INFORMED CONSENT FORM
Study Title:
Appraisal of Ambient Sound Levels and Its Effect on Neonates in NICU Observational Study
Principal Investigator: ______________________________
Contact Information: _______________________________
Introduction:
This study is being conducted to understand how different sound levels in
the Neonatal Intensive Care Unit (NICU) affect newborns. Your
participation will help us improve the care and environment for future
neonates in the NICU.
Purpose of the Study:
The goal of this study is to observe and evaluate the impact of ambient
sound levels on neonates in the NICU. The aim is to identify any potential
effects on their health and well-being.
Procedures:
- Small, non-invasive sound monitors will be placed near your baby’s
incubator to measure ambient noise levels.
- Observations will be made regarding your baby's response to different
sound levels.
- No additional procedures or interventions will be performed on your baby
as part of this study.
Duration:
The study will take place over a period of ___weeks, during which sound
levels will be continuously monitored and your baby will be observed.
Risks and Benefits:
- “Risks:” This study involves minimal risk. The sound monitors are noninvasive and will not interfere with your baby's care.
- “Benefits:” There is no direct benefit to your baby; however, the
information gathered may help improve the care and environment for
future neonates in the NICU.
Confidentiality:
All information collected will be kept confidential. Your baby’s identity will
not be revealed in any reports or publications resulting from this study.
Voluntary Participation:
Your participation in this study is entirely voluntary. You can choose not to
participate or to withdraw from the study at any time without affecting your
baby’s care.
Contact Information:
If you have any questions or concerns about the study, please feel free to
contact ___________at___________________ or_________________.
Consent:By signing below, you acknowledge that you have read and
understood the information provided above. You consent to your baby’s
participation in this observational study.
“Parent/Guardian Name:”__________________________
“Signature:” _____________________________________
“Date:”_________________________________________
“Investigator Name:” ____________________________
“Signature:” _____________________________________
“Date:”_________________________________________
Thank you for considering participation in our study. Your support is
invaluable to us.