Consent is the “process by which a subject voluntarily confirms his/her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed Consent is documented by means of a written, signed and dated informed consent form” (ICH-GCP E6 1.28 1996).
The following set out the process to be followed by all non-medics who will be obtaining informed consent for research purposes:
- Leicester’s Hospitals’ SOP S-1006 UHL Informed Consent for Research Sponsored by UHL NHS Trust
- Leicester’s Hospitals’ SOP C-2001 UHL Consent for HOSTED Studies
- Policy for Nurses Allied Healthcare Professionals and Non-Medical Staff obtaining informed participant consent for clinical research studies (Trust reference B17/2009)
It is vital that all non-medics involved in the consent process are supported by the provision of specific training and assessment to obtain informed consent. This is in addition to training required in ICH-GCP / Researcher Training for non-CTIMP Studies.
It is currently a requirement that an initial face to face session is attended and then one online refresher course can be completed before attendance at a second face-to-face session is required.
For all allied healthcare professionals (non-medics) who will be taking informed consent for a research study we provide a mandatory Consent for Research Training session. This is a face-to-face interactive classroom session with the opportunity to discuss issues around consent for research. This session is open to, and recommended for, all medics undertaking research.
Consent Training for Research Studies OCB eLearning Refresher can only be accessed via HELM. If you do not have a HELM account, please contact RITraining@uhl-tr.nhs.uk and a member of the team will set up a HELM account for you.
Please be aware that the certificate is valid for 2 years from the date of certification.
How do I book a place for the consent session?
These sessions can be booked via HELM.
Please view the calendar of training sessions to see upcoming sessions and dates or log on to HELM. To view upcoming sessions on HELM, go to the tab “My training” select course catalogue and type in consent. The course you require is Consent for Research.
National Institute of Health Research
The NIHR provide face to face consent training sessions as well as an eLearning course.