Download A Multidisciplinary Approach to the Treatment of Pediatric Patients

A Multidisciplinary Approach to the Treatment of Pediatric Patients with Cystic Fibrosis:
Scheduling Patients’ Treatments and Daily Activities
Arkansas Children’s Hospital
Consent Form
You and your child are being asked to participate in a research study being conducted with
patients with cystic fibrosis at Arkansas Children’s Hospital.
The purpose of this study is to find out if putting patients on a daily activity schedule will
increase compliance with medical treatments and other aspects of care. The study will also
evaluate whether following a daily activity schedule helps patients and families better prepare for
treatments, medications, therapy, or other activities because they know what to expect next.
The benefits of this study include: 1) the provision of consistency in expectations for patients
families, and staff allowing them to know what to expect next and what is expected of them,
which may help to increase patient compliance with treatments and therapy; 2) providing some
control for the patient while hospitalized, as the patient will participate in the creation of the
daily activity schedule, with some activities being negotiable between patient and staff; and
3) the use of a schedule may also help the staff in their ability to work with the patients in the
study without scheduling conflicts with other staff members. There are no foreseeable risks
involved in participating in this research study.
This study will involve patients with cystic fibrosis who are between the ages of 8 and 16. The
number of participants will vary depending on the number of eligible patients admitted to the
hospital during the study period.
Confidentiality of you as the respondent and your responses will be protected throughout the
course of the study and publication, with the one exception being that your responses and records
may be reviewed by the University of Arkansas for Medical Sciences Human Research Advisory
Committee.
Your participation in this research study is completely voluntary and you can decline to
participate at any time. Following parental or legal guardian consent, your participation and
assent in this study remains voluntary and you can refrain from answering any or all questions
without penalty or explanation. You can, at any time during your enrollment in the study,
withdraw your participation without penalty or affecting the care that you receive while a patient
at Arkansas Children’s Hospital. Any significant new findings that are developed during the
course of the study that may relate to your willingness to continue participating in the study will
be provided to you. In addition, your participation in the study may be terminated at the
discretion of the investigator without your consent. If you decline to participate in the study, you
will receive the same standard of care at Arkansas Children’s Hospital as study participants,
without the formal scheduling of daily activities.
The length of your participation in the study will depend on the length of your hospital stay.
Your initial participation will involve completing a 5-question incomplete story task, where you
and your parent will, individually, be asked to complete the story in your own words. A voice
recording will be made of your answers to this task. You will then be asked to work with the
investigator to develop a daily activity schedule, which you will follow throughout your hospital
stay. There will be no activity added to this schedule that you would not already be expected to
do during your hospitalization. At the conclusion of your hospital stay, you and your parent will
be asked to complete a short survey about your participation in the study.
There will be no monetary or other compensation for participation in this research study. By
signing this form you, in no way, waive any legal rights to which you are already entitled. You
and/or your parents will not incur any additional costs for treatment at Arkansas Children’s
Hospital related to your participation in this research study.
If you have any questions or comments concerning this research study the primary investigator,
Nikki Orkoskey, can be reached 24 hours a day by paging 0729 on the Arkansas Children’s
Hospital paging system. If you have any questions about your rights as a research subject, you
can call the Human Research Advisory Committee representative at phone number (501) 6865667. This study was also approved by the University of Akron Institutional Review Board for
the Protection of Human Subjects. Questions or comments can also be directed to Dr. Gerry
Parker, Director, at the University of Akron Institutional Review Board by phone at (330) 9726764 or by mail at Office of Research Services and Sponsored Programs, The University of
Akron, Akron, OH 44325-2102.
I have read the above statement and have been able to ask questions and express concerns, which
have been satisfactorily responded to by the investigator. I understand the purpose of the study
as well as the potential benefits and risks that are involved. I hereby give my informed and free
consent to be a participant in this study. I have been given a copy of this consent form.
I (We) consent to this study and allow my (our) child’s participation:
Parent or Legal Guardian
Principal Investigator
Date
Date
Parent or Legal Guardian
Date
Witness
Date
I understand what I am being asked to do by agreeing to participate in this research study and I
understand that because my parent/legal guardian signed the form above does not mean I have to
participate in this study. I understand that by signing the form below I am agreeing to participate
in this research study.
Assent provided via my signature:
Participant
Date