Policies and Procedures

We have developed and implement policies and procedures that address the logistical, procedural, and legal restrictions involved with the hESC Core Facility. Specific policy includes the following items (pdf version):

1. ALL INVESTIGATORS MUST FIRST SUBMIT A BRIEF RESEARCH PROPOSAL TO THE FACILITY DETAILING THEIR REQUIREMENTS AND HOW THEY PLAN TO USE THE HESC CORE FACILITY. THIS STATEMENT SHOULD INCLUDE AN OUTLINE OF THE STUDY BACKGROUND, METHODS AND AIMS. IT SHOULD ALSO CONTAIN COPIES OF IRB/ESCROW, AND IACUC APPROVALS. CONTACT INFORMATION AND CREDENTIALS FOR THE INVESTIGATOR AND MEMBERS OF THE INVESTIGATORS LABORATORY SHOULD ALSO BE INCLUDED.
2. THE INVESTIGATOR MUST PROVIDE DOCUMENTATION THAT THEIR STUDY HAS BEEN SUBJECT TO IRB/ESCROW AND IACUC (IF NESECCARY) REVEIW AND APPROVAL BEFORE CELL LINES ARE MADE AVALIABLE OR ANY STUDY IS INITIATED.
3. THE INVESTIGATOR WILL INITIALLY MEET WITH HESC CORE FACILITY STAFF PRIOR TO THE INITIATION OF THE STUDY TO REVIEW THE SPECIFIC NEEDS OF EACH STUDY, TO ASSESS TO WHAT EXTENT THE HESC CORE FACILITY IS ABLE TO FULFILL THOSE NEEDS, AND COUNSEL INVESTIGATORS IN IDENTIFYING WHICH CELL LINES ARE BEST SUITED FOR THEIR SPECIFIC APPLICATIONS.
4. CELL LINES IN USE BY INVESTIGATORS ARE NOT TO BE SOLD OR SHARED WITH ANY THIRD PARTY OR OTHER INVESTIGATOR. CELL LINES WILL NOT BE CULTURED OR USED OUTSIDE THE HESC CORE FACILITY, OR USED FOR RESEARCH OTHER THAN THAT DESCRIBED IN THE APPROVED STATEMENT OF RESEARCH. IF THERE ARE COLLABORATORS ON A STUDY FOR WHICH CELL LINES ARE BEING USED, THOSE INVESTIGATORS NEED TO BE LISTED AS COLLABORATORS ON THE ORIGINAL STUDY AND INCLUDED IN A STATEMENT OF RESEARCH.
5. UPON IDENTIFYING WHICH CELL LINE IS OPTIMAL THE INVESTIGATORS WILL DIRECTLY PURCHASE OR OTHERWISE LICENSE THE CELL LINE FROM THE SUPPLIER. THESE CELLS MAY BE USED IN FURTHER STUDIES EITHER WITHIN THE HESC CORE FACILITY OR IN THE INVESTIGATORS OWN LABORATORY (UNDER ANY REQUIRED AGREEMENTS OR LIMITATIONS PLACED BY THE SUPPLIER).
6. HESC CORE FACILITY DIRECTORS WILL MEET TO REVIEW ALL RESEARCH PROPOSALS ON A FIRST COME FIRST SERVE BASIS TO EXAMINE EACH STUDY FOR SCIENTIFIC AND PRACTICAL FEASABILITY.
7. DIFFERENTIATED CELL LINES RESULTING FROM INDIVIDUAL STUDIES WILL REMAIN IN THE HESC CORE FACILITY AS FROZEN STOCKS. LIVE CELL LINES MUST NOT BE REMOVED FROM THE HESC CORE FACILITY FOR USE IN INVESTIGATOR LABORATORIES.
8. CELL LINES USED HAVE A UNIQUE IDENTIFYING CODE GENERATED BY THE HESC CORE FACILITY. ALTHOUGH THEY ARE CONSIDERED HUMAN TISSUE, HOWEVER, THE LINES MAINTAINED BY THE HESC CORE FACILITY ARE COMMERCIALLY AVALIABLE AND AS SUCH HAVE NO PATIENT IDENTIFYING INFORMATION ASSOCIATED WITH THEM.
9. TIME, SPACE AND EQUIPMENT USE WILL BE ALLOCATED TO INVESTIGATORS BY THE HESC CORE FACILITY STAFF. INVESTIGATORS WILL ABIDE BY THIS ALLOCATION UNLESS THE INVESTIGATORS NEEDS CHANGE, IN WHICH CASE THE INVESTIGATOR AND THE HESC CORE FACILITY STAFF WILL MEET TO REASSESS THE INVESTIGATORS NEEDS.
10. THE INVESTIGATOR MUST AGREE TO ABIDE BY POLICIES AND PROCEDURES OF THE HESC CORE FACILITY. A SIGNED LETTER OF RESEARCH AGREEMENT BETWEEN THE HESC FACILITY AND THE INVESTIGATOR WILL BE MAINTAINED ON FILE AT THE HESC FACILITY FOR ANY WORK THAT UTILISES HESC CORE FACILITY RESOURCES OR CELL LINES.