Details of risk-benefit communication in informed consent documents for phase I/II trials.

Background: Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.

[Ethics University on Regenerative Medicine - As an Instrument for the Development of Valid Public Opinions?].

Objectives: In 2016, we invited interested citizens to participate in the "ethics university on regenerative medicine" at Hannover Medical School. The present study analyses if and how this discursive and informative event inspired participants to form their own opinion on the issues at hand and to develop their general ethics literacy.

Methods: The "ethics university" was performed twice in 2016; each run consisted of four single consecutive events.

The Public's Awareness of and Attitude Toward Research Biobanks - A Regional German Survey.

Biobanks have become an increasingly important means of biomedical research and innovation. However, they entail a variety of ethical, social and legal challenges, which need to be publicly discussed and managed collectively. A certain level of public awareness of biobank research is an important prerequisite for the public to form an opinion on the issue at hand and to be willing to participate in public engagement activities.

Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.

Background: For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers' understanding and reactions.

An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.

Background: The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved.

Do Public Involvement Activities in Biomedical Research and Innovation Recruit Representatively? A Systematic Qualitative Review.

Background: Public involvement activities (PIAs) may contribute to the governance of ethically challenging biomedical research and innovation by informing, consulting with and engaging the public in developments and decision-making processes. For PIAs to capture a population's preferences (e.g.

Collective agency and the concept of 'public' in public involvement: A practice-oriented analysis.

Background: Public involvement activities are promoted as measures for ensuring good governance in challenging fields, such as biomedical research and innovation. Proponents of public involvement activities include individual researchers as well as non-governmental and governmental organizations. However, the concept of 'public' in public involvement deserves more attention by researchers because it is not purely theoretical: it has important practical functions in the guidance, evaluation and translation of public involvement activities.