HUM-MOLGEN DIAGnostics/Clinical Research

 


24/1/96
HMGN POLICY ON REQUESTS FOR HUMAN SPECIMENS/ III MAILING


A POLICY ON REQUESTS FOR HUMAN SPECIMENS
A debate has been ongoing among HMG editors on how to process requests for specimens (blood, DNA, cells.....) from patients/donors, posted on HMG. This problem stems from the global and innovative nature of HMG. While the debate is continuing, this editor thinks it is necessary to observe a minimal standard regarding the issues of study approval and protection against identification (of a certain individual through the specimen obtained). Therefore this editor assumes that any request for human specimens, 1) originates from studies with at least an IRB approval, 2) the samples will be effectively protected against identification of the patient/donor, and 3) the IRB approval contemplates the possibility of soliciting and obtaining samples from institutions other that the home institution and from other countries. Alternatively, the message should state that samples can be sent only from a restricted number of countries. Regarding the human specimens being sent/received, HMG implies that: "Appropriate consent was obtained, for use of this material, and it should be understood that information about this sample will be stored in a database without identification of the individual from whom they were derived." (This sentence was supplied by Jeanne C. Beck, NIGMS Human Genetic Mutant Cell Repository, in conjunction with NIH). It is the responsibility of the individual sending the request, to verify that the above mentioned requirements are met; the mailing of the request to HMG implies full acceptance of these guidelines.

Carlo Gambacorti MD, Editor, Human Molecular Genetics Network Diagnostics/Clinical Research Section