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Policies and Procedures

Chapter 1: Ethical & Regulatory Standards for Protecting Human Subjects

I. Ethical Foundations: The Nuremberg Code
II. Ethical Foundations: The Declaration of Helsinki
III. Ethical Foundations: The Belmont Report
IV. Department of Health and Human Services (DHHS) Regulations
V. Food and Drug Administration (FDA) Regulations

Chapter 2: Types of Human Subject Research

I. Type of Human Subject Research

Chapter 3: Institutional Policy & Shared Responsibilities for the Protection of Human Subjects

I. The Federalwide Assurance
II. Important Definitions for the Protection of Human Subjects
III. Responsibilities within HSS

Chapter 4: Institutional Review Board (IRB) Roles and Authorities

I. Subject Protections under Federal Regulations
II. Oversight of HSS’s IRB(s)
III. Purpose and Mission of the IRB
IV. Scope of the IRB’s Authority 

Chapter 5: IRB Structure and Membership

I. Structure and Composition
II. Appointment of IRB Members, Length of Service, and Duties
III. Appointment of IRB Chairperson, Length of Service, and Duties
IV. Alternate IRB Members
V. Consultants to the IRB 

  • a. Continuing Consultants
    b. Ad Hoc Consultants
    c. Legal Counsel
     

VI. Conflicts of Interest
VII. Education and Professional Development of IRB Members

Chapter 6: IRB Administrative Support and Recordkeeping

I. Resource Allocation
II. Reporting Lines and Supervision
III. Initial Training and Professional Development of IRB Staff
IV. Duties of IRB Manager and Other IRB Staff
V. IRB Recordkeeping and Documentation
VI. IRB Records Defined
VII. Record Retention and Access
VIII. IRB Membership Rosters
IX. Education and Training Records 

  • A. Research Investigator Education
    B. IRB Member Education
     

X. IRB Research Application (Protocol) Files
XI. IRB Database
XII. Documentation of Exemptions and Exceptions 

  • A. Exempt Research in Educational Settings
    B. Exempt Research Using Educational Tests, Survey Procedures, Interview Procedures, or the Observation of Public Behavior
    C. Exempt Use of Existing Materials
    D. Exception from Informed Consent Requirement for Emergency Use of a Test Article
    E. Exemption from IRB Review Requirement for Emergency Use of a Test Article
     

XIII. Documentation of Expedited Reviews
XIV. Documentation of IRB Meetings - Minutes of IRB Meetings 

  • A. Attendance at IRB Meetings
    B. Quorum Requirements and Voting at IRB Meetings
    C. Actions Taken by the Convened IRB
    D. The Basis for Requiring Changes in or Disapproving Research
    E. Summary of Controverted Issues at Convened Meetings
    F. Required IRB Findings and Determinations

     

Chapter 7: Procedures for IRB Review

I. Review by the Convened IRB 

A. Telephonic and Video Conferencing

II. Initial Review by the Convened IRB
III. Continuing Review by the Convened IRB
IV. Approval Periods
V. Review More Often Than Annually
VI. Independent Verifcation from Sources Other than the Investigator
VII. Use of Primary and Secondary Reviewers with Convened Reviews
VIII. Use of Subcommittees to Support IRB Activities
IX. Expedited Review of Research
X. Review of Minor Changes in Previously Approved Research
XI. Expedited Review of Research in Specified Categories 

  • A. Expedited Category #1
    B. Expedited Category #2
    C. Expedited Category #3
    D. Expedited Category #4
    E. Expedited Category #5
    F. Expedited Category #6
    G. Expedited Category #7
    H. Expedited Category #8
    I. Expedited Category #9
     

XII. Protocol Revisions, Modifications, and Amendments
XIII. Investigators' Duty to Report to the IRB 

  • A. Investigators' Duty to Report Unanticipated Problems
    B. Unanticipated Defined
    C. Investigators' Duty to Report Serious Adverse Events
    D. Serious Adverse Event Defined
    E. Investigators' Duty to Report Other Adverse Events
    F. Investigators' Duty to Forward Correspondence or Reports of Monitoring or Auditing
    G. Investigators' Duty to Forward Sponsor or Cooperative Group Safety Reports
    H. Investigators' Duty to Forward Data and Safety Monitoring Board (DSMB) Reports
    I. Investigators' Duty to Notify the IRB of Serious or Continuing Noncompliance
    J. Serious and Continuing Defined
    K. Five (5) Day Requirement
    L. IRB Review
    M. Referral for Convened IRB Review
    N. Notice of IRB Determination(s)
     

XIV. Suspension or Termination of IRB Approval 

  • A. Notification of Determinations
    B. Clarification of Suspension or Termination of IRB Approval
     

XV. Institutional Reports to Federal Agencies
XVI. Expiration of Approval Period
XVII. Outcomes of IRB Review
XVIII. Research Activities in Emergency Situations

Chapter 8: Criteria for IRB Approval of Research (last updated 12/1/05)

I. Risks are Minimized
II. Psychological and Social Harms
III. Risks Are Reasonable Relative to Anticipated Benefits
IV. Selection of Subjects is Equitable 

  • a. Inclusion of Females and Minorities
    b. Inclusion of Children
     

V. Informed Consent, Parental Permission, and Child Assent Will Be Obtained
VI. Consent Monitoring
VII. Waiting Periods
VIII. Advertisements and Recruitment Incentives
IX. Payments for Research Participation
X. Indemnity and Liability Provisions
XI. Informed Consent, Permission, and Assent will be Documented 

  • a. Long Form vs Short Form Documentation
    b. Illiterate Subjects
    c. Witness Signature
    d. Date Stamp Required
    e. Copy to Decision-Maker is Required
     

XII. Safety Monitoring Is Adequate
XIII. Privacy and Confidentiality Provisions Are Adequate 

  • a. Certificates of Confidentiality
     

XIV. Additional Safeguards for Vulnerable Subjects Are Appropriate
XV. Research Involving Data Sets and Repositories
XVI. Research Utilizing Data or Tissue Repositories
XVII. Epidemiology Research
XVIII. Issues in Genetic Research
XIX. Family History Research
XX. Compliance with All Applicable Laws

Chapter 9: Required Elements of Informed Consent (last updated 4/1/2017)

I. Research Statement (Required Element #1)
II. Reasonably Foreseeable Risks or Discomforts (Required Element #2)
III. Reasonably Expected Benefits (Required Element #3)
IV. Appropriate Alternatives (Required Element #4)
V. Extent of Confidentiality (Required Element #5)
VI. Compensation or Treatment for Injury (Required Element #6)
VII. Contact Information (Required Element #7)
VIII. Voluntary Participation Statement (Required Element #8)
IX. Additional Elements Where Appropriate 

  • a. Unforeseeable Risks to Subjects
    b. Investigator-Initiated Termination of Participation
    c. Additional Costs
    d. Early Withdrawal/Procedures for Termination
    e. Significant New Findings
    f. Approximate Number of Subjects
     

X. Requirement for Authorized Personnel to Obtain Consent
XI. Waiver or Alteration of Informed Consent Requirements 

  • a. State or Local Public Benefit Programs
     

XII. Waiver or Alteration of Informed Consent Requirements 

  • a. Minimal Risk Research
    b. Research Involving Deception
     

XIII. Waiver of Documentation of Consent
XIV. Informed Consent from Non-English Speakers

Chapter 10: IRB Review of FDA-Regulated Research: Investigational Drugs, Devices, and Biologics

I. FDA vs Common Rule and DHHS Requirements
II. Investigational Drugs, Devices, and Biologics 

  • a. Investigational New Drug Application (IND)
    b. Investigational Device Exemption (IDE)
    c. Biologics License Application
     

III. Clinical Investigator Responsibilities
IV. Sponsor Responsibilities
V. IRB Review of Medical Devices 

  • a. Significant Risk (SR) Device Defined
    b. Nonsignificant Risk (NSR) Device Defined
    c. Review Procedures
    d. 510(k) Devices
    e. Radiology Devices and Radioactive Materials
     

VI. Investigators’ Responsibilities for Reporting to the IRB 

  • a. Investigators’ Duty to Report Unanticipated Problems
    b. Investigators’ Duty to Report Serious Adverse Events
    c. Serious Adverse Event Defined
    d. Investigators’ Duty to Report Other Adverse Events
    e. Investigators’ Duty to Forward Sponsor or Cooperative Group Safety Reports
    f. Investigators’ Duty to Forward Data and Safety Monitoring Board (DSMB) Reports
    g. Duty to Notify the IRB of Serious or Continuing Noncompliance
    h. Five (5) Day Requirement
     

VII. Other Reporting Responsibilities
VIII. Off-Label (Unapproved) Use of FDA-Regulated Products in Medical Practice Versus Research
IX. Treatment INDs and IDEs 

  • a. Treatment IND
    b. Single Patient Treatment IND
    c. Group C Treatment IND
    d. Orphan Drugs
    e. Parallel Track Studies
    f. Treatment IDE
     

X. Gene Transfer Research
XI. Emergency Use of a Test Article without Informed Consent 

  • a. Institutional Requirements
    b. Required Conditions

     

Chapter 11: Use of Investigational Products Outside of the Protocol

I. Emergency Use of a Test Article without IRB Review 

  • a. Institutional Requirements
    b. Required Conditions
    c. Emergency Use of Drugs
    d. Emergency Use of Devices
     

II. Compassionate Use of Investigational Drugs and Devices
III. From the FDA Guidance on IDE Policies and Procedures
IV. Planned Emergency Research

Chapter 12: HUD's and HDE's

I. Humanitarian Device Exemptions
II. HSS Requirements
III. IRB Review and Approval of HUDs
IV. Off-Label Use of HUDs

Chapter 13: Social & Behavioral Research

I. Social and Psychological Harms
II. Privacy and Confidentiality Concerns
III. Safeguarding Confidentiality
IV. Exempt Research 

  • a. Exempt Research in Educational Settings
    b. Exempt Research Using Educational Tests (Cognitive, Diagnostic, Aptitude, and Achievement Tests), Survey Procedures, Interview Procedures, or the Observation of Public Behavior
    c. Exempt Research Using Existing Data and Documents
     

V. Expedited Review of Behavioral and Social Science Research 

  • a. Expedited Review of Research Involving Existing Data and Documents (Expedited Category #5)
    b. Expedited Review of Research Involving Data from Voice, Video, Digital, or Image Recordings Made for Research Purposes (Expedited Category #6)
    c. Expedited Review of Research Involving Individual or Group Characteristics or Behavior or Research Employing Survey, Interview, Oral History, Focus Group, Program Evaluation, Human Factors Evaluation, or Quality Assurance Methodologies (Expedited Category #7)
     

VI. Research Involving Deception or Withholding of Information

Chapter 14: Research Combining Biomedical and Social & Behavioral Elements

I. Prospective Use of Existing Materials
II. Retrospective Use of Existing Materials
III. Research Utilizing Large Existing Data Sets
IV. Research Using Data or Tissue Banks (also called Repositories)

Chapter 15: IRB Considerations Regarding Study Design

I. Epidemiological Research
II. Issues in Genetic Research
III. Family History Research
IV. Research Involving Potentially Addictive Substances

Chapter 16: IRB Review of Research Involving Children

I. Risk-Benefit Analysis and Permitted Categories
II. Assent of the Child 

  • a. Documentation of Assent
     

III. Parental Permission
IV. Reasonable Expectation of Benefit

Chapter 17: IRB Review of Research Involving Adults as Vulnerable Subjects

I. Pregnant Women, Human Fetuses and Neonates
II. Prisoners
III. Research Involving Decisionally Impaired Subjects
IV. Research Involving Potentially Addictive Substances
V. Research Involving Other Potentially Vulnerable Adult Subjects
VI. Human Fetal Tissue Transplantation Research
VII. Research Involving Deceased Persons

Chapter 18: Finanical Disclosure Requirements for Investigators, Research Staff, and IRB

I. Disclosure Requirements
II. Financial Interest Defined
III. Conflict of Interest Procedures for Investigators 

  • a. Receipt and Storage of Information
    b. Basis for Findings and Determinations
    c. Notification of Findings and Determinations
    d. Requirement for Management Plans
    e. Approval and Implementation of Management Plans
    f. Disapproval
    g. Required Updates
     

IV. Managing Conflicts of Interest in IRB Review of Research 

  • a. Procedures for IRB Members
    b. Institutional Officials

     

Chapter 19: Scientific Misconduct Requirements

I. Preamble and Definition
II. Responsibility of Research Division Members
III. Process for Handling Alleged Scientific Misconduct 

  • a. Allegation
    b. Inquiry
    c. Formal Investigation
    d. Appeal

     

Chapter 20: Submitting Materials to the IRB

I. IRB Deadlines for Initial Review
II. IRB Deadlines for Continuing Review
III. Communication of Determinations

Chapter 21: External Institutional Review Board Approval

I. External Institutional Review Board Approval
II. Protocols to be considered for external IRB review must fall into one of the following categories
III. HSS Review of protocols eligible for external review
IV. Protocol Monitoring
V. Process for Protocol Submissions to an external IRB

Chapter 22: IRB Training in the Protection of Human Subjects in Research (last updated 1/19/2018)

I. Introduction
II. Policy
III. Procedures for CITI Program Certification

Chapter 23: Genetic Testing

I. Genetic Research Guidelines
II. Guiding Principles 

  • A. Federal Research Regulations and Guidance
    B. Federal and State Medical Privacy Laws
    C. Federal and State Regulation of Clinical Laboratories
    D. New York State Genetic Testing Law
    E. Issues of Research Design and Conduct
    F. Ownership of Samples and Data
     

III. Definitions 

  • A. Identifiable samples/information
    B. Genetic research
    C. Identifier
    D. Unidentified samples
     

IV. Guidelines 

  • A. Initial contact
    B. Identification of subjects
    C. Consent and HIPAA authorization of subjects
    • i. Informed Consent
      ii. HIPAA Authorization

       
    D. Subject Selection/Disclosure of Results
     
    • i. Is Disclosure Permissible?
      ii. No disclosure planned
      iii. Is Disclosure Advisable?
      iv. If Disclosure is Planned
      v. Unanticipated Results
      vi. Process for Disclosure
  • E. Informed consent process
    F. Assent
    G. Withdrawal from a study
    H. Storage, retention and disposition of samples and data
    I. Consent form
    J. Certificate of Confidentiality
     


Appendices

  • a. Biomedical Research
    b. Social and Behavioral Research
    c. Clinical Research
    d. Epidemiology Research
    e. Repository Research
    f. Pilot Studies

II. Quality Assurance Activities as Human Subject Research
III. Research Activities vs. Innovative Treatments in Medical Practice
IV. Research Activities vs. Commercial Services 

  • a. Board of Directors (or Trustees)
    b. Human Subject Signatory Official
    c. Human Protections Administrator
    d. Principal Investigators
    e. Other Members of the Research Team
    f. Research Subjects