Although one private hospital responded within a week, correspondence with another continued for more than a year after the initial application was submitted before it finally approved access to records with all identifying information removed. This defeats the purpose of the study, as such an arrangement makes it impossible to relate treatment given to outcome of treatment for a particular patient. In the event, at least a tenth of the resources committed to the investigation have been used in preparing applications to and dealing with correspondence from IECs. The report from the Review Committee identifies two guiding principles for our system of IECs, namely that the prime responsibility of an IEC is to protect the interests of the subject of the research, and that the responsibility for ethical conduct of the research is vested in the investigator and ultimately in the institution to which he or she is affiliated. It does not consider whether an IEC also has a duty in relation to the collective interests of the community that stands to benefit from the results of research.
Positive comments are many times more frequent than negative ones.
Retrospective reviews of medical records are even less intrusive than postal surveys and are a cheap, relatively rapid and efficient way of gaining a comprehensive view of the health system's response to a particular medical problem. Clearly, they involve use of medical notes for other than the primary purpose for which they were created, but, equally clearly, systematic reviews of this kind are qualitatively different from other research in which participants are asked to undergo additional or novel tests or treatments. Contrast such a prospective trial with an investigation of the same drug after it has been on the market for some time when the possibility of a rare teratogenic effect is raised. Under the present Australian system of ethical oversight, investigators collecting data to confirm or refute this association would have to submit a detailed application to the IEC of every health institution with which the mothers of affected and unaffected control children had had contact within the year before the child's birth. The example of Debendox shows that, faced with the threat of litigation and unable to wait for independent investigators to complete a cumbersome and time-consuming series of applications to IECs before even beginning their research, the manufacturer of what may be a safe and useful drug may feel that there is no option but to withdraw the product from the market.