Consent
Statement Example
ILMA
STUDY RESEARCH SUBJECT INFORMATION
Dr. ____________ is doing a study to learn whether or not using an Eschmann bougie through an ILMA
is both easier and faster to use than the standard intubation
with the ILMA. You are invited to
participate in this study because you are an emergency care provider.
If you agree to participate, you will first receive a short hands-on
educational session about how to use the ILMA.
We will conduct this study on a mannequin. Next you will attempt four intubation trials.
During each intubation trial, the ILMA will
already be placed inside the mannequin.
Two of the trials will use the gum bougie in
support of ILMA and two will use the standard intubation
method with the ILMA. For each intubation trial, two separate timers will record these
time intervals using a stopwatch.
You will be asked to fill out a pre and post trial questionnaire to
determine the perceived difference in ease of use between the two techniques. The study will be done on one day and should
take about ___________ of your time.
The risks of participating in this study relate to
confidentiality. We will keep all of the study information we
receive from your testing and questionnaires confidential. Information from this study will be kept
locked in a safe place during the study.
Once all the information is analyzed we will destroy any information
that could identify you.
You may experience some benefit by
learning to use the gum bougie in support of ILMA.
We hope to learn whether the results of this study will suggest that
future emergency personnel be trained in the use of gum bougie
in support of ILMA.
Any information collected as part of this study that can be identified
with you will be kept confidential. We
will code the questionnaires so that we can see each individual’s responses to
the pre and post questionnaire.
If you have any questions, please ask them now. If you have any additional questions later,
you may reach Dr. _____________________ at 651-254-_______.
Your participation in research is voluntary. You have the right to refuse to participate
or to later withdraw from the study without affecting your employment, your
grades, etc.
Consent is implied if you perform the testing and
complete the questionnaires. You will be
given a copy of this information form to keep.