What is involved in participating in a clinical research trial?
In short, participating in a trial differs from one study to the next. Some may require many visits and some only one. If you would like to know what is involved in each trial, please contact the GRC to advise you on the participation process. The following information relates to genetic research studies at the GRC.
Will giving a blood sample hurt?
Everyone’s pain tolerance is different, it will hurt no more than having blood collected for any regular pathology test.
What risks are involved in giving a blood sample?
As with any normal pathology sampling technique (collection method) you may experience a little stiffness or you may bruise slightly.
How do I know that my medical information is safe and not passed on to a third party?
The Genomics Research Centre is governed by a very strict code of ethics which is monitored by QUT Human Research Ethics Committee (HREC). All of our research projects and every part of the project from the consent forms, questionnaires, labeling, storage of information and samples must be approved by and is monitored by the QUT HREC. We also abide by the Australian NHMRC, and the ICCAP and Good Clinical Practice. It is against all these codes of practice to share personal identifying information with other parties. One of the conditions that we are given permission to conduct research at QUT by the HREC is that we deidentify all information and blood samples when they arrive at the Centre.
I don’t have any of the conditions that you are studying. Can I still be of any help?
Yes. With most studies that we do, we also do what is called a comparison study. This is when we compare the results between affected and non-affected people that we call controls.
What is a control?
A control is a person that has volunteered to participate in our research that is known not to be affected by the condition being studied and also no family history of the condition. Their results are compared to people affected by a disease.
Will I get any results?
No. As we are investigating the genes involved in a particular disease, we rely on the information from many hundreds of people to give a statistically significant result. Therefore we are unable to give individual results. Only once a diagnostic test has been developed and a person is specifically tested for that gene can individual results be determined.
Can you tell me what my blood group is?
No. Your sample will only be used in the research we are conducting and not for any other testing that you have not agreed to.
What is DNA?
Deoxyribonucleic acid is the body’s blueprint present in almost all the cells. DNA determines the function and structure of every component in the body. Except for identical twins, it is the slight differences in the combination of this DNA that is inherited from our biological parents that makes us unique. As our DNA is inherited half from our mother and half from our father and it is this combination of dominant or recessive traits that governs our height, hair colour and even our susceptibility to disease.
What is the procedure for participating?
If you decide to participate in any research conducted at the Genomics Research Centre there are certain procedures we need to follow.
Read and complete a consent form
The consent form explains in general the nature of research we are conducting and how we are asking you to become involved. It explains the sample and information collection and how these will be treated. Your rights to privacy and how we protect them as well as contact numbers for queries or complaints are also included. We ask that you complete this form, sign it and then post it to us with the completed questionnaire.
The Genomics Research Centre
60 Musk Avenue
Kelvin Grove QLD 4059
Phone: 07 3138 0970 or 07 3138 0972
Fax: 07 3138 6039
Phone: +61 7 3138 0970 or +61 7 3138 0972
Fax: +61 7 3138 6039
Email address: firstname.lastname@example.org
Complete a general questionnaire and disease form
The questionnaire asks questions about your health and family history. It is very general because we invite people with different conditions to help. The questionnaire covers many common diseases and we ask people to please complete the whole questionnaire to the best of their ability. Please only answer YES if a doctor has diagnosed the condition. Because many diseases have hereditary as well as environmental factors, we do ask questions about these diseases in other members (blood relatives only) of the family. We also need to know their sex and relationship e.g. 2 sisters and 1 brother (2F&1M) or paternal grandmother (PGM) or 1 maternal uncle (1MUncle) to you. Many times it is very difficult to know what grandparents suffered with and the only information available is the cause of death…it is best to complete this information and put UK as unknown as the answer to the remainder questions for them this way we do not have a false NO. Family information may not be available if you are adopted so if this is the case please just state this fact at the beginning of the Questionnaire.
The information from your questionnaire is automatically entered into a database but will not be accessed until we receive your signed consent form in the mail. If we do not receive your signed consent form within 21 days of your data, we will delete your information without accessing it. If we do receive your consent form you may be contacted on a random basis by telephone or mail to verify your details are genuine.
Depending on the disease, family history and country of residence, some volunteers may be asked to donate a blood sample.
The sample will be collected by a trained phlebotomist at a designated pathology collection center only. The collector and their pathology company will have been previously informed as to the type and amount of sample to collect into required containers and the specific handling and shipment requirements stipulated by our scientists.
What happens to my information?
When your consent form and questionnaire are received they are given a unique identifier number. Using this unique number the information in your questionnaire is then entered into the master database. From this database our researchers are able only to access or transfer a copy of the relevant information they need for their particular study into an appropriate database for their study that your de-identified information will be involved in.
If you have donated a blood sample etc., this is also given the same identifier number and your name and date of birth or any other identifying information is removed from the sample. The blood is either frozen or the DNA is extracted and stored for use in the laboratory.
A photographic diary of what happens to DNA blood samples.
After completing one of our consent forms, blood is collected from your local pathology
Blood is either collected in vacutainers or transferred into vacutainers after collection
All blood collected is labelled by hand and also bar coded (Not shown in this photo)
*NOTE: All relevant details are collected and handled with the utmost confidentiality
All samples are checked before transferring to long term storage tubes to be stored at -80 degree Celsius
-80 Degree Celsius Storage Freezers
The sample goes through a variety of procedures
The final stage of the DNA extraction process is to transfer your DNA to a bar coded tube ready to be used in Amplification and Sequencing (Testing)
Quantification of Diagnostic sample (Measuring Concentration)
PCR (Polymerase Chair Reaction) Amplifying the DNA Sample
Placing the DNA Sample ready for Amplification on the PCR thermocycler Machines (Amplifies the DNA)
Loading an Agrose gel to ensure good Specific amplification without contamination (Quality Control)
Agarose gel bands viewed with help of UV light box
After sequencing of the Diagnostic Sample, it is checked for notations
After checking, the results are recorded