Data (Re-)Use in Human-Participant Research: Guided Composition of Informed Consent Forms

Research involving human participants requires important ethical considerations. With rare exceptions, a key requirement is to obtain voluntary informed consent from participants before data collection. This consent usually involves prior information about content and aims of the study, possible burdens, compensation for participants' time investment, and the like [1]. Prior information must also extend to data usage in order for participants to understand how their (personal) data are being processed in the study at hand, as well as whether the data are shared and re-used for other purposes [2,3]. Following the EU-GDPR [4], many research institutions provide templates to help researchers create information sheets and consent forms on data processing in accordance with legal requirements. Yet, understanding these documents can pose significant challenges for persons without legal expertise – human research participants and researchers alike. In fact, when adapting data processing templates to their own studies, researchers sometimes commit substantial errors, and often feel unsure [5]. Based on this observation, we developed a data processing module within our Ethiktool software [6,7,8]. The Ethiktool is designed to guide the composition of ethics applications as well as information and consent forms for all aspects of human-participant research. The data processing module contributes to this functionality by offering user-oriented, dialogue-based guidance through all aspects of research data use. Integrating research ethics and research data management comes with significant synergies, as key pieces of information (i.e., the employed data collection methods and types of collected data) are needed for both. Our data processing module asks a series of questions to determine whether a detailed data privacy statement must be generated (e.g., because the data are not fully anonymous at all times). If yes, further questions are asked to compose an EU-GDPR-compliant data privacy statement. In either case, comprehensive questions on possible re-use of the data are asked, and the extracted information is added to the participant documents. We made sure to conceptualize the questions in our tool from the researchers' point of view and to include illustrative examples in order to avoid misunderstandings on the researchers' end. Orienting in the complex decision tree of data processing (including pseudonymization and anonymization techniques, storage duration, and more) is further supported by dynamically adapting all questions according to previous answers. Such automatic context sensitivity relieves the researcher from the tedious and error-prone usage of branching static forms and templates. We also paid attention to use wording in the data privacy statement that is understandable for participants who are not specifically versed in EU-GDPR terminology. Balancing full EU-GDPR compliance against ease of comprehension remains a challenge for which we look forward to feedback by the scientific community and by the wider community of interested citizen scientists. In general, we believe that an integration of research ethics with research data management is indispensable for conducting human-participant research, and that our software approach offers helpful support to reach this aim. After successful completion of our development, we will offer this software free of charge to the community.