Practical implementation issues and challenges for biobanks in the return of individual research results

Genetics in Medicine

Volumn 14, Issue 4, 2012, Pages 478-483

  Bledsoe, Marianna J ^a   Grizzle, William E ^b   Clark, Brian J ^c   Zeps, Nikolajs ^d,e  

^a DEPARTMENT OF VETERANS AFFAIRS   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c Qatar Biobank for Medical Research   (Qatar)

^d ST JOHN OF GOD HOSPITAL   (Australia)

^e UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

Author keywords

biobanks; implementation challenges; policy; research results; return

Indexed keywords

BIOBANK; BIOETHICS; CLINICAL LABORATORY; CONFIDENTIALITY; COST; FUNDING; HEALTH CARE FACILITY; HEALTH CARE POLICY; HUMAN; LEGAL LIABILITY; PRIVACY; PUBLIC HEALTH; QUALITY CONTROL; RESEARCH; RESEARCH ETHICS; REVIEW; VALIDITY;

EID: 84859625509     PISSN: 10983600     EISSN: 15300366     Source Type: Journal    
DOI: 10.1038/gim.2011.67     Document Type: Review

References (40)

1. National Heart, Lung and Blood Institute and Boston University. Framingham Heart Study. http://www.framinghamheartstudy.org/. Accessed 30 November 2011.
2. National Cancer Institute. Cooperative Human Tissue Network. http://chtn. nci.nih.gov/. Accessed 30 November 2011.
3. Leyland-Jones BR, Ambrosone CB, Bartlett J, et al.; Breast International Group; Cooperative Groups of the Breast Cancer Intergroup of North America (TBCI); American College of Surgeons Oncology Group; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cancer Treatment Group; National Cancer Institute of Canada Clinical Trials Group; Southwest Oncology Group; National Surgical Adjuvant Breast and Bowel Project; Radiation Oncology Group; Gynecologic Oncology Group; Children's Oncology Group. Recommendations for collection and handling of specimens from group breast cancer clinical trials. J Clin Oncol 2008;26:5638-5644.
4. Ollier W, Sprosen T, Peakman T. UK Biobank: from concept to reality. Pharmacogenomics 2005;6:639-646.
5. Wolf SM, Lawrenz FP, Nelson CA, et al. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 2008;36:219-248, 211.
6. Fabsitz RR, McGuire A, Sharp RR, et al.; National Heart, Lung, and Blood Institute working group. Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group. Circ Cardiovasc Genet 2010;3:574-580.
7. National Cancer Institute Office of Biorepositories and Biospecimen Research. NCI Workshop on Release of Research Results to Participants in Biospecimen Studies. http://biospecimens.cancer.gov/resources/publications/ workshop/rrra.asp. Accessed 30 November 2011.
8. ISBER. ISBER 2011 Annual Meeting & Exhibits. http://www.isber.org/ mtgs/2011/program.html. Accessed 30 November 2011.
9. University of Minnesota. "Should We Return Individual Research Results and Incidental Findings from Genomic Biobanks & Archives?" http://www.lifesci.consortium.umn.edu/conferences/2011-ifbb/agenda. Accessed 30 November 2011.
10. Kaye J. Do we need a uniform regulatory system for biobanks across Europe? Eur J Hum Genet 2006;14:245-248. (Pubitemid 43135869)
11. ISBER best practices for repositories: collection storage, retrieval, and distribution of biological materials for research. Cell Preserv Technol 2008;6:5-58.
12. Ravitsky V, Wilfond BS. Disclosing individual genetic results to research participants. Am J Bioeth 2006;6:8-17. (Pubitemid 44691474)
13. Beskow LM, Burke W. Offering individual genetic research results: context matters. Science Translational Medicine 2010;2(38):1-5.
14. Forsberg JS, Hansson MG, Eriksson S. Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results. Eur J Hum Gen 2009;17:1544-1549.
15. Clayton EW, Ross LF. Implications of disclosing individual results of clinical research. JAMA 2006;295:37; author reply 37-38.
16. Allen C, Foulkes WD. Qualitative thematic analysis of consent forms used in cancer genome sequencing. BMC Med Ethics 2011;12:14.
17. Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public expectations for return of results from large-cohort genetic research. Am J Bioeth 2008;8:36-43.
18. O'Daniel J, Haga SB. Public perspectives on returning genetics and genomics research results. Public Health Genomics 2011:14;346-355.
19. Beskow LM, Smolek SJ. Prospective biorepository participants' perspectives on access to research results. J Empir Res Hum Res Ethics 2009;4:99-111.
20. Bovenberg J, Meulenkamp T, Smets E, Gevers S. Biobank research: reporting results to individual participants. Eur J Health Law 2009;16:229-247.
21. Kaphingst KA, Janoff JM, Harris LN, Emmons KM. Views of female breast cancer patients who donated biologic samples regarding storage and use of samples for genetic research. Clin Genet 2006;69:393-398.
22. Meulenkamp TM, Gevers SK, Bovenberg JA, Koppelman GH, van Hylckama Vlieg A, Smets EM. Communication of biobanks' research results: what do (potential) participants want? Am J Med Genet A 2010;152A:2482-2492.
23. Wagar EA, Stankovic AK, Raab S, Nakhleh RE, Walsh MK. Specimen labeling errors: a Q-probes analysis of 147 clinical laboratories. Arch Pathol Lab Med 2008;132:1617-1622.
24. Grizzle WE, Sexton KC, Bell WC. Quality Assurance in Tissue Resources Supporting Biomedical Research. Cell Preserv Technol 2008;6:113-118.
25. Moore HM, Kelly A, Jewell SD, et al. Biospecimen Reporting for Improved Study Quality. Biopreserv Biobank 2011;9:57-70.
26. Centers for Disease Control and Prevention (CDC). Current CLIA Regulations. http://wwwn.cdc.gov/clia/regs/toc.aspx. Accessed 30 November 2011.
27. National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999). http:// bioethics.georgetown.edu/nbac/pubs.html. Accessed 30 November 2011.
28. Caulfield T, McGuire AL, Cho M, et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol 2008;6:e73.
29. Gosselin PG. Duke settles misdiagnosis in cancer case. Boston Globe 5 October 1989, p 89.
30. Reich ES. Missing part delays space mission. Nature 2011;469:280.
31. Dressler LG. Biobanking and disclosure of research results: addressing the tension between professional boundaries and moral intuition. In: Solbakk JH, et al. (eds). The Ethics of Research Biobanking. Springer: New York, 2009;85-99.
32. Christensen KD, Roberts JS, Shalowitz DI, et al. Disclosing individual CDKN2A research results to melanoma survivors: interest, impact, and demands on researchers. Cancer Epidemiol Biomarkers Prev 2011;20:522-529.
33. National Health and Medical Research Council. Australian Prostate Cancer Bio-Resource. http://www.apccbioresource.org.au/. Accessed 30 November 2011.
34. Zeps N, Iacopetta BJ, Schofield L, George JM, Goldblatt J. Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights? Med J Aust 2007;186:88-90. (Pubitemid 46178823)
35. Clayton EM. Incidental findings in genetics research using archived DNA. J Law Med Ethics 2008;286-291.
36. Beskow LM. Considering the nature of individual research results. Am J Bioeth 2006;6:38-40; author reply W10-12.
37. Haga SB, Beskow LM. Ethical, legal, and social implications of biobanks for genetics research. Adv Genet 2008;60:505-544.
38. Australian Government National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research 2007 - Updated 2009. http://www.nhmrc.gov.au/guidelines/publications/e72. Accessed 30 November 2011.
39. Beskow LM, Burke W, Merz JF, et al. Informed consent for population-based research involving genetics. JAMA 2001;286:2315-2321. (Pubitemid 33063154)
40. Shalowitz DI, Miller FG. Disclosing individual results of clinical research: implications of respect for participants. JAMA 2005;294:737-740. (Pubitemid 41159294)