Responsible Conduct of Research and Related Policy Issues
A Discussion of Scientific Research Ethics for Students, Post-doctoral Scientists and Fellows, and other Junior Investigators at the Columbia University Irving Medical Center
This course explores a variety of ethical and policy issues that arise during the conduct of basic, translational, epidemiological, and clinical biomedical research. The course's philosophy is to facilitate and encourage students to engage with Columbia faculty members who can speak from their own experience on ethical questions that can arise during the conduct of scientific research.
Class presenters include Chairs of Institutional Review Boards, the Director of the Institute of Comparative Medicine, as well as faculty who are directly involved with these issues. The goal of the course is to provide students, post-doctoral scientists and fellows, junior faculty, and other investigators with a knowledge base as well as practical advice on ethical and policy issues.
Topics addressed include:
- Research misconduct, as well as policies and procedures for addressing
- Mentee-mentor relationship
- Authorship practices and scientific publications
- Research involving human participants/subjects
- Data acquisition, ownership, sharing, management, and reproducibility
- Use of laboratory animals in scientific research
- Conflicts of interest
- Peer review
- Intellectual property and technology transfer
- The role of scientists in society
- Collaborative research
- Partnerships with industry
- The scientific method
- Strategies for a successful research career.
Course sessions include lectures, class discussion, and case studies.
Graduate level - Course number: G4010, Call number: 20996, given yearly in the Spring term; One point/credit; Pass/Fail, grade determined by attendance, class participation, and a required essay. There are twelve 1-hour sessions per term.
Location and Time
All sessions are held in the Vagelos Education Center (VEC), Room 401, on the Irving Medical Center campus of Columbia University. All sessions are scheduled for Fridays, 1:00 PM - 2:00 PM.
Macrina, Francis L. Scientific Integrity: Text and Cases in Responsible Conduct of Research, 4th ed. ASM Press, 2014. Paperback. $65.00. ISBN 978-1555816612. Very limited copies are on reserve in the Office of Graduate Affairs, P&S Building, Room 3-435.
Additional resource material (e.g., case studies) for each session will be distributed in class or via Courseworks. Columbia University faculty, post-doctorate fellows/scientists, students, and staff are welcome to audit the course. Those wishing documentation of successfully completing all course requirements should formally register. The Columbia University transcript serves as this documentation. No other documentation will be provided. Please see the Registration section for information on how to register. This course attracts class participants from diverse educational and research training programs. Directors and Mentors of these pre-doctoral, post-doctoral, and junior faculty training programs may wish to augment the course with additional requirements, including small group discussion sessions, or provide "refresher" training involving individual training program faculty. This course may not be taken twice (whether registered or auditing); i.e., it may not be taken initially and then subsequently years later as a "refresher". G4011 (call number: 68597) is the course number for the Integrated Program and Department of Pharmacology's discussion group that accompanies this class.
Columbia University faculty, post-doctorate fellows/scientists, students, and staff are welcome to audit the course. Those wishing documentation of successfully completing all course requirements should formally register. The Columbia University transcript serves as this documentation. No other documentation will be provided. Class participants who are already enrolled in a Columbia University degree granting program should register for "Responsible Conduct of Research and Related Policy Issues" (G4010) similar to their other Spring term classes.
All others should contact:
Dr. Yinghui Mao
Assistant Dean for Graduate Affairs
Dr. Arthur G. Palmer III
Associate Dean for Graduate Affairs
Robert Wood Johnson Jr. Professor
Dept. of Biochemistry & Molecular Biophysics
Black Bldg. Room 504
650 West 168th Street
New York, NY 10032
Tel: 212 305-8675
Dr. Jaime S. Rubin
Professor of Medical Sciences (in Medicine) at CUMC
Vice Chair for Investigator Development
Department of Medicine
630 West 168th Street
PH 8 West, Room 891
New York, NY 10032
Tel: 212 342-3184
Assigned text: Macrina, F.L. Scientific Integrity. Chapters 1. and 2.
CU Office of Research Compliance and Training: Research Misconduct
CU Institutional Policy on Misconduct in Research
Couzin J. Scientific misconduct. Truth and consequences. Science. 2006 Sep;313(5791):1222-6. Erratum in: Science. 2007 Feb 9;315(5813):766.
Additional material distributed in class and via CourseWorks.
AAMC's Compact Between Postdoctoral Appointees and Their Mentors
AAMC's Compact Between Biomedical Graduate Students and Their Research Advisors
CU's Graduate School of Arts and Sciences' Policies and Resources
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 3.
Hill, Linda. Becoming a Manager: How New Managers Master the Challenges of Leadership, 2nd ed. Harvard Business Review Press, 2003. ISBN-13: 978-1591391821.
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 6.
CU Institute of Comparative Medicine
CU Institutional Animal Care And Use Committee
Columbia University: Animal Research Handbook
Regulatory and Guidance Documents:
Guide for the Care & Use of Laboratory Animals, 8th edition
Office of Laboratory Animal Welfare, the including Public Health Service Policy on Humane Care & Use of Laboratory Animals
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 11.
Broderick, NA, Casadevall, A. Disequilibrium in Gender Ratios among Authors who Contributed Equally. https://www.biorxiv.org/content/early/2017/12/31/241554. posted December 31, 2017.
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
The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research).
Assigned text: Macrina, F.L. Scientific Integrity. Chapter 4.
Assigned text: Macrina, F.L. Scientific Integrity. Chapters 9. and 11
Lecture 9: Research with Industry Partners/Intellectual Property/Technology Transfer/Conflict of Interest
Assigned text: Macrina, F.L. Scientific Integrity. Chapters 7., 8., and 9.
Columbia University Policies and Resources
Stevens AJ. The enactment of Bayh-Dole. Journal of Technology Transfer. 2004. 29(1), 93-99. Full text of article
Stolberg SG. Financial ties in biomedicine get close look. NY Times. Feb 20, 2000. Full text of article
Gillis J and Schwartz J. Deeper ties to corporate cash for doubtful climate researcher. NY Times. Feb 21, 2015. Full text of article
Gillis J. Climate change researcher offers a defense of his practices. NY Times. Mar 2, 2015. Full text of article
Landry DW, Zucker HA. Embryonic death and the creation of human embryonic stem cells. J Clin Invest. 2004 Nov;114(9):1184-6. Full text of article
Landry DW, Oliver JA. Insights into shock. Sci Am. 2004 Feb;290(2):36-41.
Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. Full text of article
Landry DW. Immunotherapy for cocaine addiction. Sci Am. 1997 Feb;276(2):42-5.
Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. Full text of article
Landry DW, Zhao K, Yang GX, Glickman M, Georgiadis TM. Antibody-catalyzed degradation of cocaine. Science. 1993 Mar 26;259(5103):1899-901. Full text of article