Informed consent in Research:

Delegation of consent Form:

(Clinical Trial Assistant)

Chief Investigator/Principal Investigator
Study Title
Unique R&D or REC number
Designee Name
Band
Requirement / Designee signature
The designee is prepared and in agreement to take on this additional responsibility AND is competent to receive voluntary informed consent
I am fully aware of the risks and potential benefits to participants of taking part in the above study
I am qualified by experience and/or have received appropriate training for this study and have provided evidence for this
Approval to receive valid informed consent has been approved in writing by the: PI/CI
Written conformation supporting CTA consent is in evidence from the Trial Sponsor
Confirmation that the REC does not explicitly exclude the delegation of receiving valid informed consent by an unregistered workforce
The delegation of responsibility for receiving valid informed consent is documented on the Trials Delegation and Signature Log
The designee will ensure an effective line of communication is maintained back to 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.
The CI/PI must be available for any questions that may arise during the consent process
All personnel who have been delegated responsibility to receive valid informed consent must have a copy of their signed and dated CVs and GCP certificates placed in the Investigator Site File
Evidence of GCP training / Training Date:
Evidence of Consent Training / Training Date:

When the task of receiving valid informed consent is delegated it is the responsibility ofthe designator to ensure that the person delegated is as follows:

Requirement / PI/CI signature
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 PHT SOP “Recruiting and Consenting Patients into Clinical Research”
The designee must be aware of the extent of his/her expertise at all times and seek support from available resources when appropriate
The designee will be adequately supervised through 1;2;1’s, appraisals and supervision / Date:
The designee is suitably trained and qualified / Date:
Confirmation / Sign Off
As the named designee I am aware of my role and responsibilities and the duties delegated to my by the CI/PI / Date:
The Designee has met all above criteria and permission to recruit on to the named study is permitted (Senior Research Nursing Team) / Date:
Notes & Additional Evidence