Law and Scientific Research
Autumn 1997

The subject of this seminar is the expanding role of law in the practice of scientific research. Typical topics covered include scientific misconduct, informed consent,
legal review of peer review decisions, genetic testing and therapy, scientific evidence, and intellectual-property disputes. The seminar emphasizes the different cultures of law and science, with the goal of illuminating the proper role of law in scientific research.
 
 
Week Subject
1 Law and Science
2 Scientific Misconduct
3 Science Funding
4 Protection of Human Subjects
5 Access to Experimental Treatments
6 Scientific Evidence
7 Human Genetic Research--Discrimination and Therapy
8 Risk Assessment
9 Research Controversies--Cloning
10 Intellectual Property
In subsequent weeks, students will present their research papers.

 

Week 1
Law and Science


The Practice of Science
1. Francisco J. Ayala & Bert Black, Science and the Courts, 81 Am. Sci. 230, 234-38 (1993)
2. John Ziman, Reliable Knowledge: An Exploration of the Grounds for Belief in Science 33-38, 130-33 (1978)
3. Jon Cohen, The Culture of Credit, 268 Science 1706 (1995), and related articles
4. Daryl E. Chubin & Edward J. Hackett, Peerless Science: Peer Review and U.S. Science Policy 83-106 (1990)
Science, Law, and Politics
5. Peter H. Schuck, Multi-Culturalism Redux: Science, Law, and Politics, 11 Yale L. & Pol'y Rev. 1, 14-35 (1993)
Public Funding of Science
6. National Science Board, Science and Engineering Indicators--1996, at 4­4-4­12 (1996)
7. National Research Council, Allocating Federal Funds for Science and Technology 41-45 (1995)
8. National Science Board, Science and Engineering Indicators--1996, at 7­4-7­7 (1996)
Legal Use of Scientific Knowledge
9. Wendy E. Wagner, The Science Charade in Toxic Tort Regulation, 95 Colum. L. Rev. 1613, 1618-28 (1995)
10. Sheila Jasanoff, Science at the Bar: Law, Science, and Technology in America 11-19 (1995)

 

Week 2
Scientific Misconduct


The Regulatory Framework
1. Committee on Science, Engineering, and Public Policy, Panel on Scientific Responsibility and the Conduct of Research, Responsible Science: Ensuring the Integrity of the Research Process 18-21, 108-16 (1992)
2. Public Health Service, Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science, 42 C.F.R. §§ 50.101-50.105 (1995)
3. Frederick Grinnell, Ambiguity in the Practice of Science (Editorial), 272 Science 333 (1996)
Appellate Review of Misconduct Decisions
4. Jock Friedly, How Congressional Pressure Shaped the "Baltimore Case," 273 Science 873 (1996)
5. Department of Health and Human Services, Hearing Procedures for Scientific Misconduct, 59 Fed. Reg. 29,809 (1994)
6. David Weaver, Moema H. Reis, Christopher Albanese, Frank Constantini, David Baltimore & Thereza Imanishi-Kari, Altered Repertoire of Endogenous Immunoglobulin Gene Expression in Transgenic Mice Containing a Rearranged Mu Heavy Chain Gene, 45 Cell 247 (April 25, 1986) (for reference only)
7. Thereza Imanishi-Kari, Ph.D., Department of Health and Human Services, Departmental Appeals Board, Decision No. 1582 (1996) (skim pp. 43-47)
Whistleblowing and False Claims Act Actions
8. Commission on Research Integrity, Integrity and Misconduct in Research 21-24
9. United States ex rel. Berge v. Board of Trustees of the University of Alabama, 104 F.3d 1453 (4th Cir. 1997)
10. Amended Complaint at 1-2, 10-23, United States ex rel. Berge v. Board of Trustees of the University of Alabama, No. N-93-158 (D. Md. Dec. 23, 1994)
11. Brief of Amicus Curiae Association of American Medical Colleges in Support of Appellants at 1-16, United States ex rel. Berge v. Board of Trustees of the University of Alabama, No. 95-2811 (4th Cir. Apr. 15, 1996)

 

Week 3
Science Funding


Challenges to Peer Review Funding Decisions
1. Grassetti v. Weinberger, 408 F. Supp. 142 (N.D. Cal. 1976)
2. Marinoff v. Department of Health, Education, and Welfare, 456 F. Supp. 1120 (S.D.N.Y. 1978)
Activist Challenges to Funding Priorities
3. Eliot Marshall, The Politics of Breast Cancer, 259 Science 616 (1993)
4. National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43, §§ 401-03, 107 Stat. 122, 153-58 (1993)
5. Respondents' Brief, California Agrarian Action Project, Inc. v.
The Regents of the University of California, No. A041277, at 1-2, 7-31 (Cal. App. Oct. 24, 1988)
6. California Agrarian Action Project, Inc. v. The Regents of the University of California, 210 Cal. App. 3d 1245 (1989)
The Politics of Science Funding
7. Joseph P. Martino, Science Funding: Politics and Porkbarrel 67-83 (1992)
8. Christopher Anderson, The Anatomy of a Defeat, 262 Science 645 (1993)
Tobacco Research
9. Jon Cohen, Tobacco Money Lights Up a Debate, 272 Science 488 (1996), and related articles

 

Week 4
Protection of Human Subjects


General Principles
1. The Belmont Report
2. Declaration of Helsinki
A Notable Failure
3. James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment 1-15 (1981)
Federal Requirements
4. Food and Drug Administration, Informed Consent of Human Subjects, 21 C.F.R. §§ 50.20, 50.25, 50.27
5. Department of Health and Human Services, Protection of Human Subjects, 45 C.F.R. §§ 46.107, 46.109, 46.111, 46.116
6. In re Orthopedic Bone Screw Products Liability Litigation, 1996 U.S. Dist. LEXIS 2825 (E.D. Pa. 1996)
Particular Problems--Informed Consent for Emergency Research
7. 21 U.S.C. §§ 355(i), 360j(g)(3)(D)
8. Food and Drug Administration, Protection of Human Subjects; Informed Consent, 60 Fed. Reg. 49,086, 49,088, 49,093-49,094 (1995) (Proposed Rule), 61 Fed. Reg. 51,498, 51,498-51,502, 51,504-51,506, 51,528-29 (1996) (Final Rule)
Particular Problems--Informed Consent for Genetic Research
9. Ellen Wright Clayton et al., Informed Consent for Genetic Research on Stored Tissue Samples, 274 J. Am. Med. Ass'n 1786 (1995)
Particular Problems--Placebos for Control Subjects
10. Kenneth J. Rothman & Karin B. Michels, The Continuing Unethical Use of Placebo Controls, 331 New. Eng. J. Med. 394 (1994) (Sounding Board)
11. Jon Cohen, Bringing AZT to Poor Countries, 269 Science 624 (1995)
Particular Problems--Private IRBs
12. Ethics of Private Panels Come Under Scrutiny, Nature, May 29, 1997 (from http://www.nature.com/Nature2/serve?SID=71518289&CAT=News&PG=19970529/news011.html)

 

Week 5
Access to Experimental Treatments


Experimental Drugs and Clinical Trials
1. Investigational New Drug Applications, 21 C.F.R. §§ 312.21-312.22
2. Treatment Use of an Investigational New Drug, 21 C.F.R. §§ 312.34-312.35
3. Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People with AIDS and Other HIV-Related Disease, 57 Fed. Reg. 13,250 (1992)
4. Expedited Development of Drugs Intended to Treat Life-Threatening and Severely-debilitating Illness, 21 C.F.R. §§ 312.80-312.88
5. Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses, 21 C.F.R. §§ 314.500-314.560
6. FDA Looks To Fine-Tune Accelerated Approval Policy for AIDS Drugs, 9 AIDS Alert 135 (Oct. 1994)
7. Rachel Nowak, AIDS Researchers, Activists Fight Crisis in Clinical Trials, 269 Science 1666 (1995)
8. DeVito v. HEM, Inc., 705 F. Supp. 1076 (M.D. Pa. 1988)
Orphan Drugs
9. Orphan Drug Act, 21 U.S.C. §§ 360bb-360dd
Women and Minorities in Clinical Trials
10. Tracy L. Johnson, Women's Health Research: A Historical Perspective, 16 Women's Rights L. Rep. 23, 25-26 (1994)
11. National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43, §§ 131-32, 107 Stat. 122, 133-35 (1993)
Insurance Coverage of Experimental Treatments
12. Fuja v. Benefit Trust Life Insurance Co., 18 F.3d 1405 (7th Cir. 1994)
13. Schachar v. American Academy of Ophthalmology, Inc., 1988-1 Trade Cases (CCH) ¶ 67,986 (N.D. Ill. 1988)

 

Week 6
Scientific Evidence


The Standard of Admissibility
1. Frye v. United States, 293 F. 1013 (D.C. Cir. 1923)
2. Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993)
Evidence Assessment by Juries
3. Joseph Sanders, From Science to Evidence: The Testimony on Causation in the Bendectin Cases, 46 Stan. L. Rev. 1, 1-12, 27-60 (1993)
Evidence Assessment by Experts
4. Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996)

 

Week 7
Human Genetic Research--Discrimination and Therapy


Introduction to Genetic Research
1. Horace Freeland Judson, A History of the Science and Technology Behind Gene Mapping and Sequencing, in The Code of Codes: Scientific and Social Issues in the Human Genome Project 37-80 (1992) (for reference)
Genetic Discrimination
2. Kathy L. Hudson et al., Genetic Discrimination and Health Insurance: An Urgent Need for Reform, 270 Science 391 (1995)
3. Genetic Privacy and Nondiscrimination Act of 1997, H.R. 2198, 105th Cong., 1st Sess. (1997)
Human Gene Therapy
4. NIH Guidelines Regarding Consolidated Review of Human Gene Transfer Protocols, Appendix M (The Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into the Genome of One or More Human Subjects, ), 60 Fed. Reg. 20726, 20731-37 (1995)
5. National Institutes of Health, Recombinant DNA Research: Notice of Intent To Propose Amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) Regarding Enhanced Mechanisms for NIH Oversight of Recombinant DNA Activities, 61 Fed. Reg. 35774 (1996)
6. Recombinant DNA Committee Backs Its Proposed Reform, Nature, Dec. 12, 1996 (from http://www.nature.com/Nature2/serve?SID=50017294&CAT=News&PG=199611212/news015.html)

 

Week 8
Risk Assessment


General Issues
1. National Research Council, Risk Assessment in the Federal Government: Managing the Process 17-19, 40-47, 88-93 (1983)
EPA Assessments: Ozone and Particulate Matter Standards
2. EPA's National Ambient Air Quality Standards: The Standard Review/Reevaluation Process (Fact Sheet), July 17, 1997 (from http://ttnwww.rtpnc.epa.gov/naaqsfin/naaqs.htm
3. Opening Statement, Chairman Ken Calvert, Hearing on The Science Behind the U.S. Environmental Protection Agency's Proposed Revisions to the National Ambient Air Quality Standards for Ozone and Particular Matter, Energy and Environment Subcommittee, Committee on Science, 105th Cong., 1st Sess. (1977) [hereinafter NAAQS Hearing]
4. George T. Wolff, Written Statement, The CASAC Review of the Ozone and PM Standards, NAAQS Hearing (excerpts)
5. Testimony of Mark T. Maassel, NAAQS Hearing
6. Testimony of Daniel S. Greenbaum, NAAQS Hearing (excerpt)
Private Challenges
7. Foundation on Economic Trends v. Heckler, 756 F.2d 143 (D.C. Cir. 1985)
8. Environmental Protection Agency, Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act: Proposed Rule, 59 Fed. Reg. 60519, 60519-20 (1994)
9. Environmental Protection Agency, Notice of Limited Plant Propagation Registration for a Plant-Pesticide, 60 Fed. Reg. 4910 (1995)
10. Petition for Rulemaking and Collateral Relief Concerning the Registration and Use of Genetically Engineered Plants Expressing Bacillus thuringiensis Endotoxins 1-2, 9-15, 20-27, Greenpeace International v. Browner, No. _____ (Sept. 16, 1997)

 

Week 9
Research Controversies--Cloning


1. National Bioethics Advisory Commission, Cloning Human Beings (1997) (pages 16-22 for reference only, and note glossary)

 

Week 10
Intellectual Property


CellPro Litigation--Introduction
1. Goldie Blumenstyk, High-Stakes Patent Fight Features Big Money, Cancer Research, Politics, and Public Relations, Chronicle of Higher Education, June 27, 1997, at A3
2. Fact Sheet on Stem Cell Selection (from http://hopkins.med.jhu.edu/NewsMedia/press/cellpro/technol3.htm)
CellPro Litigation--Patent Dispute
3. US. Patent No. 4,965,204, Human Stem Cells and Monoclonal Antibodies (for reference only)
4. Johns Hopkins University v. CellPro, 931 F. Supp. 303 (D. Del. 1996)
5. Johns Hopkins University v. CellPro, ___ F. Supp. ___, 1997 WL 586749 (D. Del. 1997)
6. Order for Permanent Injunction and Partial Stay of Injunction, Johns Hopkins University v. CellPro, No. Civ. 94-105-RRM (D. Del. July 24, 1997)
CellPro Litigation--Bayh-Dole March-In Rights
7. Bayh-Dole Act, 35 U.S.C. §§ 200, 202(a), 203(1)
8. Letter from Jordon J. Cohen, M.D., President, Association of American Medical Colleges (May 30, 1997) (from http://hopkins.med.jhu.edu/NewsMedia/press/cellpro/aamc.html)
9. Office of the Director, National Institutes of Health, Determination in the Case of Petition of CellPro, Inc. (Aug. 1, 1997)