University of Xxxxxxxxxxx

RESEARCH suBject

Informed ASSENT Form FOR MINORS

+------------------+---------------------------------------------------+
| **Protocol       | ##### International                               |
| Title:**         |  Myositis Classification Criteria Project (IMCCP) |
+------------------+---------------------------------------------------+
| **Principal      | xxxxxxxx                                          |
| Investigator:**  |                                                   |
+------------------+---------------------------------------------------+
| **Emergency      | Xxxxx                                             |
| Contact: xxxxx** |                                                   |
+------------------+---------------------------------------------------+

# Why am I being asked to volunteer?

You are being invited to participate in a research study to learn more
about myositis, a rare muscle inflammatory condition, and how we can
diagnose this condition better. You are being asked to participate since
you have dermatomyositis, polymyositis, or another form of myositis, or
you have an illness that mimics myositis. You meet the requirements for
this study and thus are being asked to volunteer for enrollment. Your
participation is voluntary which means you can choose whether or not you
want to participate. This study may not help you directly, but by
participating in the study, others with similar problems may be helped.

# What is the purpose of this research study?

The purpose of this research study is to develop ways of diagnosing
patients with myositis.

# 

# How long will I be in the study? How many other people will be in the study?

You will be asked to participate in this study one time. If you agree to
participate, your doctors will conduct a review of your medical records
and collect information about the clinical features of your illness,
blood laboratory test results, imaging results, heart and lung test
results, EMG results, and muscle or skin biopsy results. You will not be
asked to do any additional testing; your doctors and their research
assistants will only review your medical record containing the results
of the testing you have previously undergone and use this information
for the research study.

# What am I being asked to do?

We would ask that you permit us to review your medical records at the
Hospital of the University of Xxxxxxxxxxx to better understand the
specifics of your illness, as outlined above. We may also ask for
written consent to contact your other health care practitioners to
discuss this study with them and to obtain more extensive medical
records than what is now contained in your chart at the Clinics of the
Departments of xxxxxx (Dermatology and Rheumatology).

# What are the possible risks or discomforts? 

There are no health risks associated with the study, since you are not
participating in any new tests.

# What if new information becomes available about the study?

During the course of this study, we may find more information that could
be important to you. This includes information that, once learned, might
cause you to change your mind about being in the study. We will notify
you as soon as possible if such information becomes available.

# What are the possible benefits of the study? 

[]{.mark}

Given the relative rarity of myositis, there is a general lack of
knowledge about the best ways to diagnose these conditions. This study
may not help you directly, but by participating in the study, others
with similar problems may be helped.

# What other choices do I have if I do not participate? 

The alternative for this study is not to participate. There is no known
real risk in not participating.

# 

# Will I be paid for being in this study?

There are no payments being offered for participation in this study.
There will be no costs to participate in this study.

# 

I have had this study explained to me in a way that I understand, and I
have had the chance to ask questions. I agree to take part in this
study.

Signature of Minor Patient: Date:

Signature of Investigator: Date: