Informed consent

Who is allowed to take informed consent from a study participant?

In general any member of a research team may take informed consent from study participants so long as the following points are met:

• For research requiring ethical approval the process for gaining consent from participants must be approved by the Research Ethics Committee (REC). Once approved it must not be changed without first seeking REC approval. Thus, if the process is explicit about who will gain informed consent, this must not be changed without first seeking ethical approval.
• The person taking consent must have a comprehensive knowledge of the study and must be able to adequately and completely inform potential participants of all aspects of the study. For example: why the study is being run, why they have been invited to take part, what taking part in the study will involve for the participant, what alternative treatments are available to the participant (as applicable), what treatment will be available to the participant following completion of the study (as applicable) and what will happen to any data collected from the patient etc.
• They should also be able to answer any questions that potential participants may have about the study. In April 2009 the Trust Executive Group (TEG) agreed that Good Clinical Practice (GCP) training should be mandatory for all Chief and Principal Investigators and for all other staff whose role is principally to support research activity on the Trust's premises. It was also agreed that for staff who remain research active, this training should be renewed every three years. 
• The Principal Investigator at the study site must be confident in the particular person's ability to perform this role and should have delegated this task to them. A 'site staff signature and delegation of site tasks log' has been drawn up by the department and is available either as part of the Investigator Site File (ISF) template found in the information and guidance section of this site or by phoning Research and Innovation.

Is it acceptable for a nurse to obtain informed consent for clinical trials?

It is acceptable for a nurse with adequate training and experience to consent patients for both non-IMP and IMP (Investigational Medicinal Product) studies. Adequate training and experience is not defined in any regulations but the following experience and training is typically expected:

• Generic training in the informed consent process
• Protocol specific training to ensure that the nurse taking consent is sufficiently knowledgeable about the protocol and accompanying information (such as the Investigator Brochure) in order to fully inform the potential research subject of the study and associated risks.
• Knowledge/experience to be able to explain alternatives to the study in sufficient detail to allow the potential research subjects to make an informed choice.

Chief Investigators (CI) have overall responsibility for ensuring that all staff involved in the study are adequately trained. At individual sites the CI will delegate this responsibility to the Principal Investigator. Under the Medicine for Human Use (Clinical Trial) Regulations 2004 a nurse may act as the CI or PI.

Nurses are accountable for their own actions under the NMC Code of Professional Conduct and must only perform this where they are confident in their knowledge, skills, and ability.

The RCN has issued guidance on nurses taking informed consent which is available on the RCN web site.