Institutional Review Board Policies and Procedures

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. Signed copies of the SOPs, as well as all prior versions, are maintained in the IRB Office. The IRB's SOPs were extensively revised as a result of our 2010 AAHRPP accreditation and 2013 re-accreditation. 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

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 Exempt from IRB Review
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 Completion
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

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 Process

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 Elements of Consent and Waiver HIPAA 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 intranet page 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

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

Pre-2006 IRB Policies
IRB Internal Policies (pre-2006)

11: Expansion of Category 5
Pregnancy Testing and Avoidance of Pregnancy by Research Subjects

Key CHOP Hospital and CHOP Research Institute Policies

Office of Research Compliance (ORC)

ORC Policies and Procedures

  • Clinical Research Essential Documents
  • HIPAA: PHI Use and Disclosure for Research
  • Research Data Ownership and Management
  • Bonus Payments in Clinical Research

Office of Clinical and Translational Research (OCTR)

OCTR Policies and Procedures

  • Research Data in CHOP Medical Records

Clinical Research Support Office (CRSO)

CRSO Policies and Procedures

  • Investigational Device - Accountability - Investigator Responsibilities and Storage
  • Investigational Drug Accountability - Investigator Responsibilities
  • Monitoring CHOP-Sponsored INDs and IDEs
  • IND and IDE Sponsorship Requirements & Responsibilities
  • Informed Consent - Subject Injury Language Required for Industry-Initiated Studies
  • Research Data in CHOP Medical Records

Research Finance (RF)

RF Policies and Procedures

  • Payments to Human Subjects

CHOP Patient Care Manual

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
  • Requesting and Documenting Interpreting Services for the Limited English Proficient

CHOP Administrative Policy Manual

Administrative Policy Manual

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

A complete listing of all of CHOP Research Institute Policies and Procedures is available on the CHOP Intranet.

Top