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

    CUMC Compliance Program for FDA-regulated Human Subjects Research

    Clinical Trials Monitoring Assistance Program for FDA Regulated Human Subjects Research

• Conflict of Interest Policies

    Columbia University Policy on Financial Conflicts of Interest and Research

    FDA Draft Guidance: Financial Disclosure by Clinical Investigators

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

    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
• Compliance

  Columbia's FDA Compliance Program

  Noncompliance Policy

• Continuing Review

  FDA Guidance - IRB Continuing Review

• Coordinating Centers
  • Clinical Coordinating Centers Guidance
• Data Security Plans Involving the Storage of Certain Electronic Research Data in Human Subjects Research
• Disclosure of Social Security Numbers Outside of Columbia for Research Purposes
  • Privacy and Security Agreement
• Electronic Approval Letter and Stamped Documents
• Engagement of Institutions in Research - OHRP Guidance
• Genetic Research:

Genetics Research - Sample Text for Consent Form

Genetic Testing: Guidance on Research Involving Genetic Testing

• HIPAA Policy and Procedures

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

• 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	Filipino	Italian	Russian	Ukrainian
  Chinese-Simplified	French	Japanese	Spanish	Vietnamese
  Chinese-Traditional	Greek	Korean	Tibetan
  Creole	Hebrew	Polish	Turkish
  Croatian	Hindi	Portuguese

• Incidental Findings from Imaging Procedures Conducted for Research Studies

  Reporting of Incidental Findings Form

  Sample Incidental Finding Consent Template Language

• Informed Consent:

  FDA Guidance on 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

  Templates

  Consent Form Builder Sample Language

  Incidental Finding Consent Template Language

  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
  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

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

IND/IDE Determinations: Roles of the IRB and IND/IDE Assistance Program

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 version 4.2, effective 11/2/2012

  Table of Contents

• 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
• Research Involving Pregnant Women

Pregnant Women: Clinical Research Involving Pregnant Human Subjects

• Reimbursement / Compensation Policy
• Stem Cell FAQ (NIH)
• Students as Researchers Policy and Guidance
• 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
• Withdrawal of Subjects from FDA-Regulated Studies

General

• OHRP Policies & Guidance

  Guidance on Withdrawal of Subjects

• 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

        Data Retention When Subjects Withdraw from FDA_Regulated Clinical Trials

        IRB Responsibilies for Revieweing the Qualifications of Investigators, Adequacy of Research Sites, and the

Determination of Whether an IND/IDE is Needed

        Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors- FDA Inspections of Clinical

Investigators

        Informed Consent Elements

        Investigator Responsibilities

        List of Guidances for IRBs, Investigators, & Sponsors

     Risks

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

 

• 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

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

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

REVISED SOP Section IX, effctive 7/9/2012

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

Summary of SOP Changes

Noncompliance Policy, 1/23/2006 version

Noncompliance Policy, 12/1/2009 version

Noncompliance Policy, 2/24/2012 version

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

WIRB Review