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

https://research.columbia.edu

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

Training https://research.columbia.edu

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 https://www.rascal.columbia.edu/

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.

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

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

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.

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

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 www.effortreporting.columbia.edu

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

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. mb3852@columbia.edu

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

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.

Contact Information Naomi Schrag, JD – Misconduct, COI, Compliance Policy VP, Research Compliance, Training and Policy ns2333@columbia.edu; 854-8123 Michael Klein, JD – Misconduct, COI Director, Research Compliance mak67@columbia.edu; 851-2896 Michelle Avallone, JD – Export controls, sanctions Director, Export Controls mla25@columbia.edu; 851-9822 Michelle Benson, PhD – Research and Data Integrity Assistant Director, Research Integrity and Compliance mb3852@columbia.edu; 851-7281 Anderson Smith – Administrative Manager aps2180@columbia.edu; 854-4261