Policies & Guidelines

IRB Policies & Procedures

Franciscan Children’s requires all research involving human subjects to receive IRB review and approval prior to initiation.

IRB submission procedures are outlined in the Franciscan Children’s IRB Application and Submission Instructions.

Ethical Principles

Research conducted at Franciscan Children’s adheres to:

  • The Belmont Report
  • Declaration of Helsinki (when applicable)
  • Good Clinical Practice (GCP) guidelines
  • ICH E6 guidelines (for applicable clinical trials)

Definitions

Research: A systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 46.102).

Human Subject: A living individual about whom an investigator obtains data through intervention/interaction or identifiable private information.

Minimal Risk: Probability and magnitude of harm not greater than those ordinarily encountered in daily life.

Responsibilities & Record-Keeping

Investigators must:

  • Obtain IRB approval prior to initiating research
  • Conduct research as approved
  • Obtain informed consent where required
  • Report adverse events and protocol deviations
  • Maintain research records securely

IRB records are maintained in accordance with federal retention requirements (minimum 3 years after study closure, or longer if required by sponsor).

Single IRB / Reliance Agreements

Franciscan Children’s may enter into reliance agreements when participating in multi-site research requiring a Single IRB (sIRB).

Reliance agreements (e.g., SMART IRB) may be executed when FCH agrees to rely on or serve as the IRB of record.

Exempt, Expedited & Full Review Policies

Research protocols are categorized as:

  • Exempt Review: Research meeting federally defined exemption categories.
  • Expedited Review: Minimal-risk research fitting expedited categories.
  • Full Board Review: Research involving greater than minimal risk.

Consent/Assent & Waiver Policies

All research involving human subjects requires legally effective informed consent unless waived.

For pediatric populations:

  • Parental permission is required.
  • Child assent is required when developmentally appropriate.

Waivers of consent or documentation may be granted when criteria under 45 CFR 46.116 are met.

Additional Regulatory Documents & Templates

Available forms include:

2026 Research Misconduct Policy

Franciscan Children’s is committed to maintaining integrity in research.

The 2026 Research Misconduct Policy defines misconduct as fabrication, falsification, or plagiarism (FFP), outlines reporting procedures, inquiry/investigation processes, and institutional corrective actions.