H – Requirement No. 1
This deliverable addresses the comments documented in the Ethics Summary Report after the successful proposal evaluation. The post-grant requirements for this deliverable are related to human participants’ involvement in the inGOV Project.
Executive Summary
This deliverable, under WP8 Ethics requirements, addresses the comments documented in the Ethics Summary Report after the successful proposal evaluation. The post-grant requirements for this deliverable are related to human participants’ involvement in the inGOV Project. In case there will be human participants in the pilot or other stakeholders’ activities, the following requirements must be fulfilled:
- The procedures and criteria that will be used to identify/recruit research participants must be submitted.
- The applicant must clarify whether vulnerable individuals/groups will be involved and the measures to protect them and minimize the risk of their stigmatization must be submitted.
- Details on incidental findings policy must be submitted.
- Copies of opinions/approvals by ethics committees and/or competent authorities for the research with humans must be obtained before the start of the relevant activities must be submitted.
To this end, D8.1:
- maps all the cases across inGOV WPs, where ethical monitoring is necessary, taking into consideration human participation; these cases are related both to human participants in pilots, as identified in Protocols 1-3 and to any other human participant involved in stakeholders’ activities.
- identifies the procedures that should be carried out in each of the cases, before any human participant is involved in any research activity.
However, since by the time this deliverable should be submitted [M06], inGOV consortium did not have the level of detail needed for the overall ethical monitoring of the project, D8.1 reports on the processes that are already in place for Protocol 1 and provides a high level presentation of Protocols 2 and 3; it leaves the detailed description of the ethical monitoring and the provision of all the respective documentation of Protocols 2 and 3 to be submitted in M18, namely in the updated version of this Deliverable, under the following rationale:
- by M18 the project itself will have progressed to a certain level, enabling the inGOV consortium to have a better overview of both WP3 and WP4;
- as such, by that period the related Protocols 2 and 3 could be described and documented in detail.
Finally, with regards to the ethical monitoring of other WPs, where human participants are involved mainly in stakeholders’ activities, a high-level description is provided in the current report along with a reference to the Deliverable, where all the ethical procedures and approvals needed will be reported.
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