Course Syllabus

Office Hours:  By appointment

Course Coordinator

Benjamin Lovell
Office: Graduate Education & Postdoctoral Affairs, room G-9556
Phone: 275-5022

Benjamin_Lovell@urmc.rochester.edu

Course Website

http://learn.rochester.edu

Instructional Staff

Faculty	Office	Email
Paul Brookes, PhD	4-7417	Paul_Brookes@urmc.rochester.edu
John Cullen, PhD	1-208 (SRB)	John_Cullen@urmc.rochester.edu
Stephen Dewhurst, PhD	2-11112 (MRBX)	Stephen_Dewhurst@urmc.rochester.edu
Robert Freeman, PhD	4-6718	Robert_Freeman@urmc.rochester.edu
Robert Gross, MD, PhD	5-4315B	Robert_Gross@urmc.rochester.edu
Paige Lawrence, PhD	4-5702C	Paige_Lawrence@urmc.rochester.edu
Kelley O’Donoghue, MPH	1-250 (SRB)	Kelley_Odonoghue@urmc.rochester.edu
James Palis, MD	1-11116 (MRBX)	James_Palis@urmc.rochester.edu
David Topham, PhD	3-9631	David_Topham@urmc.rochester.edu
Jeff Wyatt, DVM	G-6726	Jeffery_Wyatt@urmc.rochester.edu

Prerequisites:  None

Course Description

Inherent to the scientific method is the belief that scientists, whether in the basic sciences, clinical or social sciences, are honest in the conduct of their research and presentation of their results.  Equally important is that we make our results public, so that others can build upon the knowledge that we have gained.  To avoid wasting time, effort, and increasingly scarce resources, every effort should be made to ensure that the results we describe are reproducible and reliable and based on data obtained and analyzed using rigorous approaches.  Through adherence to these principles, vast knowledge has been acquired and new frontiers have been opened and explored.

Unfortunately, some individuals, whether through peer or professional pressure, frustration, or the desire for personal and professional gain, have chosen to take shortcuts or otherwise act deceptively in their research or the presentation of their results.  In fact, there is widespread and growing awareness of published research findings that are neither reproducible nor reliable.  Such abuses of the principles of the scientific method – whether intentional or the result of ignorance, sloppiness, or experimenter bias – can jeopardize the work of others and impede or even prevent the research advances we have come to expect from the scientific endeavor.  

Worse still, the abuse of the time-tested principles of honesty and integrity in research can erode the foundation upon which research is valued by the public at large. For this reason, government agencies and professional societies have developed guidelines and codes of behavior to be applied by scientists in the conduct of their own research and when reviewing the work of others.

Through a series of lectures and small group discussions, IND 501/506 provides information and insights on important tenets and topics that the National Institutes of Health considers essential to the responsible conduct of biomedical research.  While some of the issues and guidelines that will be discussed are straightforward and clear cut, others require ethical or moral considerations. In such cases, the dilemmas may be difficult to resolve, as they often lack clear, explicit answers.  In other instances, US federal law will prescribe certain steps are taken.  Nonetheless, we may not all agree with these laws.  But as scientists, we must engage in open dialogue (including honest disagreement) as we make every effort to understand and apply ethical and responsible research principles to our work.

Course Aims and Objectives

• To understand the importance of applying ethical principals during the conduct of biomedical research.
• To understand the basic framework of the guidelines, rules and regulations that exist to manage ethical issues that arise in biomedical research.
• To acquire a set of basic biomedical ethics resources to apply to biomedical research.
• To understand the importance of carrying out research that is reproducible and reliable and to appreciate the many factors that go into conducting rigorous research.  

Course Policies and Expectations

Training in Ethics and Professional Integrity in Research at the University of Rochester School of Medicine and Dentistry is required of all first-year graduate students and new postdoctoral appointees in the biomedical and health sciences.  Active participation in all 10 modules of IND 501/506 fulfills this initial requirement and provides students a foundation on which to continue their training in the responsible conduct of research in subsequent years. 

Class modules consist of a synchronous online lecture given over Zoom followed a week later by a live small group discussion of related case studies (note - small group sessions are either in person or via Zoom depending on the course section that was selected at registration).  The discussion groups are facilitated by faculty preceptors and employ a case study approach to help students understand issues related to research integrity, recognize conflicting ethical principles, and explore their own individual attitudes and prejudices.

Viewing all 10 lectures and attending all 8 small group discussion sessions, is mandatory.  If an absence is unavoidable (e.g., illness, presenting at a conference), one missed session may be permitted with the appropriate documentation (e.g., doctor’s note).  Except in the case of a medical emergency, you must notify the Course Coordinator PRIOR to any missed session.  Completion of a writing assignment will be required before any missed session will be excused.

To verify attendance and viewing of lecture videos, participants must complete an online ‘lecture quiz’ for each module.  Attendance at small group sessions will be monitored by each group’s faculty facilitator. NOTE: Students that arrive at their small group discussion session >10 min after the start of the session will be marked absent for that session, and a written assignment will be required. 

Materials and Access

Key resources:

On Being a Scientist: Responsible Conduct in Research, 3rd edition, National Academy Press, Committee on Science, Engineering, and Public Policy, National Academy of Science, National Academy of Engineering, Institute of Medicine. Washington, DC, 2009. 

ORI - Introduction to the Responsible Conduct of Research, by Nicholas Steneck, issued by the US Department of Health and Human Services, Office of Research Integrity. Washington, DC, 2007.

All other course materials, including any required and supplemental Ethics and Professional Integrity in Research resources, will be available on the course website on Blackboard: http://learn.rochester.edu

Need Help with Blackboard?

• URMC Blackboard Support Page
• Email: blackboard@urmc.rochester.edu

Assignments and Grading Procedures

IND 501 is a 1-credit course graded according to a Satisfactory/Fail (S/E) scheme.
IND 506 is a non-credit course and is graded according to a Satisfactory/Fail (S/E) scheme.

In general, graduate students should register for IND 501 and postdoctoral researchers for IND 506. Note that these courses are NOT available to audit.

Grades are based on viewing of lecture material and satisfactory completion of lecture quizzes, attendance and participation in small group discussions, and completion of the online course evaluation, each of which is required to receive a satisfactory grade.

Reminder: Attendance at ALL discussion groups is MANDATORY.

Academic Integrity

Academic integrity is a core value of the University of Rochester. Students who violate the University of Rochester University Policy on Academic Honesty are subject to disciplinary penalties, including the possibility of failure in the course and/or dismissal from the University. Since academic dishonesty harms the individual, other students, and the integrity of the University, policies on academic dishonesty are strictly enforced. For further information on the University of Rochester Policy on Academic Honesty, please visit the following websites:

• https://www.rochester.edu/College/honesty/
• https://www.rochester.edu/college/honesty/policy/index.html

Students in this course are expected to conduct themselves in an honest and ethical manner, as well as to respect the intellectual work of others. While students should complete all required readings and work on their own, open discussions with others regarding course content and issues that arise in the case studies are always encouraged. Any writing assignment completed in lieu of an approved absence must represent the student’s own work, with any ideas or text taken from others appropriately identified and cited (this includes content taken from the internet).

Accommodations for Students with Disabilities

Accommodations for Students with Disabilities Students needing academic adjustments or accommodations because of a documented disability must contact the Disability Resource Coordinator for the school in which they are enrolled (see link below for contact information). Contact Disability Resource Coordinator

 

Fall 2023 – IND 501/506 – Ethics and Professional Integrity in Research

Lectures (in Class of ’62 Auditorium unless otherwise noted) Tuesday 3:30 – 4:30 PM

Small group meetings: Tuesday 8:00 – 9:00 AM; 4:45 – 5:45 PM, or  6:00 – 7:00 PM

Course Schedule

Module	Lecturer	Lecture	Small Group Meeting Date
Course Introduction / Data Acquisition, Management, Sharing & Ownership	Paul Kammermeier, PhD	Sept 12	N/A
Animal Experimentation	Jeffery Wyatt, DVM	Sept 19	Sept 26
Collaboration and Team Science	Martin Zand, PhD	Sept 26 2-6424 Aud	Oct 3
Human (Clinical) Experimentation / Conflicts of Interest	Kelley O’Donoghue, MPH, CIP	Oct 3	Oct 10
Scientific Misconduct	Paul Brookes, PhD	Oct 10	Oct 17
Unconscious Bias and the Impact on our Research Environment	John Cullen, PhD	Oct 17	Oct 24
Mentor-Mentee Relationship	Paige Lawrence, PhD	Oct 24 2-6424 Aud	Oct 31
Research Rigor and Reproducibility	Stephen Dewhurst, PhD	Oct 31	Nov 7
Publishing – Authorship, Transparency & Peer Review	Robert Gross, MD, PhD	Nov 7	Nov 14
Ethics of AI in research	Jon Harington, PhD	Nov 14	N/A