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El presente trabajo tiene por objeto abordar, desde las áreas de la Ética y el Derecho, el alcance de una de las biotecnologías que más impacto está generando en la literatura ante su potencial aplicación clínica. Ello obedece a las infinitas posibilidades que promete la edición de genes, y, más concretamente, su afamada herramienta CRISPR/Cas9, entre las que destaca la reparación de enfermedades graves en células germinales humanas, pudiendo evitar su eventual transmisión a los descendientes. No obstante, podría, como titula acertadamente una de las múltiples obras coordinadas y co-redactadas por nuestro maestro, el Profesor Romeo Casabona, ir “más allá de la salud”, dando lugar a reminiscencias eugenésicas, y que vendrían representadas por medio de la mejora humana. Consecuentemente, se analizará, por un lado, la aceptabilidad desde el punto de vista ético de la terapia génica frente a la mejora, en ponderación con los principios bioéticos de autonomía, beneficencia, no maleficencia y justicia; y, por otro, la afectación que para los derechos fundamentales pudiera suponer su uso indiscriminado, muy especialmente, en cuanto a la dignidad humana, igualdad e identidad, así como al patrimonio genético inalterado y las responsabilidades para con las generaciones futuras, y de los que el Profesor Romeo ha sido pionero en alertar.

To conduct of scientific research involving human beings, their biological samples and/or their personal and health data, requires knowledge of the requirements and obligations established, both from an ethical and legal point of view. Ethical guidelines are a prerequisite for regulation in this area, while, at the same time, allowing the law to adapt to new scientific realities. However, while ethical guiding principle constitutes a voluntarily acceptable guide, laws establish mandatory rules and their nonobservance may give rise to legal liability on the part of scientists. In any case, scientific progress and the improvement of knowledge of diseases must be developed with respect for the people under study establishing the necessary guarantees. So that, their involvement in research must carried out bearing in mind, among other issues: safety, confidentiality, beneficence, and risk minimization. The chapter has attempted to highlight the most relevant issues from an ethical and legal perspective in biomedical research. The sections into which the chapter is structured are: The Relationship Between Ethics and Law, Ethical Principles and Research Ethics Committees, The Regulatory Framework for Biomedical Research, and The New Regulatory Framework for the Protection of Personal Data and New Technologies and Research with Health Data.

Human germline gene editing has ignited wide-ranging debates on the ethical and legal issues involved. The text of the Oviedo Convention is particularly relevant here, as it remains the only international legally binding instrument on the protection of human rights in the biomedical field which considers human genome modification. However, it is often misinterpreted. Indeed, most of the academic literature assumes that Article 13 forbids germline gene editing. This article seeks to demonstrate that this belief is mistaken. To this purpose, it develops a general analysis of the Convention, its Explanatory Report, and its historical background. As a result, it argues that the Convention does not veto genetic editing for basic research purposes, but only its clinical application on human embryos to be transferred into a womb. Nevertheless, it recommends a revision of the clause according to the original intention of the Convention.

The health and genetic data of deceased people are a particularly important asset in the field of biomedical research. However, in practice, using them is compli- cated, as the legal framework that should regulate their use has not been fully developed yet. The General Data Protection Regulation (GDPR) is not applicable to such data and the Member States have not been able to agree on an alternative regulation. Recently, normative models have been proposed in an attempt to face this issue. The most well- known of these is posthumous medical data donation (PMDD). This proposal supports an opt-in donation system of health data for research purposes. In this article, we argue that PMDD is not a useful model for addressing the issue at hand, as it does not consider that some of these data (the genetic data) may be the personal data of the living relatives of the deceased. Furthermore, we find the reasons supporting an opt-in model less convincing than those that vouch for alternative systems. Indeed, we propose a normative framework that is based on the opt-out system for non-personal data combined with the application of the GDPR to the relatives’ personal data.

Gene editing is a particularly attractive subject in the Spanish context because it was precisely a scientist of this nationality -Professor Juan Francisco Martinez Mojica, at the University of Alicante-, who was the first to name and identify the function of this region of DNA present in some bacteria and archeas that acts as an immune mechanism against viruses and which has given rise to the gene editing technique known as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats). Martinez Mojica discovered that some bacteria and archeas were able to identify and “cut” the DNA segments of the attacking viruses, incorporating them into their own genetic make-up. In this way they could recognize and degrade the specific DNA sequences of the virus against future attacks, a defense that could be inherited by the next generation of bacteria. It was this discovery that laid the foundations for the “genetic editing revolution”.

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