Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US

American Journal of Human Genetics

Volumn 100, Issue 3, 2017, Pages 414-427

  Sanderson, Saskia C ^a,b,c   Brothers, Kyle B ^d   Mercaldo, Nathaniel D ^e   Clayton, Ellen Wright ^f   Antommaria, Armand H Matheny ^g   Aufox, Sharon A ^h   Brilliant, Murray H ⁱ   Campos, Diego ^j   Carrell, David S ^k   Connolly, John ^j   Conway, Pat ^l   Fullerton, Stephanie M ^m   Garrison, Nanibaa’ A ^m,n   Horowitz, Carol R ^c   Jarvik, Gail P ^o   Kaufman, David ^p   Kitchner, Terrie E ⁱ   Li, Rongling ^p   Ludman, Evette J ^k   McCarty, Catherine A ^l   McCormick, Jennifer B ^q   McManus, Valerie D ⁱ   Myers, Melanie F ^g   Scrol, Aaron ^k   Williams, Janet L ^r   Shrubsole, Martha J ^f   Schildcrout, Jonathan S ^e   Smith, Maureen E ^h   Holm, Ingrid A ^s   more..

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b GREAT ORMOND STREET HOSPITAL   (United Kingdom)

^c MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^d University of Louisville School of Medicine   (United States)

^e VANDERBILT UNIVERSITY   (United States)

^f VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^g CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ MARSHFIELD CLINIC   (United States)

^j CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^k GROUP HEALTH RESEARCH INSTITUTE   (United States)

^l ESSENTIA INSTITUTE OF RURAL HEALTH   (United States)

^m UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

ⁿ SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

^o UNIVERSITY OF WASHINGTON   (United States)

^p NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

^q MAYO CLINIC   (United States)

^r GEISINGER HEALTH SYSTEM   (United States)

^s BOSTON CHILDREN S HOSPITAL   (United States)

more..

Author keywords

biobank research; biorepository research; broad consent; data sharing; informed consent; tiered consent

Indexed keywords

ADULT; AGED; ARTICLE; ATTITUDE; BIOBANK; CAUCASIAN; DECISION MAKING; EDUCATIONAL STATUS; ELECTRONIC MEDICAL RECORD; FEMALE; GENOMICS; HEALTH CARE SYSTEM; HUMAN; INFORMATION PROCESSING; MAJOR CLINICAL STUDY; MALE; MEDICAL INFORMATION; PRIORITY JOURNAL; RELIGION; TRUST; ADOLESCENT; CLINICAL TRIAL; CONTROLLED STUDY; ELECTRONIC HEALTH RECORD; ETHICS; HUMAN GENOME; INFORMATION DISSEMINATION; INFORMED CONSENT; MEDICAL RESEARCH; MIDDLE AGED; MULTICENTER STUDY; PRIVACY; PUBLIC OPINION; RANDOMIZED CONTROLLED TRIAL; SOCIOECONOMICS; UNITED STATES; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; ELECTRONIC HEALTH RECORDS; FEMALE; GENOME, HUMAN; GENOMICS; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; MALE; MIDDLE AGED; PRIVACY; PUBLIC OPINION; SOCIOECONOMIC FACTORS; UNITED STATES; YOUNG ADULT;

EID: 85012918005     PISSN: 00029297     EISSN: 15376605     Source Type: Journal    
DOI: 10.1016/j.ajhg.2017.01.021     Document Type: Article

References (53)

1. 1 Manolio, T.A., Rodriguez, L.L., Brooks, L., Abecasis, G., Ballinger, D., Daly, M., Donnelly, P., Faraone, S.V., Frazer, K., Gabriel, S., et al. GAIN Collaborative Research Group Collaborative Association Study of Psoriasis International Multi-Center ADHD Genetics Project Molecular Genetics of Schizophrenia Collaboration Bipolar Genome Study Major Depression Stage 1 Genomewide Association in Population-Based Samples Study, Genetics of Kidneys in Diabetes (GoKinD) Study. New models of collaboration in genome-wide association studies: the Genetic Association Information Network. Nat. Genet. 39 (2007), 1045–1051.
2. 2 Hudson, K., Lifton, R., Patrick-Lake, B., Gonzalez Burchard, E., Coles, T., Collins, R., Conrad, A., Denny, J., Desmond-Hellmann, S., Dishman, E., et al. The Precision Medicine Initiative Cohort Program: Building a Research Foundation for 21st Century Medicine. 2015, National Institutes of Health, Bethesda, MD.
3. 3 Ashley, E.A., The precision medicine initiative: a new national effort. JAMA 313 (2015), 2119–2120.
4. 4 Collins, F.S., Varmus, H., A new initiative on precision medicine. N. Engl. J. Med. 372 (2015), 793–795.
5. 5 Department of Health and Human Services. Final NIH genomic data sharing policy. Fed. Regist. 79 (2014), 51345–51354.
6. 6 Department of Health and Human Services. Federal policy for the protection of human subjects. Fed. Regist. 80 (2015), 53933–54061.
7. 7 Shabani, M., Bezuidenhout, L., Borry, P., Attitudes of research participants and the general public towards genomic data sharing: a systematic literature review. Expert Rev. Mol. Diagn. 14 (2014), 1053–1065.
8. 8 Kaye, J., The tension between data sharing and the protection of privacy in genomics research. Annu. Rev. Genomics Hum. Genet. 13 (2012), 415–431.
9. 9 Kaufman, D., Murphy, J., Erby, L., Hudson, K., Scott, J., Veterans’ attitudes regarding a database for genomic research. Genet. Med. 11 (2009), 329–337.
10. 10 McGuire, A.L., Hamilton, J.A., Lunstroth, R., McCullough, L.B., Goldman, A., DNA data sharing: research participants’ perspectives. Genet. Med. 10 (2008), 46–53.
11. 11 Trinidad, S.B., Fullerton, S.M., Ludman, E.J., Jarvik, G.P., Larson, E.B., Burke, W., Research ethics. Research practice and participant preferences: the growing gulf. Science 331 (2011), 287–288.
12. 12 Murphy, J., Scott, J., Kaufman, D., Geller, G., LeRoy, L., Hudson, K., Public perspectives on informed consent for biobanking. Am. J. Public Health 99 (2009), 2128–2134.
13. 13 Steinsbekk, K.S., Kåre Myskja, B., Solberg, B., Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?. Eur. J. Hum. Genet. 21 (2013), 897–902.
14. 14 Collins, F.S., Manolio, T.A., Merging and emerging cohorts: necessary but not sufficient. Nature, 445, 2007 259–259.
15. 15 Fullerton, S.M., The input-output problem: whose DNA do we study, and why does it matter?. Burke, W., Edwards, K.A., Goering, S., (eds.) Achieving Justice in Genomic Translation Re-thinking the Pathway to Benefit, 2011, Oxford: Oxford University Press, 40–55.
16. 16 Need, A.C., Goldstein, D.B., Next generation disparities in human genomics: concerns and remedies. Trends Genet. 25 (2009), 489–494.
17. 17 Rosenberg, N.A., Huang, L., Jewett, E.M., Szpiech, Z.A., Jankovic, I., Boehnke, M., Genome-wide association studies in diverse populations. Nat. Rev. Genet. 11 (2010), 356–366.
18. 18 Bustamante, C.D., Burchard, E.G., De la Vega, F.M., Genomics for the world. Nature 475 (2011), 163–165.
19. 19 Shavers, V.L., Lynch, C.F., Burmeister, L.F., Knowledge of the Tuskegee study and its impact on the willingness to participate in medical research studies. J. Natl. Med. Assoc. 92 (2000), 563–572.
20. 20 Bates, B.R., Harris, T.M., The Tuskegee Study of Untreated Syphilis and public perceptions of biomedical research: a focus group study. J. Natl. Med. Assoc. 96 (2004), 1051–1064.
21. 21 Hartzler, A., McCarty, C.A., Rasmussen, L.V., Williams, M.S., Brilliant, M., Bowton, E.A., Clayton, E.W., Faucett, W.A., Ferryman, K., Field, J.R., et al. Stakeholder engagement: a key component of integrating genomic information into electronic health records. Genet. Med. 15 (2013), 792–801.
22. 22 Garrison, N.A., Sathe, N.A., Antommaria, A.H., Holm, I.A., Sanderson, S.C., Smith, M.E., McPheeters, M.L., Clayton, E.W., A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States. Genet. Med. 18 (2016), 663–671.
23. 23 Kaufman, D.J., Murphy-Bollinger, J., Scott, J., Hudson, K.L., Public opinion about the importance of privacy in biobank research. Am. J. Hum. Genet. 85 (2009), 643–654.
24. 24 Platt, J., Bollinger, J., Dvoskin, R., Kardia, S.L., Kaufman, D., Public preferences regarding informed consent models for participation in population-based genomic research. Genet. Med. 16 (2014), 11–18.
25. 25 Simon, C.M., L'heureux, J., Murray, J.C., Winokur, P., Weiner, G., Newbury, E., Shinkunas, L., Zimmerman, B., Active choice but not too active: public perspectives on biobank consent models. Genet. Med. 13 (2011), 821–831.
26. 26 Gottesman, O., Kuivaniemi, H., Tromp, G., Faucett, W.A., Li, R., Manolio, T.A., Sanderson, S.C., Kannry, J., Zinberg, R., Basford, M.A., et al., eMERGE Network. The Electronic Medical Records and Genomics (eMERGE) Network: past, present, and future. Genet. Med. 15 (2013), 761–771.
27. 27 Smith, M.E., Sanderson, S.C., Brothers, K.B., Myers, M.F., McCormick, J., Aufox, S., Shrubsole, M.J., Garrison, N.A., Mercaldo, N.D., Schildcrout, J.S., et al. Conducting a large, multi-site survey about patients’ views on broad consent: challenges and solutions. BMC Med. Res. Methodol., 16, 2016, 162.
28. 28 Harris, P.A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., Conde, J.G., Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 42 (2009), 377–381.
29. 29 Hamilton, C.M., Strader, L.C., Pratt, J.G., Maiese, D., Hendershot, T., Kwok, R.K., Hammond, J.A., Huggins, W., Jackman, D., Pan, H., et al. The PhenX Toolkit: get the most from your measures. Am. J. Epidemiol. 174 (2011), 253–260.
30. 30 Fetzer Institute. Multidimensional Measurement of Religiousness/Spirituality for Use in Health Research: A Report of the Fetzer Institute/National Institute on Aging Working Group. 1999, John E. Fetzer Institute, Kalamazoo, MI.
31. 31 Ware, J. Jr., Kosinski, M., Keller, S.D., A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med. Care 34 (1996), 220–233.
32. 32 Terry, A.L., Chesworth, B.M., Stolee, P., Bourne, R.B., Speechley, M., Joint replacement recipients’ post-surgery views about health information privacy and registry participation. Health Policy 85 (2008), 293–304.
33. 33 Hall, M.A., Camacho, F., Lawlor, J.S., Depuy, V., Sugarman, J., Weinfurt, K., Measuring trust in medical researchers. Med. Care 44 (2006), 1048–1053.
34. 34 Shea, J.A., Micco, E., Dean, L.T., McMurphy, S., Schwartz, J.S., Armstrong, K., Development of a revised Health Care System Distrust scale. J. Gen. Intern. Med. 23 (2008), 727–732.
35. 35 Gaskell, G., Allansdottir, A., Allum, N., Castro, P., Esmer, Y., Fischler, C., Jackson, J., Kronberger, N., Hampel, J., Mejlgaard, N., et al. The 2010 Eurobarometer on the life sciences. Nat. Biotechnol. 29 (2011), 113–114.
36. 36 Brothers, K.B., Morrison, D.R., Clayton, E.W., Two large-scale surveys on community attitudes toward an opt-out biobank. Am. J. Med. Genet. A. 155A (2011), 2982–2990.
37. 37 Helft, P.R., Champion, V.L., Eckles, R., Johnson, C.S., Meslin, E.M., Cancer patients’ attitudes toward future research uses of stored human biological materials. J. Empir. Res. Hum. Res. Ethics 2 (2007), 15–22.
38. 38 Ludman, E.J., Fullerton, S.M., Spangler, L., Trinidad, S.B., Fujii, M.M., Jarvik, G.P., Larson, E.B., Burke, W., Glad you asked: participants’ opinions of re-consent for dbGap data submission. J. Empir. Res. Hum. Res. Ethics 5 (2010), 9–16.
39. 39 Lemke, A.A., Wolf, W.A., Hebert-Beirne, J., Smith, M.E., Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 13 (2010), 368–377.
40. 40 American Association for Public Opinion Research. Standard Definitions: Final Dispositions of Case Codes and Outcome Rates for Surveys. Seventh Edition, 2011, AAPOR.
41. 41 Chowdhury, S., Khare, M., and Wolter, K. (2007). Weight trimming in the National Immunization Survey. Proceedings of the Survey Research Methods Section of the American Statistical Association, 2651–2658.
42. 42 Potter, F. (1988). Survey of procedures to control extreme sampling weights. Proceedings of the Survey Research Methods Section of the American Statistical Association, 2651–2658.
43. 43 Rosenbaum, P.R., Rubin, D.B., The central role of the propensity score in observational studies for causal effects. Biometrika 70 (1983), 41–55.
44. 44 Rubin, D.B., Multiple Imputation for Nonresponse in Surveys. 2004, John Wiley & Sons.
45. 45 Chen, H., Manning, A.K., Dupuis, J., A method of moments estimator for random effect multivariate meta-analysis. Biometrics 68 (2012), 1278–1284.
46. 46 McQuillan, G.M., Porter, K.S., Agelli, M., Kington, R., Consent for genetic research in a general population: the NHANES experience. Genet. Med. 5 (2003), 35–42.
47. 47 Chen, D.T., Rosenstein, D.L., Muthappan, P., Hilsenbeck, S.G., Miller, F.G., Emanuel, E.J., Wendler, D., Research with stored biological samples: what do research participants want?. Arch. Intern. Med. 165 (2005), 652–655.
48. 48 De Vries, R.G., Tomlinson, T., Kim, H.M., Krenz, C.D., Ryan, K.A., Lehpamer, N., Kim, S.Y., The moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate. Life Sci. Soc. Policy, 12, 2016, 3.
49. 49 Johnson, D.R., Scheitle, C.P., Ecklund, E.H., Sørensen, J., Soule, S., Individual religiosity and orientation towards science: reformulating relationships. Sociol. Sci. 2 (2015), 106–124.
50. 50 Brossard, D., Scheufele, D.A., Kim, E., Lewenstein, B.V., Religiosity as a perceptual filter: examining processes of opinion formation about nanotechnology. Public Underst. Sci. 18 (2008), 546–558.
51. 51 Ho, S.S., Scheufele, D.A., Corley, E.A., Factors influencing public risk-benefit considerations of nanotechnology: Assessing the effects of mass media, interpersonal communication, and elaborative processing. Public Underst. Sci. 22 (2013), 606–623.
52. 52 Scheufele, D.A., Corley, E.A., Shih, T.J., Dalrymple, K.E., Ho, S.S., Religious beliefs and public attitudes toward nanotechnology in Europe and the United States. Nat. Nanotechnol. 4 (2009), 91–94.
53. 53 Department of Health and Human Services. Annual update of the HHS poverty guidelines. Fed. Regist. 81 (2016), 4036–4037.