Informed consent from study participants
Any member of a research team may take informed consent from study participants as long as:
- The process and persons responsible for gaining consent must be approved by the Research Ethics Committee (REC). Once approved, either the process or the people must not be changed without first seeking REC approval via an amendment.
- 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.
- The person taking consent should also be able to answer any questions that potential participants may have about the study.
- Delegated consent should be recorded on the delegation log and filed in the Investigator Site File. When consent is delegated NUH expects that a Consent Competency Tool should be completed, signed by the PI and filed in the Investigator Site File.
Is it acceptable for a nurse to obtain informed consent for clinical trials of IMPs?
It is acceptable for a nurse with adequate training and experience to consent patients for both non-IMP and IMP 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.
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.
Generic training on the informed consent process is provided by EIDO
The RCN has issued guidance on nurses taking informed consent which is available on the RCN web site.