Core Topics Seminar

Research Ethics:

1.  Vulnerable Research Subjects

·  Kenneth Kipnis, “Vulnerability in Research Subjects: A Bioethical Taxonomy” 2006

·  Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L and Sugarman J, The Limitations of ‘Vulnerability’ as a Protection for Human Research Participants,” The American Journal of Bioethics Vol. 4, no. 3 (2004):44-49.

Cases:

·  Susan M. Reverby, “Ethical Failures and History Lessons: The U.S. Public Health Service Research Studies in Tuskegee and Guatemala” Public Health Reviews Vol. 34, No 1, (2012):1-18.

·  Willowbrook chapter from Emanuel Oxford book

2.  Do We Own Our Bodies? Informed Consent, Ownership, and Use of Biological Samples

·  Nanibaa’ A. Garrison, “Genomic Justice for Native Americans: Impact of the Havasupai Case on Genetic Research” Sci Technol Human Values 38, no. 2 (2013): 201–223.

·  Michelle Huckaby Lewis, “Lessons from the Residual Newborn Screening Dried Blood Sample Litigation” JLME Vol. 43, (2015): 32-35.

·  R Alta Charo, “Body of Research — Ownership and Use of Human Tissue” NEJM Vol. 355 (2006): 1517-19.

·  Laura M. Beskow, “Lessons from HeLa Cells: The Ethics and Policy of Biospecimens” Annu Rev Genomics Hum Genet Vol. 17 (2016): 395–417.

Cases:

·  Havasupai Tribe v. Arizona Bd. of Regents, 204 P.3d 1063 (Ariz. Ct. App. 2008)

·  Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990)

·  Washington University v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006)

·  Beleno et al v. Texas Department of State Health Services et al Texas Western District Court, Case No. 5:09-cv-00188 

3.  Approaches to Consent in Biospecimens and Data

·  Rotimi C, et al. “Community Engagement and Informed Consent in the International HapMap Project” Community Genet Vol. 10 (2007):186–198.

·  Christine Grady, “Enduring and Emerging Challenges of Informed Consent” NEJM 372 (2015):855-62.

·  McGuire A and Beskow L, “Informed Consent in Genomics and Genetic Research” Annu Rev Genomics Hum Genet 11 (2010):361–81.

·  Lunshof JE, et al. “From Genetic Privacy to Open Consent” Nature Reviews Genetics Vol. 9 (2008): 406-11.

4.  Incidental/Secondary Findings in Research Settings

·      Susan Wolf, “The Continuing Evolution of Ethical Standards for Genomic Sequencing in Clinical Care: Restoring Patient Choice” J Law Med Ethics Vol. 45, no. 3 (September 2017): 333–340.

·      Wolf SM, et al. “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations” J Law Med Ethics Vol. 36, no. 2 (2008): 219-48.

·      Richardson HS and Cho MK, “Secondary Researchers' Duties to Return Incidental Findings and Individual Research Results: a Partial-Entrustment Account,” Genet Med Vol. 14, no. 4 (2012): 467-72.

·      Ande v. Rock 2002, Court of Appeals of Wisconsin

5.  First Use of Research Protocols in Humans

·  Rebecca Dresser, “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless” J Law Med Ethics 37, 1 (2009): 38–50.

·  Benjamin Freedman, “Equipoise and the Ethics of Clinical Research” NEJM 317 (1987): 141-145.

·  Miller FG and Brody H, “A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials” The Hastings Center Report, Vol. 33, no. 3 (2003):19-28.

·  Bartlett, R, et al, “Extracorporeal Circulation in Neonatal Respiratory Failure: A Prospective Randomized Study” Pediatrics 76 (1985): 479-87.

·  Rosenberger F and Lachin J, “The Use of Response-Adaptive Designs in Clinical Trials” Control Clin Trials 14, no. 6 (1993):471-84.

6.  The Ethics of Learning Healthcare Systems

·  Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL, “An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics.” Hastings Center Report (2013):S16-27.

·  SUPPORT Study Group, “Target Ranges of Oxygen Saturation in Extremely Preterm Infants” New England Journal of Medicine Vol. 362 (2010):1959-69.

·  David Magnus, “The Support Trial and the Debate Over Research Within the Standard of Care” AJOB 13, no. 12 (2013):1-2.

·  Wilfond & Magnus et al. “The OHRP and SUPPORT” NEJM (2013):e36 (1-3).

·  Macklin et al. “The OHRP and SUPPORT — Another View” NEJM (2013): e3(1-3).

7.  Human Gene Therapy or Gene Transfer

·  Reading on Jesse Gelsinger

·   Robin Fretwell Wilson, “The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research” Vol. 36 American Journal of Law and Medicine (2010): 295-325.

·   Gelsinger v. Trustees of the University of Pennsylvania

·  Gelsinger Complaint

·  Germ Line Editing

·   Lanphier E, Urnov F, Haecker SE, Werner M, and Smolenski J, “Don’t Edit the Human Germ Line” Nature Vol. 519, (2015):409-411.

·   Savulescu J, Pugh J, Douglas T, and Gyngell C, “The Moral Imperative to Continue Gene Editing Research on Human Embryos” Protein Cell Vol. 6, no. 7, (2015):476–479

·  CRISPR Babies

·   Jing-Bao Nie, “He Jiankui’s Genetic Misadventure: Why Him? Why China?” Hastings Center Bioethics Forum (December 2018) (Accessed July 2019)

·   Antonio Regalado, “Chinese Scientists Are Creating CRISPR Babies” MIT Technology Review, November 25, 2018. (Accessed June 2019)

8.  Data Ethics

·  Herman T. Tavoni, “Philosophical Theories of Privacy” Metaphilosophy Vol. 38, No. 1 (January 2007): 1-22.

·  McGuire A and Majumder MA, “Two Cheers for GINA?” Genome Medicine 1:6, (2009).

·  Mittelstadt BD and Floridi L, “The Ethics of Big Data: Current and Foreseeable Issues in Biomedical Contexts” Sci Eng Ethics 22 (2016):303–341.

·  Vayenne E and Blasimme A,“Biomedical Big Data: New Models of Control Over Access, Use and Governance” Bioethical Inquiry 14 (2017):501–513.

Policies and regulations

·   GINA

·   HIPPA

·   NIH Genomic Data Sharing Policy