Review of EIA screening by independent body or person to check if no significant ethical impacts are expected

Required budget (1-10% of research budget for the risk governance assessment of the nanomaterial and its applications)

90% personnel, 10% other

80% personnel, 20% other

70% personnel, 30% other

Team composition

Leader: part time research assistant Optional members: should have relevant expertise to the identified ethical issues

Leader: full time researcher Optional members: should have relevant expertise to the identified ethical issues

Leader: full time senior researcher or independent consultant Optional members: should have relevant expertise to the identified ethical issues

Formulating review criteria

Yes

Yes

Yes

Consult with stakeholders before starting the EIA 1

No

Optional

Optional

Planning identification ethical impacts. Objective: to identify and describe the ethical impacts of the nanomaterial and its applications and places these impacts in a temporal perspective, anticipating short, medium and long-term impacts. To cover differences in perception of ethical issues between different stakeholder groups, stakeholder consultations are included in all cases. However, in small EIAs this may be limited to online consultations, while large scale EIAs may require the organisation of on-site stakeholder events.

Desk research: literature research; foresight through horizon scanning, and online expert and stakeholder consultation; Ethical Impact conceptual analysis of explicit issues through ethical checklists, and empirical analysis through online consultations with experts and stakeholders; document the outcomes.

Literature research: foresight through horizon scanning, trend analysis, expert and stakeholder consultation, brainstorming, futures wheel, and roadmapping; Ethical Impact conceptual analysis of explicit issues through ethical theories, and empirical analysis through consultations with experts and stakeholders; document outcomes.

Literature research: foresight through horizon scanning, trend analysis, expert and stakeholder consultation, delphi interviews, brainstorming, futures wheel, citizen panels, roadmapping and scenario writing; Ethical Impact conceptual analysis of explicit issues through ethical theories, of intuitive issues through situational approaches, and empirical analysis of explicit issues through expert and stakeholder consultations, of intuitive issues through techno-ethical scenarios; document outcomes.

Planning evaluating ethical impacts. Objective: assess the relative importance, the likelihood of occurrence and the possible value conflicts of identified ethical impacts. Stakeholders will in all cases be involved in the evaluation, ranging from online consultations for small scale EIAs to on-site events in large scale EIAs.

Desk research: literature research of existing evaluation of ethical impacts in related projects. Use 5 rules of thumb2 to identify and resolve value conflicts. Present and discuss the ethical impact evaluation online with stakeholders.

Desk research and expert consultation. Methods: Delphi, interviews and workshops. Use 5 rules of thumb to identify and resolve value conflicts. Present and discuss the ethical impact evaluation with stakeholders.

Desk research, expert consultation, and participatory approaches focusing on stakeholder engagement. Use 5 rules of thumb to identify and resolve value conflicts. Present and discuss the ethical impact evaluation with stakeholders.

Planning ethical remediation: Review remediation in other projects, formulate and implement remediation, formulate and present recommendations to stakeholders.

Desk research: formulate societal and organisational recommendations

Formulate design, societal, organisational, regulatory and policy recommendations.

Formulate design, societal, organisational, regulatory and policy recommendations.

Planning the review of the EIA by an independent member of the RGC or external body. External reviewer provides feedback and guidelines for improving the EIA process and guards milestones and KPI.

At start: review and approve EIA plan. During: evaluate conduct and documentation. At end: review EIA process.

At start: review and approve EIA plan. During: evaluate conduct and documentation. At end: review EIA process

At start: review and approve EIA plan. During: evaluate conduct and documentation. At end: review EIA process

Guidance text

Title of EIA:

Abstract:

[This includes information on the nanomaterial and applications which will be assessed, the identified ethical issues, the scale of the EIA and who will be responsible for performing the EIA.]

Budget:

[Include an estimate of personnel cost and other costs (travel, organising events, materials).]

Team composition:

[Include information on the expertise of team members.]

Review criteria:

[E.g. validity of screening output, appropriateness of selected literature and stakeholders, quality of methodology.]

Optional: preliminary stakeholder consultation:

[If the identified issues are controversial, early stakeholder consultation about the EIA plan could be advised, in addition to consultations in later stages.]

Identification of Ethical Impacts:

[The EIA plan outlines who will identify ethical impact, how and when, using which information sources. To facilitate the creation of a list of references, possible information sources are listed here (Link). For medium or large EIAs, additional suggested methodologies are included in the CEN Workshop Agreement part 2 CWA 17145-2:2017 (E) (Link).

Evaluation of Ethical Impacts:

[The EIA plan outlines who will evaluate the identified ethical issues, and specifies the methodology which will be used, for small EIAs mainly desk research and consultation. For medium or large EIAs, additional suggested methodologies are included in the CEN Workshop Agreement part 2 CWA 17145-2:2017 (E) (Link).]

Remediation:

[The EIA plan outlines who will draft the remediation recommendations and lists the types of remediation recommendations which will be considered: in any case societal and organisational. In case of medium-large EIA, regulatory and policy recommendations may also be needed.]

Review of EIA plan:

[The EIA plan includes a short plan for external review, including the name of the reviewer and indication of when reviews will take place.]

**This work project has received funding from European Union Horizon 2020 Programme (H2020) via RiskGONE project under grant agreement nº 814425