Obtaining Informed Consent for Clinical Trials

Informed consent is defined in ICH Good Clinical Practice as:

A process by which a subject voluntarily confirms his or 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.

This SOP describes the procedure for obtaining written informed consent from a subject in a Clinical Trial of an Investigational Medicinal Product (CTIMP) study. The Medicines for Human Use (Clinical Trials) Regulations define informed consent as follows:-

“A person gives informed consent to take part in a clinical trial only if his decision:

  1. is given freely after that person is informed of the nature, significance, implications and risks of the trial;
    2. and
  2. either:
    • is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or
    • if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.”

The same definition also applies to the giving of informed consent by a person with parental responsibility, or a legal representative, on behalf of the trial subject.

This SOP applies to all investigators and research team members involved in the conduct of Clinical Trials (as defined in the Regulations) sponsored or co-sponsored by King’s Health Partner Organisations and will be followed in accordance with each Partner NHS Organisations’ local policy for consent.

The informed consent process will be monitored for compliance with the Regulations and this SOP by the KHP CTO Quality Team.

SOP: Obtaining Informed Consent for Clinical Trials (.pdf 267KB)


Related Documentation

HRA Consent Resources (external link)

Consent and Participant Information Guidance - Decision Tool (external link)