Publishing clinical trial results in plain language: a clash of ethical principles?

Plain language resources (PLR) are lay summaries of clinical trial results or plain language summaries of publications, in digital/visual/language formats. They aim to provide accurate information in jargon-free, and easy-to-understand language that can meet the health information needs of the general public, especially patients and caregivers. These are typically developed by the study sponsors or investigators, or by national public health bodies, research hospitals, patient organizations, and non-profit organizations. While the usefulness of PLR seems unequivocal, they have never been analyzed from the perspective of ethics. In this commentary, we do so and reflect on whether PLR are categorically advantageous or if they solve certain issues but raise new problems at the same time. Ethical concerns that PLR can potentially address include but are not limited to individual and community level health literacy, patient empowerment and autonomy. We also highlight the ethical issues that PLR may potentially exacerbate, such as fair balanced presentation and interpretation of medical knowledge, positive publication bias, and equitable access to information. PLR are important resources for patients, with promising implications for individual as well as community health. However, they require appropriate oversight and standards to optimize their potential value. Hence, we also highlight recommendations and best practices from our reading of the literature, that aim to minimize these biases.