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Other UCI Reviews for Stem Cell Research

Overview

All stem cell activities require hSCRO review before they are initiated.

  1. Activities involving vertebrate animals will require UCI IACUC approval.
  2. Activities involving potentially hazardous biological agents including but not limited to infectious agents, human and non-human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer will require IBC review.
  3. Activities that meet the federal definition of human subjects research require UCI IRB review and approval:
    • Interactions or interventions with living individuals

      Examples: Identifying patients for donation of residual (fresh) or stored (frozen) embryos for research; clinical investigations involving the use of human stem cells.

    • Private, identifiable information about living individuals

      Example: Information about the donor(s) is linked to the embryos or cell lines (e.g., medical information) to be created or used.

Notes:

  • If IRB review is required, hSCRO approval is required before IRB review can proceed. hSCRO comments, including hSCRO approval must be provided to the IRB at the time of their review. ORA staff will facilitate the review process for investigators.
  • All required regulatory committee approvals must be in place before stem cell activities may begin.

Institutional Review Board (IRB) Responsibilities

  • The IRB reviews and approves, requires modifications in, or disapproves the derivation and use of human stem cells to assure appropriate procurement of gametes, blastocysts, fetal tissue or somatic cells for the purpose of generating new stem cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm and somatic cells donated for development of human embryonic stem cell lines through nuclear transfer.
  • The IRB reviews, approves, requires modifications in, or disapproves human stem cell activities to ensure proper consent from the donors of sperm, oocytes, or somatic cells used to make blastocysts for research.
  • The IRB reviews, approves, requires modifications in, or disapproves human stem cell activities to assure the privacy of donors in accordance with HIPAA and CMIA regulations for use of personal health information for research purposes.
  • The IRB reviews, approves, requires modifications in, or disapproves human embryonic stem cells activities to assure the privacy of donors in accordance with HIPAA and CMIA regulations for use of personal health information for research purposes.
  • The IRB requests periodic progress reports and oversees the conduct of ongoing human subject protocols involving human stem cell research.
  • The IRB reviews and approves, requires modifications in, or disapproves proposed modifications to approved human stem cell research.
  • The IRB may suspend or terminate approved human stem cell research.
  • The IRB reviews and reports human stem cell research noncompliance in accordance with campus policy for resolving allegations of regulatory noncompliance.

Institutional Biosafety Committee (IBC) Responsibilities

  • The IBC is a committee responsible for reviewing activities involving potentially hazardous biological agents including but not limited to infectious agents, human and non-human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer.
  • The IBC assures that research involving these agents is conducted in a manner that does not endanger the researcher, laboratory worker, human research subjects, the public or the environment.  In addition, the IBC assures the safe conduct of the research, assesses decontamination and containment levels, and ensures rDNA research is conducted in compliance with the NIH Guidelines for Use of Recombinant DNA Molecules.
  • hSCRO review and approval runs concurrent with IBC review and approval.  The IBC must review and approve all human stem cell activities prior to initiation of the study.

Institutional Animal Care and Use Committee (IACUC) Responsibilities

  1. The IACUC is a committee responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories, and overseeing training and education programs.
  2. The primary role of the IACUC is to ensure the ethical and humane care and use of animals in research, testing, and teaching.
  3. Human stem cell activities that involve animals require IACUC review approval prior to initiation of the study.

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