The Past,Present,and Future of Informed Consent in Research and Translational Medicine

Schloendorff v. New York Hospital, 211 N.Y. 125, 129 (1914).

Compare N. W. Dickert et al ., “Reframing Consent for Clinical Research: A Function-Based Approach, American Journal of Bioethics 17, no. 12 (2017): 3-11, with T. L. Beauchamp, “The Idea of a ‘Standard View’ of Informed Consent,” American Journal of Bioethics 17, no. 12 (2017): 1-2.

See, e.g., G. J. Annas , “Informed Consent: Charade or Choice?,” Journal of Law, Medicine & Ethics 45, no. 1 (2017): 10-11; L. M. Beskow, L. Lin, C. B. Dombeck, E. Gao, and K. P. Weinfurt, “Improving Biobank Consent Comprehension: A National Randomized Survey to Assess the Effect of a Simplified Form and Review/Retest Intervention,” Genetics in Medicine 19, no. 5 (2017): 505-512.

See, e.g., D. Bracken-Roche , E. Bell , M. E. Macdonald , and E. Racine , “The Concept of ‘Vulnerability’ in Research Ethics: An In-Depth Analysis of Policies and Guidelines,” Health Research Policy and Systems 15, no. 8 (2017): DOI 10.1186/s12961-016-0164-6, available at <https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-016-0164-6> (last visited January 10, 2018).

See, e.g., C. Grady , S. R. Cummings , M. C. Rowbotham , M. V. McConnell , E. A. Ashley , and G. Kang , “Informed Consent,” New England Journal of Medicine 376, no. 9 (2017): 856-867; E. E. Anderson, S. B. Newman, and A. K. Matthews, “Improving Informed Consent: Stakeholder Views,” AJOB Empirical Bioethics 8, no. 3 (2017): 178-188.

See, e.g., S. Kalkman , S. Y. H. Kim , G. J. M. W. van Thiel , D. E. Grobbee , and J. J. M. Delden , “Ethics of Informed Consent for Pragmatic Trials with New Interventions,” Value in Health 20, no. 7 (2017): 902-908.

See, e.g., G. E. Henderson et al ., “The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations,” Journal of Law, Medicine & Ethics 42, no. 3 (2014): 344-355.

National Institutes of Health, All of Us Research Program, available at <https://allofus.nih.gov/> (last visited January 10, 2018).

Oxford Living Dictionaries, “consent,” available at <https://en.oxforddictionaries.com/definition/consent> (last visited January 10, 2018).

Online Etymology Dictionary, “consent,” available at <https://www.etymonline.com/word/consent> (last visited January 10, 2018).

Schloendorff v. New York Hospital, 211 N.Y. 125 (1914).

P. A. Lombardo , “Phantom Tumors and Hysterical Women: Revising our View of the Schloendorff Case,” Journal of Law, Medicine & Ethics 33, no. 4 (2005): 791-801.

J. Katz , The Silent World of Doctor and Patient (New York: Free Press, 1984).

Salgo v. Leland Stanford Jr. University Board of Trustees, 154 Cal.App.2d 560.

A. M. Capron , “Where Did Informed Consent for Research Come From?” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 12-29.

S. Gehlert and J. Mozersky , “Seeing Beyond the Margins: Challenges to Informed Inclusion of Vulnerable Populations in Research,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 30-43.

J. N. Henderson , “Personal Experiences with Tribal IRBs, Hidden Hegemony of Researchers, and the Need for an Inter-cultural Approach: Views from an American Indian Researcher,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 44-51.

M. Lamkin and C. Elliott , “Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 52-63.

A. S. Porter and E. Kodish , “The Ethics of Using Complementary Medicine in Pediatric Oncology Trials: Reconciling Challenges,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 64-71.

M. H. Biros , “Capacity, Vulnerability, and Informed Consent for Research,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 72-78.

W. Burke , L. M. Beskow , S. B. Trinidad , S. M. Fullerton , and K. Brelsford , “Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 79-86.

S. M. Wolf , E. Scholtes , B. A. Koenig , G. M. Petersen , S. A. Berry , L. M. Beskow , M. B. Daly , C. V. Fernandez , R. C. Green , B. S. LeRoy , N. M. Lindor , P. P. O'Rourke , C. R. Breitkopf , M. A. Rothstein , B. Van Ness , and B. S. Wilfond , “Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 87-109.

J. Wilbanks , “Design Issues in E-Consent,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 110-118.

E. Vayena and A. Blasimme , “Health Research with Big Data: Time for Systemic Oversight,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 119-129.