1. ARTS & SCIENCES ORIENTATION New Faculty
Research Compliance at Columbia: Key Requirements
Sept. 8, 2017

3. Roadmap Training Conflict of Interest Human Subject Research
Compensation
Research Misconduct
Data Management and Integrity
Export Controls

4. Training

5. Conflict of Interest Disclosure
Who must disclose?
Anyone who conducts research under the auspices of Columbia. May include post docs and even graduate students depending on their level of independence.
When to disclose?
On hire and at least annually thereafter
Required for proposal submission and award set-up
Update disclosure if there are changes
How to disclose?
Rascal web-based Conflict of Interest module

6. Conflict of Interest Disclosure
What to disclose?
All outside financial interests that relate to research or other institutional responsibilities that you have currently or expect to have over the next 12 months, e.g.:
Consulting or other compensation for services, but not if paid through Columbia
Equity or other ownership interests, including start-up companies even if they exist only on paper.
Not equity held in mutual funds or retirement accounts
Royalties, IP payments
Include self, spouse, dependent children
Parents and grandparents only if you know the interests, but no obligation to inquire.

7. Conflict of Interest Review
Conflict of Interest Committee reviews “Significant Financial Interests” that relate to the individual’s research.
Compensation including royalties > $5,000
Any equity in a private company
Equity in a public company with a value > $5,000
Committee asks: is there a conflict and if so, can it be managed?
Case-by-case review

8. Conflict of Interest Resources
Policy
General FAQs
Start-up FAQs
Disclosure Checklist

9. Human Subjects Research
The definition is broader than might be expected.
All human subject research protocols must be approved by one of Columbia’s Institutional Review Boards.
Submit protocols through Rascal.

10. Grants Management: Compensation
Researchers may charge a proportionate share of salary to sponsored projects.
A&S funds academic-year salary but a portion may be charged to sponsored projects
Researchers may charge summer salary to sponsored projects
Salary must be reasonable for services provided, project by project
Non-sponsored activities, e.g., teaching, service, writing new funding proposals, must be funded by school or department sources, including in the summer

11. Compensation Across the Project Lifecycle
Initial salary allocation: must reasonably approximate activity expected to be performed
Ongoing monitoring at least quarterly: allocation must be adjusted for significant changes
End-of-year effort report confirms that salary is reasonable: in October
Effort reporting training is required

12. Results Too Good to Be True?
University definition of “Research Misconduct” tracks Federal regulations
Fabrication
Falsification
Plagiarism
Office of Research Compliance & Training is a resource – call us ASAP
Formal process for allegations of research misconduct
Structured, 3-stage process set forth in University’s Institutional Policy on Misconduct in Research
Sometimes informal resolution is an option

13. Research and Data Integrity (ReaDI) Program
EVP for Health Sciences and EVP for Research asked the Office of Research Compliance and Training to initiate a new program to enhance data management and research integrity
Resources
Outreach
Consultations
Tutorials
Templates
“Best practice guidelines”
Laboratory departure checklists
And many more!
Workshops
Lectures
Topics ranging from questionable research practices to data management and federal public access policies
Evaluate research group data management practices and ensure they meet PI’s expectations
Data validation component
By PI or department request
Michelle Benson, Ph.D.

14. LabArchives: Electronic Lab Notebook
Free for any Columbia personnel with valid UNI
Unlimited storage
Unlimited number of notebooks
Max file upload into notebook is 4GB
Features:
Secure, backed-up
Collaboration space
Customizable
Searchable
Audit trail and version control
Cloud-based: ability to access from anywhere
Classroom edition also available
Approved only for use in research (other than research studies involving the provision of health care services for which study subjects are billed)
More information at: labnotebooks.columbia.edu

15. Export Controls
Export controls are laws and regulations that regulate whether certain technology or information can be shared outside the U.S. or with non-U.S. persons here.
U.S. sanctions regulations can limit transactions and travel to certain countries.
Comprehensive sanctions: Cuba, Iran, North Korea, Sudan, Syria, Crimea Region of Ukraine
Contact Michelle Avallone, Director of Export Controls, with any questions or for any projects involving sanctioned countries or entities.

16. Contact Information
Naomi Schrag, JD – Misconduct, COI, Compliance Policy
VP, Research Compliance, Training and Policy
Michael Klein, JD – Misconduct, COI
Director, Research Compliance
Michelle Avallone, JD – Export controls, sanctions
Director, Export Controls
Michelle Benson, PhD – Research and Data Integrity
Assistant Director, Research Integrity and Compliance
Anderson Smith – Administrative Manager