Introducing and establishing an infrastructure for ethics review in non-medical fields
There is fairly much variation in different countries in how ethics review is organized in non-medical fields. Sometimes there are specific review boards in place for non-medical fields; sometimes these boards are more general serving a variety of fields, and sometimes they can be field-specific (e.g. psychology); and sometimes there are no review boards for non-medical fields. In these cases, medical review boards may also handle review requests from non-medical fields, or alternatively no reviews are typically conducted in non-medical fields. With the increasing requirements from funders, publishers and international collaborators to subject research to ethics review, the latter kind of situation has become unsustainable in countries that lack an infrastructure for ethics review in non-medical fields, and there is pressure to introduce institutional review boards also for research with human participants in non-medical fields. The following are some of the considerations that need to be taken into account when establishing ethics review for non-medical fields.
What is the task of a review board?
A review board serves the research community by evaluating how ethical aspects of research are addressed, providing recommendations on how to navigate ethically sensitive aspects of the research, and issuing statements of the ethical aspects of a study. Review boards play an important role in raising awareness of the necessity of being proactive regarding the ethics of research and planning ahead rather than reacting retrospectively.
The scope of training and guidance may vary depending on how the review board’s mandate has been defined and what resources the review board has at its disposal. In addition, review boards may develop ethics review policy and practices, and sometimes review board members are active proponents of research ethics in their respective research communities. It is common for review boards to be asked to comment legislation that involves or influences research practice and/or ethics review. Also the non-medical boards, once established, have the opportunity to engage in this important dialogue with governmental parties.
Review boards may be assigned with training obligations. It is common that review board members do low-threshold advising in their respective local or field-specific communities, and chairs and secretaries may have a more formal role informing and educating the research community.
National or institutional guidelines for ethics review?
There are advantages with nationally set guidelines for ethics review as this will unify procedures and create equity for researchers. National guidelines for ethics review in non-medical fields, however, require the existence of a body that can take on the task of setting up guidelines and seeking sufficient consensus among research institutions in order for the guidelines to have effect. If there is not at a national level an institution or body that can take on the task of coordinating the set-up of guidelines, institutions in which non-medical research involving human research participants is carried out may benefit from establishing guidelines and a review board locally. Institutional cooperation is likely advantageous as it will be helpful for researchers cooperating across institutional boarders as well as for the spreading of good practices in ethics review.
What is the relationship with medical review boards?
Contrary to the mandate of medical review boards, review boards in non-medical fields do not operate on a legal basis. In order to determine which the appropriate review board is, one must always consider the prevailing law on medical research. In some countries, research that interferes with the physical integrity of research participants is always considered medical research and must consequently be subjected to review in a medical review board. In some other countries, the case is that interference with the physical integrity of research participants alone does not classify research as medical, but in addition, the study aims to address health, illness or wellbeing. This means that in some countries much of the review of research conducted within the discipline of psychology falls within the mandate of medical review boards, whereas in some countries the same research is typically reviewed in non-medical review boards. When in doubt about which is the appropriate review board, it is vital that review boards are connected for consultation. It may not always be a straightforward question for the board either in which board a particular research plan should be dealt with. Therefore mutual dialogue and consultation across boards is vital. Especially with emerging areas of use of technology, or fields such as medical anthropology, it may be difficult to determine the type and nature of the research. The same applies for studies that involve, for instance, both domestic animals and their owners, in which case the dialogue must function between the non-medical board and a board that handles research involving animals. It should be noted that there are also different boards for animal research: those based on legislative requirements, and other boards, which handle research involving animals but falling outside the scope of the legislation.
When is ethics review mandatory?
In setting up guidelines for ethics review, it is important to consider under which circumstances an ethics review is mandatory – always or when specific conditions are fulfilled in the research? In many countries, an ethics review is always mandatory in all research involving human research participants whereas in other countries review is mandatory when a study fulfills specific criteria. For instance, if the researchers deviate from informed consent, if participation in the study induces risk beyond everyday life to the participants, of if the study involves exceptionally strong stimuli. In some countries the involvement of minors in the research may be a ground for ethics review, but this is not the case in all European countries.
Review boards, if connected to a university or other educational institution, will need to have a policy on student research. Should student research be subjected to the same ethics review requirements as the work of academics and other researchers, or are there other mechanisms for dealing with the ethics of student research? Does the review boards distinguish between undergraduate versus graduate research? PhD research may be generally considered requiring the same ethics review as is required of other academics and researchers. At this level the research designs and their ethical implications may be already more complex than on undergraduate and graduate levels, where it can often be considered that it is the supervisors’ responsibility to make sure that the study meets ethical standards. This is usually sufficient if there are no intentions to publish the work. However, as soon as students become involved in research projects, they are likely to encounter the requirements posed on academics and researchers in general. Whenever student work at any level is involved, it is recommended that ethics review is sought together with the supervisor.
Full reviews or expedited reviews?
Further, some review boards only do full reviews, whereas some may apply an initial screening, based on which the research is either exempt from review or subject to full review. In cases where research is subject to ethics review when certain conditions apply, it is typical that the reviews are full as most of the studies reviewed involve potentially ethically challenging situations.
Pre or post review?
Ethics review is typically something that researchers will seek prior to beginning their research. What is the proper point before which the researchers should seek an ethics review may vary, but commonly this would be prior to commencing data collection. When setting up a review board, it is important to set the policy for whether or not the board will provide reviews post data collection.
If a board accepts to conduct reviews and issue statements post data collection, it is important to recognize how that may influence the boards work load and to consider whether the board has the capacity to determine how the study was actually carried out.
What are the resources needed to run an ethics review board?
If the choice is to make all research involving human research participants subject to ethics review, depending on the volumes of research, it may be necessary to establish job positions for review coordination and administration. Irrespective of the model, resources will be needed in terms of academic staff input, administrative work, and office space. How much resources are spent, depends on the volumes of resource, the extent to which review is voluntary or mandatory, and the extent to which the reviews are pre-screenings and full-scale reviews.
Ethics review boards in smaller institutions or in institutions with smaller volumes of research involving human participants may meet ad hoc when necessary. In most cases, however, a regular meeting schedule is helpful for both researchers who need to plan the steps of their projects, and for review board members who need to reserve time for reading sometimes relatively large volumes of text.
Medical review boards may charge researchers a fee, but this practice tends not to be common among non-medical review boards. This is likely due to the fact that non-medical research is not subject to ethics review according to law. There may be national recommendations regarding fees. When setting up review boards for non-medical fields it is necessary that there is either national and/or institutional support, and finances for at least administration and facilities.
What administrative practices and procedures should a review board have in place?
Review Boards handle data, which will require them to abide by the provisions of the General Data Protection Regulation. Boards need systems for distributing research plans and other material for review among the review board members, and a system for archiving and easy retrieval of reviewed research and related statements issued by the review board. Sometimes researchers ask for changes from their initial application to be approved in which case having a well-functioning archiving system is of crucial importance. It also helps to monitor consistency in the way the review board treats different types of research ultimately having implications for the equal treatment of researchers.
Also, review boards may wish to think of what is the best way to receive inquiries, i.e. is there a website that collects these or are inquiries received through e-mail. Most likely, the secretary receives and answers any inquiries, but a decision needs to be made also, regarding how the communication between the administrative personnel, the chair and the committee members is best organized.
What information does a review board need?
In order to be able to review the ethical aspects of a study, review boards require different types of information about the study. Typically, the following information is useful and necessary for the review board:
- research plan (the review board may wish to provide guidelines on content and length)
- researcher’s own evaluation of the ethical issues of the study and how to address them
- data protection and management plan
- information sheet for research participants
- consent sheet for research participants
- research instruments and materials given to participants (e.g. survey questionnaires, interview protocols)
For the data protection and management plan, researchers are likely to require additional guidelines and templates to avoid much of routine inquiries around the topic. Researchers are best served by instructions directly addressing the information needs and requirements related to research participation as well as those pertaining data management. It is our experience that especially in the initial phases of the changed data protection landscape in Europe, researchers need guidance on what information about personal data collection the research participants should receive (a template may be helpful) and what information about the research should be provided in the information sheets for participants. Research organisations should have guidelines for data management.
References
Finnish National Board on Research Integrity (2018). Ethical review in human sciences. Ethical principles of research in the humanities and social and behavioural sciences (revised). https://www.tenk.fi/en/ethical-review-in-human-sciences
University of Helsinki. Ethical Review Board in the Humanities and Social and Behavioural Sciences
World Health Organization (2009). Research ethics committees. Basic concepts for capacity-building. http://www.who.int/ethics/publications/9789241598002/en/