Sara Bible, Dean of Research Office Stanford University Bill by lfl12074

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									     STEM CELL RESEARCH:
GETTING ALL THE DUCKS IN A ROW




      Sara Bible, Dean of Research Office
               Stanford University
   Bill Brophy, Director of Financial Analysis
        University of California, San Diego
Presented at the SRA Western Regional
                Meeting


RESEARCH ELEVATED: MILE HIGH OPPORTUNITIES
       DENVER, CO - JUNE 7-11, 2008
  About This Session
TOPICS
 Impact of federal funding issues on administration of hESC research

  Human Embryonic Stem Cell Research Special Operating
  Procedures for:
    material transfer agreements
    accounting
    effort allocation and certification
    facilities
    equipment
    expendable materials and supplies
    derivatives
    research data and intellectual property
About This Session

ABOUT THIS SESSION
Session based on a tutorial for Stanford personnel, including faculty,
staff, postdoctoral scholars, students, visiting scholars and other
researchers, who will be working on research projects involving
human embryonic stem cells.

At Stanford, all personnel must complete this tutorial satisfactorily as a
prerequisite to beginning work or study associated with human
embryonic stem cells.
It is the PI’s responsibility to ensure that personnel complete both
tutorials. Tutorial includes post test that must be completed with
100% accuracy.
At UCSD, Research personnel with responsibilities for research using
Human Embryonic Stem Cells are required to complete training in
stem cell research, policy, and ethics.
STEM CELL RESEARCH TERMS AND ACRONYMS
Human Adult Stem Cells
Stem cell = master cell that can create the more specialized human cells
Human Embryonic Stem Cells (hESC)
Pluripotent cells that are self-replicating, derived from human embryos
and are capable of developing into cells and tissues of the three primary
germ layers. Although human embryonic stem cells may be derived from
embryos, such stem cells are not themselves embryos.
Registry Lines/Registry hESC
Those included on the NIH Human Embryonic Stem Cell Registry
Non-registry Lines/Non-Registry hESC
Those excluded from the NIH Human Embryonic Stem Cell Registry
hESC lines
A population of identical cells that all originated from a single blastocyst.
Because cell lines multiply, scientists can grow the cells for their own
research and to share with colleagues.
   CRITERIA FOR hESC RESEARCH FEDERAL FUNDING
Federal Announcement
On August 9, 2001, President George
W. Bush announced that federal funds
can be used for hESC research only if
they meet the following criteria:
  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          Please think of your own preferred
                                            quotation for this picture.
  3. the process of derivation was
     begun prior to 9 pm EDT on
     August 9, 2001.
           FEDERAL ANNOUNCEMENT IMPACTS
         FEDERAL FUNDING FOR hESC RESEARCH
Because of President Bush’s announcement, hESC lines are categorized as:

  1. Registry hESC Lines
     Federal funds may be used ONLY for research using registry hESC lines.

     Registry hESC lines = included on the NIH Human Embryonic Stem Cell
     Registry - confirms that the stem cell lines are in compliance with the
     President’s criteria as stated on August 9, 2001.

  2. Non-registry hESC Lines
     Federal funds may not be used directly or indirectly for research using non-
     registry hESC lines (or their derivatives).
     Non-registry hESC lines are excluded from the NIH registry because they
     do not meet federal criteria.

hESC Research Can Proceed
Although the August 9, 2001 announcement bars the use of federal funds for
    research on non-registry hESC lines, it does not prevent investigators from
    conducting research with non-federal funds.
GOAL
Implement Procedures:

  to ensure hESC research can proceed unimpeded,
  to ensure compliance with university, federal and state policies, laws and
   regulations, and
  to ensure federal funds are not used to support non-registered hESC
   research directly or indirectly.
  to ensure all faculty, staff, postdoctoral scholars, and students as well as
   visiting scholars and other researchers involved in hESC are trained.
 ADDITIONAL RESPONSIBILITIES
INSTITUTIONAL RESPONSIBILITIES
• Review all human stem cell protocols

• Review ownership and use restrictions for all equipment in the space

• Review and negotiate agreements for obtaining hESC lines

• Tag equipment accurately based on federal funding restriction

• Monitor space and facilities used for research on non-registry hESC

• Perform indirect cost calculation, and verify funding source of labs
ADDITIONAL RESPONSIBILITIES
RESPONSIBILITIES OF RESEARCH PERSONNEL
 • Plan the Research – where, who, what (funding, equipment,
   cell lines)

 • Review campus guidelines, complete hESC, cell culture and
   ethics training

 • Obtain approval of research protocol or amendment and
   material transfer for each hESC line requested.

 • Establish appropriate accounting for each research activity.

 • Obtain institutional biosafety approval where needed
COSTING PROCEDURES: INTRODUCTION
• The following costing procedures provide guidance to
  ensure that federal funds are not used to support non-
  registry hESC research.

• Remember that the costing procedures for hESC
  research are in addition to existing institutional policy &
  procedures.
 STANFORD PROCESS
Stem Cell Research Tracking (SCRT) Form
Form must be completed for all research that involves use of all Human
Stem Cells - registry and non-registry 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. 30 days prior to anticipated start date (for gift, department or
     university research funded project)
  3. Whenever there is a change in project location/space usage such
     as room additions or deletions.
Purpose of the Form
  • Inform and seek approval from cognizant personnel
  • Begin Stem Cell Oversight Committee (SCRO) review of scientific
    and ethical issues
  • 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).
 UCSD PROCESS
Before research/teaching w/human embryonic stem cells, must be
approved by:

• Embryonic Stem Cell Research Oversight Committee (ESCRO)
       http://research.ucsd.edu/escro

• UCSD Human Research Protections Program IRB http://irb.ucsd.edu

• Institutional Biosafety Committee - EH&S http://www-ehs.ucsd.edu

• Conflict of Interest (IRC) http://ocga3.ucsd.edu

If project calls for use of animal subjects, must also be approved by:

• Institutional Animal Care and Use Committee (IACUC)
 http://iacuc.ucsd.edu

If human embryonic stem cells provided by non-UCSD source, must have:

An MTA - Office of Contract and Grant Administration
http://ocga3.ucsd.edu, OR
A Purchase Agreement - UCSD Purchasing http://www-bfs.ucsd.edu/pur
UCSD PROCESS
If UCSD-developed cells are sent outside UCSD or transferred between
 UCSD investigators, must receive an evaluation from:

• Technology Transfer - TechTIPS http://invent.ucsd.edu

Research w/human embryonic stem cells, non-UCSD fund source, must
be approved by:

• ESCRO, and campus IRB
• Office of Contract and Grant Administration http://ocga3.ucsd.edu

OR

• Clinical Trials Administrative Services & Research Compliance Office

If research or training is funded by department or gift funds, approval is
 required from the department business office and/or department chair.
ACCOUNTING
 STANFORD
 New PTA Required

 Open a new Project Task Award (PTA) for each project
 utilizing non-registry human embryonic stem cells, whether it
 is gift, departmental university, or externally funded research.


            A research assistant prepares stem cell cultures in a lab at the Waisman Center. Photo by: Jeff
                                                                                         Miller, UWM-2001
ACCOUNTING
UCSD
Establish separate fund for each award - set up index, fund, and other
accounting elements that drive University's reporting/ledger processes
Prepare and manage award allocations
Approve financial transactions to be charged to the project
Ensure that award expenditures comply w/financial terms and conditions,
University/agency policies
EFFORT ALLOCATION AND CERTIFICATION
Use established policies for:
• tracking, allocating and confirming effort on sponsored projects for all
  personnel to ensure that effort devoted to non-registered hESC
  research is not paid with federal funds,
• monthly review and quarterly certification of expenditure statements, by
  the Principal Investigator,
• proper allocation of salaries and benefits when an individual is working
  with multiple sources of support.


       Important!

       Salary must be allocated and charged to gift and
       departmental, or university accounts commensurate with
       effort put forth on the projects!
EFFORT ALLOCATION AND CERTIFICATION
.   Special Operating Procedures for additional work involving hESC
    research for postdoctoral fellows and students funded 100% by
    federal sources.

    Postdoctoral fellows and students who are funded by federal
    institutional training grants or fellowships, such as National Research
    Service Awards (NRSA) are required to pursue their research training
    full time under the terms of the award. However, they may be
    permitted under the sponsor’s policy to engage in limited or part-time
    work beyond their federal commitments.

    Any such additional work must be compensated as part time
    employment and must be incidental to the training program.
USE OF UNIVERSITY AND FEDERAL FACILITIES

Federal funded facilities, including VA facilities, may not be
used in the conduct of non-registry hESC research.

Both Stanford and UCSD have identified their federally
funded facilities and prohibit their use for non-registry
hESC research.
FACILITIES FOR NON-REGISTRY hESC RESEARCH

 Where research on non-registry hESC is conducted

  • List each lab, room, and office that will be used. Obtain a
    determination on whether any of the proposed spaces cannot be
    used because of federal funding.

  • Review all equipment in the proposed spaces to see if any have
    been tagged as federally funded. If so, the items cannot be used on
    the non-registry research project.

  • Update and re-route the form before the project location changes.
SPACE INVENTORY CODING
Both Stanford and UCSD use their established space inventory
and inventory procedures to track the location of all hESC
research.

 • Code space as organized research or departmental research,
   depending on the funding of the research.

 • Use the Research Explanation or Comments fields to document
   non-registry hESC research
   EQUIPMENT APPROVAL - STANFORD
In a facility where non-registry hESC research is performed, all new and
existing equipment regardless of funding source, must be reviewed for
federal funding restrictions, and tagged appropriately. It will be tagged as
either APPROVED for use on non-registry hESC or DO NOT USE on
non-registry hESC.
Equipment is considered to have a purchase price of $5,000 or more and a useful
life of more than one year.
                                   • Develop a list of all equipment in a facility
                                     where non-registry hESC research will be
                                     performed. Once the list has been
   Tags for Equipment where          completed, subsequent purchases will be
      non-registry hESC is           reviewed individually.
          conducted
                                    • Will verify ownership and use restrictions.
                                    • Approval to use the equipment may or may
 APPROVED        DO NOT USE           not be granted.
 FOR USE ON         ON NON-
NON-REGISTRY       REGISTRY         • All Equipment will be tagged to indicate
    hESC             hESC             whether it is approved or not approved for
                                      non-registry hESC research.
  EQUIPMENT APPROVAL - UCSD
In 2007, an inventory was conducted of all academic equipment, to
identify current building and room location.

A red dot was affixed to all federally funded equipment, and a campus
procedure was published and disseminated, indicating that red dot
equipment could not be used for non-registry hESC research.

Capital Assets Accounting issues a red dot along with an inventory tag
for all equipment purchases that are federally funded.
EQUIPMENT OWNERSHIP CATEGORIES
Equipment ownership will fall into one of three categories and will
be tagged accordingly.

 Equipment owned by      Equipment purchased with federal            Equipment owned by
the federal government   funds may be owned by the                      the University
                         University and therefore can be used
                         for non-registry hESC research,
                         if one of the following criteria is met:

     DO NOT USE                                                           APPROVED
                         All competitive segments of the                 FOR USE ON
         ON
                         federal grant or contract supporting           NON-REGISTRY
    NON-REGISTRY
        hESC             the equipment purchase has been                    hESC
                         completed, University retains title to
                         the equipment without restriction;
                         Or
                         University purchases the equipment
                         in full, without federal restriction, and
                         can document such transaction.
EQUIPMENT INVENTORY CONDUCTED PERIODICALLY

Laboratories where non-registry hESC research is performed are subject to
periodic inventories to ensure that only approved equipment is used to support
non-registry hESC research.

Additional detail on Stanford procedures for equipment when conducting hESC
research can be found in the Property Administration Manual, Chapter 14
“Using Equipment for Stem Cell Research”.
 MATERIALS/SUPPLIES ALLOCATION METHODOLOGY
If you purchase expendable materials and supplies that benefit multiple projects,
use a reasonable allocation methodology to accurately assign costs to the
benefiting projects. This allocation methodology must be documented. When
making such purchases to support non-registry hESC research, make certain
costs are not allocated to federal projects.

To avoid risk of charging materials and supplies for non-registry hESC to federal
projects, purchase supplies for non-registry hESC research separate from all other
research where practical.
SERVICE CENTERS
Service Centers used for research with non-registry hESC must not
involve any federal resources or federal core funding.
If a service center includes equipment that is federally funded and title
remains with the federal government, some additional steps may be
needed to allow use to provide services to research with non-registry
hESC, including an increased charge rate to recognize the
depreciation of the federal equipment, and a designation of program
income for the income so produced.
 DERIVATIVES FROM hESC RESEARCH
Research using derivatives from non-registry hESC lines may not be
supported by federal funds. For costing purposes they are treated just like
the lines themselves.
Use the appropriate campus procedure to record:
1. Source of the hESC lines and the hESC derivatives,
2. Whether the source is a registry line or non-registry line,
3. Funding source of your research.




              Caption: Derived from human embryonic stem cells,in the lab of UW-Madison stem cell
                                      researcher Su-Chun Zhang, 11/01
MATERIAL TRANSFER AGREEMENTS
Follow institutional policies for receiving research materials.
  All hESC lines require a Material Transfer Agreement (MTA) or similar
  agreement in place between the provider and University before the lines
  can be transferred to investigators
  Investigators requesting hESC lines, both registry and non-registry, must
  fill out an MTA routing form.
  The provider's agreement for transferring the cell lines will be reviewed to
  ensure compliance with University policy; necessary changes will be
  negotiated before the agreement is signed.
 Stanford’s Instructions for obtaining hESC lines can be found at the ICO's
        website: http://www.stanford.edu/group/ICO/agmts/index.htm
DATA & INTELLECTUAL PROPERTY
Researchers may use data or information obtained from either registry or
  non-registry hESC research in subsequent hESC projects if:
  1. the data has been published or
  2. permission to use the data has been granted by the original researcher
     whether the subsequent projects are federally or non-federally funded.
However, the federal government may not be charged for generating data
  from non-registry hESC research, or for analyzing or manipulating data
  for subsequent use in non-registry hESC research.
   Data and information usage is subject to the usual considerations of third-
   party intellectual rights the as well as any specific grant or contract
   conditions on data usage imposed by suppliers or sponsors of the data,
   including other research institutions and federal funding agencies.

								
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