Entire Transcript in Adobe Acrobat Format - National Reference ...

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know something about the participant or that the result
that they are going to get might impact and they would like
to eventually go back then they would need to put their
proposal to the IRB and to -- if they needed to use samples
to do a new study where it was not specifically stated in
the original informed consent where a lot of our
epidemiological studies in stored samples do not have
genetic consent.
So you want to go -- if you need identifiers --
and one of the reasons you might need identifiers is that
let's say you collected studies to do hypertension and now
you want to look at renal disease because it is related to
hypertension. So that can be considered broadly related.
But let's say you wanted to look at pulmonary function and
that is not really considered broadly related, you would
need to go back to your IRB. Okay. So that is why you
might want to go back.
Now for the new studies the informed consent
should be obtained for all new studies whether they are
intended to do genetics or not, or clinical trials, or
epidemiological studies, should be obtained to facilitate
doing future genetic studies whether it is anticipated or
not just to allow the door to be opened. And that these
informed consent documents should be organized in a layered