TherVacB - A therapeutic vaccine against hepatitis B

Partner

• Helmholtz Zentrum München - German Research Center for Environmental Health (HMGU)
• Fraunhofer Institute for Cell Therapy and Immunology (IZI)
• University Medical Center Hamburg Eppendorf (UKE) and
• Klinikum rechts der Isar (MRI) of the Technical University of Munich (TUM)
• University Medicine MRI (TUM)

Subproject

Ethics Subproject:

The research group of Prof. Alena Buyx at the Institute for History and Ethics of Medicine at the Technical University of Munich is in charge of the following work package within this consortium "Ethics of Patient Recruitment.. We are investigating the ethical-social implications related to patient recruitment via social media (e.g. Facebook, Twitter) and are advising the consortium on the development of a recruitment strategy via social media.

Recruitment via social media for clinical trials promises to be a cost-effective method of targeting traditionally marginalized populations and promoting patient engagement with researchers and a particular study. Although social media recruitment has been shown to have significant potential, it comes with several practical, ethical, social, and legal challenges. These range from inadvertent unblinding, misinformation, and limited participant autonomy to issues of inequitable access and the digital divide and potentially stigmatizing effects, to name a few. In addition, there are significant uncertainties regarding legal issues in social media recruitment, as well as privacy and data security, including in light of the EU General Data Protection Regulation. Recruitment via social media for clinical trials therefore requires a precise and context-based ethical analysis to also consider the risks of this approach.

The TherVacB consortium, whose TherVacB clinical trial is a potential use case for social media recruitment, is exploring the application of the new approach. To this end, our research team is developing an overview of the ethical benefits and risks to be considered when recruiting via social media in clinical trials, and developing practical recommendations for how these considerations can be implemented in the TherVacB setting. In addition, the metrics and checklists developed can serve as a blueprint for other clinical researcher:s considering social media recruitment for their trials. In this way, we hope to minimize the risks associated with social media recruitment for patients and subjects not only for the TherVacB clinical trial, but for all clinical trials.

To support the recommendations, in addition to an extensive ongoing literature review, our team conducted a multi-stakeholder interview study with (1) patients who use social media and/or have been exposed to social media recruitment, (2) social media researchers:(1) social media researchers or social scientists who have worked with social media (recruitment), (3) practical experts in SMR, (4) legal experts, (5) members of ethics committees (DACH), (6) members of ethics committees (USA), and (7) members of the TherVacB consortium. The study was approved by the Ethics Committee of the Technical University of Munich, Klinikum Rechts der Isar.

Based on the interview study, our research team is developing a survey study to quantify the results. The primary objective of the survey study is to investigate the acceptance of social media as a recruitment channel for clinical trials in a vulnerable patient population (hepatitis B patients). In addition, factors influencing this acceptance that could be identified from the previous interview study will be quantified.