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Table 1 List of requirements for a comprehensive informed consent management.

From: The generic Informed Consent Service gICS®: implementation and benefits of a modular consent software tool to master the challenge of electronic consent management in research

No. Requirement and/or use case
1 Support of a general consent form for a research project, e. g. a digital consent template
2 Support of individual participant consents to digitally store filled-in participants’ consents
3 Clarity and transparency regarding each consent status to support Use and Access processes in compliance with data protection regulations
4 Editing and updating, i.e. consent templates, and enabling the participant to change his/her will any time
5 Support of consent exclusions [18], e.g. the participant can actively exclude the collection, use or processing of personal health information and/or biological samples or limit them to certain types of research
6 Possibility to define any number of (external) properties to support study-specific requirements
7 Possibility to define free text fields to support study-specific input fields, e. g. study site or specific dates/timestamps
8 Possibility to withdraw consent (fully or partially) in compliance with participants’ right to withdraw and to be forgotten (Art. 7 and 17 GDPR)
9 Support of consent versioning to support multiple consent versions within a study, e. g. to track changes over time or to provide consents in multiple languages
10 Possibility to freely configure automatable queries for consent status, e. g. for Use and Access processes
11 Possibility to define policies and combine them into modules to support fine-granular depiction of the participant’s expressed consent
12 Possibility to define mandatory policies/modules
13 Possibility of automated search or query of individual consented consent forms, policies, modules or specific identifiers, e. g. case number, to support use cases for data trustees such as
  List all participants, who consented to a specific policy
  List all consent forms existing for a study
  List all digital consents of a study, for which no scan of the paper-based IC is attached
  List all policies to which a participant has consented to
  List all consent forms, which exist for a participant
  Display the current consent form existing for a participant
  Answer the query, whether a given participant consented to a specific policy
14 Support of exporting consented cases, e. g. by providing a list of participants’ pseudonyms with valid consents
15 Integration of paper-based workflows, e. g. attaching documents to a participant’s digital consent
16 Management of domains (e. g. multiple projects, different study sites, or countries)
17 Intuitive usage and support of use cases, e. g. using an frontend with menu items like “search”
18 Possibility to define the time of validity of a consent