Impact of the General Data Protection Regulation on Clinical Proteomics Research.

The recently implemented General Data Protection Regulation (GDPR) has promising attributes for ensuring the protection of personal data collected and processed for clinical proteomic investigations. However, there exist ever increasing alarming concerns regarding its implications upon the future of clinical proteomics research both within and beyond the European Union. The main issues of concern regard GDPR legislative requirements for informed consent for study subjects' data collection and processing, data anonymization, and data storage and/or sharing, particularly in research areas which readily utilize databanks and biobanks, such as clinical proteomics investigations. The potential impacts of the aforementioned issues upon on-going and future clinical proteomics investigations are detailed, whilst recommendations for potentially resolving these emerging issues are proposed. Consensus between government, legislative, and research stakeholders, as well as impact assessments of final measures to be applied for medical research, is necessary so as to ensure the favorable perpetuation of clinical proteomics investigations and subsequent impact upon optimal patient health.

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.

Proteomics quality and standard: from a regulatory perspective.

Proteomics has emerged as a rapidly expanding field dealing with large-scale protein analyses. It is anticipated that proteomics data will be increasingly submitted to the U.S. Food and Drug Administration (FDA) for biomarker qualification or in conjunction with applications for the approval of drugs, medical devices, and other FDA-regulated consumer products. To date, however, no established guideline has been available regarding the generation, submission and assessment of the quality of proteomics data that will be reviewed by regulatory agencies for decision making. Therefore, this commentary is aimed at provoking some thoughts and debates towards developing a framework which can guide future proteomics data submission. The ultimate goal is to establish quality control standards for proteomics data generation and evaluation, and to prepare government agencies such as the FDA to meet future obligations utilizing proteomics data to support regulatory decision.

Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.

Issues associated with the translation of complex proteomic biomarkers from discovery to clinical diagnostics have been widely discussed among academic researchers, government agencies, as well as assay and instrumentation manufacturers. Here, we provide an overview of the regulatory framework and type of information that is typically required in order to evaluate in vitro diagnostic tests regulated by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the US Food and Drug Administration (FDA), with the focus on some of the issues specific to protein-based complex tests. Technological points pertaining to mass spectrometry platforms and assessment of potential concerns important for assurance of safety and effectiveness of this type of assays when introduced into clinical diagnostic use, as well as general approaches for evaluating the performance of these devices, are discussed.

The use of genomics and proteomics for the recognition of transplantation rejection of solid organs.

Solid organ transplantation has saved many lives since its first success in 1954. Prior to that landmark day, the greatest obstacle to transplantation success was the recipients rejection of the transplanted organ. Although much has been learned about the immune response to transplant, organ rejection remains a prevalent clinical problem. Recent advances in the fields of genomics and proteomics have opened the door to patented new technologies for detecting rejection episodes in transplanted patients, and are even beginning to prospectively diagnose the risk of rejection based on donor and recipient biomarkers. This report briefly discusses transplant rejection, with highlights of published manuscripts that incorporate current assays utilizing genomic and or proteomic methods to detect rejection, reviews patents that focus on detection or therapy of transplant rejection, and concludes with a prospective discussion of future developments in the field of transplant rejection.

Patent prosecution in structural proteomics.

This paper presents a brief overview of intellectual property rights and the various areas in proteomics to which intellectual property rights may be applicable. Technology transfer, including licensing and business agreements, are not covered in this paper. Instead, issues and complications related to national and overseas patent prosecution in this relatively new field will be discussed.

National Heart, Lung, And Blood Institute Clinical Proteomics Working Group report.

The National Heart, Lung, and Blood Institute (NHLBI) Clinical Proteomics Working Group was charged with identifying opportunities and challenges in clinical proteomics and using these as a basis for recommendations aimed at directly improving patient care. The group included representatives of clinical and translational research, proteomic technologies, laboratory medicine, bioinformatics, and 2 of the NHLBI Proteomics Centers, which form part of a program focused on innovative technology development. This report represents the results from a one-and-a-half-day meeting on May 8 and 9, 2003. For the purposes of this report, clinical proteomics is defined as the systematic, comprehensive, large-scale identification of protein patterns ("fingerprints") of disease and the application of this knowledge to improve patient care and public health through better assessment of disease susceptibility, prevention of disease, selection of therapy for the individual, and monitoring of treatment response.

Ethical and regulatory issues arising from proteomic research and technology.

Over the last two decades, medical research has begun to make extensive use of products of human origin in therapeutics, oncology, and most recently, in genetic diseases. This has raised many ethical issues involving patient rights, including issues of consent. Besides informed consent, researchers should address several topics when designing studies using human tissues. Reward for the patient should be kept minimal. Sample transfer should be organized along non-profit lines, at least in Europe. Sampling procedures should be at no risk for human volunteers, and at minimal risk for patients. Biosafety aspects should be addressed, in particular when international collaborations are intended or when collaboration is existing between academia and industry. Regulations on importation and exportation of human tissues should be observed. Data acquisition and storage should be addressed in accordance with national data protection regulations, in particular when using computerized databases. If follow-up information is to be taken, the authorization for such information should be requested. The right for patient's information (or for no information) on the research results should also be addressed. The issues of validation and patenting should be also solved, usually by informing the patient that he/she will have no commercial rights on potential research results. The patient should be told if the samples are transferred to another research laboratory or private company. Samples and related data should be destroyed on request at any time point during the course of the study. If possible, traceability of the donor should be ensured.

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.