IRB Policies and Procedures

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The IRB's SOPs provide the institution's standard approach to the interpretation of the federal regulations, best practice standards and state and local law. The SOPs serve as a reference for the IRB membership, IRB Office staff, and the CHOP community of investigators. Regulations are necessarily grey and their interpretation can evolve over time. The IRB SOPs, therefore reflect our current understanding of the Office of Human Research Protections (OHRP) and the FDA's interpretation of the regulations. In addition, the IRB has identified a number of ways to implement additional flexibility in its SOPs for research that is neither federally funded nor federally regulated.

The SOP series from 100 - 900 were written post-2006. Several pre-2006 policies have not been retired yet and are included at the bottom of this page. Copies of the approved SOPs are maintained in CHOP’s electronic policy management system. The IRB's SOPs were extensively revised as a result of our 2010 AAHRPP accreditation, and 2013 re-accreditation. Further revisions were made for the 2018 re-accreditation and the 2018 Common Rule changes. The IRB's SOPs are reviewed at least bi-annually and are revised as needed to keep pace with changes in regulations, regulatory guidance or state law.

SOP 100 Series:

IRB Oversight and Administration

101: Maintenance of Standard Operating Procedures
102: HRPP Training and Education for IRB Members and Staff
103: Management of IRB Office Personnel
104: Signatory Authority of the IRB Retired June 9, 2010
105: IRB Review Processes
106: Research That Must Be Reviewed by the IRB
107: Department of Defense
108: Research Conducted in Schools

SOP 200 Series:

IRB Composition

201: Composition and Management of the IRB
202: Duties of IRB Members

SOP 300 Series:

Protocol Submission and Meeting Administration

301: Research Submission Requirements
302: Research Meeting the Criteria for Exemption
303: IRB Meeting Administration
304: Documentation and Document Management
305: Cooperative Agreements
306: Facilitated Review Procedures for NCI CIRB Studies Retired 2014

SOP 400 Series:

IRB Review of Research

401: Expedited Review Procedures
402: Criteria for Initial IRB Approval
403: Amendments and Reports of New Findings
404: Continuing Review of Approved Research
405: Study Closure
406: Categories of Action
407: Determining When a Proposal Meets the Definition of Human Subjects Research
408: Unanticipated Problems Involving Risks to Subjects
408: Decision Tree: Reporting Unanticipated Problems and SAEs
409: Determination of IND/IDE Requirement
410: Suspensions and Terminations of Research
411: International Research
412: Humanitarian Use Device (HUD)
413: Expanded Access: Individual Patient Expanded Access IND (Drugs) and Compassionate Use (Devices)

SOP 500 Series:

Additional Protections for Special Populations

501: Vulnerable Subjects
502: Research Involving Pregnant Women, Fetuses and Neonates
503: Research Involving Prisoners
504: Research Involving Children
505: Minors Who are Not Children in the Research Context
506: Community-Based Participatory Research

SOP 600 Series:

IRB Electronic Management Systems

Reserved for future use

SOP 700 Series:

Recruitment and Consent Processes

701: Required Elements of Consent and Documentation of Consent
702: Assent and Parental Permission
703: Review of Recruitment Methods, Materials, and Compensation
704: Payment to Subjects and Families
705: Waiver of Informed Consent for Planned Research in Emergency Settings
706: Waiver of Consent or Authorization
707: Requirements for and Documentation of HIPAA Authorization

SOP 800 Series:

Investigator Responsibilities

801: Investigator Responsibilities
Information that supplements IRB SOP 801 can be found on the IRB's webpage on Investigator Responsibilities
802: Exemption to the Requirement for Prior IRB Approval for Emergency Use of Investigational Drugs, Biologics, or Devices
FDA Contact Information required to request an Emergency IND can be found on the FDA's website at: Physician Request for an Individual Patient IND and FDA's Expanded Access Contact Information
803: Data and Safety Monitoring Plans
804: Qualifications to Serve as a Principal Investigator for Human Subjects Research
805: Pregnancy Testing in Research Subjects

SOP 900 Series:

Research Compliance

901: Non-Compliance with Human Subjects Research Policies
902: Audits by Regulatory Agencies
903: Reporting Test Results and Incidental Findings
904: Policy on Avoiding Conflicts of Interest in IRB Actions
905: Handling Investigative Team Member COI Issues
906: IRB Office Quality Control and Improvement Activities
907: Reporting to Regulatory Agencies & Sponsors

Key CHOP Hospital and CHOP Research Institute Policies and Procedures

All CHOP Hospital and CHOP Research Institute policies and procedures may be found in the CHOP Institutional Policy and Procedure System.

Office of Research Compliance (ORC)

  • Bonus Payments in Clinical Research
  • Clinical Research Essential Documents Policy
  • Institutional Clearance for the Emergency Use of an Investigational Device
  • Institutional Official for the Protections of Human Subjects
  • Investigational Device Accountability – Investigator Responsibilities
  • Investigational Drug Accountability – Investigator Responsibilities
  • Mandatory Education for Research Policy
  • Monitoring CHOP-Sponsored INDs and IDEs
  • Research Data Ownership and Management
  • Use & Disclosure of Protected Health Information for Research

Clinical Research Support Office (CRSO)

  • Confirming Eligibility Criteria for Research Subjects
  • IND and IDE Sponsorship Requirements & Responsibilities
  • Informed Consent Process and Process Completion Statement
  • Protocol Management

Office of Collaborative and Corporate Research Contracts (OCCRC)

  • Informed Consent – Subject Injury Language Required for Industry-Initiated Studies

Clinical Trials Financial Management (CTFM)

  • Participant Research Card Program

Research Finance (RF)

  • Payments to Human Subjects Policy

CHOP Patient Care Manual

  • Assessment of a Decision Maker's Capacity to Make a Medical Decision
  • Consent
  • Evaluating Capacity to Consent to Clinical Care for Individuals with Diminished Capacity
  • Point of Care & Physician Laboratory Testing
  • Recording or Filming of Patients

CHOP Language Services

These policies are located in the Patient Care Manual

  • Policy: Language Services
  • Policy: Requesting and Documenting Interpreting Services for the Limited English Proficient

CHOP Administrative Policy Manual

  • Acceptable Use of Technology Resources
  • Confidentiality of Patient and Institutional Information
  • Retention and Destruction of Records