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:
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.
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.