Statement on ethical evaluation in EU-projects (general statement)
Based on various inquiries recently concerning challenges related to ethics evaluation in EU-projects, NESH has decided to give a general advice which might be applicable for others. The aim is to clarify, translate and harmonize the different approaches to ethical evaluation in the Norwegian system and H2020s Ethics Appraisal Procedure respectively. Hopefully, the statement will be helpful for the administration of the Participant Portal for H2020, when processing applications from Norway.
Regulation in the Norwegian system
In Norway, research ethics in general is regulated in The Research Ethics Act of 2017, originally introduced in 2007. The act provides a legal basis for three independent National Research Ethics Committees, initially established as advisory bodies in 1990, covering all fields of research in both private and public sector:
a) The National Committee for Medical and Health Research Ethics (NEM)
b) The National Committee for Research Ethics in Science and Technology (NENT)
c) The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH)
Since 2007, with The Research Ethics Act, we also have a fourth national body:
d) The National Commission for the Investigation of Research Misconduct (GRU)
In 2013, these four bodies were formally united in The Norwegian National Committees for Research Ethics (FEK), an independent unit under the Norwegian Ministry of Education and Research (KD).
The act also provides a legal basis for the Regional Committees for Medical and Health Research Ethics (REK), a separate body which since the introduction of The Health Research Act in 2009 has provided advance approval for medical and health research projects. For other projects, issues concerning data protection and privacy is dealt with by NSD according to the Personal Information Act of 2018, implementing the General Data Protection Regulation (GDPR).
Consequently, for projects in the social sciences and the humanities, not covered by The Health Research Act, there is no formal requirement of ethical preapproval from a national or regional committee. Instead, the Research Ethics Act of 2017 (§5) points out the responsibility for good research ethics to the research institutions, and ethics self-assessments to the researchers themselves, in their applications and documents describing their research projects. The Act also points out that all research institutions have an obligation to supervise that all projects at the institution is conducted in accordance with recognized ethical norms and guidelines. Since 1993, NESH has provided such guidelines, and they have been revised regularly in 1996, 1999, 2006 and 2016 (also in English). Other recognized guidelines, especially relevant for H2020-apprications, are the revised version of The European Code of Conduct for Research Integrity by ALLEA (All European Academies). To sum up the system of rules and regulation in Norway concerning ethics evaluation of research projects in the social science and the humanities:
General issues concerning data protection is covered by NSD.
The institutions must make sure all projects are ethically evaluated.
NESH provides ethical guidelines and can give advice upon request concerning specific projects.
H2020 Ethics Appraisal Procedure
The legal basis for requiring ethics reviews in all H2020-projects was formulated in 2013 in Article 14 of the EU-regulations for participating in the program, and the main ethical principles were listed in article 19 of the regulation establishing H2020. These ethics principles are further elaborated, and expanded, in the H2020 Model Grant Agreements, especially Article 34 – Ethics and Research Integrity.
In the last version (v5.0-18.10.2017) Article 34 was revised to align the provisions on both ethical and research integrity principles in the new European Code of Conduct for Research Integrity adopted by ALLEA in March 2017. Thus, there is an explicit obligation to comply with both research ethics and research integrity. And these European requirements does not change the other obligations under national law, which still apply.
In practice, activities raising ethical issues must comply with the formal ethics and integrity requirements. Therefore, according to Article 34.2, before the beginning of an activity raising an ethical issue, each beneficiary must have obtained:
a) any ethics committee opinion required under national law and
b) any notification or authorization for activities raising ethical issues required under national and/or European law
And in article 41, describing the internal division of roles and responsibilities it is restated that each beneficiary must submit the coordinator in good time, «any committee opinions and notifications or authorizations for activities raising ethical issues (see Article 34).»
In H2020-applications, the Ethics Appraisal Procedure consists of four parts:
- Ethics Self-Assessment
- Ethical Screening
- Ethical Assessment
- Ethics Checks and Audits
First, if required by the Ethics Issue Table in Part 4 of the H2020-application, an Ethical Self-Assessment must be completed by all applicants in accordance with the detailed Guidance for how to complete your ethical self-assessment, which specifies the necessary requirements for instance when conducting research on humans or collecting personal data.
Second, if the project is considered for funding, it will undergo an ethics review beginning with an Ethics Screening during the evaluation. The aim here is to list all (potential) issues involved and to make sure the required approvals are in place, for instance with regards to data protection, clinical trials or animal welfare.
Third, depending of the complexity of the ethical requirements, a full Ethical Assessment is required prior to the signature of the grant agreement. For instance, research on human embryonic stem cells automatically requires a full ethical assessment.
In addition, if the project is approved, a fourth set of Ethics Checks and Audits will be required during the implementation of the project. This can involve either an independent Ethics Advisor or an Ethics Check after a given period of time.
For Norwegian researchers and research institutions it is important to recognize the diligence of the H2020 Ethical Appraisal Procedure. Many issues eventually raised in the Ethics Screening should preferably be handled already in the Ethics Self-Assessment. For instance, most issues concerning personal data protection (GDPR) should be clarified with the personal data protection officer at the institution in before submitting the application, for most institutions this involves consultation with NSD.
This, however, is not regarded at an «ethical evaluation», as it is primarily concerned with protection of personal data. Thus, also broader ethical issues should be elaborated and discussed in the application and Ethical Self-Assessment, for instance in relation to the ethical guidelines from NESH.
When conducting research on humans, especially related to medicine health and care, it is important to clarify whether the project requires advance approval or not, according to The Health Research Act in 2009. This should be clarified with the Regional Committees for Medical and Health Research Ethics (REK). If not, the project does not require approval or authorization from an independent committee according to Norwegian law.
Finally, it is explicitly required in Article 34 that all projects must align the provisions on ethical and research integrity principles in the new European Code of Conduct for Research Integrity (ALLEA 2017). Yet, this document is not well known among researchers in Norway, and the institutions have an obligation to supervise that all projects are conducted in accordance with the common and recognized code of conduct. Meanwhile, FEK will arrange for translation and assist in the dissemination of The European Code of Conduct for Research Integrity in Norway.
In applications for funding from H2020, or similar funding agencies, Norwegian applicants must make sure the relevant requirements for research ethics and research integrity is met according to the same standard as the rest of the application. This involves adherence to the relevant framework in both Norway and Europe. Vice versa, it might be helpful for managers of the applications and the participant portal to have adequate knowledge of the regulation in the Norwegian system. Hopefully this statement will serve as a guide to both these challenges.
 http://ec.europa.eu/research/participants/data/ref/h2020/legal_basis/rules_participation/h2020-rules-participation_en.pdf#page=10; http://ec.europa.eu/research/participants/data/ref/h2020/legal_basis/fp/h2020-eu-establact_en.pdf#page=11
Cf. also Article 35 – Conflict of Interests, Article 36 – Confidentiality, Article 37 – Security-related obligations, and Article 39 – Processing of personal data