DIRECTOR: Dr. Richard Kessin, Professor, Department of Pathology and Cell Biology
CO-DIRECTOR: Dr. Jaime S. Rubin, Director of Research Development, Department of Medicine
DESCRIPTION: This course explores a variety of ethical and policy issues that arise during the conduct of basic, translational, and clinical biomedical scientific research. Topics addressed include: (1) research misconduct; (2) "every day" ethical issues faced by biomedical scientists; (3) the use of laboratory animals in scientific research; (4) human research participants and scientific research; (5) authorship practices in scientific publications; (6) conflicts of interest arising from scientists acting as policy consultants and experts; (7) data sharing and data secrecy; (8) mentoring; (9) research with stem cells, and (10) scientists as citizens. Course sessions will include lectures, discussion periods, and analyses of case studies.
Graduate level; Course number: G4010, Call number: 26701 (G4011 is the course number for the Integrated Program and Department of Pharmacology's discussion group). Given yearly in the Spring term; One point/credit; Pass/Fail - grade determined by attendance, class participation, and required essay. A two-three page essay on the article, "The Assault on David Baltimore", by Daniel J. Kevles (published in The New Yorker, 5/27/96, pp. 94-109) is due by April 11, 2008. See: Abstract of article. No more than 2 absences are permitted. Twelve 1-hour sessions per term.
Note: This course attracts a significant number of participants from diverse educational programs. Directors of pre-doctoral and post-doctoral training programs may wish to augment this course with additional requirements, e.g. small group discussion sessions involving program faculty. Resource material (e.g. reference texts, case studies) for such sessions may be obtained from the course directors. Faculty, post-doctorate fellows/scientists, staff, and students not wishing to formally register are welcome to audit the course.
LOCATION AND TIME: All sessions are held in Room 312 of the Hammer Health Sciences Center (701 W. 168th St), on Fridays 1:00 p.m.-2:00 p.m.
TEXT: Scientific Integrity, by F.L. Macrina., ASM Press, Washington, D.C. 3nd edition (2005). On reserve in the CU Health Sciences Library.
Companion website: http://www.scientificintegrity.net/
Features direct links to web-based resources cited in the text as well as supplemental material, updates on policies and regulations, and copies of Appendix I survey material.
Bio and Medical Research Ethics:
|Jan 25||Ethics for Graduate Students||Dr. Richard Kessin||e-mail: firstname.lastname@example.org|
|Feb 1||Responsible Conduct of Research
What Is It?
|Dr. Jaime S. Rubin||e-mail: email@example.com|
|Feb 8||Humane and Responsible Use of Laboratory Animals||Dr. Thomas Martin||e-mail: firstname.lastname@example.org|
|Feb 15||No class-President's Weekend||
|Feb 22||The History of Human Experimentation through the 1970's||Dr. Barron Lerner||e-mail: email@example.com|
|Feb 29||The Rules of Human Experimentation||Dr. Elaine L. Larson||e-mail: firstname.lastname@example.org|
|Mar 7||Publication and Authorship||Dr. Jaime S. Rubin||e-mail: email@example.com|
|Mar 14||Conflict of Interest||Dr. Henry Spotnitz||e-mail: firstname.lastname@example.org|
|Mar 21||No class-Spring Break||
|Mar 28||Data Management and Data Sharing||Dr. Richard Kessin||e-mail: email@example.com|
|Apr 4||Real Life Ethical Dilemmas||Dr. Iva Greenwald||e-mail: firstname.lastname@example.org|
|Dr. Richard Robinson||e-mail: email@example.com|
|Apr 18||Research with Stem Cells||Dr. Donald W. Landry||e-mail: firstname.lastname@example.org|
|Apr 25||Scientific Citizenship||Dr. Samuel Silverstein||e-mail: email@example.com|
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 2.
Rotblat, J. (1999). A Hippocratic Oath for Scientists. Science. Vol. 286. no. 5444, p. 1475.
Full text of Editorial.
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 1.
CU Institutional Policy on Misconduct in Research
Additional material distributed in class.
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 6.
CU Medical Research Involving Animals
Dr. Elaine Larson's Powerpoint Presentation
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 5.
CUMC Institutional Review Board and Human Research Protection Program, including links to ethical principles, government regulations, and policies and guidances
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 4.
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 7.
CUMC Conflict of Interest Policy; Faculty Handbook: Appendix L
CU Guidelines for Situations Involving Potential Conflicts of Interest Between Scholarly and Commercial Activities; Faculty Handbook: Appendix K
Statement of Columbia University Policy on Conflicts of Interest: Appendix J
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 9.
Readings to be distributed in class.
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 3.
Landry, Donald W., and Zucker, Howard A. Embryonic death and the creation of human embryonic stem cells. J Clin Invest. 2004 Nov;114(9):1184-6. Full text of article
Landry, Donald W., Zucker, Howard A., Sauer, Mark V, Reznik, Michael, and Wiebe, Lauren. Hypocellularity and absence of compaction as criteria for embryonic death. Regenerative Med. 2006 May; 1(3): 367-371. Summary of article
CU Policy on the Conduct of Research with Human Embryos and Human Embryonic Stem Cells
CU Human Embryo and Human Embryonic Stem Cell Research Special Operating Procedures
Readings to be distributed in class.