What is an Opt Out Study?
Using an opt out approach for consent in a research study means that participants are included in the research study unless they give their express decision to be excluded. Your decision must still be informed, and you will need to be given information about the study after which you can say if you do not wish to continue in the study.
An example of one of our current opt-out studies is the NeoGastric trial. It makes participation as easy as possible for families. This means that if your baby meets the eligibility criteria, they will be automatically included in the trial unless you decide to opt-out. In this example, two standards of routine care are being compared and no risks are identified in this allocation process.
Can I change my mind about joining a study even if I have given my consent?
Yes! Absolutely. All research is voluntary, and you can withdraw at any time without giving a reason and you care will not be affected.
Will I get paid for being part of a research study?
Most research studies conducted in maternity and paediatric departments will not actively pay participants, however, many studies will compensate participants for reasonable travel expenses and/or provide a shopping voucher by means of appreciation and thanks for your time involved in the study. Please ask your researcher.