Principles of Human Subjects Protections Applied in an Opt-Out, De-identified Biobank
BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The re...
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| Published in | Clinical and translational science Vol. 3; no. 1; pp. 42 - 48 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Malden, USA
Blackwell Publishing Inc
01.02.2010
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| Subjects | |
| Online Access | Get full text |
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| Abstract | BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de‐identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefi ts of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients’ preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper. Clin Trans Sci 2010; Volume #: 1–7 |
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| AbstractList | BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de‐identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefi ts of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients’ preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper. Clin Trans Sci 2010; Volume #: 1–7 BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non-human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de-identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefits of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients' preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper.BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non-human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de-identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefits of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients' preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper. BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non-human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de-identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefits of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients' preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper. |
| Author | Roden, Dan M. Clayton, Ellen Bernard, Gordon R. Pulley, Jill Masys, Daniel R. |
| AuthorAffiliation | 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA 3 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA 4 Office of Personalized Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA 5 Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA 2 Center for Biomedical Ethics and Society, Vanderbilt University School of Medicine, Nashville, Tennessee, USA |
| AuthorAffiliation_xml | – name: 2 Center for Biomedical Ethics and Society, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – name: 3 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – name: 5 Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – name: 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – name: 4 Office of Personalized Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA |
| Author_xml | – sequence: 1 givenname: Jill surname: Pulley fullname: Pulley, Jill organization: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – sequence: 2 givenname: Ellen surname: Clayton fullname: Clayton, Ellen organization: Center for Biomedical Ethics and Society, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – sequence: 3 givenname: Gordon R. surname: Bernard fullname: Bernard, Gordon R. organization: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – sequence: 4 givenname: Dan M. surname: Roden fullname: Roden, Dan M. organization: Office of Personalized Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA – sequence: 5 givenname: Daniel R. surname: Masys fullname: Masys, Daniel R. organization: Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20443953$$D View this record in MEDLINE/PubMed |
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| References_xml | – reference: Kaufman D, Murphy J, Erby L, Hudson K, Scott J. Veterans' attitudes regarding a database for genomic research. Genet Med. 2009; 11(5): 329-337. – reference: Huang N, Shih SF, Chang HY, Chou YJ. Record linkage research and informed consent: who consents? BMC Health Serv. Res. 2007; 7: 18. – reference: Pulley JM, Brace MM, Bernard GR, Masys DR. Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank. 2008; 9(1): 55-65. – reference: Ritchie MD, Denny JC, Crawford DC, Havens AK, Weiner JB, Pulley JM, Basford MA, Brown-Gentry K, Balser JR, Masys DR, Haines JL, Roden DR. Robust replication of genotype-phenotype associations across multiple diseases in an Electronic Medical Record. Am J Hum Genet. In press, 2010. – reference: Wendler D, Emanuel E. The debate over research on stored biological samples: what do sources think? Arch Intern Med. 2002; 162(13): 1457-1462. – reference: Morgan AT, Reilly S, Eadie P, Msppath AW, Simpson C. Parental consent for neuroimaging in paediatric research. Child Care Health Dev. 2009; Jul 23. [Epub ahead of print] – reference: Malin B, Karp D, Scheuermann R. Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. J Investig Med. 2010; 58(11): 11-8. – reference: Roden DM, Pulley JM, Basford MA, Bernard GR, Clayton EW, Balser JR, Masys DR. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther. 2008; 84: 362-369. – reference: Kaufman DJ, Murphy-Bollinger J, Scott J, Hudson KL. Public opinion about the importance of privacy in biobank research. Am J Hum Genet. 2009; 85(5): 643-654. – reference: Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC. Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ. 2009; 338: b866. – reference: 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. 2005; 331: 940. – reference: Pulley JM, Brace M, Bernard GR, Masys D. Evaluation of the effectiveness of posters to provide information to patients about a DNA database and their opportunity to opt out. Cell Tissue Bank. 2007; 8: 233-241. – reference: Benitez K, Malin B. Evaluating re-identification risks with respect to the HIPAA privacy rule. J Am Med Inform Assoc. In press, 2010. – reference: Jenkins MM, Reed-Gross E, Rasmussen SA, Barfield WD, Prue CE, Gallagher ML, Honein MA. Maternal attitudes toward DNA collection for gene-environment studies: A qualitative research study. Am J Med Genet. A. 2009; 149A(11): 2378-2386. – reference: Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedical research. JAMA. 2009; 302(1): 67-72. – reference: Chen DT, Rosenstein DL, Muthappan P, Hilsenbeck SG, Miller FG, Emanuel EJ, Wendler D. Research with stored biological samples: what do research participants want? Arch Intern Med. 2005; 165(6): 652-655. – reference: Buckley B, Murphy AW, Byrne M, Glynn L. Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease. Heart. 2007; 93: 1120. – reference: Hewison J, Haines A, Hewison J, Haines A. Overcoming barriers to recruitment in health research. BMJ. 2006; 333(7562): 300-302. – volume: 84 start-page: 362 year: 2008 end-page: 369 article-title: Development of a large‐scale de‐identified DNA biobank to enable personalized medicine publication-title: Clin Pharmacol Ther. – volume: 302 start-page: 67 issue: 1 year: 2009 end-page: 72 article-title: The obligation to participate in biomedical research publication-title: JAMA. – volume: 11 start-page: 329 issue: 5 year: 2009 end-page: 337 article-title: Veterans’ attitudes regarding a database for genomic research publication-title: Genet Med. – volume: 333 start-page: 300 issue: 7562 year: 2006 end-page: 302 article-title: Overcoming barriers to recruitment in health research publication-title: BMJ. – volume: 162 start-page: 1457 issue: 13 year: 2002 end-page: 1462 article-title: The debate over research on stored biological samples: what do sources think? publication-title: Arch Intern Med. – volume: 149A start-page: 2378 issue: 11 year: 2009 end-page: 2386 article-title: Maternal attitudes toward DNA collection for gene‐environment studies: A qualitative research study publication-title: Am J Med Genet. A. – volume: 9 start-page: 55 issue: 1 year: 2008 end-page: 65 article-title: Attitudes and perceptions of patients towards methods of establishing a DNA biobank publication-title: Cell Tissue Bank. – volume: 331 start-page: 940 year: 2005 article-title: Recruiting patients to medical research: double blind randomised trial of “opt‐in” versus “opt‐out” strategies publication-title: BMJ. – volume: 93 start-page: 1120 year: 2007 article-title: Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease publication-title: Heart. – volume: 85 start-page: 643 issue: 5 year: 2009 end-page: 654 article-title: Public opinion about the importance of privacy in biobank research publication-title: Am J Hum Genet – volume: 8 start-page: 233 year: 2007 end-page: 241 article-title: Evaluation of the effectiveness of posters to provide information to patients about a DNA database and their opportunity to opt out publication-title: Cell Tissue Bank. – volume: 7 start-page: 18 year: 2007 article-title: Record linkage research and informed consent: who consents? publication-title: BMC Health Serv. Res. – volume: 165 start-page: 652 issue: 6 year: 2005 end-page: 655 article-title: Research with stored biological samples: what do research participants want? publication-title: Arch Intern Med. – year: 2009 article-title: Parental consent for neuroimaging in paediatric research publication-title: Child Care Health Dev. – volume: 338 start-page: b866 year: 2009 article-title: Written informed consent and selection bias in observational studies using medical records: systematic review publication-title: BMJ. – volume: 58 start-page: 11 issue: 11 year: 2010 end-page: 8 article-title: Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research publication-title: J Investig Med – year: 2010 article-title: Robust replication of genotype‐phenotype associations across multiple diseases in an Electronic Medical Record publication-title: Am J Hum Genet. – year: 2010 article-title: Evaluating re‐identification risks with respect to the HIPAA privacy rule publication-title: J Am Med Inform Assoc. – ident: e_1_2_8_2_2 doi: 10.1038/clpt.2008.89 – ident: e_1_2_8_13_2 doi: 10.1136/jamia.2009.000026 – ident: e_1_2_8_14_2 doi: 10.1186/1472-6963-7-18 – volume: 93 start-page: 1120 year: 2007 ident: e_1_2_8_15_2 article-title: Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease publication-title: Heart. doi: 10.1136/hrt.2006.111591 – ident: e_1_2_8_6_2 doi: 10.1097/GIM.0b013e31819994f8 – ident: e_1_2_8_8_2 doi: 10.1001/archinte.162.13.1457 – ident: e_1_2_8_10_2 doi: 10.1016/j.ajhg.2010.03.003 – ident: e_1_2_8_5_2 doi: 10.1007/s10561-007-9033-4 – ident: e_1_2_8_11_2 – ident: e_1_2_8_9_2 doi: 10.1016/j.ajhg.2009.10.002 – ident: e_1_2_8_17_2 doi: 10.1136/bmj.b866 – year: 2009 ident: e_1_2_8_21_2 article-title: Parental consent for neuroimaging in paediatric research publication-title: Child Care Health Dev. – ident: e_1_2_8_12_2 doi: 10.2310/JIM.0b013e3181c9b2ea – ident: e_1_2_8_3_2 doi: 10.1007/s10561-007-9051-2 – ident: e_1_2_8_7_2 doi: 10.1001/archinte.165.6.652 – ident: e_1_2_8_16_2 doi: 10.1136/bmj.333.7562.300 – ident: e_1_2_8_20_2 doi: 10.1002/ajmg.a.33043 – ident: e_1_2_8_4_2 – ident: e_1_2_8_18_2 doi: 10.1136/bmj.38583.625613.AE – ident: e_1_2_8_19_2 doi: 10.1001/jama.2009.931 |
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| Snippet | BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office... BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non-human subjects research as determined by the local IRB and the federal Office... |
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| SubjectTerms | Adult Aged Aged, 80 and over Belmont Report Biomedical Research - ethics BioVU Databases, Nucleic Acid DNA Databank electronic medical record Ethics, Medical Female Human Experimentation - ethics Human Experimentation - legislation & jurisprudence Humans Informed Consent Male Medical Records Systems, Computerized Middle Aged Models, Organizational Risk synthetic derivative |
| Title | Principles of Human Subjects Protections Applied in an Opt-Out, De-identified Biobank |
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