A paper was submitted which enrolled elderly nursing home patients to an experimental study of the effect of a medicinal plant on skin ulcers. Although the plant is licensed for use in other skin conditions, it does not have a specific licence for this indication. The study did not mention ethical approval or whether consent was obtained so the editor wrote to the author to query it. The author replied that the patients were informed that the study was an experimental pilot study, and either they or their ‘tutor’ gave oral or written informed consent after a ‘complete explanation’. However, it is unclear what explanation was given, whether the patients were cognitively able to give informed consent, and whether ethical approval was obtained.
Is the author’s explanation sufficient?
Is oral (as opposed to written) consent acceptable in these circumstances?
It was argued that if there is no consent then the paper should be rejected. In the Netherlands all interventions are reported, and the author would have been questioned why they had no approval. In the UK the GMC might take disciplinary action.
What ever sort of consent occurs, there should be a detailed audit trail - there needs to be some sort of evidence. If this was a UK case then the editor should go to the hospitals clinical director, or the Dean or Head of Department. It should be passed up the line and must be followed up.
This type of verbal consent is unacceptable, there should be a detailed audit trail. The author should receive a stern letter outlining the reasons this is unacceptable and the case should be followed up through the authors institution.
Following the last COPE meeting I went back to the author with the following questions:
1) Was ethical approval sought from the appropriate ethical review committee?
2) The details of consent process for each patient are unclear. Specifically how many people gave written consent? How many people gave oral consent? How many gave consent by proxy, i.e. by their “tutor”? Who obtained consent from the patients? Although oral consent may be acceptable under these circumstances you should have a record of the audit trail e.g. written documentation that consent occurred. Can you provide us with evidence of the audit trail?
3) Can you please confirm where the study took place (the address of the nursing homes) and the institution to which it you are affiliated?
And I received the following reply:
1. The protocol was approved and signed by the medical and nursing teams of the institutions. No ethical committee exists in our institutions. The preparation was already present in our internal pharmaceutical list and used without standardisation. The aim of this preliminary paper was to write a protocol for using it in a standard matter and to document eventually the benefit by photos.
2. Five out of seven patients gave written consent (of which three by proxy or tutors). Two patients gave oral consent. Consent was obtained together by the chief of the nursing team, by nurses, and by myself. The chief of the nursing team signed an appropriate form in the two cases of oral consent.
3. I confirm that the study took place at the nursing homes indicated fully after my name in the documentation send to your journal.
So it's now a question of whether COPE considers his responses sufficient.
The committee noted that the author did not answer the question regarding the institution he was affiliated with. If he was a “tutor” with a higher education facility, then there would be an ethical committee, but in many places there is nowhere to go. However, “tutor” might be a term used for a carer or guardian, so out of COPE’s aegis. It was felt that this issue of research being conducted at private institutions, where there are no ethical committees, was something COPE should focus more attention on. In the meantime, the editor has to consider whether anyone was put at risk as a result of the research conducted. If so, then the matter should be referred to the appropriate regulatory body.
Further update (April 2007)
The editor in chief wrote a letter to the ethics committee. No reply was received. Correspondence with the author fizzled out as it proved impossible to find his institutional address. The journal’s ethics committee said unless there was a risk of harm to patients then a stern letter should be sent to the author with no further action.
The handling editor felt that she had reached the end of the line with this author, and that questioning him further would achieve nothing. It was agreed that there was little point in pursuing the author, but the editor in chief wrote to the author drawing his attention to the details laid out in the Declaration of Helsinki.