BACKGROUND
Medical research for processing medical data is required to incorporate a governance system. Health data governance includes various elements. Among the values of governance, this study focuses on accountability and transparency.
OBJECTIVE
This paper proposes the system requirements for a communication platform to help medical researchers be accountable and transparent about medical data processing in medical research.
METHODS
We first examined accountability and transparency to find their shared bases and confirmed their importance by visiting medical research practices. Subsequently, we explored legal syllogism as the representative of rule compliance analysis to determine the system requirements to achieve the bases.
RESULTS
By examining accountability and transparency, we confirmed that these values were inherently vague but had two shared features– "organizing information" and "effective communication." Next, by analyzing the actual research process, we found that researchers needed to communicate effectively with legal and ethical experts to obtain appropriate support at the research planning phase. From these findings, the concept of a communication platform was derived. Through the analysis of the syllogism, we found three system requirements for the platform: (1) covering the entire chain of data processing activities; (2) being capable of recording relevant information for rule compliance analysis; and (3) being able to record compliance analysis results.
CONCLUSIONS
We introduced an example of a user interface in line with the discovered system requirements and discussed how our design can facilitate patients' and society's interests by empowering researchers to be accountable and transparent for their research. To support medical researchers to be accountable and transparent for their research, we proposed system requirements for a communication platform.
CLINICALTRIAL
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