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

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