ADMINISTRATIVE PROCEDURE

Project Administration for Research Involving Human Embryos or Embryonic Stem Cell Lines Ineligible for Federal/State Funding

PURCHASING EQUIPMENT AND SUPPLIES

Whenever possible, laboratory equipment and supplies should be purchased from an outside supplier. Internal suppliers must prove that no federal/state funds were considered in developing their ISO rates. If items or services will be purchased from an ISO, the purchaser must call Accounting Services first to verify that no federal/state funds were used in developing the rate. If so, Accounting Services may need to develop an alternative rate.

OBTAINING EMBRYOS/EMBRYONIC STEM CELLS

Researchers may obtain human embryos or embryonic stem cells that have been donated for research purposes by patients undergoing reproductive therapies. If the embryos/embryonic stem cells are obtained from clinics, laboratories or other entities outside the University, these materials should be transferred to the University under a Material Transfer Agreement approved by the Office of the General Counsel and signed by the transferring institution and the University. Human embryos/embryonic stem cells may not be bought or sold, except reasonable payments are permitted associated with the transportation, processing, preservation, quality control or storage of human embryos/embryonic stem cells.

PREPARING FINANCIAL TRANSACTIONS

Individuals who prepare financial transactions for the project must include a note on each purchasing document that indicates that the purchased items will be used for federally unapproved human embryonic stem cell (hESC) research or research that involves more than minimal risk to the embryos. This information will make it easier to provide oversight over correct allocation of costs.

WHEN TO NOTIFY CENTRAL ADMINISTRATION

Project personnel must notify Sponsored Projects Administration if these items change during the life of the project:

  • Use of space (e.g., if a project that was sharing the lab space has ended)
  • Change in use of equipment
  • Change of personnel
  • Unanticipated use of an internal services organization (ISO)
  • Discovery of error in use of University resources not approved for project

PROJECT TERMINATION

Sponsored Financial Reporting will notify the Research Compliance Office (RCO) when the project has terminated and all financial obligations have been met. The Research Compliance Office will review project records and deactivate the registration as appropriate.

OVERSIGHT

Document Approvers
Approvers must ensure that financial documents include a statement that the project is using human embryos or embryonic stem cells ineligible for federal/state funding.

Research Compliance Office (RCO)
RCO conducts transaction reviews to confirm that preparer and approver responsibilities are fulfilled. RCO will review each registration holder's purchasing and inventory processes and records during the project period and when a registration becomes active or deactivated. RCO provides ongoing oversight for all regulatory aspects of the research.

Sponsored Projects Administration (SPA)
SPA will review registrants periodically (no less than once per year) during the active registration interval.

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