Procedure for Obtaining Consent (EU)
The CRASH 2 Trial involves patients who have suffered serious injuries and are at risk of life threatening haemorrhage. In this situation, most patients will have some impairment in their level of consciousness caused either by blood loss or coexisting head-injury. In this emergency situation, patients may not be able to provide written informed consent. In addition, the trial treatment has to be administered as soon as possible after injury.
1 May 2004 it is necessary that trials be compliant with Directive 2001/20/EC
in the UK. To implement this directive, the UK regulation titled "The
Medicines for Human Use (Clinical Trials) Regulations (2004)"
was published which requires that certain conditions and principles are
applied to enable an incapacitated adult to be part of a clinical trial.
See CONDITIONS below. For the full
regulation please visit the following website:
The EU Directive (2001/20/EC) requires that, prior to participation in a trial, written consent from a legal representative of any person unable to consent for him or herself be obtained.
In the first instance, the legal representative of a person unable to give consent should be close to that person, aware of his/her wishes and independent of the research. This person would be termed the Personal Legal Representative (PeLR).
If this is not possible and there is no one sufficiently close to the potential subject who is willing or able to take on the role, or if a person close enough to the potential subject cannot be contacted before it is medically necessary to give the intervention then someone nominated by the NHS Trust as a Professional Legal Representative (PrLR) will fulfil this role.
The CRASH 2 Trial is conducted in an emergency situation and the protocol requires that treatment is administered as soon as possible after injury. In the majority of cases, patients are unaccompanied. In addition, it can take time for the police to identify and contact someone who can potentially be a PeLR.
In most cases, it is expected that consent for participation will have to be obtained from a PrLR for patients to be enrolled.
OBTAINING LEGAL REPRESENTATIVE CONSENT FOR THE CRASH 2 TRIAL
PROCESS FOR OBTAINING CONSENT
FULFILS ELIGIBILITY CRITERIA
Is a person who has a close personal relationship with the patient available and knowledgeable about their wishes?
Is this person willing and able to take on the responsibilities of PeLR in this emergency situation?
there any reason to presume that this patient would NOT be willing
no, Trial Team to contact identified PrLR and obtain written consent.
no PrLR is available in the emergency situation (e.g during night time
hours), patient can be randomised into the trial, if there is local agreed
pre-arrangement, and written consent
obtained from PrLR as soon as possible thereafter.
/ when patient regains competence, or should a PeLR be identified, inform
of participation, provide patient information
sheet and obtain consent for use of information.
INSTRUMENTS - MEDICINES
PART 5: CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
11. The clinical trial relates directly to a life-threatening or debilitating clinical condition from which the subject suffers.