Consent for Research With Biological Samples: One-Time General Consent Versus a Gift Model
Authors: Guglielmo Ronco, Chris J L Meijer, Jack Cuzick, Paolo Giorgi-Rossi, Julian Peto, Nereo Segnan, Joakim Dillner
Journal: Annals of Internal Medicine (2012)

Ideas and Opinions17 April 2012Consent for Research With Biological Samples: One-Time General Consent Versus a Gift ModelDavid Wendler, PhDDavid Wendler, PhDFrom the National Institutes of Health Clinical Center, Bethesda, Maryland.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-156-8-201204170-00011 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Technological advances have dramatically increased the scientific value of the hundreds of millions of human tissue and blood samples that are currently stored in laboratories and the tens of millions of new samples that are obtained each year (1, 2). These advances have led to continuing debate over what consent process should be used to obtain and store human biological samples for future research (3).Some commentators argue that, as with other types of research with humans, donors should consent to the specific studies for which their samples will be used when the studies are proposed (4). This approach allows ...References1. National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance: Volume I: Report and Recommendations of the National Bioethics Advisory Commission. Rockville, MD: National Bioethics Advisory Commission; 1999. Google Scholar2. Eiseman E, Haga SB. Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples. Santa Monica, CA: RAND; 1999. Google Scholar3. Mello MM, Wolf LE. The Havasupai Indian tribe case—lessons for research involving stored biologic samples. N Engl J Med. 2010;363:204-7. [PMID: 20538622] CrossrefMedlineGoogle Scholar4. Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, et al. Informed consent for genetic research on stored tissue samples. JAMA. 1995;274:1786-92. [PMID: 7500511] CrossrefMedlineGoogle Scholar5. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should donors be allowed to give broad consent to future biobank research? Lancet Oncol. 2006;7:266-9. [PMID: 16510336] CrossrefMedlineGoogle Scholar6. U.S. Department of Health and Human Services. Advance Notice of Proposed Rulemaking: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Accessed at www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm on 16 August 2011. Google Scholar7. Caplan AL, Moreno JD. The Havasu 'Baaja tribe and informed consent. Lancet. 2011;377:621-2. [PMID: 20630579] CrossrefMedlineGoogle Scholar8. Murray TH. Gifts of the body and the needs of strangers. Hastings Cent Rep. 1987;17:30-8. [PMID: 3583710] CrossrefMedlineGoogle Scholar9. Helgesson G, Johnsson L. The right to withdraw consent to research on biobank samples. Med Health Care Philos. 2005;8:315-21. [PMID: 16283494] CrossrefMedlineGoogle Scholar10. National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance: Volume II: Commissioned Papers. Rockville, MD: National Bioethics Advisory Commission; 2000. Google Scholar11. Persson AH. Gifts and donations.. In: Hansson MG, Levin M, eds. Biobanks as Resources for Health. Uppsala, Sweden: Uppsala University; 2003:227-49. Google Scholar12. Wendler D. One-time general consent for research on biological samples. BMJ. 2006;332:544-7. [PMID: 16513715] CrossrefMedlineGoogle Scholar13. Harmon A. Indian Tribe Wins Fight to Limit Research of Its DNA. New York Times. 21 April 2010. Accessed at www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all on 4 December 2011. Google Scholar14. Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, et al. Patients' views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008;8:62-70. [PMID: 19003716] CrossrefMedlineGoogle Scholar15. Committee on Bioethics. Ethical issues with genetic testing in pediatrics. Pediatrics. 2001;107:1451-5. [PMID: 11389275] CrossrefMedlineGoogle Scholar16. Rhodes R, Azzouni J, Baumrin SB, Benkov K, Blaser MJ, Brenner B, et al. De minimis risk: a proposal for a new category of research risk [Editorial]. Am J Bioeth. 2011;11:1-7. [PMID: 22047112] CrossrefMedlineGoogle Scholar17. Kim SY, Kim HM, Langa KM, Karlawish JH, Knopman DS, Appelbaum PS. Surrogate consent for dementia research: a national survey of older Americans. Neurology. 2009;72:149-55. [PMID: 19139366] CrossrefMedlineGoogle Scholar18. Goldenberg AJ, Hull SC, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009;155:578-83. [PMID: 19595370] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From the National Institutes of Health Clinical Center, Bethesda, Maryland.Disclaimer: The views expressed are those of the author and do not represent any position or policy of the National Institutes of Health, the Department of Health and Human Services, or the U.S. government. The National Institutes of Health had no role in the preparation, review, or approval of the manuscript.Acknowledgment: The author thanks Sara Hull for her comments on a previous version of the manuscript.Financial Support: This work was completed as part of the author's official duties as an employee of the National Institutes of Health Clinical Center.Disclosures: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2688.Corresponding Author: David Wendler, PhD, Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892-1156; e-mail, [email protected]gov.Author Contributions: Conception and design: D. Wendler.Drafting of the article: D. Wendler.Critical revision of the article for important intellectual content: D. Wendler.Final approval of the article: D. Wendler.Administrative, technical, or logistic support: D. Wendler. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited ByRelationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysisEthics of Research Biobanks: Islamic PerspectivesSecurity controls in an integrated Biobank to protect privacy in data sharing: rationale and study designClinical Research Ethics: Considerations for the Radiation OncologistAttitudes toward medical and genetic confidentiality in the Saudi research biobank: An exploratory surveyDifferences in preferences for models of consent for biobanks between Black and White womenFactors that May Influence the Willingness of Cancer Patients to Consent for Biobanking 17 April 2012Volume 156, Issue 8Page: 596-598KeywordsChildrenCloningConflicts of interestDNADementiaForecastingHealth services researchMotivationWine ePublished: 17 April 2012 Issue Published: 17 April 2012 PDF DownloadLoading ...