Consent

PERMISSION TO PARTICIPATE IN RESEARCH
The University of Mississippi Medical Center
Title: Parasite infections in children living in Mississippi
Principal Investigator: Charlotte V. Hobbs, MD
_____________________________________________________
Introduction
Your child is being invited to be in a research study, because your child
lives in Mississippi and we think parasite infections (“germs”) might be
common there. Please ask us about anything in this document or that we
tell you that you do not understand.

Purpose
We are doing this study to see if these types of infections are a problem in
children living in Mississippi. If they are a problem we want to know how
many children are affected and if parasite infections are associated with
other infections, anemia (low blood counts), poor growth, or asthma
symptoms.

Procedures
If you and your child agree for your child to participate in this study:
We will collect your child’s measurements for height, weight, hemoglobin
(blood count) and lead from your child’s health records. A drop of your
child’s blood will be obtained by study doctors or nurses by finger prick and
applied to a special filter paper and used for immune system (infection
fighting) tests later.
We will ask you/your child or your doctor or nurse a few questions about
your child’s health, including whether or not he/she has or has had asthma
symptoms, and about possible exposures your child may have had to put
him/her at increased risk for parasite infections (like if you have a dog or
cat at home).
We will ask you to collect your child’s stool in a special container THREE
TIMES and return it to the clinic or another UMMC site..
University of Mississippi Medical Center
FWA00003630

Protocol: 2016-0111
Approved: 06/07/2019
Expires: 05/19/2020

If we find out your child is infected with worms, your child will be referred to
a local primary care physician or a UMMC clinic for proper treatment.whichever you choose.

Risks
Pain from getting his/her finger pricked (pain, bruising, or bleeding at the
place where the needle goes into the skin). There is also a small risk of
inflammation or infection, but this risk is minimized by our use of alcohol to
clean the area before the finger prick and a sterile gauze to apply pressure
afterwards.
Embarrassment about returning stool sample to clinic (which we will
minimize by a private drop-off spot) or infection risk from carrying stool. To
minimize this, study personnel will explain how to do this and recommend
hand washing.

Benefits
Your child will not receive a direct benefit from being in this research study.
If your child is infected, he/she will be referred for treatment.
We also hope to learn information that may help others in the future.

Alternatives
The alternative is not to participate in this study.

Costs
There will not be additional costs to you if your child participates in this
study.

Research-related injury
In the case of injury or illness resulting from your child’s participation in this
study, medical treatment is available to your child at the University of
Mississippi Medical Center. You will be charged the usual and customary
charges for any such treatment your child receives.

Compensation

University of Mississippi Medical Center
FWA00003630

Protocol: 2016-0111
Approved: 06/07/2019
Expires: 05/19/2020

For your time and inconvenience, you will receive a gift card for $40.00 at
time of enrollment then a $20.00 gift card for each stool sample ($100.00
total if you return all 3 stool samples to us).

Voluntary Participation
Your child’s participation is voluntary. If you decide not to allow your child
to participate in this study your child will not suffer a penalty or loss of
benefits to which your child is otherwise entitled.

Withdrawal
You may choose to stop your child’s participation in this study at any time.
If you decide to withdraw your child the information already collected about
your child may still be used in this study but additional information will not
be collected. Your decision to stop your child’s participation will have no
effect on the quality of medical care your child receives at the University of
Mississippi Medical Center.

Confidentiality
Every effort will be made to keep the information we learn about your child
private. Study personnel, the Food and Drug Administration (FDA), the
Office for Human Research Protections (OHRP), and the University of
Mississippi Medical Center’s Institutional Review Board (IRB) and Office of
Integrity and Compliance and Grants and Contracts may review the study
records. If study results are published your child’s name will not be used.

Protected Health Information
Protected health information is any personal health information through
which your child can be identified. The information collected in this study
includes: Your child’s name, date of birth and parent’s phone number. By
signing this permission document, you authorize Dr. Hobbs and her study
staff to collect this information and use your child’s records as necessary
for this study. Dr. Hobbs will use your child’s information (elements of
medical history, height, weight, hemoglobin count, lead level) for this
study.
The information collected for this study will be kept for 6 years after the
study is complete and may be combined with information collected through
other research studies or used in other studies but no information will
identify your child.
University of Mississippi Medical Center
FWA00003630

Protocol: 2016-0111
Approved: 06/07/2019
Expires: 05/19/2020

Your child’s medical information and records, once disclosed, may be redisclosed and may no longer be protected by the Privacy Standards of the
Health Insurance Portability and Accountability Act (HIPAA), which is a
federal regulation designed to protect medical information, including
medical information and records created through research.
You have the right to cancel this authorization at any time by providing Dr.
Hobbs with a written request to cancel the authorization. If you cancel this
authorization medical information and records about your child that were
created before the authorization was cancelled will still be used and
disclosed as needed to preserve the integrity of the study.
This authorization has no expiration date. If you do not sign this
permission document, your child will not be allowed to participate in this
study.
Number of Participants
We expect up to 2000 participants to enroll in this study.
Questions

If you have questions about this study or need to report any problems, side
effects, or injuries, please call Charlotte Hobbs, MD at 601-984-5361. After
hours and on weekends please call 601-984-1001 and ask for the doctor
on call for Pediatric Infectious Diseases.
You may discuss your child’s rights as a research participant with the
Chairman of the University of Mississippi Medical Center’s Institutional
Review Board, 2500 North State Street, Jackson, Mississippi 39216;
telephone, 601 984-2815; facsimile, 601 984-2961. The Institutional
Review Board is a group of people not involved with this study who have
reviewed the study to protect your child’s rights.
You will be given a copy of this permission document after it has been
signed.

University of Mississippi Medical Center
FWA00003630

Protocol: 2016-0111
Approved: 06/07/2019
Expires: 05/19/2020

Statement of Participation
I have been told about this study and the possible risks and benefits. My
child’s participation is voluntary and I may withdraw my child at any time
without any penalty or loss of benefits to which my child is entitled,
including medical care at the University of Mississippi Medical Center.
By signing this form I am not giving up any legal rights my child may have.
__________________________________________________
Participant’s Printed Name
______________________________________________________________
Printed Name of Parent or Legally Authorized Representative and relationship to
participant
______________________________________________
Signature of Parent or Legally Authorized Representative
___________________________________
Date

__________________________________________
Printed Name of Person Obtaining Consent
__________________________________________
Signature of Person Obtaining Consent
________________________________
Date
I acknowledge that the participant identified above has been entered into this
study, with properly obtained permission.
________________________________
Signature of Investigator
________________________________
Date

University of Mississippi Medical Center
FWA00003630

Protocol: 2016-0111
Approved: 06/07/2019
Expires: 05/19/2020