What is consent?
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).
What this means at Leicester’s Hospitals
Leicester’s Hospitals’ SOP S-1006 UHL Informed Consent for Research Sponsored by UHL NHS Trust and SOP C-2001 UHL Consent for HOSTED Studies and Policy for Nurses Allied Healthcare Professionals and Non-Medical Staff obtaining informed participant consent for clinical research studies (Trust reference B17/2009) set out the process to be followed by all non-medics who will be obtaining informed consent for research purposes.
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 / Research 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.
What training do we provide?
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. Researchers who are unable to access HELM will need to re-attend a face session at the end of 2 years.
The new HELM system is not currently able to issue certificates. Once course successfully completed email the R&I Training team RItraining@uhl-tr.nhs.uk to request a certificate. Please allow up to 7 days for a response.
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 cannot be booked via eUHL/HELM.
Please view the calendar on our Training and Development page to see upcoming sessions and dates.
For further information and to book a place on one of the sessions, please contact RItraining@uhl-tr.nhs.uk
For researchers undertaking National Institute for Health Research (NIHR) Portfolio studies, you can also access GCP and Consent training through the Clinical Research Network: East Midlands.
If you are an external candidate or have any questions about individual training needs, please complete the form below: