Frequently Asked Questions (FAQ)

 

 

How long will the study go for?

The longer the BIS continues the more valuable it becomes. The aim of the BIS is to develop new knowledge about how to give kids the best start to life. The initial consent covers until the end of your babies' first year of life, at which time you will be asked to provide a new consent - so as we can still see your child when they turn 2yr and again before they start school - the longer we follow the BIS babies the more we learn.

  

What are the major research questions?

There are a number of major areas that we are researching here at BIS.

BIS Immune and Allergy

The first major area of research is immune system development. BIS is seeking to learn more about how a babies’ environment effects the development of their immune system. The hypothesis is that a good diversity of microbes in the babies’ gut promotes healthy immune development. To find this out, BIS will be looking at faecal samples that have been collected and comparing the gut flora. This provides a good measure of what microbes babies have come into contact with. This information will be combined with analysis of white blood cells which will be isolated from babies’ blood samples; as well as data collected on chemical or environmental exposures. Together these findings may assist in understanding the development of allergic and other immune diseases. The BIS is also investigating correlations between vitamin D deficiency and food allergy, and maternal antenatal folate levels with asthma and allergic disease. 

 

BIS Respiratory

The second major area BIS is researching is the respiratory system, specifically, how babies’ lungs grow. When the BIS babies are four weeks old, families are invited to participate in an optional lung function test. These tests use tidal breathing washout of an inert gas during baby’s natural sleep as a means of assessing how well a baby’s lungs are working, and this in turn provides important information about how their lungs developed during pregnancy. The results of the lung function tests are correlated with information that has been gathered during pregnancy and will hopefully give BIS important information about how conditions like asthma develop.  

  

 

What happens to my records?

Data identifying you and your baby will be stored in a password protected computer file or in a locked filing cabinet in a lockable office at the Child Health Research Unit. If you give consent for you and your child’s questionnaire data to be used in other future ethically approved research projects, these will be securely stored in the BIS Cohort Database and at the BIS laboratory for an indefinite period. Any researcher(s) wishing to access data or specimens from these sources in the future must complete a comprehensive application detailing the proposed: research team, purpose and design of the study, and ethical considerations. This application will then be reviewed by the BIS Steering Committee. If it is approved at this level, it will then be submitted to the Human Research and Ethics Committee at Barwon Health.  

 

What  happens to the biological samples?

Biological samples (blood, urine, stool, and hair) taken from you or your baby are stored in a locked freezer facility at the BIS laboratory, Geelong Hospital. All samples have a unique ID number, and are not stored with any personal information. If you give consent for you and your child’s biological samples to be used in other future ethically approved research projects, these will be securely stored in the BIS Cohort Database and at the BIS laboratory for an indefinite period. Any researcher(s) wishing to access data or specimens from these sources in the future must complete a comprehensive application detailing the proposed: research team, purpose and design of the study, and ethical considerations. This application will then be reviewed by the BIS Steering Committee. If it is approved at this level, it will then be submitted to the Human Research and Ethics Committee at Barwon Health.  

 

The information collected about your baby will be used in publications in medical or scientific journals. You or your baby will not be referred to by name in any study report or publication and your/their identity will remain confidential. The data and specimens that are collected in the BIS may be used for a range of future projects. It is not possible for us to specify what these projects will be, because as scientific knowledge evolves, the important scientific questions change. Future projects that access data or specimens collected in the BIS will need to be approved by the BIS Steering Committee and the Hospital Research and Ethics Committee at Barwon Health. The confidentiality of you and your baby’s medical records and data collected during the BIS will be maintained to the extent permitted by applicable laws.

 

The data and specimens that are collected in the BIS may be used for a range of future projects. It is not possible for us to specify what these projects will be, because as scientific knowledge evolves, the important scientific questions change. Future projects that access data or specimens collected in the BIS will need to be approved by the BIS Steering Committee and the Hospital Research and Ethics Committee at Barwon Health. The confidentiality of you and your baby’s medical records and data collected during the BIS will be maintained to the extent permitted by applicable laws.
 

What happens if I change my mind?

Taking part in the BIS is completely voluntary. However, you don’t have to drop out of the study completely. If you are finding any aspect of the study challenging, please call a member of the BIS team (Mobile 0400 432976, Office 03 4215 3384) and we will try and accommodate your needs as best we can. If, however you do decide to withdraw from the study completely, please call us and we will gladly assist you.  

 

Feedback of results

During the course of the BIS, the information collected will be analysed and reports of the findings will be prepared. The results may also be published in an appropriate medical journal. Periodically we will send you a letter summarising the study’s main findings, although individual results will not be given. Should you have any further questions about results, we would be happy to discuss these with you by telephone or by correspondence.

 

 

 

BIS Cardiovascular

The third major area BIS is researching is the early life origins of cardiovascular diseases, like heart attacks and stroke. Cardiovascular disease is one of Australia’s biggest health issues, with over 3.5 million Australians affected. Parents are invited to participate in an ultrasound of their baby’s aorta (a large blood vessel) at the four week clinic visit. Even though CVD is considered to be an adult disease, there is evidence that it starts to develop in infancy and BIS hopes to investigate early life factors that may influence CVD developing later in life.
 

 

BIS Neurodevelopment

There has been an increase in behavioural and developmental problems among children over recent decades. The environmental factors contributing to this are unknown, however there is considerable concern regarding the role of modern environmental chemical exposures. The objective of BIS Neurodevelopment is to assess the prospective association between early life exposure to a panel of potential neurotoxicants, and deficits in attention, inhibition, short-term memory and general development during the first years of life.