Ethical Approval for Operational Research
Gollogly, Laragh, Bulletin of the World Health Organization
This issue of the Bulletin contains two examples of a poorly defined area of public health intervention--operational research. Better known for its use in improving assembly lines or military tactics, operational (or operations) research has its own societies, journals, conferences, terminology and conventions. (1) While much health services research could potentially be classified as operational research, (2,3) this is the first time that we have seen authors use this classification as a reason for not seeking ethical approval for a study. Manica Balasegaram et al. report the outcome of two retrospective cohort studies on patients with trypanosomiasis in the Republic of the Congo. (4,5) When the Bulletin's editors asked them why they had not sought informed consent or ethical committee approval for these studies, they explained that they were not reporting primary research.
They also explained that all data were collected as part of routine diagnosis and treatment. Patients had been diagnosed and treated according to national guidelines and agreements, and testing blood and cerebrospinal fluid was an essential step in confirming diagnosis and classifying patients. These tests were done for each patient as part of routine care, not for research purposes. The authors explained that they evaluated the existing national treatment protocol, not an experimental one. They had originally established a treatment programme, not a research project, in the Republic of the Congo. Therefore, they had only sought (and obtained) project approval from the Ministry of Health. They had planned an analysis to look retrospectively at outcomes for a large cohort of patients, and had done this initially as part of an audit/evaluation, so as to improve quality of care provided. The authors explained that the government's decision to change the threshold for the treatment of early stage patients was based on rather weak evidence. Once their analysis had confirmed clinical suspicions that the cutoff for treating early-stage patients was probably too high--exposing patients to a high risk of treatment failure and death--they felt that this information should be shared with the wider medical community, and so submitted it for publication. The authors had also asked their Medical Director for feedback regarding the need for ethical clearance for such a retrospective analysis, and had been advised that this was not warranted.
When these papers were reviewed, and the case was discussed by the WHO Research Council, and the Committee on Publication Ethics, the Bulletin's editorial team was asked to weigh up the harm that might result from publication, against the benefits of disseminating these results. …