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.

DATE

TOPIC

SPEAKER

Jan 25, 2019

Mentorship

Dr. Arthur Palmer
agp6@columbia.edu

Feb 1, 2019

The Scientific Method

Dr. Stuart Firestein
sjf24@columbia.edu

Feb 8, 2019

Data Management, Sharing, and Reproducibility

Dr. Peter Sims
pas2182@columbia.edu>

Feb 15, 2019

Science at a Crossroads: Time for Reform?

Dr. Arturo Casadevall
Bloomberg School of Public Health
Johns Hopkins University
acasadevall@jhu.edu

Feb 22, 2019

Research with Human Subjects/Participants

Dr. Elaine Larson
ell23@columbia.edu

Mar 1, 2019

Research with Human Subjects/Participants

Dr. Neil Schluger
ns311@columbia.edu

Mar 8, 2019

Humane and Responsible Use of
Laboratory Animals in Scientific Research

Dr. Brian Karolewski
bk2474@columbia.edu

Mar 15, 2019

Strategies for a Successful Research Career

Dr. Donald Landry
dwl1@columbia.edu

Mar 22, 2019

Spring Recess

-

Mar 29, 2019

University Symposium

Promoting Credibility, Reproducibility
and Integrity in Research

April 5, 2019

Research with Industry Partners/
Intellectual Property/Technology Transfer/
Conflict of Interest

Dr. Joan Martinez
jm4381@columbia.edu

April 12, 2019

Responsible Conduct of Research - What Is It?

Dr. Jaime Rubin
jsr9@columbia.edu

April 18, 2019

Deadline for required essays
No class

Submitted via
CourseWorks

April 19, 2019

No class currently scheduled

-

April 26, 2019

No class currently scheduled

-

May 3, 2019

Authorship, Publicatioins, and Peer Review

Dr. Jaime Rubin
jsr9@columbia.edu 

 

Textbook

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.

Registration

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 should clarify with their individual research training program director or research mentor on whether they are required to obtain documentation on successfully completing all course requirements (e.g., attendance, essay). The Course Directors are unable to make this determination for NIH-funded class participants [e.g., those supported by NIH training grants (T’s), individual fellowships (F’s), or career development awards (K’s)]. 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
ym2183@cumc.columbia.edu

Directors

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
email: agp6@columbia.edu

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
email: jsr9@columbia.edu
 

Sessions

Session 1: Mentorship

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.

Session 3: Data Management and Sharing/Reproducubility

Assigned text: Macrina, F.L. Scientific Integrity. Chapters 9. and 11

Session 4: Science at a Crossroads: Time for Reform?

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.

Sessions 5 and 6: Research with Human Subjects/Participants

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).

Session 7: Humane and Responsible Use of Laboratory - Animals in Scientific Research

Session 8: Strategies for a Successful Research Career

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

Session 10: 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

Session 11: Responsible Conduct of Research: What Is It?

Session 12: Authorship, Publications, and Peer Review

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