Abstract
It is not uncommon for us to receive queries from prospective authors regarding the peer review process of manuscripts submitted to our journal and some of the requirements we have for manuscripts submitted to our journal, especially Original Articles (for submission guidelines, see https://journals.sagepub.com/author-instructions/REA). In this editorial, we clarify one important aspect of the peer review process and submission requirements, namely our requirement for ethics approval, and specifically research involving human participants. There are a number of reasons why submissions to Research Ethics might be rejected by the editorial team, without even being sent for peer review. One of these reasons is lack of appropriate ethics approval or evidence of an exemption (otherwise known as a waiver), particularly where the research presented in the manuscript would suggest ethics approval would be required in most if not all jurisdictions (e.g. research involving human participants, research involving animals). Authors who do not have the appropriate approvals for their research sometimes plead ignorance of the requirements; sometimes we are informed that there was no access to an appropriate approval body.
How should authors approach research ethics approvals?
Our submission guidelines state explicitly that ‘all manuscripts reporting studies with humans or human data, including studies that involve primary collection of personal data such as surveys or interviews, must state the relevant ethics committee provided (or waived) approval.’
This is a common requirement for academic journals; studies that involve human participants and human data are not usually considered for publication unless the appropriate ethics approvals were in place prior to the commencement of the study.
Ignorance of this requirement for ethics approval is not acceptable as a justification. As such, it is commonly the case that we will reject these manuscripts without sending them for peer review. It is not our mission to encourage unethical or unlawfully conducted research, nor for Research Ethics to be a conduit to such published research. While evidence of formal ethics approval might not be a requirement for all types of research, ethics awareness and ethical conduct are essential for all research. Indeed, even desk-based research can cause harm if focused upon sensitive issues such as discriminatory, religious or illegal matters. Thus, authors who submit manuscripts that are exempt from ethics approvals may still be asked to describe how they dealt with ethical issues.
Nevertheless, we recognise that there are material differences in requirements between countries and institutions, such that some types of research (e.g. anonymous surveys) might be subject to full ethics approval in certain countries or institutions, while exempt from ethics approval in others.
Where legal or policy requirements differ, we recognise that context matters: in other words, we do take local requirements into account. Hence, we accept evidence of exemption in place of ethics approval, should that be national and/or institutional policy. Acceptable evidence of exemption might, for instance, be a waiver from the relevant ethics committee or a statement from a relevant policy document or legal instrument.
We also acknowledge that there are wide variations in access to appropriate approval bodies. While most countries now have well established national and/or institutional research ethics committees, many are under-resourced. Others might be available only for certain kinds of research, and not for other kinds, especially entirely privately funded research or research conducted by non-institutionally affiliated researchers (e.g. citizen scientists). For instance, a scoping review by Chaudhry et al. (2022) found that most research ethics committees in sub-Saharan Africa work under significant administrative and financial constraints. Additionally, in this issue, Brown (2023) describes how researchers affiliated to independent organisations and charities often do not have ready access to research ethics committees, unlike their counterparts who work within universities. So, what do we do when researchers claim there was no appropriate body to seek approval from?
We believe it would be unfair to reject such a manuscript outright; instead, we proceed to ask the authors for further information. There are at least three factors that we take into account:
Availability of appropriate body
Even when there is no available research ethics committee within the locality or institutional department, there is often another body to whom the researchers could look for approval. For instance, there might be an ethics committee in another department; there might be a mechanism at local government or community body for study approvals; a charitable organisation might have a ‘parent’ organisation with an ethics committee elsewhere. We expect researchers to have explored all reasonable options prior to commencing the study and to demonstrate to us, in writing, that they have done so.
Study justification
If a research study proceeds without ethics approval, there needs to be a very good reason why. This is especially true for research with vulnerable populations, or research that might lead to harm. For instance, a non-governmental organisation (NGO) undertaking emergency research in a crisis situation might have cause to believe that their study should go ahead, even without access to an ethics approval body, because it will lead to major benefits for the local population. On the other hand, a team of researchers who undertake interviews with staff at their institution about academic misconduct, just because they believe it is important, do not have a good justification for proceeding without ethics approval.
Evidence of ethics awareness and conduct
The steps that were taken to ensure that the study was conducted in an ethical manner must be explicit. This is vital for studies that have not been subjected to formal ethics approval. Prior to making a decision about whether or not to send for peer review, the editors may request specific information about how all relevant ethical issues were identified and addressed prior to the study commencing and over the course of the study.
We are also sometimes asked whether ethics approval and informed consent can be obtained retrospectively. It is our position that ethics approvals should not occur retrospectively. Similarly, informed consent for participation in research should be obtained before enrolment unless clear and convincing reasons are provided to us as to why this could not occur.
As we hope to have indicated in this editorial, even though we might, in some circumstances, consider sending manuscripts to peer review without the expected ethics approvals in place, we will not publish studies that involve a lowering of ethical standards. Research participants, communities, animals and environments must be awarded the same rights and protections, wherever they are based. To this end, Research Ethics will not publish studies that involve ethics dumping (Schroeder et al., 2018) and there are specific requirements for articles that detail international collaborative studies (see Global research ethics and inclusion).
We recognise that our submission guidelines should be context-specific where possible and not impose onerous requirements that would deter prospective authors from submitting their research to our journal. Ethics approval processes are sometimes criticised as overly bureaucratic, disproportionate, and not fit for purpose (including the imposition of a biomedical research paradigm onto social sciences and humanities research). Indeed, the study from Dove and Douglas (2023) in this issue brings into stark relief both the successes and weaknesses of research ethics governance, in this case, being the higher education institutional environment in Scotland. We agree that research ethics approval processes should not be seen as a burden for researchers. In this issue, Carniel et al. (2023) highlight the potential values of the ethics review process. Speaking from their own experience, they suggest that there is considerable capacity for ethics committees to engage with researchers to nurture research culture. To that end, we would encourage researchers who are embarking on research, wherever possible, to engage with local actors where they can, who can advise on the local requirements for ethics approvals and whether ethics approvals might be required for the type of research they are proposing to undertake.