For debate: should observational clinical studies require ethics committee approval?
All forms of management in medicine involve weighing up: (1) the potential benefits or efficacy of treatment (2) the potential side effects of treatment and (3) the costs or cost-effectiveness of treatment. It is well established that the randomised control trial (RCT) is the gold standard for determining treatment efficacy and it is obvious why RCTs should be subjected to ethical screening. However, RCTs are not the best methodology for every study, particularly as they are so expensive to conduct. Observational studies are particularly valuable for studying side effects and cost-effectiveness of treatment and still have value (albeit of a lesser quality) in assessing treatment efficacy. Most observational clinical studies are not ethically sensitive and, if it is agreed that therefore ethics committee screening is therefore not required for these studies, they can be completed at low cost with minimal need for industry sponsorship. Universal ethics committee requirements for all observational clinical papers would act as an unnecessary barrier to obstruct the publication of useful studies. Paradoxically, the need in many cases to seek industry funding to cover the extra expense for such a requirement would probably make observational studies less ethically sound.
Orchard
John
J
University of New South Wales, Sydney, Australia. johnorchard@msn.com.au
D001315:Australia; D030881:Disclosure; D028744:Ethics Committees, Research / Q000592:standards*; D006801:Humans; D019370:Observation; D016032:Randomized Controlled Trials as Topic