Core Topics Seminar

SCBE hosts a Core Topics in Biomedical Ethics Seminar Series twice monthly. In Core Topics, fellows and faculty will present on fundamental topics in clinical and research ethics. The format of each seminar is roughly two “classic” readings circulated prior to the session with a short (30-minute) presentation that includes 3 discussion questions.

Research Ethics:

1.     Vulnerable Research Subjects 

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

3.     Informed Consent: Approaches to Consent in Biospecimens and Data 

4.     Incidental/Secondary Findings in Research Settings

5.     First Use of Research Protocols in Humans

6.     The Ethics of Learning Healthcare Systems

7.     Human Gene Therapy or Gene Transfer

8.     Data Ethics

Clinical Ethics:

1.     Shared Decision-Making 

2.     Truth Telling in Medicine

3.     Confidentiality & Duty to Warn 

4.     Transplantation

5.     Rationing

6.     End of Life 

7.     Futility

8.     Physician-Aid-in-Dying (PAD) & Euthanasia

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.


·  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.


·  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


·   NIH Genomic Data Sharing Policy