VP&S Educational Research and Quality Improvement Involving Students and Columbia Affiliates

Overview/Rationale

This policy establishes the institutional requirement for oversight and endorsement of all educational research and quality improvement (QI) projects involving Columbia University Vagelos College of Physicians and Surgeons (VP&S) medical students or Columbia affiliates with oversight by the Vice Dean of Education at VP&S. The aim is to ensure that such projects meet the highest standards of ethical practice, educational value, student protection, and institutional alignment. 

Per Columbia policy, projects involving students or affiliates—whether classified as research, quality assurance, or quality improvement—must be reviewed and approved by the Vice Dean for Education, with guidance from the VP&S Educational Advisory Group (EAG) subcommittee, which will provide a letter of support to proceed with a given project. External projects also need review and approval to disseminate to VP&S students.  

This process also ensures alignment with LCME accreditation standards and institutional policies related to the protection of student data and the responsible conduct of educational scholarship. 

Accreditation Standards and Relevant Policies / Law

LCME Accreditation Standard 11.5 - Confidentiality of Student Educational Records

This standard requires that medical schools ensure appropriate confidentiality, access, and use of student records. Any use of student information for research or QI purposes must be conducted in accordance with these requirements.

  • FERPA (Family Educational Rights and Privacy Act) Federal law protecting the privacy of student education records. This policy supports compliance by requiring proactive oversight of all student-involved projects 

Stakeholders 

Medical students and Columbia affiliates

Policy/Procedure

All educational research or quality improvement (QI) projects involving: 

  • VP&S medical students, or 

  • Columbia University affiliates (faculty, residents, staff, etc.) in educational roles 

must undergo institutional review and receive a formal Letter of Support from the Vice Dean for Education before implementation. 

This includes, but is not limited to: 

  • Projects involving collection or analysis of student data (e.g., assessments, evaluations, surveys, interviews, focus groups) 

  • Pilots or evaluations of curricular modules or interventions 

  • Studies involving faculty teaching practices with medical students 

  • Educational projects using affiliated instructors (e.g., residents, fellows, standardized patients) 

The required review process includes: 

  1. Completion of a project intake form detailing aims, methods, data use, recruitment, privacy, and anticipated risks.  

  1. Completion of a RASCAL IRB datasheet, regardless of if the project is thought to be QA/QI or not.  

  1. Completion of a data confidentiality and security form

  1. These three documents will undergo review by a sub-committee of the VP&S Educational Advisory Group (EAG) to determine whether the project meets institutional criteria for QI or constitutes research requiring IRB oversight. 

  1. Approval of subject involvement and issuance of a Letter of Support from the Vice Dean for Education, affirming that: 

  1. Subjects are appropriate for recruitment 

  1. Student confidentiality and educational standing will be protected 

  1. Institutional priorities and protections are upheld 

No project involving students or affiliates may proceed—whether submitted to the IRB or conducted as QI—without this approval. External projects also need review and approval to disseminate to VP&S students.