Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378281
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
Testing a New Method to Improve Informed Consent in Prison Research
Sponsor:
Stéphanie Baggio
Organization:
University Hospital Geneva
Study Overview
Official Title:
Testing a New Method to Improve Informed Consent in Prison Research
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Spark BATIR
Brief Summary:
Understanding of informed consent is often limited in prison due to unique challenges faced by detained people This study will test a modified teach-to-goal informed consent process compared to standard procedures Conducted within a larger study on psychiatric outcomes it aims to enhance ethical practices for vulnerable populations
Detailed Description:
Background and rationale Informed consent is an ethical pillar of health-related research involving human subjects but participants understanding of informed consent is often limited Informed consent is also a critical issue in prison research
First detained persons are deprived from liberty a context that may undermine voluntary participation and autonomy Second detained persons have disproportionally low levels of education literacy and high rates of cognitive or substance- and psychiatric-related impairments In Switzerland a study conducted in the general population concluded that informed consent forms are too long and complex Another study conducted in prison showed a full understanding of 5 in detained persons Of note a revision of the Federal Human Research Act HRA has just begun and includes propositions to strengthen informed consent Nonetheless few studies focused on understanding of informed consent in prison research and to our knowledge no study with a robust methodology tested whether the most effective interventions in the general population are also effective in prison Objective of the study The overarching aim of this study is to estimate and improve understanding of informed consent in prison research and better understanding characteristics associated with a low understanding The informed consent process is a time-consuming process and studies may lack resources to ensure that participants provide fully informed consent To fill in this critical research gap this study will be embedded in a larger randomized controlled trial RCT parent-RCT designed to improve psychiatric outcomes We will use an RCT to compare two informed consent processes Methods This is a cross-sectional RCT ratio 11 testing the effect of informed consent processes on understanding primary endpoint and evaluation secondary endpoints of informed consent The research team and will not be blinded to the participants group but the statistician will be Participants will be partially blinded Data will be collected in two prisons among sentenced men n100 The intervention will be modified teach-to-goal vs standard informed consent process In the modified teach-to-goal intervention the participant is asked to describe the research procedures Misconceptions are corrected by a study team member and the participant is asked to describe again the corresponding components The procedure is iterated until correct and full understanding is reached Analyses will include intention-to-treat bivariable and multivariable regressions We will also explore associations between understanding and socio-demographic variables using logistic linear or negative-binomial regressions to identify characteristics associated with lower understanding Expected results and impact There is a growing recognition that prison research is needed Improving informed consent in prison research therefore constitutes a critical but neglected issue both as a separate research topic and for future research projects focusing on detained persons and more broadly on vulnerable populations Embedding a RCT on informed consent in an already existing RCT is an unconventional research process We believe that it will provide real study life information on how informed consent is informed and ways to improve it It will also ensure that ethical requirements are fully met in the parent-RCT This study will thus provide scientific evidence on how to improve informed consent in prison research
Results will be valuable for other vulnerable populations including people with low levels of education and literacy and high burden of disease We plan to publish results in a high-impact biomedical journal and to share them in international conferences and with Swiss cantonal Ethics Committees to raise awareness on informed consent as a core component of medical ethics in research and more specifically research involving vulnerable populations The project may provide meaningful information for the revision of the HRA and help improving informed consent processes in Swiss research
First detained persons are deprived from liberty a context that may undermine voluntary participation and autonomy Second detained persons have disproportionally low levels of education literacy and high rates of cognitive or substance- and psychiatric-related impairments In Switzerland a study conducted in the general population concluded that informed consent forms are too long and complex Another study conducted in prison showed a full understanding of 5 in detained persons Of note a revision of the Federal Human Research Act HRA has just begun and includes propositions to strengthen informed consent Nonetheless few studies focused on understanding of informed consent in prison research and to our knowledge no study with a robust methodology tested whether the most effective interventions in the general population are also effective in prison Objective of the study The overarching aim of this study is to estimate and improve understanding of informed consent in prison research and better understanding characteristics associated with a low understanding The informed consent process is a time-consuming process and studies may lack resources to ensure that participants provide fully informed consent To fill in this critical research gap this study will be embedded in a larger randomized controlled trial RCT parent-RCT designed to improve psychiatric outcomes We will use an RCT to compare two informed consent processes Methods This is a cross-sectional RCT ratio 11 testing the effect of informed consent processes on understanding primary endpoint and evaluation secondary endpoints of informed consent The research team and will not be blinded to the participants group but the statistician will be Participants will be partially blinded Data will be collected in two prisons among sentenced men n100 The intervention will be modified teach-to-goal vs standard informed consent process In the modified teach-to-goal intervention the participant is asked to describe the research procedures Misconceptions are corrected by a study team member and the participant is asked to describe again the corresponding components The procedure is iterated until correct and full understanding is reached Analyses will include intention-to-treat bivariable and multivariable regressions We will also explore associations between understanding and socio-demographic variables using logistic linear or negative-binomial regressions to identify characteristics associated with lower understanding Expected results and impact There is a growing recognition that prison research is needed Improving informed consent in prison research therefore constitutes a critical but neglected issue both as a separate research topic and for future research projects focusing on detained persons and more broadly on vulnerable populations Embedding a RCT on informed consent in an already existing RCT is an unconventional research process We believe that it will provide real study life information on how informed consent is informed and ways to improve it It will also ensure that ethical requirements are fully met in the parent-RCT This study will thus provide scientific evidence on how to improve informed consent in prison research
Results will be valuable for other vulnerable populations including people with low levels of education and literacy and high burden of disease We plan to publish results in a high-impact biomedical journal and to share them in international conferences and with Swiss cantonal Ethics Committees to raise awareness on informed consent as a core component of medical ethics in research and more specifically research involving vulnerable populations The project may provide meaningful information for the revision of the HRA and help improving informed consent processes in Swiss research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None