Plasma Proteomes Can Be Reidentifiable and Potentially Contain Personally Sensitive and Incidental Findings.

The goal of clinical proteomics is to identify, quantify, and characterize proteins in body fluids or tissue to assist diagnosis, prognosis, and treatment of patients. In this way, it is similar to more mature omics technologies, such as genomics, that are increasingly applied in biomedicine. We argue that, similar to those fields, proteomics also faces ethical issues related to the kinds of information that is inherently obtained through sample measurement, although their acquisition was not the primary purpose. Specifically, we demonstrate the potential to identify individuals both by their characteristic, individual-specific protein levels and by variant peptides reporting on coding single nucleotide polymorphisms. Furthermore, it is in the nature of blood plasma proteomics profiling that it broadly reports on the health status of an individual-beyond the disease under investigation. Finally, we show that private and potentially sensitive information, such as ethnicity and pregnancy status, can increasingly be derived from proteomics data. Although this is potentially valuable not only to the individual, but also for biomedical research, it raises ethical questions similar to the incidental findings obtained through other omics technologies. We here introduce the necessity of-and argue for the desirability for-ethical and human-rights-related issues to be discussed within the proteomics community. Those thoughts are more fully developed in our accompanying manuscript. Appreciation and discussion of ethical aspects of proteomic research will allow for deeper, better-informed, more diverse, and, most importantly, wiser guidelines for clinical proteomics.

Beyond Genes: Re-Identifiability of Proteomic Data and Its Implications for Personalized Medicine.

The increasing availability of high throughput proteomics data provides us with opportunities as well as posing new ethical challenges regarding data privacy and re-identifiability of participants. Moreover, the fact that proteomics represents a level between the genotype and the phenotype further exacerbates the situation, introducing dilemmas related to publicly available data, anonymization, ownership of information and incidental findings. In this paper, we try to differentiate proteomics from genomics data and cover the ethical challenges related to proteomics data sharing. Finally, we give an overview of the proposed solutions and the outlook for future studies.

Clasificación del sujeto de derecho frente al avance de la genómica y la procreática / Subjects of rights classification facing genomic and proteomic development / Classificação do sujeito de direito contra o avanço da genômica e da procriativa

Resumen: El Derecho cataloga la vida humana de acuerdo al estado con el cual se presenta en sociedad con la finalidad de darle una adecuada seguridad. La teoría del sujeto de derecho se sustenta en la conceptualización jurídica de la vida humana. Como teoría, fue creada para reconocer una real y efectiva regulación jurídica a las relaciones que lleve a cabo el hombre en la sociedad, tomando en cuenta que la vida humana tiene numerosas formas de presentarse en sociedad. La vida es una, pero -sea biológica o social- adopta diversos estadios que merecen una regulación acorde con su estatus. Es esta esencia y forma como la vida se presenta en sociedad lo que permite categorizarla jurídicamente y de esto se encarga la teoría del sujeto de derecho. De esta forma se regula la vida humana en su verdadera esencia y dimensión; sin embargo, la biotecnología procreática y genómica vienen alterando su clásica taxonomía, variándolo, al presentar nuevos actores en un mundo de relación.

Abstract: Law categorizes human life according to its situation in society with the goal to provide adequate safety. The theory of the subject of rights is based on the juridical conceptualization of human life. As theory, it was created to recognize a real and effective legal regulation to human relations in society, taking into account that human life has many ways to appear in society. Life is one, but -be biological or social- it adopts diverse stages which deserves regulation according to their status. This essence and way in which life is presented allows its juridical categorization by the subject of rights theory. In this way, human life is regulated in its true essence and dimension; nevertheless, genomic and proteomic biotechnology have being altering their classic taxonomy, changing it when presenting new actors in a world of relations.

Resumo: O Direto cataloga a vida humana de acordo com o estado com a qual se apresenta na sociedade com a finalidade de dá-la um nível adequado de segurança. A teoria do sujeito de direito é baseada no conceito jurídico de vida humana. Como teoria, foi criada para reconhecer uma real e efetiva regulação jurídica das relações realizadas pelo homem na sociedade, tendo em conta que a vida humana tem inúmeras maneiras de se apresentar na sociedade. A vida é uma, embora -seja biológica ou social- adota diferentes fases que merecem uma regulação em conformidade com o seu estatuto. É essa essência e forma como a vida surge na sociedade é o que permite categorizá-la juridicamente e disso se encarga a teoria do sujeito do direito. Assim, regula a vida humana na sua verdadeira essência e dimensão; no entanto, a biotecnología procriativa e genômica vem alterando sua taxonomia clássica, variando-a, introduzindo novos atores em um mundo de relações.

On sharing quantitative trait GWAS results in an era of multiple-omics data and the limits of genomic privacy.

Recent advances in genome-scale, system-level measurements of quantitative phenotypes (transcriptome, metabolome, and proteome) promise to yield unprecedented biological insights. In this environment, broad dissemination of results from genome-wide association studies (GWASs) or deep-sequencing efforts is highly desirable. However, summary results from case-control studies (allele frequencies) have been withdrawn from public access because it has been shown that they can be used for inferring participation in a study if the individual's genotype is available. A natural question that follows is how much private information is contained in summary results from quantitative trait GWAS such as regression coefficients or p values. We show that regression coefficients for many SNPs can reveal the person's participation and for participants his or her phenotype with high accuracy. Our power calculations show that regression coefficients contain as much information on individuals as allele frequencies do, if the person's phenotype is rather extreme or if multiple phenotypes are available as has been increasingly facilitated by the use of multiple-omics data sets. These findings emphasize the need to devise a mechanism that allows data sharing that will facilitate scientific progress without sacrificing privacy protection.

Using human samples in proteomics-based drug development: bioethical aspects.

Human samples and related medical data are expected to play an elevated role in application-based biomedical proteomics research. Against this framework, some facts should be kept in mind by academic and industrial researchers: international framework conditions on the use of human samples for research purposes are heterogeneous. For example, the value added by the use of human samples for product development is significant and the patient's personal and property rights may be affected. The body of national laws is growing and these laws are binding; guidelines published by international organizations should be respected. The most important aspect regards the informed consent of the patient, which is addressed in detail.

Estudios farmacogenéticos: guía de evaluación para comités éticos de investigación clínica. Fundamentos científicos y marco legal (I) / Pharmacogenetic studies: evaluation guidelines for research ethics committees. Scientific background and legal framework (I)

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Key roles of government in genomics and proteomics: a public health perspective.

This paper is based on the presentation of Dr. Allan Noonan at the third biennial Asan-Harvard Medical International Symposium on "Genomics and Proteomics: Impact on Medicine and Health" that took place in Seoul, Korea, July 3-4, 2001. Dr. Noonan is a senior advisor to the Surgeon General of the United States and was representing the then Surgeon General, Dr. David Satcher. In this final presentation of the symposium, Dr. Noonan reviews the key roles of government in US health care and discusses several areas where genomic- and proteomic-based information will necessitate changes in the functions of public health. In particular, Dr. Noonan discusses the need for appropriate training to meet the challenges of the genomic future; for sensitivity in the development of policies to address the ethical, legal, and social implications of genomic information; and for dissemination of genomic information to both the professionals and the public. Dr. Noonan concludes with a vision of the genomic future of the next 30 years and a reiteration of the need for partnership among health professionals, educators, and social services professionals.