Comparing different scientific approaches to personalized medicine: Research ethics and privacy protection

Personalized Medicine

Volumn 8, Issue 4, 2011, Pages 437-444

  Langanke, Martin ^a   Brothers, Kyle B ^b   Erdmann, Pia ^a   Weinert, Jakob ^a   Krafczyk Korth, Janina ^a   Dörr, Marcus ^c   Hoffmann, Wolfgang ^a   Kroemer, Heyo K ^a   Assel, Heinrich ^a  

^a UNIVERSITY OF GREIFSWALD   (Germany)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY MEDICINE GREIFSWALD   (Germany)

Author keywords

biorepositories; personalized medicine; research ethics; research regulation

Indexed keywords

BIOLOGICAL MARKER; BIOMATERIAL;

BLOOD SAMPLING; CLINICAL DATA REPOSITORY; ELECTRONIC MEDICAL RECORD; GENETIC ANALYSIS; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL INFORMATION; PATIENT ASSESSMENT; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PRIVACY; RESEARCH ETHICS; REVIEW;

EID: 79960945053     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.11.34     Document Type: Review

References (23)

1. Golubnitschaja O. Predictive Diagnostics and Personalized Treatment: dream or reality. Golubnitschaja O (Ed.).Nova Biomedical Books, NY, USA (2009).
2. Niederlag W, Lemke H, Golubnitschaja O, Rienhoff O: Personalisierte Medizin. Health Academy, Wissenschaftliche Buchreihe zur Hochtechnologiemedizin, Dresden, Germany, 14 (2010).
3. Hüsing B, Hartig J, Bührlen B, Reiß T, Gaisser S. Individualisierte Medizin und Gesundheitssystem. Büro für Technikfolgen-abschätzung beim deutschen Bundestag Arbeitsbericht, 126 (2008).
4. Trusheim MR, Berndt ER, Douglas FL. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat. Rev. Drug Discov. 6(4), 287-293 (2007). (Pubitemid 46505879)
5. Kettis-Lindblad A, Ring L, Viberth E, Hansson MG. Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think? Eur. J. Public Health 16(4), 433-440 (2006). (Pubitemid 44310264)
6. Federal Register: 45 CFR §46.102(f ) Definitions.
7. Office for Human Research Protection: Guidance on research involving coded private information or biological specimens. Department of Health and Human Services 45 CFR part 46 (2004).
8. Roden DM, Pulley JM, Basford MA et al. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin. Pharmacol. Ther. 84(3), 362-369 (2008).
9. Brothers KB, Clayton EW. 'Human non-subjects research': privacy and compliance. Am. J. Bioeth. 10(9), 15-17 (2010).
10. Denny JC, Ritchie MD, Basford MA et al. PheWAS: demonstrating the feasibility of a phenome-wide scan to discover gene-disease associations. Bioinformatics 26(9), 1205-1210 (2010).
11. Ritchie MD, Denny JC, Crawford DC et al. Robust replication of genotype-phenotype associations across multiple diseases in an electronic medical record. Am. J. Hum. Genet. 86(4), 560-572 (2010).
12. Pulley JM, Brace MM, Bernard GR, Masys DR. Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank. 9(1), 55-65 (2008). (Pubitemid 351279801)
13. Brothers KB, Clayton EW, Morrison DR, Pulley JM, Masys DR. Acceptability of an opt-out pediatric biobank based on electronic medical record and residual blood samples. Presented at: Pediatric Academic Societies, Vancouver, British Columbia, Canada 1-4 May 2010.
14. Ryan KJ, Brady JV, Cooke RE et al. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. US Department of Health, Education, and Welfare, Washington, DC, USA (1979).
15. Pulley JM, Clayton E, Bernard GR, Roden DM, Masys DR. Principles of human subjects protections applied in an opt-out, de-identified biobank. Clin. Transl. Sci. 3(1), 42-48 (2010).
16. Harnischmacher U, Ihle P, Berger B, Goebel J, Scheller J. Checkliste und Leitfaden zur Patienteneinwilligung: Grundlagen und Anleitung für die klinische Forschung. Medizinisch wissenschaftliche Verlagsgesellschaft, Berlin, Germany (2006).
17. Reng CM, Debold P, Adelhard K, Pommerening K. Generische lösungen der TMF zum datenschutz für die forschungsnetze in der medizin. Medizinisch wissenschaftliche verlagsgesellschaft, Berlin, Germany (2006).
18. Simon JW, Paslack R, Robienski J, Goebel JW, Krawczak M: Biomaterialbanken- Rechtliche Rahmenbedingungen. Medizinisch Wissenschaftliche Verlagsgesellschaft, Berlin, Germany (2006).
19. Langanke M, Erdmann P. Die MRT als wissenschaftliche Studienuntersuchung und das Problem der Mitteilung von Zufallsbefunden, Probandenethische Herausforderungen. In: Tragfähige Rede von Gott, Festgabe für Heinrich Assel zum 50. Geburtstag am 9. Februar 2011. Theissen H, Langanke M (Eds).Verlag Dr. Kovac Hamburg, Germany (2011)
20. Heinemann T, Hoppe C, Listl S, Spickhoff A, Elger CE. Zufallsbefunde bei bildgebenden Verfahren in der Hirnforschung: Ethische Überlegungen und Lösungsvorschläge. Deutsches Ärzteblatt 104(3), 1982-1987 (2007).
21. Wolf SM, Lawrenz FP, Nelson CA et al. Managing incidental findings in human subjects research: analysis and recommendations. J. Law Med. Ethics 36(2), 219-248 (2008).
22. Junghans C, Feder G, Hemingway H, Timmis A, Jones M. Recruiting patients to medical research: double blind randomised trial of 'opt-in' versus 'opt-out' strategies. BMJ 331(7522), 940 (2005).
23. Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ 168(6), 707-708 (2003). (Pubitemid 36363667)