Consent for research with biological samples: One-time general consent versus a gift model

Annals of Internal Medicine

Volumn 156, Issue 8, 2012, Pages 596-598

  Wendler, David ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

GIFT GIVING; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; NOTE; PRIORITY JOURNAL; RESEARCH ETHICS; SAMPLING;

EID: 84859735681     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-156-8-201204170-00011     Document Type: Note

References (18)

1. 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.
2. Eiseman E, Haga SB. Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples. Santa Monica, CA: RAND; 1999.
3. Mello MM, Wolf LE. The Havasupai Indian tribe case-lessons for research involving stored biologic samples. N Engl J Med. 2010;363:204-207. [PMID: 20538622]
4. 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;274:1786-1792. [PMID: 7500511]
5. 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;7:266-269. [PMID: 16510336]
6. 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.
7. Caplan AL, Moreno JD. The Havasu 'Baaja tribe and informed consent. Lancet. 2011;377:621-622. [PMID: 20630579]
8. Murray TH. Gifts of the body and the needs of strangers. Hastings Cent Rep. 1987;17:30-38. [PMID: 3583710]
9. Helgesson G, Johnsson L. The right to withdraw consent to research on biobank samples. Med Health Care Philos. 2005;8:315-321. [PMID: 16283494]
10. 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.
11. Persson AH. Gifts and donations. In: Hansson MG, Levin M, eds. Biobanks as Resources for Health. Uppsala, Sweden: Uppsala University; 2003:227-249.
12. Wendler D. One-time general consent for research on biological samples. BMJ. 2006;332:544-547. [PMID: 16513715]
13. 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.
14. 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]
15. Committee on Bioethics. Ethical issues with genetic testing in pediatrics. Pediatrics. 2001;107:1451-1455. [PMID: 11389275]
16. 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]
17. 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;72:149-155. [PMID: 19139366]
18. Goldenberg AJ, Hull SC, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009;155:578-583. [PMID: 19595370]