Ethics review in non-medical research

The task and role of ethics review board in non-medical research

Ethics review on research involving human beings is carried out by different review boards: 

  • Review boards for research in the field of medicine

    • The tasks of these review boards is regulated by law. The review boards may be located at universities’ schools of medicine, hospitals or national bodies. 

  • Review boards in humanities, social sciences and behavioural sciences: 

    • However, in many institutions review boards in humanities, social sciences and behavioural sciences have been established to better serve the needs of researchers in these fields. However, the presence of these review boards is not as established as those in medicine. Internationally, many medical review boards have also served researchers in other fields than medicine who conduct research with human participants.  

​Here, we focus on the latter. The tasks of review boards in humanities, social sciences and behavioural sciences is to serve the ethical review needs of researchers in humanities, social sciences and behavioural sciences. The interface between medical and non-medical research is defined through national legislation on medical research. What falls outside medical research falls within the domain of ethical review boards in humanities, social sciences and behavioural sciences. Thus, it is vital that board members are familiar with the laws regulating medical research I their country as researchers may not always be familiar, and might mistakenly send their request for an ethics review to a review board in humanities, social sciences and behavioural sciences. Clinical research always requires ethical review according to the regulation on medical research. In addition to providing ethics statements, these review boards guide researchers on matters related to research ethics and also set standards for expectations. 

Protecting human research participants 

The most important task of an ethics review board is to ensure the protection of human research participants. This includes the assesment of risk and benefit, identification of potential harm to participants, and protection of participants’ identities. As a rule, reviews are conducted at the very beginning of a research project, before any data collection has taken place. Some review boards may have as a rule that they do not deal with ethics statement requests received from ongoing research projects. Therefore, it is vital that researchers have access to information about the board’s policies and procedures, and can plan the review sufficiently well ahead of start of data collection. It may come as a surprise to researchers that the board may have its next meeting a month away, or that there may be several rounds of in the board meetings before an ethics statement can be issued.  

Some review boards may issue negative statements, whereas others do not issue negative statements, but support researchers in working on the ethical aspects of their research until these are acceptably managed. There may be different practices across countries/institutions. 

Sometimes in can also be surprising for researchers that they may require a statement from an ethics review board, permission to conduct research in specific institutes (e.g. schools), and informed consent from participants. It is important to clarify for researchers that ethics review boards issue statements, not research permits, which must be obtained from other authorities.  

There are different ethically demanding research scenarios, which may include, for instance, following elements: 

  • Research involving intervention in the physical integrity of research participants 

  • Deviating from the principle of informed consent 

  • Involving children 

  • Involving person incapable of consenting for themselves 

  • Researching institutionalised individuals 

  • Exposure of participants to exceptionally strong stimuli 

  • Risking to subject research participants to long-term mental harm beyond the risks encountered in normal life 

  • Signifying a security risk to subjects 

Practices for how to handle these features in research, varies from country to country, and sometimes from institution to another. In some contexts, ethics review boards will adopt a strictly forbidding take on these questions, whereas in other contexts these settings can be carried through provided that an ethics review has taken place, and the researcher has appropriate safeguards in place.  

Good practices in ethics review boards 

  • Members acknowledge conflict of interest. They refrain from taking part in decision-making regarding research proposals with which they have a conflict of interest, e.g. due to close collaboration, supervision relationship, or leadership role. 

  • Discussions in board meetings are generally confidential. 

  • Discussion focuses on truly ethical issues, not methodological disputes, unless the method poses risks to research participants.  

  • If the review board lacks expertise in a specific area (e.g. regarding the invasiveness of a specific research method), it should consult appropriate experts. 

Further resources:

European Commission. Horizon 2020 Online Manual. https://ec.europa.eu/research/participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm  

European Commission (2019) Horizon 2020 Programme. How to complete your ethics self-assessment-material guidance. Potential misuse of research results, page 37. European Commission. Directorate-General for Research & Innovation.

Text moved

  • European Commission. European Textbook on Ethics in Research http://ec.europa.eu/research/science-society/document_library/pdf_06/textbook-on-ethics-report_en.pdf
    • The aim of this textbook is to contribute to the infrastructure for ethics deliberation and ethics review in Europe and beyond. It covers key issues in the ethics of research involving human participants, including some of the ethical issues associated with new technologies.
    • While many of the annotated cases would regularly be reviewed in medical review boards, they are excellently guided and the reader may find parallels to questions arising ethics review boards in humanities, social sciences and behavioural sciences, e.g. children’s consent; deviation from informed consent.
  1.  Horizon 2020 Online Manual. European Commission.
  2. Potential misuse of research results, page 37. in European Commission (2019) Horizon 2020 Programme. How to complete your ethics self-assessment-material guidance. European Commission. Directorate-General for Research & Innovation.
  3. Office for Human Research Protections. IRB Guidebook https://archive.hhs.gov/ohrp/irb/irb_guidebook.htm. 

  • This guidebook offers a background and frame of reference for review board members and administrators. Based on US context.

Learning objectives

  • Understanding the tasks and role of ethics review boards in non-medical research
  • Knowing the regulative framework that defines medical research in order to be able to establish the domain within which the non-medical REC operates
  • Being able to analyse ethical issues in research from point of view how they may affect research participants, other stakeholders and researchers
  • Identifying good practices of RECs in non-medical research context

Introduction

Increasingly, financing bodies as well as journals in humanities, and social and behavioural sciences have begun to require ethics review, and there may be external pressure to set up review boards where these do not yet exist. Safeguards applied in medical research may not be appropriate in many types of non-medical research. Therefore, a review board that consists of individuals with a broad understanding of the various research approaches and methods applied in humanities, social sciences and behavioural sciences is better placed to assess ethical aspects of research in these fields.  

The set-up of the board depends on whether it serves a specific field, (e.g. psychology) or a number of fields (e.g. humanities, social sciences and behavioural sciences). If the board serves the researchers of a variety fields, it is important that there is sufficient representation of different fields, including a broad understanding of different methodological approaches applied in social sciences and humanities. The board may or may not include laypersons. This depends on institutional regulation. It may be relevant to bear in mind, that in a multidisciplinary board, the members are often laypersons in other fields than their own. In humanities, social sciences and behavioural sciences the spectrum of accepted research approaches is immensely broad, and therefore, it is necessary that members in these boards have an appreciation for different research approaches, even if they themselves do not engage in that type of research. 

The safeguard practices and procedures may vary greatly from field to field, and these are often less established than in medicine.  Thus, ethical review boards in humanities, social sciences and behavioural sciences serve an important function in steering and guiding the ethical practices in these fields. 

Further resources:

European Commission. Horizon 2020 Online Manual. https://ec.europa.eu/research/participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm  

European Commission (2019) Horizon 2020 Programme. How to complete your ethics self-assessment-material guidance. Potential misuse of research results, page 37. European Commission. Directorate-General for Research & Innovation

Cases and Questions - Ethics review in non-medical field

 
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Case 1 Deviation from the norm of informed consent - Research on racist attitudes in workplace recruitment.  

 Researchers in sociology intend to present themselves as immigrant job seekers and record how they are treated in a preliminary telephone job interview, especially with focus on how the recruiters react to information about the jobseekers ethnic background. In the context country, researchers may deviate from informed consent provided that they seek ethics review.

- Is deviation from the norm of informed consent acceptable? Please, consider how you as a member of an ethics review board would approach this case.