How
do I develop consent forms and who reviews them?
Consent forms are the primary way to inform a research participant
about the details of your study. Once enrolled,
participants may refer to this document for facts about the
frequency of study visits, who to call for questions and
other study-related information. It is very important
that consent forms are easy to read, understandable and that
all technical language is explained and defined. Participants
must understand the potential risks and benefits, the difference
between standard care and investigational care, the concepts
of voluntariness and ability to withdraw consent at any time
during the study.
The Code of Federal Regulations (45
Part 46.116) provides guidance on general requirements
for a consent form. An Informed
Consent Checklist from OHRP clearly describes the basic
required elements and additional elements in consent forms. Most
IRBs will request that consent forms be written at a 6-8th
grade reading level. Microsoft Word has a readability
program which can be found under “Tools - Options”. But
more importantly, you may want to ask persons similar to
your study participants in age and educational level to
read the form, ask questions, and provide suggestions for
improvement.
Once your IRB has approved your study consent forms, you
must send the approved version to your Program Director. Please
forward the accompanying approval letter or the consent form
with the official IRB stamp and date. NHLBI has Guidelines
for Consent Forms in Multicenter Clinical Studies which
outlines content and format for consent forms that will be
used at multiple centers for a single protocol.
Your IRB may require that you include HIPAA Privacy Rule information in your consent form or that you create a separate form to explain this to research subjects. For more information see: What is HIPAA and how do I abide by the requirements?
Other resources to guide you in creating a good informed
consent document:
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