Faculty & Staff

Columbia University requires all of its NY-hired and locally hired employees and consultants to be in compliance with laws and University and funding-agency policies regarding research with human subjects.

To ensure compliance in the research conducted, Columbia University requires that University personnel and programs use RASCAL, Columbia University’s online Research Administration System, to process compliance for:

• Health Insurance Portability and Accountability Act (HIPAA) and Good Clinical Practices Training Certifications
• Human Subjects (Institutional Review Board - IRB)

For all research, including public health evaluations and special projects, University personnel are typically required to follow these steps:

1. Develop the protocols for the research
2. Develop the proposal and budgets as required
3. Enter the required information in the RASCAL Proposal Tracking Module
4. Have the proposal reviewed and approved by Research Administration
5. Submit the funding application
6. If notified of the possibility of obtaining funding, enter the required information in the RASCAL IRB Module, attaching necessary documents
7. Submit the protocols for review by Columbia University’s Institutional Review Board (IRB) for either a non-human-subjects research determination or for review and approval as human-subjects research
8. Once IRB approval is received, transmit evidence of approval to the funding agency and, if required, submit a copy of the research protocols
9. Obtain funding agency approval
10. Maintain complete records for the compliance filing

For further information, see:

• Developing International Projects, which provides information on proposal and budget development, institutional review and approval, risk management procedures, and other compliance topics
• The University’s Sponsored Project Handbook covers many related topics and has a section on “Special Approvals” that is particularly of interest for compliance filings for research
• The University’s Research Compliance and Training site