Genetics: Ethics, Law and Policy

Maxwell J. Mehlman, Case Western Reserve School of Law

Mark A. Rothstein, University of Louisville School of Law

Sonia M. Suter, George Washington University Law School

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Table of Contents

Teacher’s Manual – 4th Edition

• Chapter 1 and 2 in 4th ed. replaced with Part I, chapters 1-4.
• Introduction 4th ed. Ch. 1 and scientific overview in Ch. 2 deleted.
• 5th ed. Ch. 1 has revised and updated History of Genetic Science.
• 4th ed. Ch. 5 on Race and Ethnicity moved and revised in 5th ed. as Ch. 3. Winker and Wood deleted. Section IV on Genetics and Ethnicity deleted.
• New 5th ed. Ch. 4 New Developments: Precision Medicine, New Gene Editing Techniques, Germline Gene Editing, Direct-to-Consumer Testing (DTC), DNA for Forensic Identification, Do-It-Yourself Gene Editing, Epigenetics.
• 4th ed. Ch. 3 on Genetic Research reorganized in 5th ed. as Part II. In new Ch. 5, Greely and Harsanyi deleted from section on biobank research, Lynch added. 4th ed. Regulation of Genetic Testing in Ch. 7 moved and revised as 5th ed. Ch.5, section III. 4th ed. Ch. 7, section VI on DTC testing moved to 5th ed. Ch. 5 and shortened, with Kerouac and FDA Letter deleted.
• Additional portions of 4th ed. Ch. 7 on Clinical Applications moved and heavily revised. Section D on Access to Genetic Services deleted. 5th ed. Part III, Gene Therapy, begins with new Ch. 11, Regulation of Gene Therapy Research.
• 4th ed. Ch. 8 moved and heavily revised as 5th ed. chs. 12-14. 4th ed. Section D on Germline Therapy becomes 5th ed. Ch. 13, with Gyngall and Center for Genetics and Society substituted for Zimmerman. 4th ed. Ch. 10 on Genetic Enhancement, 34 pp., becomes 5th ed. Ch. 15, 12 pp. Gordon, Stock, Parens deleted.
• Chapters 13-17 in 4th ed. Became 5th ed. Chapters 23-32. Material has been reorganized and cut from 123 pp. to 68 pp.
• Ch 13 (4th ed.). Deleted Part V on Education (657-667) and Part VI on Tort Law (668-670).
• Ch 14 (4th ed.) Deleted Bok (671), Allen (673), Orentlicher (674), and Andrews (677). Replaced Rothstein & Talbott (681) with newer Rothstein & Talbott (2017). Deleted Murray (689) and Rothstein (690, 702, 704), and replaced with Rothstein & Tovino (2019).
• Ch 15 (4th ed.) Replaced Hall (714) with Rothstein (2018). Deleted Rothstein (723) and Katskee (729). Replaced Rothstein & Joly (735) with Rothstein (2018). Deleted Lowden (736) and Rothstein (747).
• Ch 16 (4th ed.) Deleted Ridley (763) and Epstein (767). Replaced Poore (789) with Lowe v. Atlas. Added Rothstein (2018).
• Chapter 4, Commercialization of Genetic Research, is now in Part IV, including an introduction and Chapters 16 and 17
  • Chapter 16 covers patents
    • International Aspects of Biotech Patents (Section V of Chapter 4 in the 4th edition ) is now reduced to notes of Section IV of new Chapter 16 with updates on debates regarding patentable subject matter
    • Diamond v. Chakrabarty reduced to notes and a description in the main text
    • Added a diagram to Association for Molecular Pathology v. Myriad to explain cDNA
    • Reduced Harvard College v. Canada to a note
    • Added Goulding et al. and Sherkow & Contreras pieces to Section V, Tech Transfer
  • Chapter 17 covers Patients: Sources of Genes and Cell Lines
    • Updated notes with recent case law and scholarship addressing property rights in genetic information and cell lines.

• Old Chapter 6, Genetics and Reproduction, and old Chapter 7, Clinical Applications of Genetics in Diagnosis, are now part of Part II, Genetic Screening and Testing in Medicine and Research, which includes Chapters 5-10.
  • The discussion of genetic testing technology of the old Chapter 7 is now in Section I of the new Chapter 5 and has been updated
  • Chapter 6 of the new edition covers Genetic Counseling and Genetic Testing for Susceptibility to Disease
    • It begins with genetic counseling (from old Chapter 7) and includes updates on testing for late-onset conditions
    • The Bloch piece has been cut and is explained in text or notes.
    • Updated notes following the discussion of Liability Issues (now section III)
  • The new Chapter 7
    • includes a discussion of Genomic Analysis, which adds a piece from Suter on Genomic Medicine and includes updates on the science and liability issues
    • It also includes the section of cancer genomics from old Chapter 7 with a few updates
    • Section II on Genetic Testing of Children and Adolescents replaced the ASHG Points to Consider from 1995 with the 2015 Points to Consider
  • The New Chapter 8 covers Genetic Testing using much of the material from the old Chapter 6.
    • Added Farrell’s piece and updated descriptions of the technologies
    • Added a section describing preimplantation genetic testing
    • In the section on liability, reduced Molloy v. Meier and Doolan v. IVF American to notes
    • Cut Section II.C on Mandatory Prenatal Screen of the old Chapter 6 and added a short discussion on carrier screening and how the technology is changing
    • Reduced Johnson v. Superior Court of LA County and Harnicher v. University of Utah to notes (with updates on other litigation)
    • Cut entirely from the casebook the section on Paternity and Assisted Reproduction and the section on human cloning from the old Chapter 6
  • The New Chapter 9 covers Reproductive Genetic Technologies for Non-medical purposes
    • Added Suter, which discusses new technologies, and Kettering, which addresses selecting for disabilities
    • Reduced Ferrell v. Rosenbaum to notes in the section on Conceiving a Sibling to be a Donor
  • The New Chapter 10 covers Newborn Screening using material from the old Chapter 9 on Public Health
    • Cut the discussion of public health in genetics
    • Shortened the AAP Report (in Section 1)
    • Cut Clayton and described some parts of it in notes, and added the more recent Suter, describing new technologies and NBS approaches
    • Reduced Baily and Murray into note discussions
    • In Section II on parental consent, added Suter excerpt
    • In Section III on research on NBS spots, added Suter excerpt and updated the notes regarding litigation in this area
  • The Old Chapter 11 on Parentage and Family Law has been cut altogether

• The old Chapter 12 on Forensics has been moved to a few chapters (18-21) in Part V, Non-Medical Uses of Genetics
  • The introduction of that Part adds new material on ancestry testing
  • Chapter 18 covers Forensics
    • Includes a new diagram to explain PCR and updates the discussion emerging technologies
    • Lander reduced to a note
    • Williams v. Illinois reduced to a note
    • Section IV has updates on case law including a substantial note summarizing the new case Carpenter v. US
    • Andrews & Nelkin reduced to a note
  • Chapter 19 covers the constitutionality of Forensic Databases
    • State v. Medina, Kaemmerling v. Lappin, and Rothstein & Carnahan reduced to notes
    • Mayfield v. Dalton, from Section IV of old Chapter 12, reduced to a note
    • Notes have added descriptions of DNA used for immigration purposes
  • Chapter 20 covers Uses of DNA forensic DNA Databases
    • Added Mercer & Gabel on the underregulation of DNA databases
    • Added a new section on DNA familial searches with Suter’s piece on the use of government databases, Murphy’s piece on the use of Genealogy Databases, and descriptions of recent developments in this area in notes
  • Chapter 21 covers post-conviction DNA testing and with updates
    • District Attorney’s Office v. Osborne has been reduced to a note
  • Chapter 22 of Part II now includes part of what the old Chapter 13
    • General description of mental and behavioral genetics, its history, and science from the old Chapter 13 (sections I, II, and III) cut entirely
    • Section IV of the old Chapter 13 is now the substance of new Chapter 22
    • Hill v. Ozimint and Kansas v. Crane reduced to notes
    • Section V from old Chapter 12, discussing Education, and Section VI, discussing Tort Law, cut entirely.

Learn more about this series.