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

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Molecular biopolitics, somatic ethics and the spirit of biocapital. Strangers at the bedside : a history of how law and bioethics transformed medical decision making. New York: Basic Books. Genetic exceptionalism and legislative pragmatism. Bioethics and the global moral economy: the cultural politics of human embryonic stem cell science. The moral obligation to create children with the best chance of the best life. Why the way we consider the body matters: reflections on four bioethical perspectives on the human body. Del naturalismo al escenario posempirista.

In: Shuster, Federico Ed. Buenos Aires: Manatial.

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In: Alonso, Aurelio Ed. Buenos Aires: Clacso. Manuale di bioetica , v. Milano: Vita e Pensiero. Theology and bioethics : exploring the foundations and frontiers. Dordrecht: Reidel Publishing. The duty to obey the law. In: Patterson, Dennis Ed. A companion to philosophy of law and legal theory. London: Blackwell. An analysis of the many issues that complicate the debate about conflicts of interests in bioethics. Male pregnancy and the limits of reproductive liberty. Narratives of race and indigeneity in the genographic project. The activities of Unesco in the area of ethics.

Human genetics studies: the case for group rights.

Barcelona: Gedisa. Is bioethics applied ethics? Acceso en: 17 sep. Partnership in U. We will argue that "responsible innovation" understood as "responsible new non-validated practice" is ethically permissible and poses an acceptable medical option in exceptional circumstances where no reasonable alternatives can be provided to an individual patient. Finally, we focus on the peculiarities and specific difficulties the category of new non-validated practice poses to the Latin American context.

We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America. Save to Library. Book chapter: ethical aspect in precision medicine: an introduction to the ethics and concept of clinical innovation more. We argue for clinical innovation as an alternative approach to We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions.

Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features.

We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research. Doi: Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas Estas pruebas implican el testeo de las drogas en animales y su estudio en seres humanos, sanos o enfermos.

View on dx. I call this the democratic reciprocity model. It would not be sufficient to obtain approval from the REC of the biobank which has not yet been authorized until the special regimen for provision of samples by biobanks is approved.. As mentioned, consent to storage of samples in a biobank must be clearly separated from consent to participation in the study, and it must be possible to provide consent independently eg, by marking separate checkboxes.

Study participants must receive guarantees that the samples will be handled and used responsibly and confidentially..

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

Evaluation of research projects has centered mainly on the assessment of those ethical and legal considerations related to the information given to the patient and the provision of informed consent. The evaluation is mainly carried out electronically, thereby reducing the mean time from receipt of the application to provision of a final report.. Our experience shows that healthcare professionals need to have greater awareness of the rights of individuals who participate in biomedical research.

In particular, they need to be active in protecting the right to autonomy. Therefore ethics committees have an important role to play in promoting ethical practices in biomedical research and in identifying solutions to ensure that the interests of researchers and society do not take precedence over the rights of the participants.. We are grateful to the members of the REC for their selfless work in the careful and exhaustive review of the research projects submitted to them..

Corresponding author: Avda. Home Articles in press Current Issue Archive. ISSN: Previous article Next article. Issue 6. Pages June Download PDF. Corresponding author. This item has received. Article information. Introduction and objectives Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples.

The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects. Methods A descriptive study of the observations made on research projects registered between June 1, and June 30, Results About two thirds of the projects evaluated in this period needed some type of amendment. The remaining observations involved incomplete or incorrect documentation, or requests for additional information. Conclusions The largest number of observations related to the autonomy of research participants.

Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research. Palabras clave:. Such research includes the collection, donation, and use of cells, tissues, and organs for research purposes. The RECs must therefore be in a position to help identify appropriate ways in which to balance the interests of research against the need to protect the rights of study participants, and ultimately to work towards meaningful advances in science that remain adapted to the needs of society.

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The committee for the evaluation of research involving human subjects is currently made up of 9 members from a range of specialties: medicine, bioethics, nursing, epidemiology, and philosophy, as well as social work as a lay member of the committee. Due to the nature of the institute as a public research organization, and to the number of foundations it supports, the committee receives a large number of studies involving the use of biological samples, many of which were stored and collected prior to the introduction of the LBR or that have been obtained from other centers.

To this end, all of the research projects submitted to the committee for approval during that period were analyzed.


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The number of versions presented for each protocol was recorded along with the mean time taken until approval. The observations were initially grouped into 3 blocks according to their relationship with: 1.

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Defects in the supporting documentation. Requests for more information on a specific aspect of the project. These included protection of privacy and confidentiality; information on rights to access, correct, cancel, or oppose personal data, and the procedures to exercise those rights; and the right to know the results of the research and to consent to the donation of biological samples and data.

When disagreements occurred, the committee secretary indicated those points of disagreement and facilitated discussion in order to reach agreement on the response to be given to the investigator. If observations were made on the project, a response to the investigator containing proposals for improvement was prepared.

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The same procedure is followed when an investigator has a direct relationship with a member of the committee. Discrete variables were expressed as percentages or, when the spread of the data was large, as median interquartile range. Results During the period analyzed, 66 projects were registered: 32 during and 34 during Relating to the principle of autonomy Relating to the principles of beneficence and nonmaleficence 50 Incomplete documentation 41 Request for additional information regarding a specific aspect of the project 21 7.

Informed Consent. Absence of informed consent form 6 6. Lack of specificity in the informed consent form 17 Lack of information relating to participation of the subject in the study 14 Clarification regarding the type of samples, their consequences, and provision of genetic counseling 8 8.

Of note are the observations made regarding the requirement for specific consent to donate samples to third parties from nonaccredited biobanks 3 projects Table 3. Guarantees of confidentiality 19 Failure to indicate the participant's right to know the results and the procedure to follow to receive that information 9 Description of the procedures to follow to exercise the rights of access, correction, cancellation, and opposition 27 Provision of samples to third parties by unaccredited biobanks 3 5. Finally, in 2 studies the care of the patients could have been adversely affected by research interests; in these cases the investigators were reminded of their responsibility in this area.

Discussion The LBR serves as a reference point for all types of research, not only that involving clinical trials of drugs. Independent evaluation of the scientific merit of a research project, its compliance with state legislation, and its ethical acceptability are essential to guarantee that these principles are respected. In practical terms, these principles are applied by assessing the risk-benefit ratio, informed consent procedure, selection of samples, and protection of confidentiality.

Most of the observations made by the REC were related to the principle of autonomy, mainly the provision of informed consent, but also regarding the principles of beneficence and nonmaleficence. This is of particular importance in research involving children or vulnerable adults. If irreversibly disassociated anonymized data are used, the participants should be informed of this and the implication that the information will no longer be identifiable in the future explained; again, they must consent to this use.

This explains, for instance, why participants may be informed of all of the rights of the donor without providing details on how to exercise those rights or who to contact in order to withdraw their samples, or the finding that the consent form does not provide options or checkboxes in which to indicate decisions. In all cases, unconditional consent or a lack of direct indication on the form would be unacceptable. Nevertheless, the LBR recognizes the possibility of use without consent if samples have previously been anonymized second transitory disposition of the LBR , and this option has therefore also been offered to investigators.

In other words, provision of samples requires approval of the specific project or line of research for which the samples are requested by the ethics committee of the center in which the samples were obtained. It would not be sufficient to obtain approval from the REC of the biobank which has not yet been authorized until the special regimen for provision of samples by biobanks is approved.

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