Research Protections Policies

RP14 Human Embryonic (Pluripotent) Stem Cell Research

Policy Status: 

New

Subject Matter Expert: 

Candice Yekel, 814-865-1775, cay3@psu.edu

Policy Steward: 

Associate Vice President for Research, Director of the Office for Research Protections

Contents:

  • Purpose
  • Scope
  • Policy
  • Definitions
  • Submission Procedure
  • Further Information
  • References
  • Cross References
  • 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 fundamental aim of this policy is to ensure that all hPSC research conducted at or by the University or using University resources is in accordance with the National Institutes of Health Guidelines on 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 conducted at or by the University or using University resources regardless of funding and applies to all University campus locations, including the Penn State College of Medicine.

    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 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 also includes 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:   
     
     
    hPSC Research that involves the derivation of new hESC lines from human embryos or blastocysts is not 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 forms and instructions for all University campuses can be obtained from the ORP website.

    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:

    1. Final Report of the National Academies’ Human Embryonic Stem Cell Research (2010) 
    2. Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research (2016) 
    3. National Institutes of Health Guidelines on Human Stem Cell Research (2009) 
    4. 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 20, 2021 - New policy.

     

    Revision History (and effective dates) :

    • May 20, 2021 - New policy.

     

    Date Approved: 

    May 20, 2021

    Date Published: 

    May 20, 2021

    Effective Date: 

    May 20, 2021