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HUM-MOLGEN
DIAGnostics/Clinical Research
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HMGN POLICY
ON REQUESTS FOR HUMAN SPECIMENS AND PARTECIPATION IN CLINICAL TRIALS
A debate has been ongoing among HMGN editors
on how to process requests for specimens (blood, DNA, cells.....)
from patients/donors, posted on HMGN. This problem stems from the global
and innovative nature of HMGN. 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 HMGN assumes that any request for
human specimens will meet the following conditions:
-
it originates from studies with at least an IRB approval,
-
the samples will be effectively protected against identification of the
patient/donor, and
-
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, HMGN
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." (sentence 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 HMGN implies acceptance of these guidelines.
Carlo Gambacorti MD, Editor,
Human Molecular Genetics Network
Diagnostics/Clinical Research Section
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