La Investigación Clínica. Leyes y ética que la regulan. (Spanish Edition)

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View on dx. I call this the democratic reciprocity model. The original idea of the democratic reciprocity model is to claim that the obligation of continued access correlates with the right to health. El GFBR es una Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos.

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View on philpapers. Guidance Document [Version 1. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. This information must also be disclosed to participants during the informed consent process. However, there is no guidance on how to fulfill these responsibilities i. To fill this gap, the MRCT Center convened a working group in September of to develop a framework to guide stakeholders with identified responsibilities.


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Post-trial obligations in the Declaration of Helsinki classification, reconstruction and interpretation [pre-peer reviewed version] more. The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki Transitioning research participants to the appropriate health Transitioning research participants to the appropriate health care when a research study ends is a global problem.

The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki identifies at least two clearly different types of post-trial obligations, specifically, access to care after research and access to information after research.

The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature.

I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from to to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations.

New clinical trials regulation in Spain: analysis of royal decree 1090/2015

Post-trial obligations in the Declaration of Helsinki classification, reconstruction and interpretation. Developing World Bioethics , pp. Does the pragmatic model undermine the importance of the ethical obligations involved in information process? A defence of continuous genetic counselling for research participants. View on jme. Appelbaum, Erik Parens, Cameron R. Chung, in the Chung, in the July-August issue.

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View on bmj. Bioethics and Research Ethics. Publication Date: View on tcba. The relevant articles of the declaration are identified and two possible interpretations of the principle of post-trial access are set out; one robust and one permissive, inspired by different models of distributive justice. A critical evaluation of both interpretations is presented and arguments against the permissive one advanced.

Una de Second, the interpretation of reasonable availability model and the fair benefits model of the condition of access to post trial benefits are examined. Finally, I present and criticize the moral counterproductive argument which affirms that post trial obligations towards the community prevent new drug research and make population in developing countries worse off. Salud Publica , Salud , and Bioetica. View on bit. Immanuel Kant , Etica , and Pobreza Global. View on dspace. Interview with Dr. The CEIm will also be advised by the appropriate experts whenever the evaluated protocols include surgical or diagnostic procedures, healthcare products, or advanced therapies.

However, some definitions in Article 2 are clarified; specifically those regarding clinical trial, clinical study, and observational study. This aspect is of the utmost importance as prior definitions led to differences of opinion among investigators and regulatory authorities and among the regulatory authorities of the different States, occasionally causing paradoxical situations, since the very same study could be considered to be a clinical trial in some countries, but not in others [ 18 ].

For the first time, it is considered that the risk for subjects in clinical trials is not the same when the treatment applied is similar to that of routine clinical practice; as its quality, safety, and efficacy have been established in previously conducted clinical trials and by use.

Hence, it is considered that low-intervention clinical trials should be subject to less stringent standards as regards monitoring, master file requirements, and traceability of the medicinal products. In this regard, a significant decrease is anticipated in the administrative and financial burdens derived from the less strict monitoring requirements of medications with a well-characterised toxicity profile [ 19 ]. The inclusion of low-intervention clinical trials has been acknowledged by most scientific associations [ 18 , 20 , 21 , 22 ].

Obviously, the safety requirements for well-known medications need not be as demanding as for medicinal products that might be first-in-class drugs that have specific regulations to reduce risks [ 23 ]. The patent of many of these well-known medications may have expired; however, they may still have a high treatment index, although the lack of trials dedicated to their study may bias the perception of efficacy in comparison to newer drugs.

The future development of these medicinal products may lack commercial interest for the companies that market them; nevertheless, studying how to optimize the use of these medications in terms of duration of treatment, treatment regimes, new indications for less frequent diseases or minority populations; comparative cost-benefit or drug utilization studies in real-life conditions, or those studies aimed at examining the rational use of the medicinal product may portray an enormous benefit for patients and the society in general.

Some scientific associations, however, have expressed their concern, because, in accordance with the fundamental principles of pharmacovigilance, the safety and efficacy profile of drugs during the first years after marketing authorisation may not be fully characterised [ 21 ]. That is, that from a theoretical perspective, if the risks are similar to those of routine clinical practice, a compensatory system other than that of routine clinical practice should not be necessary. This aspect has received strong support from scientific societies [ 18 , 20 ], although in general, it has been deemed insufficient.

It must be acknowledged that the need of an insurance policy is one of the basic obstacles to academic research in Spain and probably elsewhere; and causes that a large part of the funding of public or charitable origin must be spent on this expense. Of course, this does not unbind investigators from their responsibility under the law. From a practical standpoint, in neighbouring countries where, prior to the effective date of the new Directive, there was no formal obligation to take out insurance, it was up to the regulatory bodies and to the ethical review boards to examine whether or not the sponsor would be capable of assuming claims for compensation; which predetermined that, de facto, a specific insurance policy had to be taken out to cover the trial.

Bearing in mind the experience in countries, such as Great Britain, it is not foreseeable that in the short term, financial guarantees can be considered covered by the standing guarantees outside the trial. Nonetheless, in countries, such as Denmark, the usual mechanism of compensation already covers most academic clinical trials [ 24 ]. Undoubtedly, getting the States or private bodies to accept these proposals in current times is tremendously challenging.


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However, when one considers the large sums of public money used for private individual insurance policies for each trial and the benefits of academic research for public health and the society in general, the idea begins to make sense. Moreover, non-commercial sponsors might be the ones most interested in carrying out research to optimize already established treatments in terms of treatment duration or new schemes or to examine which medicinal product provides better outcomes, and this is the research that can optimize healthcare costs, allowing healthcare systems to save great sums of money in the long run.

The Royal Decree also establishes that, in the case of non-commercial research, the clinical trial authorisation application can be submitted without having taken out the insurance, although the contract must be submitted after a positive judgment from the CEIm. This provision can be an advantage for the small percentage of trials, generally promoted by non-commercial investigators, that will ultimately not be authorised in Spain, trials were authorised; 9 were rejected, and 33 trials were withdrawn in [ 6 ].

Another critical point of the current regulation is the submission of a single dossier for clinical trials conducted in different countries including the submission made to the Ethics Committee , which was one of the most important demands made by the pharmaceutical industry and cooperative groups in recent years to avoid having to submit basically identical information to all Member States and multiple committees, in most cases in specific formats [ 7 , 18 , 20 , 24 , 25 , 26 ]. Undoubtedly, the single portal for the European Union will simplify the administrative procedures for industry and cooperative groups once it is operating.

The current submission though the AEMPS portal by means of a single contact point also simplifies the process for multicentre trials. The establishment of a single template for the contract for the entire National Healthcare System has also received strong support, even though this template has not yet been provided. The single joint position by all Member States is even more relevant. The assessment is divided into Part I quality, preclinical, pharmacology, toxicology, clinical efficacy and safety data, and methodological aspects , that will be carried out by a single State by means of an assessment report that will be reviewed by the rest; and Part II consent, compensations, how subjects will be selected, personal data protection, suitability, compensations, and compliance with the rules for the use of samples for future research that is deemed to cover aspects that are intrinsically national in nature and that, in our country, will be performed by a single CEIm.

In the establishment of the assessment consensus reached by the AEMPS and the CEIm, it is important to acknowledge that consideration has been given to avoid a complete dissociation between the evaluation of the scientific and ethical aspects, i. Thus, certain intrinsically national aspects, such as informed consent, determined to a large extent by educational, social, and cultural issues, will remain outside the scope of the cooperation between Member States. In this regard, it must be pointed out that from now on, a single CEIm shall be responsible for assessing the suitability of the investigators and that of the facilities of all centres in Spain, which will demand that both sponsor and researchers pay special attention to those aspects that objectively justify the conditions of suitability.

Revista Española de Drogodependencias

Therefore, the CEIm continues to play an essential role in the assessment of the ethical components of the study, which, as previously mentioned, cannot be dissociated from the methodological aspects. Nevertheless, there can be situations in which a methodologically impeccable trial can be deemed adequate in one European country, but not in another, including the different standard treatments, general vulnerability of the patients, as well as the different educational, cultural, or historical determinants. Even today, the wording of the informed consent form, advertising and the methods for subject recruitment, and all closely linked to the aforementioned conditions determine the largest discrepancies between different countries and between the different ethical review boards of a single country.

This simplified assessment procedure will not only decrease the administrative procedures that investigators must carry out, but will probably also enrich the assessment from a scientific standpoint, as the experience from the centralised authorisation procedure shows us. One clear risk of this new form of coordinated assessment is that the applicants give priority to the assessment by one Member State over the rest, with the consequent economic and scientific repercussions for the others, since, in the event of disagreement between the Member States, the country proposed by the applicant will be the reporting party [ 27 ].

Another central aspect of this Directive is the increase in transparency. The Declaration of Helsinki and its subsequent revisions determine that all research involving human subjects must be registered prior to recruitment of the first patient and that there is an ethical obligation to publish the results of these studies, including negative or inconclusive outcomes [ 28 ]. The current Directive regulates the creation of a new European database containing all the information and data related to clinical trials.


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This database will not only include the final report of the trial, but also summarise the results in lay terms intended for the general public. Of course, personal data protection, commercially sensitive information, and communications between the Member States during the assessment will be guaranteed. By means of the current Directive, general safety notifications are also simplified, since serious and unexpected adverse event shall be reported through EudraVigilance, although until the effective date of the Regulation, notifications can be made to the AEMPS.

Notification to the CEIm of information that, in general, the committee was not capable of processing, and is thereby ended. In addition, the coordinated assessment of clinical trials will probably enhance the scientific quality of the assessments, as it will foster the debate between the different European agencies and between the agencies and CEIm.

Another crucial aspect is the increase in transparency, since clinical trial data accessibility for the general public in general and the stimulation of cooperation among the Member States in assessing safety will strengthen the system of guarantees. Last but not least, non-commercial research will probably be stimulated by means of the inclusion of a monitoring strategy and compensations system which is proportionate to the risks for subjects. It might be deemed insufficient, but there is no doubt that it is the first step toward the recognition of the fact that the risk for subjects participating in certain studies does not differ substantially from that of routine clinical practice.

Of course, progress in this sense cannot make without the collaboration of all the social stakeholders involved. The authors declare that they have no conflict of interest and received no funding. Skip to main content Skip to sections. Advertisement Hide. Download PDF. Authors Authors and affiliations M. Martin Jimenez A. Calvo Ferrandiz J. Aparicio Urtasun R. Garcia-Campelo E. Gonzalez-Flores M. Lazaro Quintela M.

Rodriguez Sanchez A. Santaballa Bertran J. Sepulveda Sanchez R. Vera Garcia J. Virizuela Echaburu M. Segui Palmer. Open Access. First Online: 07 October Furthermore, this directive sought to harmonise the dispositions that governed conducting trials in different countries of the European Union and to simplify procedures.

Open image in new window. Definitions of clinical trial, clinical study, and observational study.

Ethics research in critically ill patients | Medicina Intensiva (English Edition)

Therefore, it is acknowledged for the first time that the risks for the participants of clinical trials cannot be the same when the treatment applied is similar to that of routine clinical practice, i. This is so even if this medicinal product is not used in accordance with the conditions of its marketing authorisation, but its use is supported by scientific data. Low-intervention clinical trials are, therefore, considered to be subject to less stringent rules as far as monitoring, and master file requirements and traceability of the medicinal products are concerned.

Non-commercial clinical research is defined as the research conducted by the investigators without the participation of the pharmaceutical or medical devices industry that has all of the following characteristics: 1st The sponsor is a university, hospital, public scientific organisation, non-profit organisation, patient organisation, or individual investigator.

Compliance with ethical standards Conflict of interest The authors declare that they have no conflict of interest and received no funding. Google Scholar. European Commission Memo. Brussels: European Commission. Memoria de actividades — AEMPS Memoria de actividades.

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Does the European clinical trials directive really improve clinical trial approval time? Br J Clin Pharmacol. Hearn J, Sullivan R. Eur J Cancer. European Medicines Agency [sede Web]. Londres: Clinical Trial Regulation. Accessed 8 May Ministerio de Sanidad, Servicios Sociales e Igualdad. Kearns P. The need for proportionate regulation of clinical trials. Lancet Oncol. European Cancer Organization.

European cancer organisation backs proposals to revise EU Clinical trials directive. Expert Rev Anticancer Ther. CrossRef Google Scholar.



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