Cell cultures and DNA samples are distributed only to qualified professional persons who are associated with recognized research, medical, educational, or industrial organizations engaged in health-related research or health delivery. There are two requirements for ordering biomaterials from The NHGRI Sample Repository for Human Genetic Research at Coriell to ensure compliance with the Office for Human Research Protections (OHRP), Department of Health and Human Services (DHHS) regulations for the protection of human subjects (45 CFR Part 46).
Each order placed with the Repository must be placed electronically using our online catalog system. The information required by the Statement of Research Intent can be submitted electronically during the checkout of the order. The Assurance Form (if not already on file) must be submitted by email before an order can be reviewed and approved- this form can be downloaded during the checkout process or may be obtained by contacting Customer Service (see below)
The DHHS Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens (October 16, 2008) clarifies when research on human specimens is considered to be human subjects research. According to this Guidance, samples obtained by researchers from the NHGRI Sample Repository for Human Genetic Research are not considered to be human subjects because conducting research with the samples does not involve an intervention or interaction with the individual and the samples do not contain identifiable private information. The Repository has policies in place that prohibit the release of any information that would allow investigators to identify the individual from whom the cell culture or DNA sample was derived. Although approval by an IRB at the investigator's institution may not be required, investigators are encouraged to seek advice from their IRB.
PROCEDURE
All orders for cell cultures or DNA samples must be submitted using the online catalog. Customers must register online and after their registration has been approved, can add items to their shopping cart from the catalog and checkout. See Create Account for more information about this process. Before requests can be processed, the required information and supporting documentation must be reviewed and approved by the Coriell Order Review Board.
ADDRESS
All purchase orders should be addressed to:
SHIPPING CHARGES
Shipping charges vary depending upon the mode of shipment requested by the purchaser. Domestic shipments are usually made via Federal Express with a guaranteed second day delivery.
SHIPMENT OF CELL CULTURES AND DNA SAMPLES
Cell Cultures
When an order is received, a frozen ampule is usually recovered from liquid nitrogen on the following Thursday. The culture is inspected for growth and contamination and the medium is changed on Friday. The following Monday, the culture is inspected, the medium is removed, and the T25 flask is filled with fresh medium, packed, and shipped. The flask is enclosed within two watertight plastic envelopes within a styrofoam box in a cardboard mailer to prevent leakage, overheating, or freezing during shipment. The only exception to this schedule occurs when a frozen biopsy is ordered. All requests for frozen biopsies will be reviewed for acceptance. If the order is to be filled, the biopsy will be recovered from liquid nitrogen, established in culture, and tested for contamination before it will be shipped. There will be a 2-month time period needed to process orders for biopsies.
Upon receipt, cell cultures should be placed in an incubator at 37°C or at the temperature specified on the shipping information sheet for a few hours or overnight without removing any medium to permit recovery from damage which may have occurred during shipment. It is suggested that the recipient store aliquots of cells in early passage in liquid nitrogen to assure that the entire culture is not lost as a result of contamination, artifacts associated with aging, or accidents.
Frozen ampules are not shipped because experience has shown much better success in shipping freshly recovered growing cultures.
Pertinent suggestions to improve the effectiveness of the Repository are appreciated. Over the past twenty-two years, 95 percent of shipments have arrived in satisfactory or better condition.
Cell Culture Quality Control
The Coriell Cell Repositories has developed and maintains preventative and surveillance procedures to guarantee that the NHGRI Sample Repository for Human Genetic Research distributes highly-characterized, viable, and contaminant-free cell cultures.
All cell cultures are grown and frozen in antibiotic-free media to aid in the detection and prevention of contamination. Cultures are tested and found free of mycoplasma, bacteria, and fungi during expansion, at the time of frozen storage, and after recovery of stock for distribution from liquid nitrogen. Recovered cultures are also examined to determine viability and growth potential and to verify species of origin.
DNA Samples
DNA samples are recovered from storage at -70°C and shipped on Mondays and Wednesdays at ambient temperature. Recipients should centrifuge the vials prior to opening. Continued storage at -70°C is recommended to maintain the integrity of the DNA.
DNA Quality Control
All DNA samples prepared by the Repository are characterized for the following:
Feedback from DNA recipients including utilization surveys and publications citing the use of Repository DNA samples have also been reviewed for this purpose.
DESCRIPTIVE DATA
Each shipment includes a packing slip and general information about cell cultures or a listing of DNA concentrations. Specific details for each cell line or DNA sample and pertinent reference citations (if available) can be printed from the Coriell Web Catalog. Search the catalog by using the catalog number.
REQUEST FOR CITATION AND REPRINTS
The Repository requests that the Repository number be cited in publications in which cell cultures or DNA samples from the Human Genetic Cell Repository are used. The Repository would also appreciate receiving a reprint of each publication that references a Repository cell line or DNA sample.
