Research Compliance Foundations

Presented by the Office of Research Compliance and Training, Sponsored Projects Administration, Sponsored Projects Finance, and Columbia Technology Ventures.

Session Description: This session explores the shared responsibilities of principal investigators (PIs), administrators, and central offices in managing sponsored projects at Columbia. Participants learn about the administrative, financial, and oversight requirements that ensure compliance with sponsor terms, University policies, and federal regulations. The session clarifies PI obligations for scientific, fiscal, and ethical stewardship while outlining the vital role of administrators in budget monitoring, effort reporting, and project closeout. Key services provided by Sponsored Projects Administration (SPA) and Sponsored Projects Finance (SPF) are introduced, along with resources such as the Office of Research Initiatives and Columbia Technology Ventures (CTV). By the end of this session, participants understand how responsibilities are distributed across stakeholders and how research administrators can effectively support PIs in maintaining accountability throughout the life cycle of a sponsored project

Summer 2026 date: Tuesday, June 9, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by Sponsored Projects Administration.

Session Description: This session provides participants with the essential knowledge and tools needed to prepare and submit sponsored project proposals at Columbia. The discussion covers how to distinguish grants from gifts, proposal requirements at both the sponsor and University levels, and the critical role of Sponsored Projects Administration (SPA) in the review and submission process. Participants are introduced to University resources such as the EVPR website, research handbooks, and electronic systems like Rascal for proposal tracking and compliance. Key topics include PI eligibility, internal deadlines, budget justification, subrecipient requirements, and conflict of interest disclosures. The session also highlights recent federal expectations around researcher disclosures, biosketches, and current and pending support. By the end of this session, participants will understand how to navigate proposal preparation effectively, ensure compliance with sponsor and University requirements, and work closely with SPA to submit accurate and timely applications

Summer 2026 date: Tuesday, June 16, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by Sponsored Projects Finance.

Session Description: This session introduces participants to the federal regulations and University policies that shape the financial administration of sponsored projects. Topics include the Uniform Guidance, OMB circulars, the Federal Demonstration Partnership (FDP), and key compliance areas such as effort reporting, indirect costs, fringe benefits, and cost transfers. Participants learn how these regulations apply to both federal and non-federal awards, the importance of internal controls, and Columbia’s responsibilities as steward of over $1.5 billion in sponsored funding. The session also explains audit requirements, unallowable costs, and documentation standards to ensure compliance and accountability. By the end of this session, participants will be able to recognize regulatory concerns, understand the principles guiding cost allocation and financial management, and appreciate the role of administrators in safeguarding the integrity of sponsored funds.

Summer 2026 date: Tuesday, June 23, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by the Office of Research Compliance and Training.

Session Description: This session examines the policies and processes that govern compensation charged to sponsored projects and the reporting of faculty and staff effort at Columbia. Participants learn key concepts such as Institutional Base Salary (IBS), Total University Effort (TUE), and the distinction between sponsored and non-sponsored effort. The session covers each stage of the sponsored project lifecycle, from proposal preparation to award management and final certification, with emphasis on ensuring that salaries charged are reasonable, appropriately documented, and aligned with effort commitments. Special topics include cost sharing, summer salary, extra service pay, and the NIH salary cap. Participants also gain an understanding of Columbia’s effort reporting system (ECRT), quarterly monitoring requirements, and the responsibilities of PIs, administrators, and effort coordinators in maintaining compliance. By the end of this session, participants will be equipped to support accurate salary allocation and effort certification, helping to protect both individual researchers and the University from compliance risks.

Summer 2026 date: Tuesday, June 30, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by IACUC and Environmental Health & Safety (EH&S)

Session Description: This session introduces the regulatory frameworks, ethical considerations, and institutional resources that support research involving animals and hazardous materials at Columbia University. Participants examine the requirements governing animal research, including the Animal Welfare Act, Public Health Service (PHS) Policy, and the Guide for the Care and Use of Laboratory Animals, along with Columbia’s commitment to humane and ethical animal care. The session highlights the role of the Institutional Animal Care and Use Committee (IACUC) in protocol review, facility oversight, and ensuring compliance, as well as the responsibilities of researchers and administrators in maintaining approved protocols and reporting concerns.

In addition, participants are introduced to the role of Environmental Health & Safety (EH&S) in promoting safe research environments across the University. Topics include hazardous materials management, laboratory safety, regulatory training requirements, and the support EH&S provides for inspections, certifications, and incident response. The session emphasizes common points of interaction between research teams and EH&S, including grant-related safety certifications, lab setup and compliance, and ongoing safety monitoring.

By the end of this session, participants will understand how to support compliance in animal research and laboratory safety, recognize key regulatory requirements, and effectively engage with IACUC and EH&S as central resources in maintaining safe, ethical, and compliant research environments.

Summer 2026 date: Tuesday, July 7, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by the Human Research Protection Office (HRPO)

Session Description:

This session provides a focused introduction to the ethical principles, regulatory requirements, and institutional processes governing research involving human subjects at Columbia University. Participants explore the historical foundations of human subjects protections, including key milestones that shaped modern research ethics, and examine the core principles outlined in federal regulations and guidance.

The session introduces the role of the Human Research Protection Office (HRPO) and Institutional Review Boards (IRBs) in reviewing and overseeing research to ensure the rights, welfare, and safety of participants are protected. Participants gain an understanding of what constitutes human subjects research, the different levels of IRB review, and the criteria used to evaluate research protocols. The session also walks through the IRB submission process in Rascal, including protocol development, training requirements, and ongoing compliance responsibilities such as reporting, continuing review, and protocol modifications.

By the end of this session, participants will be equipped to identify when IRB review is required, navigate the submission and review process, and support researchers in maintaining compliance with federal regulations and University policies governing human subjects research.

Summer 2026 date: Tuesday, July 14, 12 - 1:30 pm, EST

Click here for this session's handout

Topics:  Conflicts of interest; research misconduct; public access, data management, and data security; research and data integrity; responsible conduct of research training requirements; code of conduct.  Presented by the Office of Research Compliance and Training.

Session Description: This session highlights some of the most pressing issues in research compliance today, including conflicts of interest, conflicts of commitment, research security, research misconduct, and evolving requirements for public access, data management, and data security. Participants explore Columbia’s policies on financial and institutional conflicts of interest, disclosure obligations for faculty, and the growing federal emphasis on transparency in current and pending support, biosketches, and foreign affiliations. The session also covers case studies in research misconduct, Columbia’s Research and Data Integrity (ReaDI) program, and NIH/NSF requirements for Responsible and Ethical Conduct of Research (RECR) training. By the end of this session, participants will understand how these issues impact researchers and administrators alike, and how to apply University resources and federal guidance to support research integrity and compliance.

Summer 2026 date: Tuesday, July 21, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by the Office of Research Compliance and Training.

Session Description: This session introduces the complex regulatory landscape governing international research, focusing on U.S. export control laws, economic sanctions, and compliance considerations for Columbia researchers. Participants learn how federal regulations such as ITAR, EAR, and OFAC sanctions impact the transfer of items, technology, and information to foreign entities, both abroad and within the U.S. The session explains the concept of “fundamental research,” red flag issues requiring escalation, and the role of restricted party screening. It also highlights the compliance risks associated with international travel, collaborations, shipping of research materials, and visa attestations. Finally, the session reviews key questions to consider when planning or supporting international projects, including funding sources, high-risk locations, and regulated activities. By the end of this session, participants will understand when and how to escalate concerns, and the critical role administrators play in supporting compliant international research.

Summer 2026 date: Tuesday, July 28, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by the Office of Research Compliance and Training.

Session Description: This review session reinforces key concepts from the Foundations program through interactive case studies and review exercises. Participants work through real-world scenarios involving cost allowability, effort allocation, rebudgeting, and compliance challenges to apply what they have learned in earlier sessions. The session also features a review game to test knowledge of topics such as Uniform Guidance, conflicts of interest, IRB and IACUC oversight, effort reporting, and data management. By practicing how to identify compliance risks and respond appropriately, participants strengthen their ability to support principal investigators, safeguard research integrity, and navigate complex sponsored project requirements. Completion of this session prepares participants to take the required Rascal test and move forward toward earning the Certificate in Administration of Sponsored Projects

Summer 2026 date: Tuesday, August 4, 12 - 1:30 pm, EST

Click here for this session's handout

Presented by the Clinical Trials Office.

Session Description: This session focuses on the unique regulatory, financial, and administrative considerations involved in managing clinical trials at Columbia. Participants are introduced to the Clinical Trials Office (CTO), its structure, and its role in supporting investigators with budgeting, contracting, compliance, and trial oversight. Topics include budgeting for industry-sponsored and investigator-initiated trials, contract negotiation, informed consent, and post-award financial management using IBM CTMS and Epic systems. The session also reviews regulatory requirements for FDA-regulated research, ClinicalTrials.gov registration, Good Clinical Practice (GCP) training, and departmental quality assurance programs. Participants explore inspection readiness and common issues identified during FDA audits, as well as tools like RecruitMe for participant recruitment. By the end of this session, participants will understand the specialized responsibilities and resources associated with clinical trials and how to support investigators in meeting these obligations.

Summer 2026 (CUIMC and CUIMC-affiliated ZMBBI departments Only) date: Tuesday, August 11, 12 - 1:30 pm, EST

Click here for this session's handout