Other UCI Reviews for Stem Cell Research
- Overview
- Institutional Review Board (IRB) Responsibilities
- Institutional Biosafety Committee (IBC) Responsibilities
- Institutional Animal Care and Use Committee (IACUC) Responsibilities
- Flowchart for hSCRO, IRB, IACUC and IBC Reviews
Overview
All stem cell activities require hSCRO review before they are initiated.
- Activities involving vertebrate animals will require UCI IACUC approval.
- Activities involving recombinant DNA or infectious agents will require IBC review.
- 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.
- Interactions or interventions with living individuals
Notes:
- If IRB review is required, the review process is concurrent; ORA staff facilitate will 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 recombinant DNA (rDNA) molecules, risk group pathogens and select agents.
- 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.
- Human stem cell activities that involve rDNA methodologies (including gene transfer) require IBC review approval prior to initiation of the study.
Institutional Animal Care and Use Committee (IACUC) Responsibilities
- 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.
- The primary role of the IACUC is to ensure the ethical and humane care and use of animals in research, testing, and teaching.
- Human stem cell activities that involve animals require IACUC review approval prior to initiation of the study.
