INFORMATION SHEET FOR NEWBORN SCREENING
Introduction:
You are being invited to participate in a research study. It is important that you should understand why the research is being conducted and what is involved in it, before you decide to participate. Please take as much time as you need to read the following information carefully and if you wish, discuss about it with your friends and relatives. If there are words that are difficult for you to understand, please ask the study doctor or study nurse who are attending to you.
Do We Have to Participate ?
You should understand that your participation in this study is absolutely voluntary. You will not get any money to participate, nor do you have to spend any money for this study. You have the freedom to decide whether you want to participate in this study or not.
If you decide not to participate, you will be given the standard treatments determined by your doctor. This decision will not in any way affect your treatment or your relationship with your doctor.
If you decide to participate, and later wish to withdraw from the study, you can withdraw at any time without affecting the normal treatment and quality of medical care you will be receiving.
Purpose of newborn screening program? (Objective of the study)
The purpose is to test newborn babies for 2 genetic conditions namely, hypothyroidism (deficiency of thyroid hormone), and Congenital Adrenal Hyperplasia (patients can present with intersex disorders and life threatening illness) for which early diagnosis and treatment prevents illness or mental retardation caused by the disorder. The research will help scientists to understand how common are these disorders in the country and how can we plan to prevent them. The study is being funded by the Indian Council of Medical Research, New Delhi.
What is the chance that my baby will have any of these disorders?
The chances are very small as these are very rare diseases. However if the disorder is picked up early, treatment can prevent disability.
Procedures
Small amount of blood / will be collected by heel prick on filter papers as blood spots. When blood as collected from heel prick (on Day 2 or 3 of life), this can cause mild discomfort. About 4-5 drops of blood of your baby will be collected on filter paper. In addition some information will also be collected from you like details of your address, family history and some medical details. These will be recorded in a form. The samples on the filter paper will be sent to a lab for carrying out tests to screen for 2 genetic conditions. The results will reach your doctor within two weeks and will be communicated to you. In case of any abnormal values of the tests or test failure you may be asked to come again for re-testing for confirmation.
Sites of the Study
This study is being done at 6 sites in the country- Delhi, Mumbai, Hyderabad, Kochi, Kolkata and Bangalore.
v) Number of children being tested
In a period of two years screening of 1 lakh newborn babies will be done at 6 centres in the country.
Expected duration of participation
This will be a one time collection of sample. In a few cases you may be asked to come again for a repeat test within 2 weeks after the birth of your baby. Results of the tests would be available within 1-2 weeks.
Benefits of this research
The primary aim of this research is to detect some of the disorders which can cause mental retardation and other serious problems in children. In an affected child early diagnosis will be very useful in prevention and treatment of the condition. So the primary benefit will be early diagnosis and timely institution of treatment. This research would also help scientists to understand the burden of disease in different parts of the country. The information would be useful to the Government for planning future strategies for tackling these diseases.
Risk of this research
There is no risk to your baby if you participate in this study. There will only be a slight discomfort/pain when blood sample is collected from your baby.
Confidentiality of records.
Your baby will be assigned a number and all information and results will be kept confidential. A clinical photograph may be taken for academic purpose in case the baby is found to be affected with an inborn metabolic disorder.
Storage of Samples for future Research
Your babies samples will be stored for a period of 20 years with the study doctor. After completion of 20 years, either the samples would be discarded or would be anonymised (your baby’s name/address would be removed) and samples will be given to the National Repository for future storage and research. In case you do not want the samples to be stored for future research , it is your right to refuse that now. In case there are plans to use the samples for another research study, the investigators would obtain necessary permission from the Institutional Ethics committee and from the Indian Council of Medical Research. In case such a study is approved you shall be re-contacted to ask for your permission. However you have a right to refuse if you do not want to be re-contacted for any future research.
You may check on any the following options:
a) I agree that my sample may be used for any future research without my permission
b) I agree for the sample to be used for future research if anonymised and permitted by Ethics committee and ICMR
c) I agree for the sample to be used for future research on Inborn Metabolic Disorders only without a need to take permission from me again
d) I agree for the sample to be used for future research but I may be re-contacted for my permission again
e) I want to be contacted for future research study and also to know study results.
f) I do not want the samples to be used for any future research
Treatment and Management
If your baby is found to be positive, another 2-3 tests will be done to confirm the diagnosis with no cost to you. Once the diagnosis is confirmed, you will be adequately explained and counseled by the researchers about management and treatment of the diseased and the treatment costs will be borne by the family.
Freedom to withdraw from research at any time
You are free to decide if you want to participate or not. Even if you decide to participate you can withdraw at any time without any penalty or loss of benefits to which you are otherwise entitled.
Whom to contact for further information
In case of any questions or doubts or difficulties you may contact your study doctor
Name ______________________
Address ______________________
Tel No ______________________
Email ______________________
In case of any complaints/ difficulties/ questions about your rights you may contact
1. Dr Vasantha Muthuswamy
Chairman Institutional Ethics Committee
Scientist E, Head, Division of BMS,
Indian Council of Medical Research, New Delhi- 110029
Tel No: 91-11-26589791
2. Dr Name ______________________
Tel.No ______________________
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