Sara Bible, Office of Research Administration

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Stanford University Human Embryonic Stem Cell
Research Administration

• Sara Bible, Office of Research Administration
• Kathleen Thompson, Research Management Group
• http//ora.stanford.edu/hesc/

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Federal Directives Impact Federal Funding for
hESC Research

• On August 9, 2001, President George W. Bush
  announced that federal funds cannot be used for
  research using human embryonic stem cell (hESC)
  lines unless (1) the stem cells were derived
  from an embryo that was created for reproductive
  purposes and was no longer needed (2) informed
  consent was obtained for the donation of the
  embryo, 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.
• Because of the federal funding directives,
  Stanford has categorized hESC lines as
• 1. Registered hESC LinesFederal funds may be
  used ONLY for research using registered hESC
  lines. Registered hESC lines are those included
  on the NIH Human Embryonic Stem Cell Registry
  which confirms that the stem cell lines are in
  compliance with the Presidents criteria as
  stated on August 9, 2001.   
• 2. Non-registered hESC LinesFederal funds may
  not be used directly or indirectly for research
  using non-registered hESC lines (or their
  derivatives). Non-registered hESC lines are
  excluded from the NIH registry because they do
  not meet federal criteria.
• hESC Research Can Proceed
• Although the August 9, 2001 directive bars the
  use of federal funds for research on
  non-registered hESC lines, it does not prevent
  investigators from conducting such research with
  non-federal funds.

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Roles and Responsibilities

• Responsibilities of
• Research Personnel
• Complete both the hESC Tutorial and the Human
  Subjects Tutorial.
• Initiate IRB review for research on all hESC.
• Complete the HESCRT Form for research on all
  hESC.
• Complete a Material Transfer Agreement Routing
  Form for each hESC line requested.
• Open new Project Task Award (PTA) for each
  research activity.

• Responsibilities of
• Cognizant Offices
• Institutional Review Board (IRB) review hESC
  research protocol
• Property Management Office (PMO) review
  ownership and use restrictions for all equipment
  in the space
• Industrial Contracts Office (ICO) review and
  negotiate agreements for obtaining hESC lines
• Department Property Administrator (DPA) tag
  equipment accurately based on ownership
• School Facilities Group monitor space and
  facilities used for research on non-registered
  hESC
• Cost Management Analysis (CMA) perform
  indirect cost calculation, and verify funding
  source of labs
• Research Management Group (RMG) or your
  institutional representative process the HESCRT
  Form

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HESCRT Form

• The Human Embryonic Stem Cell Research Tracking
  (HESCRT) Form
• The form must be completed for all research that
  involves the use of registered
• and non-registered hESC or human embryos
  regardless of funding source - gifts,
• departmental funds, university research or
  externally funded grants and contracts.
• When Must the Form Be Completed?
• 1. At the time of proposal (for an externally -
  funded project).
• 2. At least thirty days prior to the anticipated
  start date (for a gift, department or university
  research funded project).
• Whenever there is a change in project location or
  space usage such as room additions or deletions.

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HESCRT Form

• The Human Embryonic Stem Cell Research Tracking
  (HESCRT) Form
• The Purpose of the Form
• Identify projects using hESC lines for compliance
  with
• Federal regulations
• National Academy of Sciences (NAS) regulations
• Inform and seek approval from cognizant office
• Alert CMA so they can assess funding of buildings
  to the room level
• Alert PMO your DPA so they can assess ownership
  of the equipment to be used in research
• Initiate accounting to open a Project Task
  Award (PTA)

Information will be verified award cannot be
accepted until all verifications/approvals are
complete.
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HESCRT Form Tracks Information About

• Personnel identifies personnel working on
  project all personnel are required to complete
  training must confirm salary support from a
  non-federal source when using non-registered hESC
  lines
• Stem Cell Information identifies if registered
  or non-registered lines are being used in
  research
• Research Compliance information on both IRB and
  APLAC approvals
• Note - IRB approval required for ALL stem cell
  research
• Material Transfer Agreement required to obtain
  cell lines some vendors require separate MTA for
  each researcher

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HESCRT Form Tracks Information About

• Funding Sources verifies funding appropriate
  for type of research
• Space identifies space no federal funded space
  can be used for research using non-registered
  lines
• (E)SCRO Review
• NAS requires the establishment of an
  institutional Embryonic Stem Cell Oversight
  Committee (ESCRO) the committee provides
  assurance that research adheres to both legal and
  ethical guidelines
• Equipment the Property Office will notified for
  non-registered line research

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Equipment Ownership Categories
Equipment ownership will fall into one of three
categories and will be tagged accordingly.
Equipment owned by the federal government
Equipment owned by Stanford
DO NOT USE ONNON-REGISTERED hESC
APPROVED FOR USE ON NON-REGISTERED hESC

• This equipment may be approved if one of the
  following criteria is met.
• All competitive segments of the federal grant or
  contract supporting the equipment purchase has
  been completed, Stanford retains title to the
  equipment without restriction and PMO confirms
  to the PI that its use is permitted based on the
  terms of the federal grant or contract
• or
• Stanford purchases the equipment in full, without
  federal restriction, and has documentation of
  such transaction.

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California Institute of Regenerative Medicine
(CIRM)

• CIRM Funding Opportunities at
• http//www.cirm.ca.gov/rfa/
• Application instructions and forms must be
  completed in Adobe 7.0 (standard or professional)

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California Institute of Regenerative Medicine
(CIRM)

• Application reminders
• salary cap of 200,000
• Graduate Students Postdoc budgeted as stipend
  at CIRM levels
• VSC animal per diem costs should be budgeted in
  supplies at non-government rates

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California Institute of Regenerative Medicine
(CIRM)

• Application of Facilities Administrative Costs
• Budget the Facilities Costs separate from the
  Administrative Costs
• Facilities costs
• Direct cost of project
• Itemized into Category A B
• Administrative costs
• 25 applied to direct costs including Facilities
  Costs

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California Institute of Regenerative Medicine
(CIRM)

• Facilities Description Page
• for non-registered line research, add the
  following statement
• The research will be conducted in the space
  described or in comparable space to be identified
  by the University

For research conducted at the Stem Cell and
Regenerative Medicine Institute, contact your
institutional representative for the facilities
description.
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Questions?

• Contact your Institutional Representative for
  information on proposals
• Research Management Group
• Office of Sponsored Research
• For Policy Issues contact
• Sara Bible sbible_at_stanford.edu
• Kathleen Thompson klt_at_stanford.edu