gms | German Medical Science

Introduction: Research is a decisive factor for progress in medicine in order to better understand diseases, to identify these faster, to treat them in a more targeted manner or to also prevent them [1]. However, researchers have to consider different national regulations depending on the research project. Accordingly, approvals must be obtained from the ethics committee and data protection officer. In German university hospitals that are part of the Medical Informatics Initiative (MII) [2] additional proposals must be submitted to Use & Access Committees (UAC) and the Data Integration Center if data are required for processing. Depending on the study design, these applications differ and often this process is non-transparent, so that especially inexperienced researchers have to invest a lot of time in formalities. The aim of this project is not only to optimize this process, but also to facilitate the completion of various application forms for researchers at the University Hospital Frankfurt.

Method: The current research proposal process was analyzed to identify potential improvements and possible IT-supported systems for optimization. Based on the findings, the desired process was modelled in BPMN and a prototype web application was designed, which provides the required forms for the researcher depending on the type of study. The web application should be implemented with state-of-the-art technologies.

Results: Based on the process modeling and forms to be submitted, which resulted from the requirement analysis, it was evident that researchers need to enter information redundantly in the various forms for ethics, privacy, and the data integration center. The developed application addresses this burden by providing a simple, harmonized, and digitally supported process for researchers to submit research proposals with one-time information entry. This application then generates populated forms based on the University Hospital templates, which can then be forwarded to the appropriate parties. The generated documents can be saved in PDF or Word format.

Discussion: The web application is intended to provide researchers an easy entry point into the proposal process while minimizing workload. It is intended to eliminate the need to search for relevant templates. The process is also more transparent for researchers because by providing the required forms, the researcher will also have a better understanding of the remaining regulatory steps. In addition, it minimizes errors caused by typical copy-paste tasks or even by changing the templates in unanticipated parts. However, the establishment of such a prototype is only successful if there is a certain level of user satisfaction, so that the development should be driven forward in a user-centric manner.

Conclusion and outlook: The development of this web application is an important first step towards optimizing the process of submitting research proposals. In addition, the application is currently limited to retrospective study forms and is to be extended to further study forms, whereas the application is designed for extensibility. Finally, the degree of digitalization of the process should be improved by linking it to other systems such as EthikPool [3] or ProSkive [4], used by the ethics committee or data integration center, respectively.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.