Recontacting participants for expanded uses of existing samples and data: A case study

Genetics in Medicine

Volumn 19, Issue 8, 2017, Pages 883-889

  Chen, Stephanie C ^a   Berkman, Benjamin E ^a,b   Hull, Sara Chandros ^a,b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

Author keywords

Biobank research; Biospecimen research; Data sharing; Research ethics; Secondary uses

Indexed keywords

ADULT; ARTICLE; CASE STUDY; CHILD; COHORT ANALYSIS; CONFUSION; CONTROLLED STUDY; DATA PROCESSING; DATA SHARING; DESCRIPTIVE RESEARCH; FRUSTRATION; GENOMICS; HUMAN; INFORMED CONSENT; QUALITATIVE RESEARCH; RESEARCH ETHICS; RETROSPECTIVE STUDY; SEMI STRUCTURED INTERVIEW; DUTY TO RECONTACT; FEASIBILITY STUDY; GENETICS; INFORMATION DISSEMINATION; PATIENT PARTICIPATION; RARE DISEASE;

ADULT; CHILD; DUTY TO RECONTACT; FEASIBILITY STUDIES; GENETIC RESEARCH; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; PATIENT PARTICIPATION; RARE DISEASES; RETROSPECTIVE STUDIES;

EID: 85020590199     PISSN: 10983600     EISSN: 15300366     Source Type: Journal    
DOI: 10.1038/gim.2016.207     Document Type: Article

References (27)

1. Manolio TA. Cohort studies and the genetics of complex disease. Nat Genet 2009;41:5-6.
2. Collins FS, Manolio TA. Merging and emerging cohorts: necessary but not sufficient. Nature 2007;445:259.
3. Sawyer SL, Hartley T, Dyment DA, et al.; FORGE Canada Consortium; Care4Rare Canada Consortium. Utility of whole-exome sequencing for those near the end of the diagnostic odyssey: time to address gaps in care. Clin Genet 2016;89:275-284.
4. Tabor HK, Berkman BE, Hull SC, Bamshad MJ. Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics research. Am J Med Genet A 2011;155A:2916-2924.
5. Giesbertz NA, Bredenoord AL, van Delden JJ. When children become adults: should Biobanks re-contact? PLoS Med 2016;13:e1001959.
6. McCarty CA, Chapman-Stone D, Derfus T, Giampietro PF, Fost N; Marshfield Clinic PMRP Community Advisory Group. Community consultation and communication for a population-based DNA biobank: the Marshfield clinic personalized medicine research project. Am J Med Genet A 2008;146A: 3026-3033.
7. Tassé AM, Budin-Ljøsne I, Knoppers BM, Harris JR. Retrospective access to data: the ENGAGE consent experience. Eur J Hum Genet 2010;18:741-745.
8. Vayena E, Ganguli-Mitra A, Biller-Andorno N. Guidelines on biobanks: emerging consensus and unresolved controversies. In: Elger B, Biller-Andorno N, Mauron A, Capron AM (eds). Ethical Issues in Governing Biobanks: Global Perspectives. Ashgate Publishing: Aldershot, UK, 2008:23-36.
9. Florida Atlantic University. Guidance on Use of Secondary Data for Research. https://www.fau.edu/research/research-integrity/files/Guidance- Secondary%20Data%20Analyses-February%202016%20.pdf. Accessed 31 May 2016.
10. Cote ML, Harrison MJ, Wenzlaff AS, Schwartz AG. Re-contacting participants for inclusion in the database of Genotypes and Phenotypes (dbGaP): Findings from three case-control studies of lung cancer. Genome Med 2014;6:54.
11. Knoppers BM, Abdul-Rahman MH. Biobanks in the literature. In Elger B, Biller- Andorno N, Mauron A, Capron AM (eds). Ethical Issues in Governing Biobanks: Global Perspectives. Ashgate Publishing: Aldershot, UK, 2008:13-22.
12. US Department of Health and Human Services. Protection of human subjects. 45 CFR § 46 (2005).
13. Wendler DS, Rid A. Genetic research on biospecimens poses minimal risk. Trends Genet 2015;31:11-15.
14. Bathe OF, McGuire AL. The ethical use of existing samples for genome research. Genet Med 2009;11:712-715.
15. National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance. National Bioethics Advisory Commission: Rockville, MD, 1999.
16. US Department of Health and Human Services. Federal policy for the protection of human subjects: proposed rules. Fed Regist 2015;80:53933-54061.
17. Yin RK. Case Study Research: Design and Methods. Sage Publications: Thousand Oaks, CA, 2013.
18. National Institutes of Health. National Institutes of Health Genomic Data Sharing Policy. 2014. https://gds.nih.gov/PDF/NIH-GDS-Policy.pdf. Accessed 31 May 2016.
19. Hansson MG. Building on relationships of trust in biobank research. J Med Ethics 2005;31:415-418.
20. Sandelowski M. Whatever happened to qualitative description? Res Nurs Health 2000;23:334-340.
21. Lincoln YS, Guba EG. Naturalistic Inquiry. Sage Publications: Thousand Oaks, CA, 1985.
22. Rare Disease Protocol. Consent Forms. 2008-2014.
23. National Human Genome Research Institute Institutional Review Board. Review of Amendment [minutes]. 3 September 2014.
24. Rare Disease Protocol. Investigator Records. 2014.
25. Claes E, Evers-Kiebooms G, Boogaerts A, Decruyenaere M, Denayer L, Legius E. Communication with close and distant relatives in the context of genetic testing for hereditary breast and ovarian cancer in cancer patients. Am J Med Genet A 2003;116A:11-19.
26. Beskow LM, Burke W. Offering individual genetic research results: context matters. Science Translat Med 2010;2:38cm20.
27. Vellinga A, Cormican M, Hanahoe B, Bennett K, Murphy AW. Opt-out as an acceptable method of obtaining consent in medical research: a short report. BMC Med Res Methodol 2011;11:1-4.