BIPOLAR RELAPSE FOLLOWING CHILDBIRTH: STUDY TO QUANTIFY THE RISK
PARTICIPANT INFORMATION STATEMENT
You are invited to take part in a research study into bipolar relapse in women following childbirth. The object is to quantify the risks of such relapses based upon the experiences of women suffering from bipolar disorder who have children. The results of the study will guide pregnancy planning as well as the prevention of relapse for women with bipolar disorder when they have children. The study is being conducted by Professor Philip Boyce, Associate Professor Megan Smith, Associate Professor Anthony Harris, Professor Gin Malhi, Dr Amanda Bray and Ms Alena Rahmanovic.
If you agree to participate in this study, you will be requested to complete an online survey. This should take approximately 10-15 minutes to complete. You will be asked questions relating to general aspects of your bipolar disorder, including management, and questions about your bipolar disorder as it relates to your reproductive health, pregnancy and childbirth. You will not be asked to provide your name or any information that can identify you (except for your age), so your responses will remain anonymous.
All aspects of the study, including results, will be strictly confidential and only the investigators will have access to information on participants, except as required by law. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
While we intend that this research study furthers medical knowledge and may improve treatment of bipolar disorder in pregnant and postpartum women in the future, it may not be of direct benefit to you.
Participation in this study is entirely voluntary. Whether you decide to participate or not, your decision will not affect your medical treatment or your relationship with medical staff.
Being in this study is completely voluntary and you are not under any obligation to consent to complete the survey. Submitting a completed survey is an indication of your consent to participate in the study. Once you have submitted your survey anonymously, your responses cannot be withdrawn.
When you have read this information, the researchers would be happy to discuss it with you further and answer any questions you may have. If you would like to know more at any stage, please feel free to contact Professor Philip Boyce on +61 2 9845 6687 or study coordinator Alena Rahmanovic on +61 2 9845 5967.
If you would like to be notified of the results of this study, please send an email to email@example.com with the subject line “Bipolar Survey Results”. You will be prompted to do this upon completion of the survey. By sending an email to the abovementioned email address, your email address can in no way be linked to your responses, maintaining anonymity. A summary of the results will be emailed to you upon the completion of the study.
Any person with concerns or complaints about the conduct of a research study can contact The Manager, Human Ethics Administration, University of Sydney on +61 2 8627 8176 (Telephone); +61 2 8627 8177 (Facsimile) or firstname.lastname@example.org (Email).
If you would like to keep a copy of this information statement, please copy the text, paste into a program such as Microsoft Word or Notepad, and save/print.