Consent

Survey consent and patient questionnaire, in person
Study of long-term impact of RMSF
Flesch-Kincad (grade level 5.2)

Date of Interview _____________________

Our records show that you/your child had RMSF in (mm/yyyy).
We are members of the tribal health department, working with the Centers for Disease Control and Prevention
to conduct a study looking at the long-term effects of Rocky Mountain spotted fever with a special focus on
nervous system problems. We would like to ask you a few questions about you (your child’s) Rocky Mountain
spotted fever illness. Your answers will help us better understand how people are impacted by Rocky Mountain
spotted fever years later. The questions should take about 10 minutes to complete. You do not have to
participate in the study. You can stop answering questions at any time, and your decision to do so will not affect
any care you normally receive. All information will remain private. Only study staff will have access to your
responses. If we identify that you have nervous system problems, we may ask you to take part in an additional
medical exam to research these issues more closely.
I have been told about the study. I have been allowed to ask questions. I had all of my questions answered. I
would like to be in the study. By signing this form, I agree to be in the study.
Participant’s signature: ____________________________ DATE: _________________

NAME (print):________________________________________

Survey consent and patient questionnaire, telephone
Study of long-term impact of RMSF
Flesch-Kincad (grade level 5.2)

Date of Interview _____________________

Our records show that you/your child had RMSF in (mm/yyyy).
We are members of the tribal health department, working with the Centers for Disease Control and Prevention
to conduct a study looking at the long-term effects of Rocky Mountain spotted fever with a special focus on
nervous system problems. We would like to ask you a few questions about you (your child’s) Rocky Mountain
spotted fever illness. Your answers will help us better understand how people are impacted by Rocky Mountain
spotted fever years later. The questions should take about 10 minutes to complete. You do not have to
participate in the study. You can stop answering questions at any time, and your decision to do so will not affect
any care you normally receive. All information will remain private. Only study staff will have access to your
responses. If we identify that you have nervous system problems, we may ask you to take part in an additional
medical exam to research these issues more closely.
Would it be alright if I asked you a few questions about your illness, and your subsequent recovery?
Yes

/

No

--If yes, proceed
--If no, ask if there is a better time to contact them.
--If they refuse, state, “Thank you for your time. We hope that you have experienced recovery from
your illness. If you change your mind, you can reach me at (phone number)”.

Verbal consent/permission obtained from

______________________________

Date _______________

Verbal consent/permission obtained by

______________________________

Date _______________

Neurological exam consent
Consent/Permission for physical exam
Flesch-Kincaid (Grade 8.1)
TITLE: Study of long-term impact of RMSF
PRINCIPAL INVESTIGATOR (PI): Naomi Drexler, MPH
DATE: __________

PARTICIPANT’S NAME: ____________________________

We are with the: local tribal healthcare facility/Indian Health Service /Centers for Disease Control and
Prevention (note: PI will select provider agency) and are conducting a research study on the long term affects
Rocky Mountain spotted fever has on the nervous system. You (or your child) have been invited to take part in
this study because you (or your child) had Rocky Mountain spotted fever (RMSF). We would like to see how this
illness has affected your (or your child’s) health.

I. Purpose of investigation
The purpose of this investigation is to learn if and how often RMSF causes neurologic damage.

II. Your rights



You do not have to participate in this study.
You (or your child) may decide not to take part or to quit the study at any time without any penalty.

III. Procedures
We will do a physical exam to test your (your child’s) alertness, strength, sensation, reflexes, and
coordination. This will be done by having you (your child) answer questions, having you (your child)
follow commands and show your (your child’s) strength; we will test your reflexes by touching your
(your child’s) skin and gently tapping your (your child’s) muscles with a reflex hammer. The exam should
take about 30 minutes.

IV. Risks and Benefits
1. BENEFITS: You may benefit by having the results of your exam shared with you and your medical
providers. Also, by taking part, you (or your child) will help us improve understanding and treatment of
RMSF in Arizona.
2. RISKS: Only study staff will have access to your (or your child’s) personal information. However, since
we are keeping this information, there is a small risk that your (or your child’s) identity could be
revealed. There may also be some slight discomfort with strength or reflex testing. However, this is rare,
and the exam would be stopped if you asked.

V. Compensation
A $10 gift card will be given to those who participate in the physical exam. But otherwise you will not be paid to
participate in the study.
VI. Costs
There should be no costs to you (or your child) for being part of this study.

VII. Confidentiality
Your (or your child’s) study records will be kept private to the best of our ability. The study records and answer
sheets will contain information on your name and date of birth. However, this information is kept in a locked,
secured space. No one other than the study staff will have access to this material. We will use this information
only to contact you about the study. Your (or your child’s) name will not be used in any reports or articles that
are written about the results of this study.

VII. Questions
Please feel free to ask any questions you may have about the study. If you have other questions later, you may
contact Naomi Drexler, (404) 718-4669 or Paige Armstrong (404) 639-8450 with the Centers for Disease Control
and Prevention or __________________________________ at your tribal health facility.

The purpose and procedures of this study have been explained to me. I have been told about all of the potential
risks that might result. I agree to participate (or for my child to participate) in this investigation. I have been
told that this is voluntary, and I may end my (my child’s) participation at any time. I give consent (permission)
for the following:

О Yes

О No

Neurologic examination

О Yes

О No

I would like any and all results relayed directly to
my (my child’s) physician.

Participant’s signature: ____________________________ DATE: _________________

NAME (print):________________________________________

Name of Primary/Personal Physician: ____________________________________
Contact information for Primary Physician: ________________________________
___________________________________________________________________
___________________________________________________________________

Signature of investigator providing consent: ___________________________ Date: ___________

Neurological exam assent
Child assent for examination (for children 8 years or older)
(Flesch-Kinkade Grade Level 6.0)

TITLE: Study of long-term impact of RMSF
PRINCIPAL INVESTIGATOR (PI): Naomi Drexler, MPH DATE: __________

PARTICIPANT’S NAME: ____________________________

We are with the: local tribal healthcare facility/Indian Health Service /Centers for Disease Control and
Prevention (note: PI will select provider agency) and are doing a study about Rocky Mountain spotted fever
(RMSF). This study looks back at people who had Rocky Mountain spotted fever in the past, to see if they are
having any problems since their illness. This study will help us better understand the disease and how it could
affect people in your community. You can say you don’t want to participate for any reason and at any time. If
you decide that you want to be part of this study, you will be asked to take part in an exam by a doctor or nurse.
In the exam we will ask you to show how strong you are, check your reflexes, and see how you walk, among
other things. We expect the exam to take about 30 minutes.

There might be some slight discomfort with the exam. But if that happens, just tell us, and we will stop. There
are no needles or shots involved in this exam.

You might benefit from knowing the results of your exam. A benefit means that something good happens to
you.

When we are finished with this study, we share with you and your parents what we have learned and the results
will be included in a summary of all persons in the study. This report will not include your name.

You do not have to be in this study if you do not want to be. If you decide to stop after we begin, that’s okay too.
Your parents know about the study and can be present if you want during the exam.

If you decide you want to be in this study, please tell the investigator your name, and that you agree to
participate.

NAME (print):________________________________________

Age: ______ (years)

( ) Assent provided
( ) Assent not provided

Signature of investigator providing consent: ___________________________ Date: ___________