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Brief Report: Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design
Danny A Young-Afat1, Helena A M Verkooijen, Carla H van Gils
1From the aDepartment of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; bDepartment of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands; cImaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; dDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; and eSchool of Health and Related Research (Public Health section), University of Sheffield, Sheffield, United Kingdom.
A staged-informed consent procedure can avoid prerandomization in cohort multiple randomized controlled trials (cmRCTs). This approach ethically integrates multiple trials within a cohort, enhancing pragmatic research.
Area of Science:
- Clinical Trials Methodology
- Pragmatic Research Design
- Bioethics in Research
Background:
- Cohort multiple randomized controlled trials (cmRCTs) embed multiple trials within a cohort, offering advantages over conventional RCTs for pragmatic research.
- Challenges include slow recruitment, testing multiple interventions, patient/doctor preference for new treatments, and risks of disappointment bias, cross-over, and contamination.
- Conventional cmRCTs may involve prerandomization, which is ethically contentious in clinical settings.
Purpose of the Study:
- To propose and justify a staged-informed consent procedure to avoid prerandomization in cmRCTs.
- To present an ethically acceptable alternative for conducting pragmatic trials within a cohort structure.
- To maintain participant engagement throughout the research process.
Main Methods:
- A three-stage informed consent process is introduced for cmRCTs.
- Stage 1: Broad consent for cohort participation and potential randomization is obtained upon entry.
- Stage 2: Specific consent for intervention is sought only from those randomly selected for an intervention arm.
- Stage 3: Aggregate results are disclosed to all cohort participants post-trial.
Main Results:
- The proposed staged-informed consent procedure effectively eliminates prerandomization in cmRCTs.
- This method addresses ethical concerns associated with randomization timing in pragmatic trials.
- The procedure aims to enhance participant engagement by clarifying consent at different research stages.
Conclusions:
- Staged-informed consent provides an ethically sound alternative to prerandomization in cmRCTs.
- This methodology supports the efficient and ethical conduct of pragmatic trials with multiple interventions.
- The approach respects participant autonomy while facilitating robust clinical research.
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