Informed consent: time for more transparency

The World Health Organization has developed a single international standard for the information that authors of clinical trials must disclose [1]. The informed consent form (original or subsequent versions if the trial protocol necessitates) is not among the listed items. More recent schemes to expand registration of clinical trials also do not include full disclosure of informed consent forms [2,3]. We strongly feel that the exclusion of informed consent is a serious omission in our current attempt to make clinical trials more transparent; we give four specific reasons in support of this view:1. The patients and the public should know whether the study involves a medication that has already been shown to be effective in other similar studies. Informed consent forms are supposed to include this information to help patients make an informed decision about the possible benefit they may get from participating in the trial. Although all clinical trials should ideally be conducted with the goal of improving medical knowledge, other reasons for clinical trials, including simple promotion, are seen [4]. There is little scientific or societal gain in repeating clinical trials with medications that have already shown efficacy [5].2. There can be considerable variation in how informed consent is addressed by investigators from different cultures and socioeconomic settings, even within the same multinational trial [6]. These differences can become more important and worrisome when drug trials are conducted in developing countries [7] where the investigators and sponsors might be more relaxed as to ethical standards of human experimentation. Transparency of the informed consent forms may facilitate the local and international surveillance of unethical scientific conduct.3. There are examples of clinical trials that appear unnecessarily prolonged after the evidence is already available for a clear beneficial effect. We had expressed such concern for a major drug trial in rheumat