Columbia University Human Research Protection Program

Policies and Guidance

Selected University Research Policies & Guidances

• 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 Guidelines  

    Sponsored Projects Handbook

    Clinical Research 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 Activitie

    Sample Disclosure Forms

    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

• New York Presbyterian Hospital (NYP) Policies

    NYPH Policy: Use and Control of Investigational Drugs

    NYPH Policy: Emergency Use of an Investigational Drug or Biological Product

    Listserv message (July 9, 2009) regarding NYP Safety Reporting for Research Studies

             Incident Reporting to the New York State Department of Health  

             Serious Adverse Events/Sentinel Events (SAE/SE)

    NYPH Policy: Research Drugs (Investigational or Commercially Available) from Protocols Originating at Other 

    Institutions

• CUMC Research Pharmacy Policies

     Investigational Drugs- Inpatient

     Investigational Drugs- Outpatient

• WIRB Review

    Memo Regarding Policy for Review of Research by Western IRB

    For research safety policies please consult with the Environmental Health and Safety website

IRB Policies, Procedures, and Guidance

• Audio/Video/Photographic Recording of Human Subjects
• Cancer Center Data Safety Monitoring Plan
• Case Report Policy
• 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)

• Clinical Trial Registration
• Disclosure of SSNs Outside of Columbia for Research Purposes
  • Privacy and Security Agreement
• Electronic Approval Letter and Stamped Documents
• Engagement of Institutions in Research - OHRP Guidance
• Disclosure of Social Security Numbers Outside of Columbia for Research Purposes
• FDA Compliance Program
• Genetic Research:

Genetics Research - Sample Text for Consent Form

Genetic Testing: Guidance on Research Involving Genetic Testing

• HIPAA Policy and Procedures
• HIV Serostatus, Informing Those Tested, PHS Policy

• HIV Serostatus, Sex-Partner Notification, PHS Policy

• Enrollment of Non-English Speaking Subjects in Research
• Administrative Review of Translated Documents  
• English Sample Short Form Consent Document
• Short Form Consent Translations:

Arabic

Chinese-Simplified

Chinese-Traditional

Creole

Croatian

French

Greek

Hindi

Italian

Japanese

Korean

Portuguese

Russian

Spanish

Vietnamese

• Informed Consent:

  Informed Consent Policy

  Consent Form Builder Sample Language

  General requirements for informed consent (45 CFR 46.116)
  Genetics Research - Sample Text for Consent Form

  Radiation Exposure Calculator and Risk Statements (Duke University)
  Same Day Consent for Elective Surgery Policy

  Tips for Increasing Comprehension of Informed Consent Documents
  Tips on Informed Consent - OHRP Guidance
  Tips to Facilitate Efficient IRB Review - Informed Consent

• Investigational Devices:

  Device Studies: Important Information to Include in Submissions

  Standard Operating Procedure for Medicare Approval of Device Trials

  Instructions for NGS Submission to Request Coverage Decision

• IRB Review:

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

IRB Reviewer Form for Behavioral Research

IRB Reviewer Form for Medical 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, effective 8/24/2009, revised 10/26/2011

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

• Medicare Approval for Billing of Investigational Devices: Instructions for NGS Submission

Standard Operating Procedure for Medicare Approval of Device Trials

• Noncompliance Policy
• Oral History Projects Policy
• Pathology Approval Form
• Pre-IRB Review Pediatric Human Subjects Checklist
• Pregnant Women: Clinical Research Involving Pregnant Human Subjects
• Reimbursement / Compensation Policy
• Stem Cell FAQ (NIH)
• Students as Study Subjects in Research
• Tissues:

  Department of Pathology Approval Form

  Guidance on Research Involving Coded Private Information or Biological Specimens

  IRB Terminology Related to Tissue or Data Collection

  NCI Best Practices for Biospecimen Resources
  Repositories, Tissue Storage Activities, Data Banks, OHRP Guidance (Nov. 1997)
  Review of Research Using Human Specimens

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

  FDA/NIH Safety Reporting Portal

• Use of Publicly Available Datasets

General

• OHRP Policies & Guidance
• FDA Links:

  Center for Drugs Evaluation and Research

  CDER Guidance Documents
  Content and Format of IND Applications for Phase I Studies
  Emergency Use of an Investigational Drug or Biologic

  FDA Guidance – Frequently Asked Questions: Statement of Investigator (Form FDA 1572)
  Form FDA 1571

  Form FDA 1572

  IND Exemptions for Drugs or Biological Products in Cancer Treatment

  IND Safety Reporting Requirements

  Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
  Medwatch

   

  Center for Devices and Radiological Health

  IDE Policies
  Emergency Use
  Compassionate Use (or Single Patient/Small Group Access)
  Treatment Use
  Continued Access
  Humanitarian Use Devices

  In Vitro Diagnostic Products (IVDs) - Draft Guidance
  

  Guidance for IRBs and Clinical Investigators

           Investigator Responsibilities

             List of Guidances for IRBs, Investigators, & Sponsors

     Risks

Antiretroviral Pregnancy Registry (registry for teratogenetic effects of antiretroviral agents)

International Standards

• CIOMS
• International Conference on Harmonization (ICH) Guidances

• World Medical Organization (WMA)

• World Health Organization (WHO)

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

Related Information

• Acronyms
• HHS Reference Collection
• History of Human Subject Protections

Timeline of Laws Related to the Protection of Human Subjects

Archive

Adverse Event Reporting Policy, 4/13/2004 version

Case Report Policy

Enrollment of Non-English Speaking Subjects in Research, 12/6/2006 version

Human Embryo and Human Embryonic Stem Cell Research Special Operating Procedures

Informed Consent Policy, 5/8/07 version

Informed Consent Policy, 11/19/09 version

Informed Consent Policy; 4/1/10 version

Investigational Devices:

IRB Procedures for obtaining CMS Approval

IRB Standard Operating Procedures, 6/9/2008 version

IRB Standard Operating Procedures, 12/15/2008 version

Noncompliance Policy, 1/23/2006 version

Noncompliance Policy, 12/1/2009 version

Policy on the Conduct of Research with Human Embryos and Human Embryonic Stem Cells (9/2006 version)

WIRB Review