1.3.1. Review procedure

We shall now analyze in detail the ethical review procedures. Even if they are known by researchers who have submitted projects, they are nevertheless unknown to their colleagues or to society as a whole. Applicants however only rarely have an idea of the modes of governance of these ERs. They sometimes know only the Ethical Review Questionnaire (ERQ). And some officials of the EC may have regretted that when applicants are designing their projects, they too often hastily fill in the latter in the final minutes before completing their file.

Detailed knowledge of what exists in these fields is crucial and is done by moving closer to the practice and texts on which ethical reviews are based in order to discuss, understand the benefits, and also the limits, or even to compare them with RRI. This will be discussed in the last part of Chapter 2. As a reminder, the EC’s problem is that, basically, it does not have the competence to rule on ethical issues [SUT 13]. In effect, there are sometimes ethical disagreements not only within countries, but also between the different countries of the European Union. However, if it is one of the largest projects funders, it must ensure that these are carried out under good conditions, in particular good ethical conditions. We shall immediately see that the 10 issues⁷ – that is the themes or topics selected by the EC – do not directly fall under the two ethical areas mentioned above, namely scientific integrity or controversies in broader terms under scientific policy, or simply politics. First, EC-funded projects do not question priority research areas but are instead supposed to contribute. Second, if some projects do help to shed light on scientific or ethical controversies, then the 10 types of issues identified in ethical reviews are of a different order. These ethical issues are however often found in international lists governing research practices⁸.

Even if the ERQ talks of 10 issues, it should be noted that there are only 9. In effect, the 10th theme, entitled “other ethical issues”, opens the door to all ethical issues that applicants or evaluators could detect or consider. This 10th theme therefore marks the non-closure of the list.

In practice, few applicants or evaluators use them. However, this could be the basis of development of the questionnaire. In effect, this list of 10 types of issues that we shall discuss in detail has undergone changes over the course of various Research Funding Framework Programs. We are in the eighth framework program, called Horizon 2020 that shall be abbreviated H2020 as is often the case in European research world.

The list is marked by the domination of bioethics, both in the statement of issues as well as requirements associated with them. Yet, in recent years, themes such as data protection, particularly in the development of projects based on computer information technology, have overshadowed bioethics, without however changing the approach to issues.

We may say to be as brief as possible that these 10 issues could be discussed in line with the following questions: on what or with whom – or what, in the case of human cells, animals or sensitive data – do researchers want to work? Where – and with which States – will the work take place? What is the potential misuse and dual use of research (for example, terrorism) and military use? A last type of concern is that of environmental protection. What matters are people and the countries involved, as well as the environment.

This list of ethical issues comes up very early in the development of a research project. According to the EC, these concerns have to be integrated from the design of the research protocol⁹.

As a reminder, here are the stages from the submission of a project to its accomplishment: (1) submission, including ethical self-assessment; (2) assessment to determine the scientific value of the project and establish a ranking; (3) ER; (4) preparation for allocation; (5) project implementation.

In a research project cycle¹⁰, control of the consideration of ethical issues therefore comes up the first time during submission, with a self-assessment of applicants. For all projects, it must appear in at least two digitized documents, namely Part A, a document of about 50 pages which has four parts, including one part on ethics (Section 4) and technical annexes, a larger document that comprises an item entitled “Ethics and Security”, ethics being Section 5.1. The new development for H2020 lies in the fact that there is a small section in Part A devoted to ethics which is more summarized and essential as it is the one first read. A short comment is expected, if the project does not require consideration of potential ethical issues in the list, or longer if otherwise, in order to support measures taken to address them and provide documents requested. In medical research, for example, these documents must be completed and validated by an appropriate authority of the institution or national authority. In this case, researchers are not the only ones to assess these aspects of the proposed work.

It sometimes happens, but rarely, that applicants provide a lengthy development of guarantees they intend taking to respond as fully as possible to the ethics questionnaire requirements. The document entitled Part A, contains the 10 issues with sub-issues. You have to answer by “yes” or “no” in the boxes provided for this purpose while indicating where appropriate the pages of the relevant project. A box is also provided in order to ensure that applicants have taken the ethical issues of the ERQ into account, if some of them pose problems, and that they sent the appropriate documents requested.

In another area, the ethical self-assessment, responses are recorded in the form of a questionnaire on a Web page¹¹ of the EC self-identification service¹². It is this questionnaire, which goes a step further through its sub-questions than Part A that shall serve as our basis for discussion.

When the files have been validated as complete and eligible, they are assessed for their scientific merit. However, the EC documents add that at this stage their “ethical and social impact¹³” should also be assessed. During the individual, remote then collective (remote or real presence) scientific assessment¹⁴, evaluators, peer reviewers, strive to reach a consensus. However, in this phase, security issues can already be discussed alongside ethical issues. The EC documents talk of pre-screening and screening. Hearings are sometimes required for certain types of projects, for example, Starting Grants projects, managed by the European Research Council. It should be noted that the ERC is responsible for its ethical reviews separately from the rest of the other departments that handle all other research and innovation projects¹⁵.

Similarly, we shall see that the last question in the questionnaire based on the indispensable use of human embryonic stem cells to achieve research objectives is already directed to evaluators who judge the scientific quality of the project and thus the ethical review in the previous stage strictly speaking. This question, which depends on the first question human embryo/fetus, is not numbered. It is for this reason that we did not count 11 themes.

1.3.2. The work of evaluators in ethics

After the scientific ranking of projects is completed (Phase 2), applicants are informed if they have been selected or not and they receive the results of their assessments. It is then that the external ethical review (EER)¹⁶ actually starts. This applies to all projects. It is equally carried out in several stages. It also seems quite complex since a slide sent to external evaluators is entitled “Ethics appraisal simplified”. This document extends beyond the external ethical review.

Up to three phases are identified in the document. The first phase entitled “Ethics screening”, identifies based on the WEQ proposals requiring ethical approval at national level and needing a full ethical review because of the complexity or nature of the ethical issues involved. In the first case, the following are cited as examples: data protection, conduct of clinical trials and animal welfare; and for the second: serious interventions on humans, the use of “non-human primates” in research, research on “human embryos” and “human embryonic cells”. Other requirements (documents) may be demanded such as research protocols, certificates of competence or ethics reviewers’ approval.

The second phase “Full Ethics Review Assessment” can be established on the EC’s decision for the above-mentioned cases. This “mandatory” ethical review is performed by experts, who first work individually and remotely, before coming together to discuss projects in terms of ethics and then produce a report. In the third stage “Follow-up and audit”, these experts or the EC services identify projects that require control and follow-up. The aim is to make applicants comply with the conditions, verify whether they have been taken into account and, if necessary, “take preventive and/or coercive measures”.

All projects are assessed (external evaluation) by at least two experts based on the WEQ in case problems emerge. Whereas ER is not as strict because, often, ethical issues that arise are less sensitive. The 10 questions of the WEQ are first answered by the applicants, and, if relevant, the question on the use of human embryonic stem cells is answered.

We are going to take a closer look at the breakdown of work expected from external ethical evaluators. The procedure is also divided into three phases, requiring different investments:

1. 1) a pre-screening without comment helps to detect and see if all potential ethical issues were identified and related pages noted;
2. 2) a comprehensive screening of the entire project allows an expert to comment on the project, guided by the questions and pre-filled answers. The expert may adapt them to the uniqueness of the project. There is also space available for the expert to enter comments as well as briefly and clearly explain related issues. If the expert makes comments, we will see that s/he has several possibilities to do so. The expert must conclude with a general comment for the EC services;
3. 3) the third stage is the one that will enable achievement of a consensus between experts working remotely. This effort to achieve consensus sometimes requires several days of work with direct presence of experts.

The external evaluation process is conducted in three phases by at least two experts. This is performed for many projects and most is done remotely. If experts easily reach a consensus and the file is complete, an ethical clearance is given. In case of difficulties or certain calls for research proposals, projects are discussed at sessions with the actual presence of experts with the EC in Brussels. The period destined for the establishment of consensus reports between two experts also stands as an opportunity for the EC officials who are responsible for the follow-up of selected projects to try to better understand what the experts want. In effect, they will be the ones to ensure afterwards that applicants understand what is expected and know what documents to provide. These officials are also there to make sure that experts understand the different assessment options available and their consequences, especially the forwarding of projects for in-depth ethical review when they are ethically very sensitive.

It should be noted that external experts sign a contract and are paid by the EC in the same way as the evaluators of the scientific part. This contract covers a limited period, commitments to meet certain standards, including independence (they assess on their own behalf, without representation of their country¹⁷ or employer)¹⁸, fairness (it applies to the processing of projects judged on their merits and not the origin of projects), objectivity (depending on what the proposal is and not what it could be), consistency (applying the same assessment standard for all proposals), privacy (with regard to applicants and in external terms; for documents that should be destroyed after evaluation) or commitment to provide full assessment within the required periods. As indicated earlier, conflicts of interest must be avoided with regard to each assessment. This question is asked before the assessment of each project. However, an expert may withdraw if he later detects a conflict while assessing the project.

It should be emphasized that experts only give their views. The last person to decide is the official in charge of the call for projects and follow-up of projects selected¹⁹. Sometimes telephone exchanges may take place for adjustments between evaluators and the EC administrators.

Very practically, evaluators are selected by the EC services. Often, researchers or post-doctoral candidates are those chosen by the latter through the portal H2020²⁰. This is documented by volunteer researchers on a series of plans: institutional affiliation, involvement in European projects, but mostly range of expertise based on training, language skills, specialties, work experience including background, previous work with the EC, main publications and achieved results.

This portal puts forward research ethics as a crosscutting theme. Consequently, it is often people conscious of the handling of ethical issues that are chosen, and they must not necessarily be moral philosophers²¹. It seems that the choices made by the EC try to balance age, gender, national allegiances and disciplines.

None may exercise their expertise beyond the number of days per Framework Program (120). Most often, the two experts work remotely and assess around 30 projects in approximately seven full days. Once the conflicts of interest have been eliminated²², for example when projects are from the same team or the same department²³ or if they could benefit the expert in one way or another, s/he accepts to assess them and consequently obtains access to the EC portal where s/he can download or consult Part A and the projects technical annexes.

The expert then fills in the WEQ following the three phases outlined above:

1. – screening to determine whether ethical issues arise or not (Ethics Screening);
2. – moving to Ethics Review;
3. – comparison with the assessment of the other expert and establishment of a Consensus Report.

Other steps follow: quality control carried out by another expert, mostly concerned with the consistency and clarity of the assessment, a possible shuttle in case of disagreement between this expert and the rapporteur of the consensus report, establishment of a summary report. The quality control and summary report are done by two different people. Thus, normally, each project is assessed by at least four different experts on their computer. A final review is conducted by the EC officials.

1.3.3. Research ethics in 10 issues

We shall now see in detail the various ethical issues considered and the sub-issues associated with them. It should be noted that if these issues are not relevant to the project under assessment, the sub-issues also do not apply. Answers are pre-completed, if positive, from the previous questions. Ethics experts can discuss or modify them or add their formulations.

Thus with regard to each issue it should be known whether the considered ethical issue applies to the project or not and indicate, where appropriate, the pages relating thereto in Part A and the Technical Annexes. For each issue, a box is reserved for comments. Answers to every ethical issue reported are followed by requirements. It is worth noting that the requirements are attached to short and pre-completed comments, which may also be accompanied by experts’ remarks.

1. 1) Human embryo/fetus: 1. this first entry seeks to know whether the project involves Human Embryonic Stem Cells. If so, the following questions are formulated: 1.1. Will they come directly from embryos within this project? 1.2. Are they previously established cell lines? 2. Does this research involve the use of human embryos? 3. Does this research involve the use of human fetal tissues/cells?

   The requirements are as follows. If the answers to the preceding questions are positive, the following must be provided: information on the origin and human stem cell lines, the authorization details and control measures exercised by competent authorities of the Member States involved, the necessary information on the origin of embryos including tissues and human cells and finally the details on (obtaining) informed consent procedures for the use of embryos/fetus, tissues and cells. A last box is reserved for “other”. This shall be found for each ethical issue.

2. 2) Humans: the issues are as follows: 1. Does this research involve human participants? 1.1. Are they volunteers for social or human sciences research? 1.2. Are they persons unable to give their informed consent? 1.3. Are they vulnerable individuals or groups? 1.4. Are they children/minors? 1.5. Are they patients? 1.6. Are they healthy volunteers for medical studies? 2. Does this research involve physical interventions on the study of participants? 2.1. Does it involve invasive techniques? 2.2. Does it involve collection of biological samples?

   As regards requirements, if the answer is positive we shall be obliged to: provide details of the procedures and criteria used to identify and recruit research participants, details on (obtaining) informed consent procedures that will be implemented; say whether vulnerable children and/or adults incapable of giving their informed consent will be involved and, if so, justify their involvement; give guarantees relating to obtaining consent/agreement where children and/or vulnerable adults would be involved, but will not be able to give their informed consent and, also in this case, specify the measures taken to avoid increasing the vulnerability/stigmatization of these individuals or groups; say whether invasive physical procedures will be used; give details of the policy to be pursued in the case of incidental findings. Just like in the first issue, there is a last section “Other” which ends the question.

3. 3) Human cells/tissues: the questions include: 1. Does this research involve human cells or tissues (Other than “Human Embryos/Fetuses”, as in the first question)? 1.1. Are they available commercially? 1.2. Are they obtained with this project? 1.3. Are they obtained from another project, laboratory or institution? 1.4. Are they obtained from a bio-bank? A last box is reserved for comments.

   The requirements are as follows. In the case of commercially available human cells/tissues, details about their type and how they were provided must be given. In the case where human cells/tissues are obtained through the project, details about the type of cells/tissues must be provided as well as an ethics approval. In the case where cells/tissues are obtained through another project, details about the type of cells/tissues must be given as well as an authorization from the owners of the data (including an ethics approval references). In the case where human cells/tissues kept in a bio-bank (are used), details about the type of cells/tissues must be provided, as well as details relating to the bio-bank and its access. The section “other” ends this list.

4. 4) Protection of personal data: 1. We ask whether the research involves the collection/processing of personal data. 1.1. Whether the research involves the collection/processing of sensitive personal data such as health, sexual lifestyle, ethnicity, political opinions, religious or philosophical convictions. 1.2. Whether the research involves the processing of genetic information 1.3. Whether it involves tracking or observation of participants? 1.4. Whether it involves further processing of previously collected personal data (secondary use)? A last box is reserved for “Other”.

   If the answers to any of the above questions are positive, the requirements are then to be complied with. Copies of ethics approval must be submitted for the collection of personal data by the person – or authority – responsible for data protection, for example for the university or recognized national authority. A justification must be provided in case of the collection and/or processing of sensitive personal data. Detailed information must be provided regarding the procedures that will be established for data collection, storage, protection, archiving and destruction, as well as confirmation that these processes comply with the national and the EU legislation. Detailed information must be given on consent procedures that will be established. Applicants must explicitly confirm that existing data are available for public use. Otherwise, the relevant authorizations must be provided. This point ends with a space provided for the section “Other”.

5. 5) Animals: the issues are as follows: 1. Does this research involve animals? What species? 1.1. Are they vertebrates? 1.2. Are they non-human primates (NHPs)? 1.3. Are they genetically modified? 1.4. Are they cloned farm animals? 1.5. Are they endangered animals? The last section is reserved for “comments”.

   The related requirements are as follows: copies of relevant authorizations must be submitted (for farmers, sub-contractors, users and equipment providers) concerning animal experiments. A copy of the project authorization (also covering, if necessary, work with genetically modified animals) and research protocols must be provided. In the case of undefined research protocols, the nature of experiments must be specified including procedures to ensure animal welfare, and how the three Rs²⁴ principle will be applied. Where appropriate, copies of training certificates/personal licenses of staff involved in animal experiments should be provided. Applicants must indicate whether non-human primates will be involved in research. In this case, a copy of their individual historical record must be provided. There is a last section entitled “Other”.

6. 6) Third countries: 1. In case non-EU countries are involved, do the research related activities undertaken in these countries raise potential ethics issues? 2. Is it planned to use local resources (e.g. animal and/or human tissue samples, genetic material, live animals, human remains, material of historical value, endangered fauna or flora samples, etc.)? 3. Is it planned to import any material – including personal data – from non-European countries into the EC? 3.1. If yes, specify the material and countries involved²⁵. 4. Is it planned to export any material – including personal data – from the EU to non-EU countries? 4.1. If yes, specify the material and countries involved²⁶. 5. Does this research involve low and/or medium resource countries, and in this case, is a benefit sharing action planned? 6. Could the situation in the country put the individuals taking part in the research at risk? A space is also reserved for “comments”.

   The requirements for this issue are as follows: applicants must confirm that ethical standards and H2020 recommendations shall be strictly applied, regardless of the country where the research is conducted. Detailed information must be provided confirming that equitable arrangements for profit sharing with International Cooperation Partnership Countries (ICPC) stakeholders²⁷ will be guaranteed during the project. Applicants must provide details about the material which will be imported/exported from and into the EU and give the appropriate authorizations. Detailed information must be provided regarding intended measures to reduce participants’ risks including that of staff involved in the project.

7. 7) Environmental protection and security: the issues are as follows: 1. Does this research involve the use of elements that could cause harm to the environment, to animals or plants? 2. Does this research deal with endangered fauna and/or flora protected areas? 3. Does this research involve the use of elements that may cause harm to humans, including research staff? A space is reserved for comments.

   The requirements are as follows: applicants must specify the type of damage that the research could cause on the environment and explain the measures that would be taken to reduce risks. If relevant, copies of the authorizations of the means used must be provided (for example, the classification of security level [to be taken] according to laboratory or the authorization to use genetically modified organisms). Applicants must ensure that appropriate procedures which are consistent with relevant local/national rules/legislations are observed by staff involved in the project. Details relating to endangered and/or protected species involved in the research must be given, and in this case, relevant authorizations must be forwarded. The section “other” ends this list.

8. 8) Dual use²⁸: 1. Does the research have the potential for military applications? A space is left after this question for comments.

   The requirements are as follows: specify the possible implications in case of dual use of the project and strategies to reduce risks; submit a copy of the ethical clearance, in relevant cases. Also specify the offensive/defensive nature of the research. The last section “Other” appears at the end of the list.

9. 9) Misuse, (misappropriation): 1. Does this research have the potential for malevolent/criminal/terrorist abuse? After this question, there is a space reserved for comments.

   The requirements are as follows: provide details of measures to safeguard the research results against misuse (misappropriation) for malicious, criminal or terrorist purposes. There is a second section entitled “Other”.

10. 10) Other ethical issues: as we noted above this section is special as it might take various dimensions: 1. Are there any other ethics issues that should be considered? Please specify²⁹. A space is reserved to answer the section “comments”.

For requirements, the questionnaire provides a space “Other”.

This is followed by a separate question, not numbered: Use of human embryonic stem cells. This section should be completed only in the case of a positive answer to Section 1. Human embryos/fetuses. It is formulated as follows:

Do scientific evaluators confirm that the use of human embryonic cells is necessary to achieve the scientific objectives of the proposal?

A space is reserved for comments.

The subsequent sections of the questionnaire are of a different order. They are intended only for evaluators. In effect they must give their “ethical opinion”. The “ethical” opinion can be expressed under four choices: (1) agreement “ethical clearance”, (2) conditional agreement, (3) request for additional documents, and (4) recommendation to go through ethics review. These possibilities can be accompanied by a request for audit. In the latter case, it must include an additional assessment. No comment is entered in phase 1. For steps 2 and 3, additional requirements are specifically requested. To achieve this, the EC staff proposed pre-completed comments³⁰, which could always be changed and may be supplemented by experts’ remarks. These comments seek to be at the same time harmonized, or at least compatible, with the legal texts available to help fill the EQ. Ethics experts can add comments. Step 4 requests justifications from experts. This assessment is entrusted to other experts present. The audit should also be justified and recorded in the project period. If the project requires an (added) ethical review, it is formulated as follows: would you recommend an ethical review for this project? If so, please provide a schedule for this ethical review.

It is worth noting that this ethical review can be carried out even two years after the project ends. A final box is reserved for comments.

Applicants could be called upon in the course of the project to make regular reports on ethics, appoint an ethics counselor in the project governance, as well as be subject to ethical reviews and audits. They may even be required to adapt their research methodology to comply with ethics.

The document sent to ethics experts also indicates a fifth option: the ethical non-acceptability of a project. It should however be noted that acute cases are rare, but that, on the EC decision, measures can be taken ranging from a reduction of grant to termination of agreement.

There is one box where it is asked whether the project is very sensitive or normal in terms of ethics.

A last major section is left for comments to be forwarded to the Commission services.

The steps therefore include a review of the research proposal by two experts with special attention paid to ethical issues covered by the EQ. Then they both have to reach a consensus. One of them, who is appointed, writes the report. It is in turn validated by the other. Quality control is carried out by a third expert and a fourth validates the latest version, which will be sent to the project initiators. All comments and requests have to be clear, be they intended for project members or the EC. At times the third and fourth experts do not revisit all the assessment but check the overall consistency and presentation.

Other experts may be engaged in case of difficulties or disagreements between experts or because an officer of the Commission considers that the assessment poses problems. The officers that we questioned concerning these issues told us that disagreements were not based on differences in opinion in specifically ethical terms. Discussions mostly center around estimation differences relating to the need or not to provide copies of texts in order to obtain informed consent or the appraisal of assessment of ethics risk taken by applicants. The differences in opinion sometimes depend on the initial training of experts. For example, lawyers may be very demanding regarding the availability or non-availability of documents requested. Officers insist that there should be real “added value” in terms of ethics if an additional ethical review is requested.

Generally, close attention is paid not only to indicating ethical issues that may have not been seen or insufficiently taken into account, but also to explain how to deal with them, while equally stating the period in the course of the project.

1.4.1. Inflation of background legal texts for ethical principles lists

If we have chosen to stay closer to the list of ethical issues raised and expected requirements to respond to them, it is because they are a compulsory passage point. Meanwhile, these issues have a background of legal texts, sometimes presented as ethical or based on ethical concepts. Researchers and evaluators can refer to these documents that help to address ER through references in the form of hyperlinks that provide access to these texts. For H2020 program, this is the case with, the Annotated Template of Financing Agreement in Article 34³², a 698-page text! Or The European Code of Conduct for Research Integrity, mentioned above. This one is shorter since it comprises 24 pages. The Template covers the entire project cycle from development to assessment and in all aspects.

The article based on ethics is important for the ERs. Though it may be very useful because it helps to fix things and forms the basis of the EQ, we however identified several problems after reading it. Our goal here is simply to indicate, through these limits, possible improvements or even decisions to take for programs follow up in such a way that research are scientifically fruitful while respecting certain ethical dimensions.

1. 1) The Template may help to understand the legal provisions on which the questionnaire could be based, yet the scope of the text, and especially the numerous references between Articles stand as the first challenge for project developers. The latter therefore keep to the questionnaire, usually for reasons of time. The questionnaire’s virtue can be recognized here. It functions as a translation aid or Template summary, proposed by the Commission³³.
2. 2) If the Article ethics in the Template is valuable for any project development, a single research team will have to go a lot further if it has to observe all that is required. In effect, the “international (…) ethical principles of the EU and national laws have to be complied with”. Of course, laws must be observed in research, but for research consortia the laws of countries involved and European laws must equally be complied with. We are therefore concerned with laws distributed at several levels. Certainly, one can think that these laws are often congruent, or at least convergent, but this is not always the case. Moreover, on the basis of the subsidiarity principle, the laws of these different levels should not be contradictory. To undertake research, at least one of the consortium institutions must be found in a State that allows the project to be carried out on its territory. It must therefore be checked whether this part of the project is effectively carried out there.
3. 3) This text may help experts who have to assess projects from an ethical perspective. Indeed, Article 34 of the Template includes lists of principles that could provide bases for interpretation.

   What then could be said regarding what is presented as ethical principles and their relationship with the legal texts to which the Template refers?

   There is no available space here to enable us accurately carry out a comparison between the specified laws and these principles. It is not certain that they are all incorporated and translated in the same way by the laws. Inversely, it might be possible for other principles to be derived from these laws.

4. 4) Another issue regarding ethical assessment is the scope to be considered. In effect, in the introduction of this chapter, we chose to consider the Code on research integrity as a guide that applies primarily to this practice for itself and not so much for the people and animals involved or damage to the environment. Whereas this code is found in the Template text. It requires the observance of the highest standards of research integrity³⁴. This last request of the Template explicitly refers to the Code of Conduct for research integrity. Hence there are several possible interpretations: either research integrity specific to research itself is part of the ethics review and should be assessed, or the Code on research integrity has the same principles as the ER. The answer is straddling between the two. On the one hand, the ER, as evidenced by the questionnaire, does not address the issue of research integrity³⁵. It is assumed and expected. On the other hand, the lists of principles of Article 34 and the Code are not congruent. Even if the Code denies having over expanded its scope, distinguishing what it calls the “ethical context of science” from “responsible conduct³⁶” of science, it however goes beyond research ethics strictly speaking, by opening its principles to individuals, humans or animals, involved in it.

   Let us take a closer look at the Code’s list of principles: honesty in communication, seriousness, liability in carrying out research, objectivity, impartiality and independence, openness and accessibility, duty of care, fairness in quoting other researchers, scientists and researchers responsibility for the future.

   Several principles are not assessed in the ER questionnaire. It would even be an affront to applicants asking them whether and how they intend to honestly communicate their results. Part of this list is therefore unnecessary for the ER.

   Conversely, the Code’s principles only indicate that for some expectations go well beyond those contained in the list of the 10 ethics investigation issues. This is however surprising and paradoxical. In effect, if the research sphere in itself is more restricted than that of ER, why then have principles like the latter, “responsibility for the future”? Certainly, in explaining this principle, the authors of the Code have in mind the “supervision of young scientists and students”. But this interpretation is very specific.

   The Template would avert uncertainties resulting from a combination of different texts by retaining from the Code only principles that relate to the involvement of individuals, humans or animals, the environment, partners and research uses. This, assuming that researchers are supposed to comply with codes of conduct expected from good research practice, or if this was not the case, by providing themselves with resources to assess it, upstream and throughout the projects. However, this second concern could well be taken over by other bodies, academies, universities or administrative bodies in case of abuses³⁷.

5. 5) The Template includes many other principles in addition to those of the Code: respect for human dignity and integrity; assurance of honesty toward research subjects (people involved) by particularly seeking to obtain free and informed consent and even assent where relevant; the protection of vulnerable people; the promotion of justice and inclusion. It also calls on the need to: minimize damage and maximize profits, share profits with underprivileged populations (especially if the research was carried out in developing countries), maximize animal welfare (especially by reducing the use of animals in research), respect and protect the environment and future generations.

The principles written in italic go beyond what is presented and assessed in Ethics Investigation. This is the case with the promotion of justice and inclusion.

This list covers some principles of the Code, but the latter goes further. The meaning of certain principles change. For example, honesty applies here to people involved in research and not the relations within research communities as well as scientific interpretations.

We believe the scopes or simply the considered contexts are different if they are more or less expanded and can be integral. Even when ethical principles are common and relevant, or when they are common, they differ in their interpretation with regard to honesty.

Finally, one may say the lists of ethical principles, two³⁸ of which have been discussed, can be nested like Russian dolls, though they more often create tension, have various scopes and engage in very different directions. It would be better instead, strictly speaking, to preferably reduce the lists intended to be merged than accumulate without careful study, collections of texts with the norms they incorporate which may very well be longer and tedious. It is better to agree on a few principles and provide resources to observe them.

1.4.2. Closer to law than ethics

The document which serves as the basis for some calls for H2020, which varies little according to calls, summarizes the legal anchoring of ER:

“all proposals must describe ethical problems that arise and how they will be handled in order to comply with national, European and international regulations”.

We interviewed people who know about this subject at the Commission and they acknowledged that the terms ethics compliance, or even ethics appraisal, fall far short of what ethics is. Some would be willing to requalify this process under the reference “Human Protection Committee” and “Animal Protection Committee” for example. The idea is to indicate that we are very close to law and that funded researchers cannot escape compliance with certain legal standards. This also constitutes the strength of ethical reviews, which can be based on legal texts to be observed, as well as their limits in terms of ethics in its moral theories diversity that will be discussed later in this chapter. The same applies to the importance of freedom as an ethics condition³⁹. In effect, law sanctions according to the misconduct or wrong committed, whether freedom intervenes or not. Certainly, the law may consider the place of freedom, which, if limited, could be involved in the assessment of a misconduct committed. In ethics, sanction is not the same. It may take the path of blameworthiness for example or in a positive manner of praiseworthiness, which will be discussed in Chapters 3 and 4.

This issue of law dominating ethics is also found in bioethics. Certainly, the latter does not emanate from law strictly speaking. For example, Sophie Monnier, Associate Professor in law, argues that ethics committees produce a normative system that is detached from morals and offer an alternative to the legal and ethical model [MON 05]. She talks of paralegal regulation. This is understandable. If the law in all its positivity was established to handle new issues that technological innovations address, these discussions raised by the unknown or new developments, mostly technological, would not be required. The ethical issues raised by these new opportunities are questioned, including the various justifications, to mobilize or create, in order to arrive at possible ethical choices, which later lead to legal options.

Such complementarity, confirmed for example by an expert lawyer for the Commission’s⁴⁰ ethical assessments, might even forge an agreement between positivist law theorists, on the one hand, on whose behalf the law is established by legal entities, parliaments for example, somehow “impervious” to ethics, and legal theorists, on the other, who on the contrary think of an interrelationship and solidarity between ethics and law⁴¹. In these bioethical debates, or more broadly ethics of emerging technologies, the discussion is not so much to know what national or European legislations propound, but rather the direction in which the law should evolve. A sort of continuum can be seen moving from ethical discussion, to the forefront of development and the use of new technologies and preparing the ground for a future legal formulation.

For example, during bioethics conventions Estates General or States-General – a French experiment to which we shall return [REB 10a, REB 10b] in the general conclusion of the book – much of the debate focused around the discussion based on the desired evolution of bioethics laws. The section reserved on the state of the law on each question asked was the same level as that of the state of technology.

It is true that bioethics has often been built on principles. In this sense, it is close to the law. Works have even sought to establish the convergence of bioethics principles in the European context [KEM 00, REN 00].

It should be noted that the texts to which researchers and evaluators can refer for ER are of a varying nature and legal force. Staying only within the legal framework, we could examine their value and carry out a prioritization work.

It should be recalled that ethics committees are interdisciplinary in their composition. As a result of the interdisciplinarity of composition, work is done in various ways when files are being discussed. This will be seen in Chapter 5 which is devoted to collective assessment processes.

The backing from legal texts also helps to prevent problems with regard to projects that would have been selected for their “technical” part, this is the term used though it covers the scientific aspect of the project, but had been rejected during the ethical review. Evaluators may proceed in different ways, in case of reticence for a project that did not deserve to be funded because it would pose ER problems. Most often, they only have to remember that significant ethical issues exist with respect to the nine themes of the questionnaire. They may also request that very high or several guarantees are put in place, making projects impossible or requiring their reconstruction, and thus a second assessment. The second refusal strategy would also have implications on the division of funding between researchers, as well as the content of Work Packages.

1.4.3. Fictitious separation between “technical” and ethical assessment

The assessment of a project is often divided into two parts: a “technical” and an ethical part. European officers and some evaluators often observe and seem to endorse this separation. However, other experts do not share this vision as they believe that the two cannot be separated. The argument they put forward for example is that technology is never neutral or that values are embedded in technology design. Works on value sensitive design that will be discussed in Chapters 3 and 4, go in that direction, including those of a certain sociology of science. Without going too far and claiming that techniques have a moral – that would be exposing oneself to a problem of ethics without freedom, and the question of knowing which ethics and from what do technical objects “have a moral” – we prefer to talk of codependency in the assessment between “what is” and “what ought to be”. We do not commit the naturalistic fallacy of the deduction of the “ought to be” of what “is”, yet we do not see how a problem or project could be assessed, without taking into account what it is, to decide on what it ought to be in normative terms⁴². We shall talk of the “technical” part which is distinguished by some evaluators from the ethical part. However, the distinction will not be worth dichotomy. Indeed, some evaluators believe that these two research project dimensions cannot be separated.

Beyond a comfortable distinction between the “technical” and the ethical part, European officers are faced in their practice with the issue regarding the accompaniment of the scientific assessment of projects that are sometimes out of their training field, and especially in moving from the technical part to the ethical part of the project. Certainly, they entrust the scientific and ethical review to experts, expected⁴³ to be proficient for either the scientific part or the ethical part. Yet in practice, officers and ethics experts in their ethical review do not consider the questionnaire, platform or the relevant pages. In effect, one must rely on the presentation of the entire project to address the issues it raises and report other ethical issues if necessary. We should even go further and see whether the responses implemented by applicants to address the ethical issues are appropriate, taking into account their conduct throughout the project. We will return to this issue of appropriate governance methods to adequately address ethical issues if they arise.

Some research areas face tensions between scientific objectives and certain ethical requirements. Though famous anthropologists may have never actually cared to obtain the informed consent of the tribes they studied, like for example Claude Lévi-Strauss, this point is however found in the Ethics Questionnaire of projects funded by the EC and exists in various forms for national funding. However, if we often think of more invasive, medical or biological sciences, to talk about research ethics, human and social sciences (HSS) then have many responsibilities to handle. Let us take for example vulnerable groups or stigma issues that may arise when some particular results are produced. The issues of the Ethics Questionnaire list are not so easy to manage in HSS. Let us take the case of researchers interested in social sciences, jihadists courses or athletes who dope. To what extent is it possible to obtain their informed consent? Will obtaining the informed consent not prevent research from continuing if the “subjects” refuse to comply? Obtaining the informed consent will at least have effect on research and constitute a bias. In effect, the significance of this commitment will depend on how studied people shall respond.

More generally, all methods of observation of situations that involve many groups pose problems of informed consent; especially, if it concerns situations that are not experiments prepared by researchers, but might be “in real life”. Let us imagine that researchers want to study a meeting of World Youth Days. It seems difficult to ask thousands of people to say whether they agree that research be done on such a gathering.

Some blockages can be very difficult to remove in the case of research on ancestral remains (or supposed ancestors) that some tribes would not want anthropologists to study. The famous dispute over the Man of Kennewick⁴⁴ went right to the US courts. After several appeal trials, the skeleton was handed back to scientists.

A guide has however been made available to HSS researchers taking into account their specificities⁴⁵, without any solution actually found for all these problems.

Tensions between research requirements and ethical issues found in the Questionnaire exist for other disciplines. For example, a biologist who is a specialist in biodiversity and wants to collect live samples from a river to study their resilience capacity may not know in advance the number of species that would be found. From this perspective, the Questionnaire appears to originate from, or at least be designed for, laboratory research.

1.5.1. Morals and ethics, an issue of level of analysis

To locate the different levels that would allow us to venture beyond the detection of issues, and maybe suggest answers, we are going to discuss an issue which has become the pons asinorum of ethics: the difference between morals and ethics. The terms “morals” and “ethics” are often used differently by different specialists, who may even reverse each term. The terms “ethics” and “morals” are often interchangeable and their etymologies, Greek or Latin, are of little help. Beyond French trends which tend to use the term ethics to distance themselves from moralism, it should be recognized that the two terms can indicate an object or area of concern which relates to the various forms of bad, good and just or other normative concepts, or problems such as the difficulty of choice, meaning of life, development of justification rules, definition of principles and even the definition of moral sentiments. It may sometimes be easy to know what these issues are, yet they are often the subject of controversy, with regard to knowing what ought to be done and how to justify it. So, we often deal with gray rather than black or white areas, or the immensity of good and bad. Even the prohibition of murder may in some cases be justified, for example with tyrannicide. Due to their uncertainties, problems specific to new technologies instead fall within these gray areas. They are bearers of hope or damage, or they hide in their hopes, like Janus with his two faces, deleterious adverse effects.

However, when we use the terms “ethics” or “morals” different levels must be distinguished, including:

1. 1) areas of application, mores that seem self-evident,
2. 2) moral theories, and
3. 3) more reflexive meta-ethics.

We therefore distinguish applied ethics from normative ethics (with moral theories), and meta-ethics, even if they are permeable. For example, based on these three levels, to hear a matter relating to the ethical legitimacy of a certain type of GMO maize (applied ethics), one should consider several ways to justify its position (according to various normative theories) by asking what are the requirements of a justification (meta-ethics).

Contrary to some authors like John Rawls who includes in what he calls the comprehensive doctrines, shared references, such as religious references, as other moral theories, we give the latter greater abstraction and universality. Even religions in their assessments of a particular problem according to their own logic cannot do without the explicit and implicit support of these theories.

1.5.2. Pluralism of ethical theories

Broadly speaking, these theories are mainly deontologism (rights-based ethics, based on duties); consequentialism (including one particular form, utilitarianism); contractualism; virtue ethics; moral egoism; teleologism and intuitionism⁴⁶. Often some moral and political philosophers refer to three major ethical theories: consequentialism (and its sub-part, utilitarianism), deontologism and virtue ethics.

If the Ethical Questionnaire was to be pulled on the side of ethics, with its almost exclusive resort to principles, it would be broadly deontological from the perspective of moral theories that it mobilizes. We might very well want to test other theories in order to assess scientific projects. In effect, moral theories are pluralistic with regard to the mere existence of these robust and tried and tested forms of justification. As opposed to relativists they enable the assessment of a problem in ethical terms and as opposed to monists, they think more rational paths can be followed.

Here is therefore how the ethical pluralism of multilevel theories could be summarized in the form of a table, by aiming as exhaustively as possible at means of ethics assessment in justification context⁴⁷.

1. 1) Types of entities assessed from a normative ethics perspective:

   These are the type of entities or objects (often abstract) that draw attention, that is, they are targeted and assessed: such as the states of affairs, actions, character traits, feelings, institutions, norms of behavior (individual or collective) and foundational rules and theories.

2. 2) Normative factors:

   These support and form part of an ethical review on the basis of the following elements: a perspective oriented toward good, just, equality, equity (to be promoted) or bad (to be avoided); optimism or pessimism in assessment or forms of commitments to the future; consequences and results; restrictions on what is allowed and forbidden to do (rights of convergence with ethics); general obligations and contracts (in respect of all or individuals); promises; principles; norms; values; virtues⁴⁸.

3. 3) Foundations in foundational normative theories:

   These allow the justification of factors as well as their generalization and management in case of conflict.

Theories could be monistic strong, defending one factor and one type of assessed entity; monistic weak, defending one factor and several types of assessed entities; pluralistic weak, defending several factors and one type of assessed entities; pluralistic strong, defending several factors and several types of assessed entities.

In the case of monism, we have to explain the rule that always allows the selection of only one entity to be assessed and one factor (simple monism) or their ranking before others (complex monism).

For pluralism, we have to explain why selection or rankings are arbitrary or could be different (thus make a counter-proposal).

The management of factors’ conflicts could be done from a personal, impersonal or collective perspective. The theory could target promotion or maximization (or even reach a point of excellence) of the factor (or factors) selected.

It may include optional dimensions or conversely what goes beyond duty or obligation (supererogatory).

With these distinctions between the three ethical levels and pluralism of moral theories, we note that the Researchers Integrity Code poses problems of consistency as it puts together care which falls within virtue ethics with duty, which is attached to deontological ethics. In effect, it talks about the “duty of care⁴⁹”.

Certainly, these distinctions are not impervious boxes. In the reality of assessments we may sometimes get to hybrid forms of reasoning. But we must be take care. In this direction, a first step for ERs toward ethical pluralism, which is recognized in moral philosophy, by the mere existence of normative ethical theories, would be to try to interpret the principles in many ways, and not just in a deontologist manner.

We saw in this chapter that responsibility and research ethics are present at different levels in the practice of research. Although a formal European ethics is yet to be clarified and validated, the EC has adopted forms of accountability systems of research practices in terms of ethics. The forms of this accountability have evolved with different framework programs. Currently, they especially ensure the observance of regulations and/or national or international laws, established to protect humans, animals and the environment, and finally to avoid misappropriation of research for military or malicious purposes. Among the main mechanisms used which were borrowed from bioethics we obtained informed consent or profit sharing. More recently, sensitive data protection issues have taken center stage. Yet, while high guarantees are expected from researchers, States are at the same time adopting security or intelligence laws which tend to be partially in the opposite direction.

We have finally showed that what is called ethics review or assessment, is simply still respect of the law. Broadly speaking, we could recognize that it is only deontologist ethics from a moral theory perspective. Meanwhile, ethics is broader and pluralistic. It requires more in terms of reflexivity and responsibility. Yet, as shall be seen, responsibility is not only to be understood as a liability, a blend of duty to respond and pay in case of damage and reliability.