Ethical review of biobank research: Should RECs review each release of material from biobanks operating under an already-approved broad consent and data protection model?

European Journal of Medical Genetics

Volumn 58, Issue 10, 2015, Pages 545-549

  Strech, Daniel ^a  

^a HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

Access committee; Approval; Biobank; Biospecimens; Broad consent; Data access; Ethics review; Research ethics committee

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; BIOBANK; COST CONTROL; DEMOGRAPHY; GENE SEQUENCE; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; MEDICAL INFORMATICS; MEDICAL RESEARCH; MODEL; PROFESSIONAL PRACTICE; PROFESSIONAL STANDARD; PROTECTION; RESEARCH ETHICS; RISK; TISSUE SECTION; ADVISORY COMMITTEE; COMPUTER SECURITY; ETHICS; LEGISLATION AND JURISPRUDENCE; STANDARDS;

ADVISORY COMMITTEES; BIOLOGICAL SPECIMEN BANKS; COMPUTER SECURITY; INFORMED CONSENT;

EID: 84945969612     PISSN: 17697212     EISSN: 18780849     Source Type: Journal    
DOI: 10.1016/j.ejmg.2015.09.008     Document Type: Article

References (27)

1. Antes A.L., Wang X., Mumford M.D., Brown R.P., Connelly S., Devenport L.D. Evaluating the effects that existing instruction on responsible conduct of research has on ethical decision making. Acad. Med. 2010, 85:519-526.
2. Budimir D., Polasek O., Marusic A., Kolcic I., Zemunik T., Boraska V., Jeroncic A., Boban M., Campbell H., Rudan I. Ethical aspects of human biobanks: a systematic review. Croat. Med. J. 2011, 52:262-279.
3. Burke W., Diekema D.S. Ethical issues arising from the participation of children in genetic research. J. Pediatr. 2006, 149:S34-S38.
4. Capron A.M., Mauron A., Elger B.S., Boggio A., Ganguli-Mitra A., Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst. Ethics J. 2009, 19:101-124.
5. Danis M., Largent E., Wendler D., Hull S.C., Shah S., Millum J., Berkman B., Grady C. Research Ethics Consultation. A Casebook 2012, Oxford University Press, New York.
6. Elger B., Biller-Andorno N., Mauron A., Capron A. Ethical Issues in Governing Biobanks 2008, Ashgate Publishing Limited, London.
7. Emanuel E.J., Wendler D., Grady C. What makes clinical research ethical?. J. Am. Med. Assoc. 2000, 283:2701-2711.
8. Emanuel E.J., Wendler D., Grady C. An ethical framework for biomedical research. The Oxford Textbook of Clinical Research Ethics 2008, 123-135. Oxford University Press, Oxford. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, D. Wendler (Eds.).
9. Ethikrat Deutscher Biosicherheit - Freiheit und Verantwortung in der Wissenschaft 2014, Berlin.
10. Gymrek M., McGuire A.L., Golan D., Halperin E., Erlich Y. Identifying personal genomes by surname inference. Science 2013, 339:321-324.
11. Harmon A. Tribal Genes and a Fair Settlement; 27.4.2010 2010, A22. N. Y. Times.
12. Hirschberg I., Knuppel H., Strech D. Practice variation across consent templates for biobank research. a survey of German biobanks. Front. Genet. 2013, 4:240.
13. Hirschberg I., Kahrass H., Strech D. International requirements for consent in biobank research: qualitative review of research guidelines. J. Med. Genet. 2014, 51:773-781.
14. International Society for Biological and Environmental Reposotories (ISBER) 2012 best practices for repositories collection, storage, retrieval, and distribution of biological materials for research international society for biological and environmental repositories. Biopreserv Biobank 2012, 10:79-161.
15. McCarthy C.R. The origins and policies that govern institutional review boards. The Oxford Textbook of Clinical Research Ethics 2008, 541-551. Oxford University Press, Oxford. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, D. Wendler (Eds.).
16. Meslin E.M. The value of using top-down and bottom-up approaches for building trust and transparency in biobanking. Public Health Genomics 2010, 13:207-214.
17. National Cancer Research Institute (NCRI) Samples and Data for Research: Template for Access Policy Development 2009.
18. NCRI Samples and Data for Research: Template for Access Policy Development 2009, National Cancer Research Institute.
19. P3G Model Framework for Access Policy: Core Elements 2013, Public Population Project in Genomics and Society (P3G).
20. Rodriguez L.L., Brooks L.D., Greenberg J.H., Green E.D. Research ethics. The complexities of genomic identifiability. Science 2013, 339:275-276.
21. Schmidt H., Callier S. How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system for genetic samples. J. Med. Ethics 2012, 38:304-309.
22. Shaw J.L., Robinson R., Starks H., Burke W., Dillard D.A. Risk, reward, and the double-edged sword: perspectives on pharmacogenetic research and clinical testing among Alaska native people. Am. J. Public Health 2013, 103:2220-2225.
23. Spece R.G., Shimm D.S., Buchanan A. Conflicts of Interest in Clinical Practice and Research 1996, Oxford University Press, New York.
24. Verlinden M., Nys H., Ectors N., Huys I. Access to biobanks: harmonization across biobank initiatives. Biopreserv Biobank 2014, 12:415-422.
25. Wiesing U. Die Ethik-kommissionen 2003, Deutscher Arzte-Verlag, Berlin.
26. WMA WMA Declaration on Ethical Considerations Regarding Health Databases and Biobanks, 2015-03-18 2015, A Draft from the Work Group Intended for Open Consultation after Acceptance of the Executive Committee of the WMA, World Medical Association.
27. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 2013, Fortaleza.