Publishers are seeing an increase in submitted data generated from qualitative research studies. These studies are answering important questions such as identifying unmet need or highlighting the lived experience, potentially adding real value to the body of evidence especially in rare diseases. They are often Pharma funded and / or patient advocacy group led.
Many of these studies have been conducted compliantly in accordance with the EPHMRA guidelines, which state that Ethics committee approval is not required if studies meet the criteria of market research. In addition, these studies are non-interventional and the Health Research Authority tool also indicates that Ethics committee approval is NOT required.
However, our interpretation of the COPE guidelines is that ethics committee approval should be provided for all studies involving humans. This potential disconnect is frustrating for potential authors as is often not identified until after the study has been performed and is ready for publication. Furthermore, there does seem to be some inconsistency in the published literature, with some such studies being published without ethics approval.
Further clarity from publishers regarding when Ethics approval is required for non-interventional questionnaire-based market research studies, and alignment with the existing market research guidelines, would be welcome to ensure that these important qualitative research data are reported. Publication of such studies may highlight important aspects of rare disease and prevent repetition of similar studies in often limited populations. The need to submit to an Ethics board unnecessarily is costly and can be a real barrier to non-HCP led research (e.g. patient-led research) who do not have access.
Question for COPE Council
- Does COPE have any existing (or new) advice on the need for ethics committee approval for this type of research?
Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the COPE Forum where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.
This is a difficult area of publication ethics, and one where legal or institutional requirements differ from country to country. Some institutional research boards may not consider applications from areas which are not traditionally ‘interventionist’, making it difficult for such work to gain this form of approval. Human Research Ethics Committees may not exist in certain countries, and researchers can hardly be tasked with forming their own HREC and expecting their review to be arms-length. Also, just as ethics approval does not guarantee that research is ethical, neither is true that research without approval is automatically ‘unethical.’
It should also be noted, however, that many types of research will involve legal and safeguarding obligations, regardless of whether or not a given project falls within the remit of an ethics committee or receives its approval. In many science subjects no distinction is drawn between qualitative and quantitative research: any study involving human participants must be approved by an ethics committee. In social sciences, too, this is starting to be more universally adopted, and there is a thin line between studies that are focus on internal process-improvement as opposed to more traditional forms of scholarly research. Further, it is within the journal’s rights to demand ethics review (approval or official waiver) in whatever cases they define, and it is the author’s responsibility to have checked their target journal’s policies well in advance of submission.
COPE recommends that journals consider, firstly, whether they consider this type of 'market research' as within their scope, and if so, whether to develop policies that offer an alternative to Ethics Committee approval. For example, the journal could consider requiring all authors of market research studies which involve human subjects to submit an ethics statement (for example, as an appendix, as supplementary material, or as a separate document linked to the article). This statement could include how the authors handled consent (to participate and to publish), data privacy, how they considered potential risks and harms and weighed these against benefits of the research, whether they followed any particular framework or guidance, if there were any 'vulnerable' groups included how they handled this, whether the research was subject to any particular regulations or industry guidance and so on. This would clearly require more editorial work to assess, but it would provide a rigorous policy where a journal does consider this type of work within their scope. It would also provide clarity in setting a minimum expectation of universal research ethics rules, even where studies have been exempted from formal authorisation by an ethics committee or where such authorisation was outside the remit of such bodies.
The Standards for Reporting Qualitative Research (SRQR), as recorded on the Equator Network of publication guidelines has a useful check list. While the paper focuses on biomedical research, the publication guideline could reasonably be extended to other areas. The requirements to 'document approval by an ethics board and patient or explanation of lack thereof' seems like a reasonable expectation no matter the source of the work and is in line with the recommendations made above.
Editors should also be mindful that there may be more potential issues over competing interests where market research is published as original scholarly research. This could be assessed on a case-by-case basis.
COPE’s guidance for editors on dealing with research audits and service evaluations may be useful.