References
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. US Government Printing Office, Washington, DC, USA (1979).
- Trials of War Criminals Before the Nuernburg Miltary Tribunals Under Control Council Law No. 10, Volume II: Nuernburg, October 1946–April 1949. US Government Printing Office, DC, USA, 181–182 (1946).
- World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association, Ferney-Voltaire, France (2008).
- Pulley J , ClaytonE, BernardGR, RodenDM, MasysDR. Principles of human subjects protections applied in an opt-out, de-identified biobank. Clin. Transl. Sci.3(1) , 42–48 (2010).
- Trinidad S , FullertonS, LudmanE, JarvikG, LarsonE, BurkeW. Research practice and participant preferences: the growing gulf. Science331(6015) , 287 (2011).
- Brothers KB . Biobanking in pediatrics: the human nonsubjects approach. Per. Med.8(1) , 71–79 (2011).
- Brothers KB , ClaytonEW. ‘Human non-subjects research‘: privacy and compliance. Am. J. Bioethics10(9) , 15–17 (2010).
- Gymrek M , McGuireAL, GolanD, HalperinE, ErlichY. Identifying personal genomes by surname inference. Science339(6117) , 321–324 (2013).
- Homer N , SzelingerS, RedmanM et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet. 4(8) , e1000167 (2008).
- Marsolo K , CorsmoJ, BarnesMG et al. Challenges in creating an opt-in biobank with a registrar-based consent process and a commercial EHR. J. Am. Med. Inform. Assoc. 19(6) , 1115–1118 (2012).
- Roden DM , PulleyJM, BasfordMA et al. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin. Pharmacol. Therapeut. 84(3) , 362–369 (2008).
- Lantos J . Informed consent the whole truth for patients? Cancer72(Suppl. 9) , 2811–2815 (2006).
- Pulley JM , BraceM, BernardGR, MasysD. Evaluation of the effectiveness of posters to provide information to patients about a DNA database and their opportunity to opt out. Cell Tissue Bank.8(3) , 233–241 (2007).
- Fortney JA . Assessing recall and understanding of informed consent in a contraceptive clinical trial. Stud. Fam. Plann.30(4) , 339–346 (1999).
- Howard JM , DemetsD. How informed is informed consent? The BHAT experience. Control. Clin. Trials2(4) , 287–303 (1981).
- Joffe S , CookEF, ClearyPD, ClarkJW, WeeksJC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet358(9295) , 1772–1777 (2001).
- Mccollum AT , SchwartzAH. Pediatric research hospitalization: its meaning to parents. Pediatric Res.3(3) , 199–204 (1969).
- Riecken HW , RavichR. Informed consent to biomedical research in Veterans Administration hospitals. JAMA248(3) , 344–348 (1982).
- Toccaceli V , FagnaniC, NisticòL et al. Research understanding, attitude and awareness towards biobanking: a survey among Italian twin participants to a genetic epidemiological study. BMC Med. Ethics 10(1) , 4 (2009).
- Ormond K , CirinoA, HelenowskiI, ChisholmR, WolfW. Assessing the understanding of biobank participants. Am. J. Med. Gen.149(2) , 188–198 (2009).
- Brothers KB , MorrisonDR, ClaytonEW. Two large-scale surveys on community attitudes toward an opt-out biobank. Am. J. Med. Gen.155(12) , 2982–2990 (2011).
- Raymond TT , CarrollTG, SalesG, MorrisMC. Effectiveness of the informed consent process for a pediatric resuscitation trial. Pediatrics125(4) , e866-e875 (2010).
- Standard Definitions: Final Dispositions of Case Codes and Outcome Rates for Surveys. The American Association for Public Opinion Research, IL, USA (2011).
▪ Websites
- OHRP: Guidance on Research Involving Coded Private Information or Biological Specimens (2008). www.hhs.gov/ohrp/policy/cdebiol.html
- 45 CFR 164.514 – Other Requirements Relating to Uses and Disclosures of Protected Health Information (2002). www.law.cornell.edu/cfr/text/45/164.514