Bringing personalized medicine to people
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AbstractMany financial, organizational, regulatory, ethical and societal challenges may hinder or delay the provision of personalized medicine (PM) to people. PM aims to adapt prevention, diagnosis and treatment to the molecular and genetic characteristics of the individual patient and her disease. The overarching aim of the thesis was to explore the views of researchers, representatives from patient organizations, and policymakers regarding potential challenges to the provision of PM to people. The researchers explained that they often do not have the necessary resources to feedback individual genetic research results to research participants when such results could have been useful in health care settings to provide more targeted care. To this adds the lack of a regulatory framework to provide results in a sustainable manner. Better solutions are also needed to communicate with research participants and manage informed consent. The representatives from patient organizations were supportive of PM but expressed concerns regarding its cost; they feared that PM might be available only to the socio-economically advantaged. They believed that health care professionals and patients have insufficient knowledge of genetics to endorse PM and questioned whether the majority of patients would be able to take greater responsibility for their health. This contrasts with the views of policymakers who view patients and citizens as highly health literate and actively engaged in their own health care. Researchers and representatives from patient organizations proposed several strategies to help address these challenges. Strategies include the design of harmonized guidelines for the feedback of genetic research results to research participants, the development and implementation of dynamic consent procedures, increased education of patients and health care professionals in PM, and the development of sustainable funding mechanisms for PM.
List of papers
|Paper I: Budin-Ljøsne I, Mascalzoni D, Soini S, Machado S, Kaye J, Bentzen HB, Rial-Sebbag E, D'Abramo F, Witt M, Schamps G, Katić V, Krajnovic D, Working Group 1 (COST Action CHIP ME IS1303 “Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives”), Harris JR. Feedback of individual genetic results to research participants: Is it feasible in Europe? Biopreservation and Biobanking. 2016 Jun; 14(3):241-8. The article is included in the thesis. Also available at: http://urn.nb.no/URN:NBN:no-63661|
|Paper II: Budin-Ljøsne I, Harris JR. Ask not what PM can do for you -- ask what you can do for PM. Public Health Genomics. 2015;18 (3):131-8. The article is included in the thesis. Also available at: http://urn.nb.no/URN:NBN:no-52959|
|Paper III: Budin-Ljøsne I, Harris JR. Patient and interest organizations’ views on PM: a qualitative study. BMC Med Ethics. 2016 May 13;17(1):28. The article is included in the thesis. Also available at: http://urn.nb.no/URN:NBN:no-53929|
|Paper IV: Budin-Ljøsne I, Teare HJA, Kaye J, Beck S, Bentzen HB, Caenazzo L, Collett C, D’Abramo F, Felzmann H, Finlay T, Javaid MK, Jones E, Katić V, Simpson A, Mascalzoni D. Dynamic Consent: a potential solution to some of the challenges of modern biomedical research. BMC Med Ethics. 2017 Jan 25;18(1):4. The article is included in the thesis. Also available at: http://urn.nb.no/URN:NBN:no-56812|