Informed consent in Research:

Delegation of consent Form:-CTIMP

(Nurses/Midwives/AHP’s Band 6 and above)

Chief Investigator/Principal Investigator
Study Title
Unique R&D or REC number
Research Nurse/Midwife/AHP Designee Name
Band

In addition, where the task of consent for a CTIMP trial is being delegated, the designee

Is:-

Requirement / Designee signature
The designee is preparedand in agreement to take on this additional responsibility AND is competent to receive valid informed consent
I have a comprehensive understanding of the study, potential pharmacological interactions treatment toxicities and the associated disease area.
I am fully aware of the risks and potential benefits of taking part in the clinical trial
I am qualified by experience andhave received appropriate training for this study and have provided evidence for this
The delegation of responsibility for receiving valid informed consent is documented on the Trials Delegation and Signature Log
Research nurse/midwife approval to take informed consent has been permitted in writing by the PI/CI and evidenced
Written conformation from the Trial Sponsor has been evidenced
Confirmation that the REC does not explicitly exclude nurse/midwife consent or a non-medic
I understand an effective line of communication must be maintained with the CI/PI who is ultimately the person responsible for the patient’s care and for ensuring that subjects have fully understood what they are consenting to.
All persons who receive valid informed consent must have a copy of their signed and dated CVs in the Study Site File and must have completed the Delegation and Signature Log
Up to date in GCP training / Date
Evidence of Consent Training / Date

The General Medical Council (GMC) recommends that when doctors delegate the task of receiving valid informed consent it is their responsibility to ensure that the person delegated is as follows:

Requirement / PI/CI signature
The designee is suitably trained and qualified
The designee has sufficient knowledge of the proposed investigation or treatment, and understands the risks
The designee acts in accordance with guidance as set out in GMC "Seeking Patients Consent ; the ethical considerations”
Ensure all staff delegated the responsibility to received valid informed voluntary consent are adequately supervised
The CI/PI must be available for any questions that may arise during the consent process
The CI/PI must ensure they are available for audit and inspection both internal and external.
Confirmation / Sign Off
As the named designee I am aware of my role and responsibilities and the duties delegated to the CI/PI / Name:
Date:
The designee has met all above criteria and has permission to recruit on to the named study
(Senior Research Nursing Team or Trust Lead Research Nurse) / Name:
Date:
Notes & Additional Evidence