Columbia University Human Research Protection Program

Policies and Guidance

Selected University Research Policies

• General Policies

  Institutional Policy on Misconduct in Research

  Principal Investigator Eligibility Policy

  Risk Management Procedures for International Research and Service Projects       

  Short-term Visitors in Research-related Activities Guideline

  Sponsored Projects Handbook
      

• Conflict of Interest Policies

  CUMC Conflict of Interest Policy

  Guidelines for Situations Involving Potential Conflicts of Interest Between Scholarly and Commercial Activities

  Sample Disclosure Forms

  Statement of University Policy on Conflicts of Interest

Institutional Review Board (IRB)

• Audio/Video/Photographic Recording of Human Subjects
• Certificates of Confidentiality:

  OHRP Guidance
  NIH CoC Kiosk

• Children as Study Subjects in Research

Age of Majority Chart for states within the U.S.

Age of Majority Chart for Canadian provinces

State-by-state "Marriage Age of Consent" Laws

Worldwide ages of consent (sexual activity) 

Guttmacher Institute: An Overview of Minors’ Consent Law (Aug 1, 2009)

• Education Training Requirement for Researchers
• Engagement of Institutions in Research - OHRP Guidance
• Enrollment of Non-English Speaking Subjects in Research
  • English Sample Short Form Consent Document
  • Short Form Consent Translations:

  Arabic

  Chinese-Simplified

  Chinese-Traditional

  Croatian

  French

  Greek

  Italian

  Japanese

  Russian

  Spanish

Vietnamese

• Exemption: Can My Project Be Considered Exempt from Full Board Review?
• HIPAA Policy and Procedures
• Informed Consent:

Informed Consent Policy, effective 5/8/07

Consent Form Builder Sample Language

General requirements for informed consent (45 CFR 46.116)

Guidelines for Writing Informed Consent Documents

Standard Format for Social/Behavioral Science Consent Documents
Tips for Increasing Comprehension of Informed Consent Documents
Tips on Informed Consent - OHRP Guidance

• Internet-Based Research
• IRB Standard Operating Procedures, effective 8/24/2009
• IRB Reviewer Form for Behavioral Research
• IRB Submissions:

Does My Research Project Require IRB Review?

How to Apply for IRB Approval

Research Protocol Format (for RASCAL Study Description)

• Noncompliance Policy
• Oral History Projects Policy
• Recruitment Material
• Students as Study Subjects in Research
• Students as Researchers
• Tips to Facilitate Efficient IRB Review - Protocols
• Tissues:

IRB Terminology Related to Tissue or Data Collection
Repositories, Tissue Storage Activities, Data Banks, OHRP Guidance (Nov. 1997)

• Unanticipated Problems: Reporting to the IRB of Unanticipated Problems Involving Risks (replaces Adverse Event Reporting Policy)
• Use of Publicly Available Datasets

General

• OHRP Policies & Guidance

International Standards

• CIOMS

Related Information

• Acronyms
• HHS Reference Collection

Archive:

IRB Standard Operating Procedures, effective 12/15/2008