Informed consent

Delegating informed consent

Obtaining informed consent can be delegated to an appropriate, suitably qualified research staff member. This should be considered on a study by study basis with local circumstances and good clinical practice guidelines taken into account.

Staff acquiring informed consent in writing must have a signed and dated copy of their CV in the study site file and complete the delegation of duties log.

Non-medical staff

Staff who are not medically trained or qualified but have been delegated the role of obtaining consent must:

• ensure the Research Ethics Committee (REC), study sponsor and the organisation hosting the study are aware of the delegated member of staff who is gaining informed consent and have copies of the patient information sheet and consent form
• adhere to professional codes of conduct
• be fully informed and familiar with the verbal and written information being giving to study subjects
• seek advice from the Research and Development (R&D) Governance team if unsure

Principal investigator

The principal investigator is responsible for ensuring that staff gaining informed consent:

• are suitably trained and qualified
• have sufficient knowledge and understand the risk of the proposed investigation or treatment
• act in accordance with regulatory requirements
• are prepared to take on additional responsibility and are confident taking informed consent in line with applicable requirements
• have a comprehensive understanding of the study, potential pharmacological interactions, treatment toxicities and the associated disease area
• should be fully aware of the risks and potential benefits of taking part in the study
• should be qualified by experience or have received appropriate study training
• must have their responsibilities documented in the delegation of duties log
• have been approved by the relevant REC, study sponsor and study host. Approval for UHB sponsored or hosted studies is issued in an authorisation letter

Providing informed consent information to participants

Oral information must reflect the written information provided to study participants and should include:

• a statement that the study involves research
• the study purpose
• study treatment(s) and the possibility of random assignment to each treatment
• study procedures to be followed, including all invasive procedures
• the subject’s responsibilities
• experimental aspects of the study
• any foreseeable risks or inconveniences for the study subject
• reasonably expected benefits (the subject must be made aware if there is no intended clinical benefit)
• alternative treatments and procedure(s) that may be available and the potential benefits and risks
• the compensation and/or treatment available to the subject in the case of any injury relating to the study
• the anticipated pro-rated payment, if any, to the subject for participating in the study
• the anticipated out of pocket expenses, if any, to the subject for participating in the study
• that study participation is completely voluntary and that the subject can withdraw or refuse to participate, at any time, without penalty or loss of benefits to which they would otherwise be entitled and without affecting their future care
• that where applicable, authorised representatives from regulatory bodies, pharmaceutical companies (or other commercial companies), study sponsors or RECs will be given access to the subject’s records to verify study procedures and collected data, without violating the subject's confidentiality. The subject’s GP will be informed of their study participation in writing. By signing the informed consent form the subject authorises such access
• records identifying the subject will be kept confidential and will not be made publicly available. If the study results are published, the subject's identity will remain confidential
• the intention to use any obtained samples for further research
• that the subject or legal representative will be informed in a timely manner if any information becomes available that may be relevant to the subject's willingness to continue to participate in the study
• staff contact details for further information regarding the study. If possible a 24/7 phone number where the subject can receive advice out-of-hours if required
• any foreseeable circumstances where the subject’s participation in the study may be terminated
• the expected duration of the subject’s participation in the study
• the approximate number of subjects involved in the study

If a participant would like a family member present at their appointment this should not be discouraged.

More information

Visit the NHS Health Research Authority (HRA) website for further guidance on informing participants and seeking consent.

• HRA: consent and participant information guidance