SUMMARY

In this article, the ethical features that are more directly involved with the patient participation in clinical trials are reviewed. Some of the advocated previous requirements to the beginning of the clinical trial are the existence of a systematic review, in order to find out what has been subject of research within the same field to the moment, and thus determine whether somebody is carrying out a similar study to the proposed one and be able to refuse, on reasons of redundancy, many of the trial protocols that are not to provide anything neither to the participant patients nor to the overall medicine; the proper design of the clinical trial to objectively assess the treatments’ safety and efficacy, boosting the researchers to design the trial protocols with the necessary quality to make possible the fact of getting right estimations of the efficacy and safety of the study treatments, as sharp as possible to avoid certain wrongs or mistakes; the warranty that it doesn’t exist deprivation of receiving an effective alternative treatment, basing the existence of this warranty on the justification and safety of the new study treatment, and taking under consideration which therapy will receive the control group, in the case of the commonest double-armed design; the prospective record of the clinical trials, as a previous requirement to its authorization and carrying out since it would foster the minimization of known risks and potential damages derived from the exposure to previously studied interventions that have been shown to be ineffective or damaging; the local warranties to carry out the study, assuring that the Clinical Research Ethics Committees (CREC) assess the scientific quality and the fulfillment of the ethical and legal requirements of the clinical trials under their approval and also analyze the suitability of the centre where they are going to be carried out as well as that of the researchers that will take part in it; and the patient participation assessing and improving the properness of the scientific activities, thus showing that some patient associations work closely with groups of researchers to foster the most suitable studies, and the public involvement with the clinical research, in order to improve its priorization, hiring, development and disclosure.

In the chapter embracing the ethical requirements that must be kept during the clinical trial, the focus is on the coherence regarding the possible rewards of the doctor or the participant patients, whose aim is that of boosting the recruitment of patients and compensating the researchers for their extra effort and establishing that the agreements between researchers and promoters must be transparent and found on a written file that must be assessed by the clinical research ethics committee; on the information provided about the trial, as for example that the voluntary and free decision of taking part in the study must be reflected through an informed consent document, once apprised of the nature, importance, involvements and risks of the study; and on the participants’ rights, making sure that the acceptance of taking part in a clinical trial does not imply the loss of any right neither as patients nor as citizens, and as a last requirement, on the risks of interrupting the clinical trial over schedule, thus monitoring properly and actively all the side-effects derived from the administered treatment in a trial.

Finally, some of the requirements needed after the conclusion of the clinical trial are: the freedom of publishing a clinical trial, no matter the results, since the disclosure of the research results is an unavoidable ethical imperative, to such an extent that if not carried out, the scientific practice becomes wrong because of an omission of duty; the disappearance of the “ghost” editors, since at a certain amount level, the authors appearing on a proportion of published trials do not suit the minimum requirements to be thought of as such regarding the criteria of the International Committee of Medical Journal Editors (ICMJE); the stating of full declarations on potential interest conflicts, so that the readers may count on every necessary compound to come up to self conclusions; and the assurance of the availability of the results of a trial to update the systematic reviews, to be included, after its conclusion , in the updating of a previous review or in a new one and effectively contribute to a sharper determination of the real effects of the study intervention.

Finally, this article embraces the idea of an overall active engagement on everyone’s behalf: the researchers, the institutions where they work and especially, the clinical research ethics committees and the centre managers; the Administration and also, the patients and citizens, so that the clinical trials can practically and not only theoretically respect the ethical principles and requirements that justify themselves.