HUM-MOLGEN archive: DIAG: PT rel req/HMGN policy on human specimen (II mailing)

************************************************************** HUM-MOLGEN DIAGnostics/Clinical Research ************************************************************** This DIAG message contains 2 submessage(s): 1) PATIENT REL. REQUEST/AMNIOCENTESIS IN MELBOURNE 2) HMGN POLICY ON REQUESTS FOR HUMAN SPECIMENS/ II MAILING Carlo Gambacorti MD, Editor, Human Molecular Genetics network Diagnostics/Clinical Research Section ************************************************************** ************************************************************** I have a patient who will be moving to Australia from the US in early November. She would like to have amniocentesis for maternal age (36). She will be in the Melbourne area. Does anyone have suggestions about who she could contact in the Melbourne area to make such arrangements? She would prefer someone with a reasonable amount of experience with prenatal testing. Thank you. From: Robert Resta <bc928@SCN.ORG> ************************************************************** ************************************************************** 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 acceptance of these guidelines. Carlo Gambacorti MD, Editor, Human Molecular Genetics Network Diagnostics/Clinical Research Section ************************************************************** **************************************************************