RESPONSIBLE CONDUCT OF RESEARCH AND RELATED POLICY ISSUES


COURSE DESCRIPTION

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.

Related Resources:
Bio and Medical Research Ethics:
http://www.cumc.columbia.edu/dept/gsas/ac_programs/bio.htm

Course:
http://www.cumc.columbia.edu/dept/gsas/ac_programs/rcr-crse.htm


SCHEDULE OF SESSIONS: SPRING 2008

Date Topic Speaker Contact Information
Jan 25 Ethics for Graduate Students Dr. Richard Kessin e-mail: rhk2@columbia.edu
Feb 1 Responsible Conduct of Research
What Is It?
Dr. Jaime S. Rubin e-mail: jsr9@columbia.edu
Feb 8 Humane and Responsible Use of Laboratory Animals Dr. Thomas Martin e-mail: tem2103@columbia.edu
Feb 15 No class-President's Weekend
-
-
Feb 22 The History of Human Experimentation through the 1970's Dr. Barron Lerner e-mail: bhl5@columbia.edu
Feb 29 The Rules of Human Experimentation Dr. Elaine L. Larson e-mail: ell23@columbia.edu
Mar 7 Publication and Authorship Dr. Jaime S. Rubin e-mail: jsr9@columbia.edu
Mar 14 Conflict of Interest Dr. Henry Spotnitz e-mail: hms2@columbia.edu
Mar 21 No class-Spring Break
-
-
Mar 28 Data Management and Data Sharing Dr. Richard Kessin e-mail: rhk2@columbia.edu
Apr 4 Real Life Ethical Dilemmas Dr. Iva Greenwald e-mail: greenwald@cuccfa.ccc.columbia.edu
Apr 11 Mentoring
Essays Due
Dr. Richard Robinson e-mail: rbr1@columbia.edu
Apr 18 Research with Stem Cells Dr. Donald W. Landry e-mail: dwl1@columbia.edu
Apr 25 Scientific Citizenship Dr. Samuel Silverstein e-mail: scs3@columbia.edu


|Lecture 1| |Lecture 2| |Lecture 3| |Lecture 4| |Lecture 5| |Lecture 6|
| Lecture 7| | Lecture 8| | Lecture 9| | Lecture 10| | Lecture 11| | Lecture 12|

Lecture 1: Ethics for Graduate Students

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.

Lecture 2: Responsible Conduct of Research: What Is It?

Assigned text: Macrina, F.L. Scientific Integrity. Chapter 1.

CU Institutional Policy on Misconduct in Research

Additional material distributed in class.

Lecture 3: Humane and Responsible Use of Laboratory Animals in Scientific Research

Assigned text: Macrina, F.L. Scientific Integrity. Chapter 6.

CU Medical Research Involving Animals

Lectures 4 and 5: Research with Human Subjects

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

Lecture 6: Publications and Authorship

Assigned text: Macrina, F.L. Scientific Integrity. Chapter 4.

Lecture 7: Conflict of Interest

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

Lecture 8: Data Sharing and Data Management

Assigned text: Macrina, F.L. Scientific Integrity. Chapter 9.

Lecture 9: Real Life Ethical Dilemmas

Readings to be distributed in class.

Lecture 10: Mentoring

Assigned text: Macrina, F.L. Scientific Integrity. Chapter 3.

Lecture 11: Research with Stem Cells

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

Lecture 12: Scientific Citizenship

Readings to be distributed in class.