium AT cecilebadoual facingnewchallengestoinformedconsentprocessesinthecontextoftranslationalresearchthecaseincarpemconsortium AT anitaburgun facingnewchallengestoinformedconsentprocessesinthecontextoftranslationalresearchthecaseincarpemconsortium AT mariefrancemamzer facingnewchallengestoinformedconsentprocessesinthecontextoftranslationalresearchthecaseincarpemconsortium |