clinical research studiesWhy would I want to participate in a research study? And other commonly asked questions.
Why do you have research studies?
At Monash IVF we are committed to new and creative scientific developments for the treatment of fertility, genetic problems in reproduction and the provision of excellence of service. Profits generated from our treatment services at Monash IVF are reinvested into research to accelerate innovation and development of new high quality services for patients. The very technology that provides you with the opportunity to conceive would not have been possible without research.
The Monash IVF Clinical Research Centre
To assist in the development of clinical research, Monash IVF has established a Clinical Research Centre. We are expanding our research resources to include a doctor and nursing staff to complement the scientists and fertility specialists that are creating new opportunities for patients. To assist in the smooth operation of research studies, the role of the Clinical Research Centre is to ensure that:
- research studies are coordinated efficiently
- additional demands are minimised for the patients
- increased support and additional information are provided to patients and staff
Is it safe to participate in a research study?
New research techniques are extensively studied in animal models. With evidence of success and no adverse risks they are then studied in humans. Monash IVF also implements new techniques that have already been studied overseas or in other IVF clinics.
However, this is only done if we can be satisfied that there is enough evidence that the new methods are safe and effective.
Before a research study is implemented there is a long and comprehensive process that the researcher must satisfy. Firstly, a research proposal has been reviewed internally, and approval obtained from an institutional Human Research and Ethics Committee, and where appropriate, the Victorian Infertility Treatment Authority (ITA).
Counselling and consent forms
For research studies that are sensitive in nature, for example, if the technique has not been studied with humans before and it is intended that it will lead to the creation of human embryos, the law stipulates that separate counselling must occur with an ITA approved counsellor and written consent of the participants is required.
In cases where there are known concerns with a particular technique, these risks must be documented in the patient explanatory statement accompanying the consent form. Some research studies do explore new technology and every effort is taken to minimise any risks of adverse outcomes.
Counselling is also available at any stage of the treatment process and is free of charge. If you have any worries about the study or any other aspects of your treatment you may find it helpful to talk it over with a counsellor.
How can participating in a research study benefit me?
 Monash IVF is committed to helping people get pregnant and deliver healthy babies. We are constantly reviewing our procedures and technologies to ensure continual improvements in success rates, with a view to minimising the number of treatment attempts and the overall burden of infertility. In order to do this we need to do research, and study different procedures. The very treatment procedures you may be undergoing would not have been possible had it not been for the commitment of people like yourself to help us in this goal.
Participating in a research study may provide you with an alternative treatment option from the ones you have already undergone. If it works, your goal has been achieved. If it doesn't work, you know that your participation has provided valuable information not only for the researchers but also your Monash fertility specialist, who may be able to use that information in making other decisions about your future treatment.
Who will look after me during the studies?
All clinical studies at Monash IVF are approved by the doctors. Your doctor will continue to be involved in your care as normal. For most research studies your usual clinical nurse will be the main person with whom you will deal. In addition to this, a research coordinator will oversee the treatment process to ensure that the requirements for the research studies are met. This person may also work collaboratively with your IVF nurse. This is to ensure that there is continuity of care and that there is ongoing communication with the medical team.
Confidentiality
The National Health & Medical Research Council (NHMRC) has very strict guidelines about protecting information obtained in research studies. Monash IVF strictly adheres to these guidelines and your anonymity in these studies is guaranteed. The research investigators who may deal with potentially identifying information about participants are named in the consent forms so that participants will know who will be looking at their treatment results. In the vast majority of studies a report is written based on a summary of the research data from which statistics are compiled, e.g. pregnancy rates or the success rate of the technique. No identifying information about the participant is required nor is it recorded in the written report.
Can I withdraw from the research study?
The Infertility Treatment Act (1995) states quite clearly that any person has the right to withdraw their consent to participate in a study at anytime.
What if I refuse to participate in the study, will I still be treated the same?
You are under no obligation whatsoever to participate in a research trial. If you choose to say no, there will be no difference at all to your clinical treatment. We respect people's decision to decline and we understand that your first priority is going to be to your own treatment and to getting pregnant.
Further information
If you have any questions or would like further information about clinical research studies you may contact the Clinical Research nurse on 03 9543 2833.
Your participation is greatly appreciated.
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