Open Science for Human Subject Research

Human subject research describes observational or interventional scientific investigation involving human beings as research subjects. Since people are involved in this research, the consistent pursuit of an open science paradigm plays a particularly important role.

Below we briefly describe the general research process in human subject research. Below we provide an overview of relevant Open Science building blocks along the research process.

Human Subject Research Process

In principle, the human subject research process can be divided into different phases. In our Open Science-based research framework we differentiate between six phases:

Problem – In a first step the research problem is identified and defining the problem that needs to be investigated.
Research Design - Next, the methodological approach to address the problem is planned.
Data Collection - This stage involves gathering data according to the research design.
Data Analysis - The collected data is then analyzed to draw conclusions.
Interpretation - Insights and results from the data analysis are interpreted.
Communication - Finally, the findings and insights are communicated to a wider audience.

Each stage of the human subject process seamlessly leads to the next, and the final stage linking back to the initial problem identification, suggesting that the output of one human subjects research cycle could serve as input to new problems to investigate.

Open Science Building Blocks

Open Science offers numerous building blocks that can be used throughout the research process.

The figure visualizes a rough assignment between the building blocks and the phases of the research process. It should be mentioned that some building blocks can be used in several phases of the research process. Since the Open Science field is developing rapidly, the figure does not claim to be complete.

In the following we briefly explain the meaning and basic concepts of the listed building blocks. We partially rely on the UNESCO Recommendation on Open Science (https://unesdoc.unesco.org/ark:/48223/pf0000379949.locale=en).

Building Block	Short Description
Citizen Science	Citizen science encompasses the engagement of non-professional scientists in scientific research. This participatory approach allows a wider array of societal actors to contribute to scientific inquiries. Citizen Science is traditionally leveraged in the data collection phase. However, it can also be performed in other phases, e.g. the problem, the interpretation or dissemination phase.
Data Protection	Data protection refers to the processes, policies, and practices designed to secure personal or sensitive information from unauthorized access, use, disclosure, disruption, modification, or destruction. It ensures the privacy, integrity, and availability of data and is crucial for maintaining individual privacy rights.
Institutional Review Board	Institutional review boards (IRBs) review and approve the research design proposed for a research project to ensure the protection of the rights, welfare, and well-being of human subjects involved in research.
Registered Reports	In a registered report a two-stage publication process to enhance transparency is followed. In particular, the research design and data analysis methods are peer-reviewed and approved before the research is conducted. It emphasizes quality of the research design and data analysis, rather than the novelty or positive outcomes of the data analysis
Preregistration	Preregistration involves documenting and publicly registering the research hypotheses, methods, and analysis plan before conducting the study and analyzing the data. This practice also aims to enhance the transparency of research by preventing selective reporting.
Crowdsourcing	Crowdsourcing describes the provision of tasks that are executed by a crowd of people working on problem-solving or data collection, contributing to a common goal. When the crowd receives a monetary reward for their contribution, it is called crowdworking. In research crowdsourcing can be leveraged to collect data with and without incentives from crowd of people.
Open Data	In general, open data refers to data that is made available to the public freely. The open data building block in Open Science targets promoting transparency and facilitating collaboration.
Open Source	Following an open source approach means that the software source code is made publicly available. It offers different license models that grants others the right to use, modify, study, create derivative works from, and share both the software and its source code. In the research context, open source targets to increase transparency.
Open Access	The open access building block of Open Science targets to make research free and available to anyone with internet access and promote advances in the sciences.
Open Peer Review	In open peer review the identities of the reviewers and authors are disclosed to each other. Furthermore, the review reports are often made publicly available. Again, this Open Science building block aims to increase transparency and accountability peer review process and potentially leading to enhanced quality and integrity of scholarly feedback.

To successfully implement the Open Science building blocks in the human subject research process, there is a need for tools and infrastructures in addition to an understanding of the underlying building block approach. Further information about tools and infrastructures as well as resources can be found here: https://openscience.kd2lab.kit.edu/73.php