Principal Investigators who intend to purchase samples that are to be shared should read the statement below and then contact the Order Department of Coriell Cell Repositories by calling 800-752-3805 before proceeding with the order.

Genetic research often involves collaborations among several laboratories that share materials toward a common goal. Also, as a result of new genomic technologies, data are often generated by multi-user core facilities. Many labs often benefit from using common biological standards for research or clinical purposes. Thus, consistent with the mission to facilitate genetic research, the Repository will permit secondary distribution to accommodate certain situations if it can be established that protection of human subjects and quality control can be assured. Examples of situations in which the issue of secondary distribution or shared use might be raised are described below, along with recommendations and the rationale behind the recommendations.

1. Single purpose collaboration - Two or more investigators initiate a collaborative project that requires the use by each laboratory of the same cell line or DNA sample. One investigator purchases a sample and explains in the statement of research intent that the sample will be shared with specific, named collaborators for a common research purpose. Secondary distribution to named collaborators is permitted when the research intent is identical for the collaborators and is thus consistent with the informed consent and quality can be reasonably assured by virtue of the collaboration.

2. Multi-purpose use - A Principal Investigator working on a particular project purchases a sample and submits a statement of research intent describing that project. At some time after obtaining the sample, the investigator wishes to give a portion of the DNA sample to a colleague who is working on another project. In this case, secondary distribution is prohibited because the Coriell Institute for Medical Research (CIMR) IRB cannot assure that use of the sample by the original purchaser’s colleague is consistent with the informed consent. In addition, errors in identification of DNA samples can occur and could compromise the Repository’s reputation.

3. Multi-user core facility - A core facility (for high-throughput genotyping, for example) purchases samples for use by the scientists in the facility to perform assays for investigators at that institution or at a consortium of institutions. The statement of research intent describes the range of studies (i.e., the kinds of phenotypes for which genotyping studies would be performed) but explains that the number of users and the exact phenotypes cannot be predicted. In this situation, the use of the samples in the core facility is permitted after the CIMR IRB is assured that the use of the samples is consistent with the informed consent. Since the samples will be used in the same facility for multiple investigators, quality can be assured.

4. Distribution of aliquots or derivatives of samples for use as biological standards - An organization purchases a sample and describes in the statement of research intent that the sample will be distributed, either with or without modification, for use as standards. The statement may or may not be able to specify the purpose(s) for which the distributed material will be used or the laboratories that would receive the materials. The Repository must decide this type of request on a case-by-case basis. In cases where the CIMR staff, with the advice of the Repository’s project officer, can reasonably expect that the organization would produce high quality control standards (based on the proposed methods of quality control and the expertise and past experience of the organization), and where the CIMR IRB can assure that the uses of distributed samples are limited to those that the IRB approves, secondary distribution should be permitted. The secondary distribution of aliquots or derivatives of samples of Repository materials for commercial purposes is prohibited under all circumstances. The burden of proof must be on the purchaser of the sample from the Repository. Furthermore, samples that are distributed must be accompanied by a disclaimer of the Repository’s responsibility regarding safety and quality.