A journal received a manuscript on risk factors for a disease, which had no ethics committee approval or dispensation. The clinical data were collected from the electronic and physical histories of the patients during hospitalization. The authors stated that the study was not submitted to an ethics review board because these data are "secondary." In some countries, this type of research will require an ethics committee approval as well as specific approval by the hospital director. The journal was not aware of what the laws were in the country where the study was conducted.
The WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks (2016) clearly states in number 19 that:
‘19. An independent ethics committee must approve the establishment of Health Databases and Biobanks used for research and other purposes. In addition, the ethics committee must approve the use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have to be taken to protect the donor. The committee must have the right to monitor on-going activities. Other ethical review mechanisms that are in accordance with par 6 can be established.’
According to this declaration, some national regulatory frameworks, and the journal’s previous practice, ethics committee approval would be required for any research conducted involving human beings, even when databases are used.
Questions for COPE Council
- What are other medical journals' policies regarding retrospective observational clinical research?
- Would it be acceptable to request a postdated ethics committee approval letter?
- Should the journal reject publication of this paper solely based on the absence of an ethics letter of approval?
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.
If an editor is unsure of the laws and practices in a country where questionable work was done, they could ask an editorial board member from that country, if there is one, who could help obtain the information. If the WMA declaration applies to the case in question, the paper should be rejected since it clearly implies the need for prior approval. If it is uncertain whether it applies to the case and/or whether it is binding (or merely a recommendation), the editor could request the ethical committee's own guidelines from the institution in question, or from the country's health ministry.
For retrospective analysis, ethical approval may still be needed despite the observational nature of the study. Hence it would be useful to ask for proof of waiver status, as confirmed by an ethics board, if possible. Occasionally, an author might say the local ethics board does not consider applications on clinical audits or evaluations of aggregate/anonymous data from routinely gathered records (giving proof of this policy). A statement from the hospital or institution that owns the data might then be sought.
If the authors did not follow the local standards, rejection will be the right choice. Accessing patients' medical records in most countries requires prior approval to make sure that privacy is preserved, that only the necessary records are used, that the data are appropriately de-identified, and to allow for reasonable oversight to verify that those standards are maintained. It is important to verify that this is the case.