Valid informed consent for participation in research must be given voluntarily, in light of sufficient information by legally competent individuals. Requests for informed consent for research should avoid any form of coercion and the process must be recorded in writing. See Declaration of Helsinki.
Potential participants should understand that they are free to withhold consent and that doing so will not affect the standard of treatment they receive or upset the people responsible for their health care. Assurance should be given that once enrolled in a research study participants may withdraw at any time, without having to give a reason. See the Directives for Human Experimentation of the Nuremberg Code.
Potential participants must have a clear understanding that they are being asked to take part in research. Where one exists, the alternative standard treatment should also be explained. The purpose of the study, together with the actual and potential risks should be discussed. Arrangements for confidentiality and anonymity must be described, including who will have access to the participant's data. Investigators should disclose who is funding and/or sponsoring the research, that participants will not be identifiable from publications and whether or not travel expenses will be paid. See Guidance for Applicants on the NRES site.
Special requirements apply to research involving children, adults whose competence is compromised and other vulnerable groups. Contact the LREC for advice when planning research with these groups.
In English Law no adult can give proxy consent for another adult to be enrolled in research in the event of incapacity. Advice may be sought on the patient's probable attitude to research. The reasons for not obtaining informed consent for any research study must be documented in writing and submitted to the Research Ethics Committee. See the National Research Ethics Service (NRES)
Informed consent is a process, not a signature on a form. The consent form indicates that there has been full discussion of all relevant facts with time and opportunities for the potential subject to ask questions. Signed consent forms should be witnessed and dated. A copy should be given to the participant with the Information Sheet and the original stored with the raw data for the study for a minimum of ten years for Randomised Controlled Trials and five years for other research. One reason for doing this is to ensure that proof is available that informed consent was given should it be questioned at a later date.
The investigator is responsible for assuring the adequacy of informed consent from or on behalf of (minors) each subject. Although the investigator may delegate another appropriately qualified person to obtain consent from prospective participants, the responsibility remains with the investigator.
'The dignity, rights, safety and well-being of participants must be the primary consideration in any research practice.'
All studies must have appropriate arrangements for obtaining consent and the ethics review process will pay particular attention to those arrangements.
Informed consent should be requested for research which involves interventions, observations or interviews with patients or healthy volunteers (including NHS employees), and/or their tissue or data relating to them.