Ethical review process

Ethical review is about helping you as a researcher to think through the ethical issues surrounding your research. The principles of good research practice encourage you to consider the wider consequences of your research and engage with the interests of your participants.

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Ethics review by a Research Ethics Committee (REC) is typically required when (sensitive) personal data are being collected. The role of a REC is to protect the safety, rights, and well-being of research participants and to promote ethically sound research. Among other duties, this involves ensuring that research complies with national and international data protection laws regarding the use of personal information collected in research.

Ethical self-assessment

Regardless whether there is a formal requirement, we recommend you to perform an ethical self-assessment. The type of questions which are generally to be answered in an ethical review is shown in the illustration below. These questions are derived from the Ethical guidelines for research by the Norwegian National Research Ethics Committees (n.d.)

Since FP7 (the European Union's Research and Innovation funding programme for 2007-2013; European Commission, 2013) ) and its successor Horizon 2020 (running from 2014-2020; European Commission, n.d.) the EU has started to require ethical review. We have used the H2020 ethical guidelines (European Commission, n.d.) to get you acquainted with the steps which may be taken in an H2020 ethical review process. Do note that step four will be very rare.

  1. Ethical self-assessment
    The first step when applying for funding under the H2020 scheme is for the applicants to perform an ethics self-assessment (European Commission (2016), pages 16 and 17) to submit with their research proposal. This entails completing an ethical checklist about how you will protect your participant’s personal data and involves considering questions around how the data will be collected and stored securely and safely, how the data will be retained, and whether any of the data will be transferred to any non-EU countries.
  2. Ethical screening
    The ethical screening process takes place during the scientific evaluation of the proposal or soon after it is considered for funding. It takes into account the ethical self-assessment conducted by the researcher. If an ethical issue is identified the ethical aspects of the proposals objectives, methodology, and potential impact will be considered by ethical experts.
  3. Ethical assessment
    In limited cases, an ethical assessment may need to be undertaken, which involves an in-depth analysis of the ethical issues of the proposal. The conclusions of the ethical screening are also taken into account. This typically happens in cases where there will be severe intervention on humans.
  4. Ethics check
    During the ethical screening or ethical assessment, the experts identify the projects that need an Ethics Check to be executed during the course of the research project. In case of substantial breach of ethical principles, research integrity or relevant legislation, the Commission can afterwards carry out an Ethics Audit. The checks and audits can result in an amendment of the grant agreement.

European diversity in ethical review

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Ethical guidelines for research involving people are often issued by professional bodies, host institutions, and funding organisations. Therefore, these rules and guidelines will differ from country-to-country as well as from research funder to research funder. This wide variation in requirements for ethical review across countries is challenging, especially for multi-national research projects. Usually, when working in more than one country, the strictest regulations typically apply. It is also good practice to engage with any local regimes, where possible.

For examples of local diversity in ethical review, you can click the accordion.

According to the Act on Scientific Activity and Higher Education, the Croatian Parliament appoints the Committee for Ethics in Science and Higher Education which shall promote ethical principles and values in science and higher education, business and public relations, and in the application of advanced technologies and environmental protection. The Committee adopted the Code of Ethics determining principles of ethics in higher education, the publication of results, relations among scientists, teachers and other participants in the process of science and teaching, procedures and activities related to market competition, as well as relations to the public and the media.

By the same law, higher education institutions, scientific research institutes and other scientific research organisations may, in accordance with the statute, establish their own ethics committees and adopt their own codes of ethics, which must comply with the Code of Ethics of the Committee for Ethics. For example, Faculty of Humanities and Social Sciences Department of Sociology and Department of Psychology have formed their own committees and published guidelines and procedures on how and why researchers and students should submit their research proposal for ethical review. In their work, they follow national and international professional codes of ethics in addition to general ethical principles. In the case of research on children, applicants are advised to familiarize themselves with the Code of Ethics for Research on Children (the new version is soon to be published).

The Croatian Science Foundation, the major funder of basic, applied and developmental research adopted the Code of Ethics of the Croatian Science Foundation. This Code of Ethics contains a set of principles in the area of scientific integrity and scientific ethics that serve as guidelines for professional activities and public actions of all Foundation’s employees, members of the Foundation’s bodies and boards, evaluators and beneficiaries of the Foundation’s funds, as well as other researchers whose work is connected with the Foundation’s activities. The Code is based on the European Code of Conduct for Research Integrity, which establishes best scientific practice on the principles of scientific integrity, guiding the researchers in their encounters with practical, ethical and intellectual challenges, including reliability, honesty, respect and accountability.

There exist several ethical codes and standards that apply to empirical social research in the Czech Republic. The general ethical principles for research are introduced in the Ethical Framework for Research, the set of recommendations (not obligations) approved by the Czech government.

Large research organizations in the Czech Republic have their own ethical codes and committees, for example Charles University´s Code of Ethics or Code of Ethics for Researchers of the Czech Academy of Sciences.

There are professional associations in different fields of social science research and humanities, e.g. Czech Sociological Association or Czech-Moravian Psychological Society. While the psychological society has defined field-specific ethical rules and maintains ethical committee, the Czech Sociological Association is lacking both specific ethical rules and ethical committee and it is often a problem to get any official expert opinion on ethical issues from this organization.

Data collection for research purposes, even the academic ones, is usually conducted by credible commercial research agencies. Such agencies are members of international and national professional organizations (SIMAR, resp. ESOMAR) and adhere to recognized standards, codes of ethics and other rules (ISO 20252 etc.). Individual researchers are often members of professional organizations (EFAMRO, WAPOR)

Ethical review of Social Science research

Research ethics has received increased attention over the past years. Besides regulations like Federal and State Data Protection Laws (Datenschutzgesetze, see the website of the Federal Commissioner for Data Protection and Freedom of Information for an overview), there are voluntary ethical statutes of organizations like the German Association of Sociology (DGS, German only), the German Association for Political Science (DVPW, German only), or the German Association for Psychology (DGP, German only).

The German Ethics Council (Deutscher Ethikrat) publishes policy-relevant guidance on all areas of research ethics (mostly German, English Abstracts available). The German Data Forum (RatSWD) has published recommendations and teaching material on research ethics (German only). It also hosts a(n) (incomplete) list of local ethics commissions. The incompleteness (as of December 2019) is due to the fact that many individual universities are just now beginning to set up general Ethical Review Boards that handle all types of human subjects research. Finally, the Data Ethics Committee has also published a broad expertise for ethical conduct concerning the handling of research data in general under the auspices of the Federal Data Protection Commissioner (German only).

 

Intellectual Property Rights and data

Concerning data archiving, creators of data and documentation are treated as owning the Intellectual Property Rights of the research data. When archiving, they transfer the non-exclusive rights of use and rights of reproduction to the archive on the basis of an archive agreement. The non-exclusive rights of use comprise the right to pass data and documentation to a third-party and the right to change the format of digital objects (data files, tables, etc.) for the purpose of long-term preservation (e.g. migrating files to the latest formats). All incoming datasets are checked for possible ethical and data protection issues (voluntary consent, direct personal references, etc.).

The agency Euraxess offers an overview of German intellectual property rights.

Article 14 of the Law on scientific and research work (2008) establishes a national level Ethics’ board, 9 member body, 6 of which are proposed/appointed by the Intra-university conference and 3 by the Macedonian academy of sciences and arts. The main function of the board is “monitoring and evaluation of ethical principles and values in scientific work, protection of human integrity in scientific research, and ethics in professional relations among those performing scientific research”.

The Board adopted an Ethical code that addresses ethical principles in: scientific work, in the publication of the results of scientific work, in the relations among researchers, in the procedures and activities related to competition, and in the relations with the public and public media.

Universities are not obliged, but they can adopt their own Ethical codes. Biggest universities have done this.

Research disciplines in which ethical behavior is of utmost importance (medicine, psychology etc.) have adopted their own Ethics codes.

The Law on personal data protection (2005) also addresses important issues that, although not explicitly, apply to ethics in scientific research.

The Norwegian National Research Ethics Committees (n.d.) are independent agencies for questions regarding research ethics and investigation of misconduct, within all subject areas. All the committees provide ethical guidelines on research ethics within the different subject areas.

The Regional Committees for Medical and Health Research Ethics (REK) must give prior approval for medical and health research projects and general research biobanks. REK may also grant exemption from the duty of confidentiality for health information used for non-medical research.

For other subjects (science, technology, social sciences, law, humanities and research on human remains) there are advisory bodies (NENT, NESH and The National Committee for Research Ethics on Human Remains) for research ethics in its subject areas which provide advice and recommendations for specific projects submitted to the committees. Obtaining advice prior to a research project is not mandatory, but researchers are encouraged to contact the committee if the project is considered to present challenges in terms of research ethics.

NSD – The Norwegian Centre for Research Data AS, as a Data Protection Service, offers research institutions an agreement to assess the processing of personal data in research projects in accordance with data protection legislation.

Within the Ministry of Education, Science and Technological Development of the Republic of Serbia, the National Council for Scientific and Technological Development functions as the highest decision-making body. On February 21, 2018, the Council adopted a Code of Conduct for Scientific Work, which the Ethics Committee for Science takes care of. Apart from this central body, each accredited university, faculty, and institutes have an obligation to produce its own document that will regulate ethics in the scientific research of a particular institution.

The three main Universities in Slovenia adopted their Codes of Ethics: University of Ljubljana, University of Maribor and University of Primorska (only in Slovenian language). Committees for Ethics in Research are established on the level of faculties. For instance, Committee for Ethics in Research at the Faculty of Social Sciences (CER FSS) examines the applications for ethical assessment of research tasks and projects undertaken at the Faculty of Social Sciences involving research work that interferes with the privacy of people or engages in research involving people. The Committee discusses the applications of teachers, researchers and research associates employed at FSS, and students upon the proposal of a mentor. The Committee gives opinion on proposals of research projects that involve research work with people, using methods of humanities and social sciences.

On the national level there are National Medical Ethics Committee, Administration for Food Safety, Veterinary Sector and Plant Protection, which discuss the ethical issues of the relevant field of research, and if needed the researcher shall obtain the opinion from the relevant body or organization.

The Act concerning the Ethical Review of Research Involving Humans (2006:460) was implemented with the purpose to protect the individual person and ensure respect for human dignity in research. It includes provisions with a requirement for ethical review of research involving living and deceased persons or biological material from humans.

In Sweden, if you are going to process personal data, and you work with research at a Swedish university or authority, you need a Data Protection Official for Research to help you ascertain that you follow the GDPR and Swedish legislation.

Research may only be approved if the risks it may entail to study participants in regard to health, safety, and personal integrity are outweighed by the scientific value. Research cannot be approved if the expected results can be reached in a way that presents fewer risks to study participants. Research may only be approved if is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence.

The Act includes provisions on information to study participants. Researchers are required to inform study participants of the overall plan for the research, the purpose of the research, the methods that will be used, the consequences and risks that the research may entail, the identity of the research principal, and the facts that participation is voluntary and that participants can withdraw their participation at any time. An ethical review is always required, even if study participants have given their expressed consent to the use and handling of their data.

In Switzerland, the legislation makes it mandatory for a research project to be evaluated by a cantonal commission when it falls within the scope of the Swiss Federal Act on Research on Human Beings (Human Research Act, HRA). The HRA’s scope of application is “any project for which biological material is collected from a person or personal data related to his or her health are collected in order to respond to a scientific problem or to reuse biological material or health-related data for research purposes” (Art. 6). All researchers working on subjects related to the diseases, structure and functioning of the human body, or at least those working with personal data related to these subjects should, therefore, consult their cantonal commission to determine whether or not they are subject to the HRA. If so, they must submit their project for evaluation before any data is collected.

 

For research projects that do not fall within the scope of the HRA, there is no legal obligation to be evaluated by an ethics committee. However, in some universities there are committees through which it may be mandatory to go through, depending on the type of subject being studied. Other universities offer such commissions as a service for research that requires ethics validation in order to meet the increasing demands of funders, publishers, fields, disciplines, etc.

In the UK, some form of ethical review is required for most research involving human participants, personal (sensitive) data or controversial methodologies (e.g., covert research). Funders, universities, journals, or other bodies may make these requirements. The major funder of social research in the UK, the ESRC, requires reviews to be completed prior to the start of research (but not when submitting a proposal) (ESRC, 2017a). On their website guidance is offered (ESRC, 2017a).

Most institutions offer a graduated review system of review, ranging from a self-assessment checklist to a light-touch review for most student and low-risk projects, to comprehensive review at the institutional level. This flowchart (Economic and Social Research Council, n.d.) helps in deciding what type of ethical review your project needs. Furthermore, the case studies (ESRC, 2017b) may help you in gaining a picture of the ethical dilemma's which may arise during your own research project.

Expert tips

TIP 1. Educate your REC

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RECs may be informed and supportive of efforts to share data. However, there is great variation, and some oppose data sharing, fearing (mistakenly) that sharing data violates participants’ confidentiality. As a researcher, you may need to ensure that your REC is fully informed on these subjects. At a minimum, REC members should know that:

  • Many research funders and journals expect or require data publication (i.e., data to be made available in an archive or repository);
  • Consent forms should allow for participants to opt in or opt out of data sharing, whilst also protecting their confidentiality (see 'Informed consent');
  • Data protection laws only apply to personal data, but they do not apply to anonymised data;
  • Identifiable information may be exempt from data sharing;
  • A combination of gaining consent, anonymising data and controlling access to data can enable the ethical and legal sharing of data; even sensitive data can be shared if suitable procedures and precautions are taken, as is done at major data repositories.

Tip 2. Finding RECs

Find the REC at your own institution or have a look at The European Network of Research Ethics Committees - EURECis (EUREC, n.d.) - which brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level.