‘Re-consenting’ trial participants
Hi all,
I’ve been searching for some time now (without success) for information regarding whether trial participants need to provide additional consent/re-consent in certain situations. Examples of such situations include:
- a substantial amendment to the protocol is implemented that involves an additional visit/assessment/procedure
- a participant consent to take part in a trial but is found to be ineligible at screening due a transient/reversible condition. E.g. the subject meets all other criteria but is showing early signs of a common cold infection (that will likely fully resolve within a few weeks); another example is where an inclusion criterion is a flare-up of a dermatological condition (e.g. eczema) that must be above a minimum severity score – a patient’s condition may not be sufficiently severe at one screening visit but in the subsequent weeks/months increases in severity above the minimum threshold. Should/can this participant be contacted to attend a second screening visit at a later date, and if so, should additional consent be sought given that no aspect of the trial (and therefore what the participant is consenting to) has changed since the first screening visit?
If anyone has come across such guidance/information elsewhere I’d be very grateful if you could point me in the right direction!
Many thanks
Re-consenting Trial Participants
Concerning re-screening, the approved protocol should state the criteria for re-screening, considering safety/ethical implications as well as any impact to the data integrity and statistical analysis. Many measures cannot just be repeated without adversely effecting the outcomes data. Often there may be a need to use alternative forms of certain scales and there may need to be a defined waiting period between screening and re-screening. In other circumstances re-screening may not be allowed at all. The approved protocol should give clear guidance about the procedure for re-screening, including tests that need to be repeated, if the subject needs to be considered a screen failure to be re-screened and any timelines that need to be considered. Data management procedures should also be defined in the appropriate site instruction materials according to approved practices.
In regards to re-consenting, ICDs must be signed prior to any study activities being conducted . Informed consent should be viewed as a process, rather than a single event;. Informed consent as a process includes maintaining the subject's consent during the entire study The site staff should also be aware that once the ICD is signed any observed or reported SAE must be reported …”
We are obliged by ICH GCP 4.8.2, to inform ongoing subjects in a timely manner, if new information becomes available that may be relevant and might impact their wish to remain in the study. Changes in the number or nature of visits would definitely impact the subjects willingness to continue in the trial ad therefore the subject should agree to this through a consent form.