We live in an environment we constantly change and manipulate and we need to identify the health hazards these changes entail. We develop new economic structures and means of global trade and travel that greatly increases the risk of rapid and global spread of new and changed old pathogens. We need research to meet these challenges. New food technologies, production methods, aggressive marketing methods for new drugs and changes in living conditions worldwide may impact on health. We have seen epidemics of cardiovascular diseases, asthma and obesity that have to be met with evidence based preventive effort using sound epidemiologic studies. Procedures for approving epidemiological research should not be based on those needed for clinical research and randomized trials of potentially harmful interventions. Using inappropriate procedures and criteria, even with the best of intentions, will take away our limited time and resources for research and may set conditions that are impossible to meet without compromising quality of research. 1
People employed to do epidemiologic research have to use their talents to meet these needs. We believe not doing so is unethical conduct, not the opposite.
The IEA fully respects that research must rest upon accepted ethical standards but we advocate that these standards are applied in a way that take into consideration the actual risk involved in the research and the need for high quality research. Poor research may do more harm than no research.
Much of what epidemiologists do is to observe, to record and make inference based on these observations without risky, invasive procedures. Some of what we do may provide unwanted information for those who are doing harm. Perhaps the time has come to discuss if we need a committee with censoring functions to oversee all these activities for epidemiologic and public health research. Ethical appraisals are often time consuming and costly and may pose serious threats to the validity of the studies that pass through these committees. Experience has shown that decisions vary widely between different committees, although they may consider that they are applying the same ethical principles. Large multicenter studies must follow procedures that are accepted by all committees and that may not be enough to ensure the quality of the study.
Often an atmosphere is generated where the active and creative epidemiologists feel they are doing something wrong because they, and not their less active colleagues, have to defend even low risk research protocols all the time. This is neither good nor right.
We know that research during the course of history has violated important ethical standards but these examples should not lead to use of the wrong means of assessment, undue paternalism and bureaucratic obstacles that use unreasonable amounts of time and resources.
Jorn Olsen, Shah Ebrahim, Chitr Sitthi-amorn
- Hemminki A, Kellokumpu-Lehtinen P.Harmful impact of EU clinical trials directive / academic clinical research in cancer seems to have no future in Europe. BMJ 2006; 332: 501-2. ↩