Coming soon, stay tuned…
The participant centered consent (PCC) toolkit is just about ready for
its first release next month at Sage
Bionetworks.
The goal of the PCC toolkit is to transform the concept of consent from
a signature on a legal form to a process that engages participants, and
to allow as many people as possible to engage in consented studies.
We’ll be providing several elements in the toolkit.
-
a visual dictionary for informed consent - icons that
represent the ways that data might be gathered or used;
-
workflows for visual informed consent - a set of designs and
patterns that can map an informed consent document to the visual
dictionary, for use in various consent interactions;
-
sample clinical documents - a template informed consent form
and instances of toolkit as implemented in a successful IRB filing for
an observational clinical study;
-
implementation support - step by step instructions on how to
use the toolkit, a sample piece of workflow softare, detailed FAQs,
and more.
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The PCC toolkit will be licensed to the commons and will be usable in
any context, by any user, for any purpose, as long as attribution is
provided back to Sage Bionetworks. The
EDM Forum was a
key supporter of the toolkit, and essential to its development.
More to come. We’re excited. You can check out
a
recent presentation to see an example of the toolkit in action - start
on slide 21.