P341: Broad Consent in Clinical Trials: Ethical Implications for Secondary Use of Data
Poster Presenter
Katharina Goldner
Regional Regulatory Affairs Manager
Bayer AG Germany
Objectives
Prioritizing participants' rights and preferences in implementing broad consent in clinical trials to ethically utilize existing data for secondary scientific purposes enhances trust in research and improves patient outcomes.
Method
We explore values-based schemata for broad consent focusing on the compatibility of research goals with individual values and the tension between data sovereignty and public interest. We evaluate opportunities and limitations of implementing broad consent, including data linkage and synthetic data.
Results
Utilizing clinical trial data for secondary scientific purposes which are beyond the scope of the study drug not only advances scientific knowledge but also improves patient outcomes. It saves resources, increases efficiency, and avoids additional physical harm to participants. To ensure that the collection, storage and utilization ar in accordance with the current legal requirements, broad consent is required. With such optional consent, participants agree to utilization of their clinical trial data for additional scientific purposes which are not known at the time of the primary study. This may include development of new ways to use scientific data, new research questions, new diagnostic tests, and scientific analysis methods. The areas of study may differ. But broad consent is not to be mistaken as blank consent - the trial participants must have the autonomy to decide for which purpose their clinical trial data can be used beyond primary research without knowing the secondary research goal in detail at the time.
Existing regulatory requirements for re-use of data in the EU and US have been subject to fragmentation and, at times, ambiguous interpretation. Although the European Health Data Space regulation will permit re-use of health data for research once fully implemented, legal grey areas regarding re-use of clinical trial data will, for now, persist. This uncertainty underscores the need for ongoing evaluation and adaptation of bioethical frameworks as fundamental guardrails to best protect and serve clinical trial participant interests.
Often discussed as an ethical imperative utility of available data beyond the primary research goals can only be maximized, when participants’ rights and preferences have highest priority.
Broad consent respecting participant´s personal value brings complexity which must be manageable and not an obstacle to future research. We will present feasible options and discuss limits in the context of respecting patient´s autonom
Conclusion
In addition to informed consent which manages the agreements related the primary research goal and methods, broad consent can be an opportunity
- for researchers to run supplementary and alternative analysis of already gathered data. This will be done in a compliant and transparent manner by publicly posting protocol and results.
- for trial participants to actively determine the scientific value of their data by balancing their individual system of moral value vs public interest in scientific progress.
Implementing ethical considerations in the broad consent process will not only foster patients trust in research but also enhance company reputation, mitigate risks, mutually benefit both patients as well as companies, and ultimately advance science.
