Informed Consent Training

Consent is the “process by which a subject voluntarily confirms their 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.

Training provided
For all allied healthcare professionals (non-medics) who will be taking informed consent for a research study the NIHR provides a training session. This is usually 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.

Please be aware that the certificate is valid for 3 years from the date of certification.