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

  Columbia University Policy on Financial Conflicts of Interest and Research

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

  Statement of University Policy on Conflicts of Interest

• Stem Cell Research Policies

  Policy on the Conduct of Research with Human Embryos and Human Embryonic Stem Cells

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)

• Collaborating Individual Investigators
• Data Security Plans Involving the Use, Storage or Transmission of Electronic Research Data Containing Sensitive Data
• Disclosure of SSNs Outside of Columbia for Research Purposes
  • Privacy and Security Agreement
• Education Training Requirement for Researchers
• Electronic Approval Letters
• Electronic Informed Consent (e-Consent) Guidance
• 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	Filipino	Italian	Romanian	Turkish
  Chinese-Simplified	French	Japanese	Russian	Ukrainian
  Chinese-Traditional	Greek	Korean	Spanish	Vietnamese
  Creole	Hebrew	Polish	Tibetan
  Croatian	Hindi	Portuguese

• Exemption: Can My Project Be Considered Exempt from Full Board Review?
• Genetic Testing Policy

Decision Tree

• HIPAA Policy and Procedures

Guidance Regarding Methods for De-identification of PHI in Accordance with the HIPAA Privacy Rule

• Incidental Findings from Imaging Procedures Conducted for Research Studies

  Reporting of Incidental Findings Form

  Sample Incidental Finding Consent Template Language

• Informed Consent:

Informed Consent Policy

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
Templates

Minimal Risk Consent form template

Minimal Risk Consent form template for studies involving audio/video recording

Tips for Increasing Comprehension of Informed Consent Documents
Tips on Informed Consent - OHRP Guidance

• Internet-Based Research
• IRB Review:

Abbreviated IRB Submission for Multicenter Studies Sponsored by Industry or NIH Cooperative Groups

Additional Requirements for Protocols Funded by Specific Federal Agencies or Subject to Specific Federal Policies

IRB Reviewer Form for Behavioral Research

IRB Continuing Review (Renewal) Reviewer Form

Research Protocol Format (for RASCAL Study Description)

Tips to Facilitate Efficient IRB Review - Protocols

IRB Fee Schedule

Decision Charts

NIH Private Info or Biological Specimens Decision Chart

• IRB Standard Operating Procedures version 4.2, effective 11/2/2012

Table of Contents

HRPO Process Updates

Process Updates - August 27, 2014

• Withdrawal of New Protocols
• Converting and Naming Attached Documents (including tips)

• 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
• Protocol Deviations and Violations
• Recruitment Material
• Students as Study Subjects in Research
• Students as Researchers Policy and Guidance
• 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)

     Guidance on Processing External Adverse Events

• Use of Publicly Available Datasets

General

• OHRP Policies & Guidance

 

• Department of Defense

Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Department of the Navy HRPP Training and Education Guidance

International Standards

• CIOMS
• OHRP's Compilation of International Standards for Human Subjects Protections

Related Information

• Acronyms
• HHS Reference Collection

Archive:

Data Security Plans Involving the Storage of Certain Electronic Research Data in Human Subjects Research, 2/1/2013

Attached Document Conversion, October 2012

Enrollment of Non-English Speaking Subjects in Research, 12/6/2008 version

• Genetic Research:

Genetics Research - Sample Text for Consent Form

Genetic Testing: Guidance on Research Involving Genetic Testing

Incidental Findings from Imaging Procedures Conducted for Research Studies, 8/7/2012 version

Informed Consent Policy, 5/8/07 version

Informed Consent Policy, 11/19/09 version

Informed Consent Policy, 4/1/10 version

IRB Standard Operating Procedures, 12/15/2008 version

IRB Standard Operating Procedures, effective 8/24/2009, revised 10/26/2011

Section IX, revised, effective 10/28/11; supercedes section within 8/24/09 version

• IRB Standard Operating Procedures version 4, effective 6/12/2012

Table of Contents for IRB SOP version 4, effective 6/12/12

Noncompliance Policy, 1/23/2006 version

Noncompliance Policy, 12/1/2009 version

Noncompliance Policy, 2/24/2010 version

Noncompliance Policy, 11/15/2012 version

Protocol Deviations and Protocol Violations, 10/29/2013 version

Students as Researchers