Project Title: Infant Sleep Questionnaire
Principal Investigator: Mark S. Blumberg, PhD
Research Team Contact: Greta Sokoloff, tel. 319-335-3975; email email@example.com
We invite you to participate in a research study. The purpose of this study is to learn about sleep-related movements, or twitches, that normally occur in children across early development. Specifically, we are interested in the fine movements, or twitches, that occur during rapid eye movement (REM) sleep. In the process of studying these sleep behaviors in the lab we have become interested in collecting survey data from parents about their infants' sleep and changes they observe during development. Ultimately, we hope to develop tools to track and predict developmental trajectories with the ultimate aim of detecting neurodevelopmental disorders much earlier than possible using standard clinical assessments.
If you agree to your child's participation, we will ask you to complete the questionnaire providing information about your child's sleep as well as general questions about birth date, gender, etc. The survey takes approximately 10 minutes to complete. After you submit your survey a unique identifier is saved with your email address so we can send a brief follow-up survey after about one month. We will continue to send the follow-up survey at one-month intervals until you stop completing it, at which point we will stop contacting you.
All survey data about your child are confidential and are secured on a password-protected server maintained at the University of Iowa. Your survey data will be assigned an ID code that will keep the content separate from your email address. However, federal government regulatory agencies, auditing departments at the University of Iowa, and the University's Institutional Review Board may inspect and copy records pertaining to this research. If we write a report about this study we will do so in such a way that your child cannot be identified.
Only research team members will have access to questionnaire data, which will be kept in a password-protected database. We will retain your email for the follow-up questionnaire but will delete your email from our records when you stop participating. There are no known risks from participating in this study. Your child will not benefit personally from being in this study. However, we anticipate that the information you provide will teach us a lot about the relationship between sleep and human development.
Taking part in this questionnaire is completely voluntary. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify. No information is saved unless the submit button is pushed.
If you have any questions about the survey itself or if you wish to report a research-related injury related to participation in this project, please contact Dr. Mark Blumberg at 319-335-2424. If you have any questions about the rights of research subjects, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Road, The University of Iowa, Iowa City, IA 52242-1098, 319-335-6564, or e-mail firstname.lastname@example.org. If at any time you want us to remove your email from the database, please email email@example.com.