RP14 Human Pluripotent and Multipotent Stem Cell Research (encompassing Embryonic, Induced Pluripotent, and Adult Stem Cells)
Contents:
PURPOSE
This policy sets forth standards for and outlines the mechanism used by The Pennsylvania State University (“University”) to evaluate and oversee research involving human embryonic stem cell (hESC) lines as well as human induced pluripotent stem cells (iPSC lines), collectively referred to as human pluripotent stem cells (hPSCs) herein. The policy also includes research involving adult stem cells (multipotent), and human cell lines derived from fetal tissue. The fundamental aim of this policy is to ensure that all hPSC research, including adult stem cells, and human cell lines derived from fetal tissue, conducted at or by the University or using University resources is in accordance with the National Institutes of Health Guidelines for Human Stem Cell Research (“NIH Guidelines”), the National Academies’ “Guidelines for Human Embryonic Stem Cell Research” (2010) (“NAS Guidelines”), all applicable federal and state laws and regulations, and the ethical standards of the University.
SCOPE
This policy is applicable to all hPSC Research activities, including adult stem cells, and human cell lines derived from fetal tissue, conducted at or by the University or using University resources regardless of funding and applies to all University campus locations.
POLICY
ESCRO Committee - Purpose
The Office for Research Protections (“ORP”) at University Park has established an Embryonic Stem Cell Research Oversight Committee (“ESCRO Committee”), which is charged with the review, approval, and oversight of all research involving hPSCs, including adult stem cells, and human cell lines derived from fetal tissue, conducted at the University or using University resources (“hPSC Research”). Approval by the ESCRO Committee is required prior to conducting any hPSC Research. The activities of the ESCRO Committee will be carried out in conformity with the NIH Guidelines, the NAS Guidelines, the Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research, applicable federal and state laws and regulations, and this policy.
ESCRO Committee – Composition
In accordance with its Charter, the ESCRO Committee is comprised of faculty and staff from both the University Park campus and the College of Medicine (COM), includes at least one representative of the public, persons with expertise in developmental biology, stem cell research, molecular biology and assisted reproduction. The Committee is also advised by individuals with experience in hPSC ethical and legal matters. ESCRO Committee reviews will be coordinated through the ORP at the University Park campus. Depending on the proposed research, other compliance committee reviews (e.g., Biosafety, Institutional Animal Care and Use (IACUC), and/or Institutional Review Board (IRB)) may be required in addition to the ESCRO review.
Allowable hPSC Research
The ESCRO Committee will only approve hPSC research that involves:
- hESC Lines that are included on the NIH Embryonic Stem Cell Registry,
- Induced Pluripotent Stem Cells (iPSC),
- Adult stem cells, or
- Human cell lines derived from fetal tissue.
hPSC Research that involves the derivation of new hESC lines from human embryos or blastocysts is not permitted. Moreover, experiments to immortalize cells taken from aborted fetuses will also not be permitted.
DEFINITIONS
- Human Embryonic Stem Cells (hESC)
- Self-replicating cells derived from human embryos that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves human embryos.
- Induced Pluripotent Stem Cells (iPSC)
- adult cells that have been genetically reprogrammed to an embryonic stem cell-like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells.
- Human Pluripotent Stem Cells (hPSC)
- Term collectively referring to hESCs and iPSCs herein.
SUBMISSION PROCEDURE
Submission process for all University campuses is through the CATS Safety electronic protocol submission platform.
FURTHER INFORMATION
For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.
REFERENCES
- Final Report of the National Academies’ Human Embryonic Stem Cell Research (2010)
- Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research (2021)
- National Institutes of Health Guidelines on Human Stem Cell Research (2009)
- Title 18 Pa.C.S.A. §3216.
CROSS REFERENCES
Other University Policies may have specific application and should be referred to, especially
RP03 - The Use of Human Participants in Research (Formerly Policy RA14)
RP04 - Care and Use of Vertebrate Animals (Formerly Policy RA15)
RP11 - Use of Regulated and Biohazardous Materials in Research and Instruction
Most recent changes:
- May 28, 2024 - Updated scope of materials the committee reviews to include adult stem cells and human cells derived from fetal tissue. Changes reflected in policy title, purpose, scope, and ESCRO Committee purpose. Additional clarification added under heading for Allowable hPSC Research.
Revision History (and effective dates) :
- September 1, 2023 - Updated Subject Matter Expert to Debra Thurley, Associate Vice President for Research.
- March 18, 2022 - Updated Reference #2; minor editoral edits.
- May 20, 2021 - New policy.