Conseils & Comités
Last update : 20/03/2009
Research on persons whose consent cannot be obtained
due to emergency situations
The emergency situation applies if the use of the tested product (medicinal product, medical equipment) at the time of inclusion in the research study, is specifically intended for persons
- whose life is threatened or whose clinical condition can cause serious and permanent after-effects;
- for whom the available treatments have not been efficient or are not satisfactory.
Following conditions are essentials :
- The research project and its design (including randomisation, placebo control group) are essential to determine the safety and the efficacy of the proposed treatment.
- The research project should be essential for the validation of data obtained from research on subjects who were capable of giving their consent or from other investigation methods (animal experiments).
- These previous research studies should show a direct likely benefit for the subject and a reasonable risk considering the clinical condition of the subject, the currently available therapeutic means and the design of the research project.
- The protocol has been designed to minimise the pain / inconveniences imposed on the patient.
- No incentive or financial award is provided.
- An "Independent Project Monitoring Committee" should be set up for the research project.
- The research cannot be conducted without exemption from the principle of informed consent.
The prior consent cannot be obtained because:
- the clinical condition of the subject is such that he/she is incapable of receiving any information and giving his/her consent;
- the clinical condition of the subject is such that the treatment has to be administered quickly and there is no time to contact a legal representative.
- The protocol should define an assessment of the available therapeutic time frame to try and contact the legal representative of the patient.
- The patient records should document the efforts made to contact the legal representative of the patient.
- The local PI undertakes to inform the following persons and obtain consent to continue as soon as possible
- a legal representative pursuant to the Patient Rights Act, at first;
- the participant as soon as the clinical conditions allows, i.e. as soon as the participant is again capable of giving his/her consent.
- If the participant dies before a legal representative could be contacted, the local PI undertakes to inform, where possible, the legal representative or the family of the participant of the inclusion of the patient in a research protocol.
Role of the Ethics Committee
The Ethics Committee verifies during the review of the research project whether all legal provisions have been implemented.
The Ethics Committee can approve this type of research if it has a member who possesses competencies related to the relevant illness or population (emergency doctor, neurologist) or if it consults persons who possess competencies in the clinical, ethical and psychosocial aspects related to the relevant illness and population.
The Ethics Committee shall explicitly express its opinion in its approval on the exemption from the principle of informed consent prior to the research study.
In the e-mail sent to the PI to remind him/her of his/her obligations as investigator, the Ethics Committee defines the period after which a first report should be provided for the continuous assessment of the protocol.
The report to be submitted by the PI
- should provide a summary of the clinical conditions in which the patients have been included in the protocol;
- should document the attempts to obtain the consent of a legal representative within the defined time frame;
- should document whether the consent to continue has been obtained or not of the legal representative or patient;
- should provide a report of the first clinical observations;
- should contain the new assessment of the benefit-to-risk ratio for the patients included in the research study.