Table 5.

Informing and enabling participants and the public

Potential participants need to be informed about:

–the type of research being carried out, the activities of health databases and/or the research results [10, 19, 31];

–the legal basis and objectives of the data processing by third parties [22];

–how consent can be withdrawn, as well as the implications of and limits to withdrawal [17, 19, 31];

–whether the participants retain any rights over the data [19];

–whether return of individual-level findings derived from analysis of the data is foreseen and the right to opt-out from receiving such information [17, 19];

–how the data and the confidentiality of these data will be protected [17, 19];

–the limits to anonymity and confidentiality of data [10, 16, 17, 19];

–the exceptional circumstances and conditions under which researchers may access data that is not coded or anonymous [19];

–the potential adverse consequences of breaches of confidentiality [17];

–information about an actual significant data breach or misuse of data [22];

–significant modifications to databases’ policies, protocols and procedures [19];

–entering into commercial collaborations or commercialisation of research resources [19].

Enable participants to exercise the following rights:

–the right to withdraw consent [17, 19, 22, 31];

–the right to choose whether (and how) individual-level findings will be returned [17, 19];

–the right to request for information about their data and its use [31];

–the right to request for corrections of omissions in data [31];

–the choice to opt-out of being re-contacted for research purposes [17].

Related to data sharing, public information should include the following items:

–the terms, procedures, policies and/or governance frameworks for data access or sharing [10, 16, 18, 19, 22];

–for what purposes and ways in which data may be shared [10, 16, 22];

–a summary of (approved) data transfers [10], including a list of categories of approved data recipients [22];

–the legal bases for sharing data [22];

–a catalogue of the resources accessible for research purposes [19];

–the duration of data storage [10];

–a specification of conditions attached to the use of the data [18];

–a summary of research results [19];

–commercial involvement and propriety claims [10];

–processes of withdrawal from data sharing [10];

–contact information and answers to frequently asked questions [19];

–procedures for handling complaints [31];

–the purpose, background, funding, scope, uncertainties and risks, scientific rationale of the initiative or database and its funding [19];

–the disclosure of any conflict of interest involving personnel [19].