We invite you or your child to participate in a research study, the Tiniest Babies Registry, which is a web-based listing of the world's smallest surviving babies. The purpose of this study is to compile a listing of individuals who were born weighing less than 400 grams (14.1 ounces) and survived to go home from the hospital, and to provide some basic information about the health issues they faced, both in the hospital and after discharge.
We invite you or your child to be in this study if you or your child weighed less than 400 grams at birth and survived to discharged home from the hospital. We assume you are reading this because you have found the Tiniest Babies Registry on the internet or were directed to the website by one of your child’s health care providers. The number of persons eligible to be listed in the Tiniest Babies Registry is quite small. As of April 2011, only 118 persons were listed. These individuals come from all over the world, although the majority were born in the U.S.
If you agree to participate, or agree for your child to participate, and are submitting new information to the Tiniest Babies Registry, we invite you to submit the information requested on the form found on the Registry website. No other relative except the parent or legal guardian should enter a child’s information. With your permission, your child’s doctor may enter the information into the Registry database. If you or your child was submitted by someone else, it is your choice to keep the listing or have it removed from the Tiniest Babies Registry website.
If you or your child is already listed in the Registry and you wish to have the listing remain there, we invite you to review the information listed for you or your child and to send any corrections or additions to Dr. Edward Bell (Department of Pediatrics, University of Iowa, 200 Hawkins Drive, Iowa City, IA 52242; edward-bell@uiowa.edu). We also invite you to send us updates from time to time. Updated information can be submitted directly through the Registry website or by e-mail to Dr. Bell at the e-mail address shown above.
If you or your child is listed in the Registry and you wish to have the listing removed, please let us know this by contacting Dr. Bell (Department of Pediatrics, University of Iowa, 200 Hawkins Drive, Iowa City, IA 52242; 319-356-4006; edward-bell@uiowa.edu), and we will remove the information about you or your child from the website. If you wish us to keep the listing but remove certain items or links to other websites, please let Dr. Bell know and we will honor your wishes.
If you provide your name and contact information, we will keep these in our confidential and secure files so that we can contact you if we need further information. We will not list your or your child's name or contact information on the website, and we will not provide your contact information to anyone else without your permission. You may submit photos of your child (or yourself if you were the "tiniest baby") to be included with the information provided about your child (or yourself). If you submit a photo, we will still protect your privacy by not listing your name.
There are no known risks from being listed in the Tiniest Babies Registry except the small risk of loss of confidentiality. There is also no direct benefit to you or your child from participating.
You will not have any costs for being listed in the Registry, and you or your child will not be paid for your participation.
Taking part in this research study is completely voluntary. If you decide not to be in this study or decide for your child not to participate, or if you decide for you or your child to stop participating at any time, you or your child will not be penalized or lose any benefits for which you otherwise qualify.
If you have any questions about the research study itself, please contact Dr. Edward Bell (Department of Pediatrics, University of Iowa, 200 Hawkins Drive, Iowa City, IA 52242; 319-356-4006; edward-bell@uiowa.edu). If you have questions about the rights of research subjects, please contact the University of Iowa Human Subjects Office (105 Hardin Library for the Health Sciences, 600 Newton Road, University of Iowa, Iowa City, IA 52242-1098; 319- 335-6564; irb@uiowa.edu). To offer input about your experiences as a research subject or to speak to someone other than the research staff, call the Human Subjects Office at the number above.
Thank you very much for your consideration. If someone else placed you or your child in the Registry already and we do not hear otherwise from you, the lack of response will be taken to indicate your willingness to have yourself or your child continue to be listed in the Tiniest Babies Registry.
Thank you very much for your interest in the Tiniest Babies Registry.
Sincerely,
Edward F. Bell, M.D.
Professor of Pediatrics
University of Iowa