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Name: Human Embryonic Stem Cell Research Policy - Interim
Responsible Office: Research

Applies to: (examples; Faculty,Staff, Students, etc)

Faculty , Staff , Students

Policy Overview:

Issued: 05-01-2017
Next Review Date: 05-01-2018
Frequency of Reviews: Annually

St. Louis College of Pharmacy (STLCOP) is committed to maintaining the highest ethical standards in our community and our professions, and complying with relevant laws and regulations. The College also expects investigators to commit to the ethical and responsible conduct of research, the protection of human subjects and the appropriate stewardship of sponsored funds.

St. Louis College of Pharmacy publishes these guidelines to support investigators engaged in human embryonic stem cell research, assure the responsible conduct of human embryonic stem cell research and comply with federal, state and local laws and regulations.

These Guidelines are based on the National Academy of Science report, Guidelines for Human Embryonic Stem Cell Research, (2005).

The College guidelines governing human embryonic stem cell research apply to all investigators, regardless of funding source. Awards will be established only after appropriate compliance is documented.


Table of Contents:

I.                 Institutional Oversight

II.               Guidelines

III.              ESCRO Scientific and Ethical Review of Proposed Research

IV.              Procurement of Gametes, Blastocysts or Cells for Human Embryonic Stem Cell Generation

V.               Standards for Investigators Who Wish to Bank Cell Lines

VI.              Other Applicable Policies

VII.             Financial and Costing Policies

Definitions:

See glossary of terms in Appendix A.

Details:

I.       Institutional Oversight

The St. Louis College of Pharmacy Institutional Review Board (IRB) will convene an Embryonic Stem Cell Research Oversight committee (ESCRO) whenever necessary or required under this policy to provide appropriate review and oversight of human embryonic stem cell research.

ESCRO committee members will be appointed by the IRB Chair in consultation with the IRB membership, and the Chief Research Administrator (CRA). The membership of this committee should reflect the scientific, medical and ethical expertise necessary to perform the above responsibilities.  The IRB may retain outside experts or consultants with the prerequisite experience to staff or assist the ESCRO committee and IRB as necessary. 

The ESCRO membership must include a faculty representative experienced in conducting research involving human subjects and a representative of the public. Additional members may be appointed who are qualified to address the following areas:

• Developmental biology
• Stem cell research
• Molecular biology
• Assisted reproduction
• Medical ethics or legal issues

II.       Guidelines

The oversight and guidance of the IRB is required consistent with the following guidelines.

  1. STLCOP requires IRB review and approval for all human embryonic stem cell research that use human embryonic stem cell preparations.
    1. Research involving pre-existing anonymous human embryonic stem cell lines is regarded as non-human research but must be reported to and reviewed by the IRB to confirm and document the non-human determination provided. Any questions about the status of non-living human research must be referred to the IRB which is solely responsible for such determinations.
    2. Appropriate documentation of the provenance of the cell lines (including evidence that the procurement process was approved by an IRB, to ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality) and evidence of compliance with any required compliance reviews must be provided. (See Section VI for other applicable, compliance policies.)
    3. Research involving the procurement of pre-existing cell lines in which identifiable information is available must be reviewed by the IRB.
    4. Research involving the donation or procurement of blastocysts, gametes, or somatic cells requires IRB review. (See Section IV).
  2. Appropriate review and approval by other STLCOP compliance committees prior to IRB review may be required. Section VI provides more information about these potential types of review.
  3. The IRB may require investigators or other members of the research team to complete educational programs including but not limited to the STLCOP mandatory human subjects research program or programs in good tissue practice.

III.    Scientific and Ethical Review of Proposed Research

The IRB will divide research proposals into four categories that will be used to set limits on the types of research conducted at STLCOP and determine the appropriate level of oversight. These four categories are:

  1. Research that is purely in vitro human embryonic stem cell research using pre-existing coded or anonymous human embryonic stem cell lines is generally permissible provided that notice of the research, documentation of the provenance of the cell lines, and IRB approval.
  2. The ESCRO committee and IRB must review and approve all research proposals that involve an attempt to derive new human embryonic stem cell lines. The scientific rationale for the need to generate new human embryonic stem cell lines, by whatever means, should be clearly presented, and the basis for the numbers of blastocysts or oocytes needed should be justified. Such requests should be accompanied by evidence of the appropriate IRB approval of the derivation process or the procurement of blastocysts, gametes or somatic cells (See Section IV).
    1. The ESCRO and IRB must review and approve all research proposals involving the introduction of human embryonic stem cells or any products derived from human embryonic stem cells into non-human animals. Particular attention will be paid to the probable pattern and effects of differentiation and integration of the human cells into the nonhuman tissues.
    2. The ESCRO and IRB must review and approve all research proposals involving the introduction of human embryonic stem cells into murine blastocysts including the generation of chimeric mice.
    3. The ESCRO and IRB must review and approve all research proposals in which personally identifiable information about the donors of the blastocysts, gametes or somatic cells from which the human embryonic stem cells were derived is readily ascertainable by the investigator.
  3. The IRB will not approve the following types of research at this time:
    1. Research involving human embryonic stem cells derived from blastocysts obtained from IVF that was performed for research purposes only;
    2. Research involving in vitro culture of any intact human blastocyst, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first;
    3. Research involving the introduction of embryonic stem cells obtained from any species (including humans) into human blastocysts.
  4. Research that is not permitted.
    1. Transfer of products of somatic cell nuclear transfer (SCNT) into the human uterus, including research on cloning to have children.
    2. Transfer of human blastocysts containing embryonic stem cells into the uterus of any non-human species.
    3. Breeding of animals in which human embryonic stem cells have been introduced at any stage of development.

In addition to the scientific and ethical review, the ESCRO committee and/or the IRB will review the research proposal for compliance with other regulations or policies including the human embryonic stem cell Financial and Costing Policies. (See Section VII.)

IV.    Procurement of Gametes, Blastocysts or Cells for Human Embryonic Stem Cell Generation

IRB review, approval and monitoring is required for the procurement process used to obtain donated blastocysts in excess of clinical need after infertility treatment. Similarly, IRB review and approval is required to obtain oocytes, sperm, and somatic cells donated for development of human embryonic stem cell lines derived through SCNT. Informed consent must be obtained from any person whose somatic cells, gametes or blastocysts are used in human embryonic stem cell research. In addition, the IRB will review research protocols for compliance with the Common Rule governing human subjects research, the Health Insurance Portability and Accountability Act (HIPAA), and other applicable federal and state laws and regulations.  For more specific guidance from the IRB regarding the consent process, please see the IRB’s STLCOP website.

V.    Standards for Investigators Who Wish to Bank Cell Lines

STLCOP anticipates investigators may want to bank human embryonic stem cell lines. There are currently no plans for an institutional approach to cell line banking. Investigators must follow these standards when establishing and maintaining a cell line bank:

  • Obtain IRB review and approval, including appropriate informed consent for the banking of cell lines;
  • Maintain appropriate records;
  • Protect donor privacy;
  • Develop tracking and distribution guidelines and systems;
  • Cell lines that are shipped into the College must have a Material Transfer Agreement approved by the Office of the General Counsel, must be registered with the ESCRO and all documentation required by the ESCRO must be provided;
  • Cell lines that are shipped out of the College must have a Material Transfer Agreement approved by the Office of the General Counsel and must be shipped according to College policy;
  • All members of the research team must be appropriately trained in these standards, and
  • The College reserves the right to monitor cell banks for compliance with this and other policies, guidelines and regulatory standards.

VI.    Other Applicable STLCOP Policies

Investigators should be aware that the review and approval by the IRB is in addition to other College policies, federal regulations and state and local laws governing research. Other policies that may need to be considered include but are not limited to:

  • Institutional Animal Care and Use Committee 
  • Conflicts of Interest 
  • HIPAA 
  • Institutional Review Board Policies and Procedures
  • Certain types of research may be subject to other regulations such as those promulgated by the FDA.

VII.    Financial and Costing Policies

On August 9, 2001, President Bush announced that federal funds may not be used for research using human embryonic stem cell lines unless:

  1. The stem cells were derived from a blastocyst that was created for reproductive purposes and was no longer needed;
  2. Informed consent was obtained for the donation of the blastocyst, and the donation did not involve financial inducements; and
  3. The process of derivation was begun prior to 9 pm EDT on August 9, 2001.

The National Institutes of Health (NIH) has established a registry of the stem cell lines that satisfy these criteria (“registry lines”) making research on these lines eligible for federal funding. The registry is available at http://grants.nih.gov/stem_cells/registry/current.htm​. Research on human embryonic stem cell lines not listed on the NIH registry is ineligible for federal funding.

Although the August 9, 2001 policy bars the use of federal funds for ineligible human embryonic stem cell research, it does not prevent researchers from conducting such research with non-federal funds. To comply with the August 9, 2001 policy, researchers and institutions that receive federal funding must keep separate accounts of the expenses associated with ineligible human embryonic stem cell research to ensure that no federal funds are used, directly or indirectly, to support such research. According to the NIH, institutions will satisfy that requirement if they treat the costs of ineligible human embryonic stem cell research as “unallowable” costs and follow applicable federal cost principles included in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance). See NIH, Stem Cell Information, Frequently Asked Questions (NIH FAQs), available at http://stemcells.nih.gov/info/faqs.asp.

The following STLCOP guidelines, based on the cost principles outlined in the Uniform Guidance and on guidance provided by the DHHS Division of Cost Allocation, provide essential information about the financial compliance requirements for investigators who plan to conduct human embryonic stem cell research. For more specific information on the financial policies, contact the Vice President Finance & CFO.

Proposal Budget Preparation

All human embryonic stem cell research proposals must include a budget that will be reviewed and approved by the College’s Business Office. This review will assess the appropriate budgeting of direct costs.

Direct and F&A Costs

  • The direct costs of human embryonic stem cell research that are eligible for federal funding must be charged to the appropriate federal sources of funding and accumulated in a separate account.
  • The direct costs of human embryonic stem cell research that are ineligible for federal funding must be charged only to non-federal sources of funding and accumulated in a separate account.
  • Normally the same laboratory may not be used for both federally funded and non-federally funded research. Decisions about the use of laboratory space must be made in conjunction with the Dean.
  • Investigators and their staffs must separate eligible and ineligible activities in such a way that assures that costs incurred in the research are charged consistently to the appropriate funding source.
  • Federal regulations forbid the shifting of costs from ineligible research activities to federally sponsored activities.
  • During preparation of federal F&A cost proposals, the College will strictly adhere to the Uniform Guidance principles regarding the allocation of F&A costs to both federally sponsored and other activities, which would include ineligible human embryonic stem cell research. The costs of ineligible human embryonic stem cell research should be included in the regular F&A cost allocation base and associated indirect costs must be allocated pursuant to ordinary allocation principles.

 

Responsibilities:

Position/Office/Department

Responsibility

Chair, Institutional Review Board

Oversee the ESCRO and compliance with this policy

Chief Research Administrator

Provide compliance support to the IRB and ESCRO

Vice President Finance, CFO

Oversee budget preparation administration for the Business Office and compliance

Resources:

Federal Policy for the Protection of Human Subjects, 49 CFR Part 1

NIH, Stem Cell Information, Frequently Asked Questions (NIH FAQs), available at http://stemcells.nih.gov/info/faqs.asp.

Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance), 2 CFR Part 200