New information, questions and ongoing consent

Even though you signed the consent form at the start of the study to say you intended to complete the trial, new information or a change in circumstances may mean you need to withdraw your consent.

There might be times when you forget what you were told at the start of the study, or have thought of new questions you didn’t have before.

Any time you have questions about the trial or treatment, you should ask the researchers, and you don‟t necessarily have to wait until your next clinic visit to ask. The information sheet for the trial should provide the phone numbers of who to contact if you have any questions and don’t want to wait until your next study visit.

There may also be times when new information becomes available that might make you change your decision to continue in the study, such as additional study visits or tests being requested, or new safety information, or a change in the researcher or sponsor of the trial. A trial site is obliged to give you new information during the trial if there is a chance it may affect your decision (consent) to remain in the trial.  Ig that happens, the trial site will usually ask if you are happy to remain in the trial and will ask you to sign an updated “consent‟ form to document that you received the information and are happy to remain in the trial (or not).

 

Ethical review of new information – urgent and non-urgent

Regulations require researchers to get any written information given to patients reviewed by an ethics committee before it is provided. For new information that is not considered urgent, you will receive the information once the ethics committee have approved the new information.

For information that is considered urgent for you to know, the research team may first tell you about the update before the ethics committee have approved the form and document your verbal agreement to continue in the study. They will then follow up with you at a later date with the paperwork once it is approved by the ethics committee. This process is allowed for urgent information because regulators understand that your safety must come first, ahead of making sure the paperwork is complete.

 

Research teams expect you will have questions along the way. Don’t be afraid to ask.

 

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