Model documents on Informed Consent

Introduction

This page provides detailed information on the standard operating procedures and model documents which underlie the process of donor registration and consent. Figure 1 shows which model registration forms can be used depending on the local mode of operation of the Brain Bank. The accompanying model registration forms have been given the same colour as the text balloons in Figure 1.

Figure 1: How to choose which registration forms to use?

Informed consent and authorization forms

The way different Brain Banks obtain tissue differs substantially. Current modes of acquisition include:

1.     clinical autopsies

2.     medico-legal autopsies

3.     brain autopsies performed in the framework of a donor program

4.     ante-mortem diagnostic procedures and surgical interventions for treatment purposes. Please note that ante-mortem procedures are explicitly excluded from the scope of this workpackage. Ante-mortem procedures for research purposes must comply with substantially stricter legal requirements than those laid down in the Code of Conduct and Model Brain Bank Regulations. This includes requirements to informed consent, review of the study protocol by an ethics committee and other legal obligations such as insurance for possible damages to the study participants.

The model forms and information leaflet presented here can be utilized for procedures mentioned under 1, 2 and 3.

The informed consent form should be signed by a person who wishes to become a brain donor or a person who gives consent to own post-mortem autopsy and removal of the brain. In the experience of the Netherlands Brain Bank signing of this form (co-signed by the next of kin) has been sufficient to meet all current legal requirements for autopsy.

The Authorization form can be used in cases where the person concerned is either incapable or incompetent of making a decision on their own. In such cases the next of kin or a legal representative may sign the form. The authorization form can also be used for post-mortem consent for autopsy by the next of kin.

Flowchart

For a detailed explanation of the donor registration process please click on the flowchart.

Information to the Informed consent or Authorization

Regardless of the registration mode, the donor and the next of kin should be supplied with sufficient information in order to make a well-considered decision. For this purposes a model information leaflet, presented on this webpage, has been compiled.

The guidelines on which information exactly should be made available are included in Chapter II of the Model Brain Bank Regulations. Please note that the information does not have to be provided in a leaflet form per se. It is required that, by signing an informed consent or authorization form, a person makes an informed decision, whereas information upon which such decision is based can be provided in written, oral or other form (e.g. by the means of a video).

Incompetent persons

Incompetent persons are persons who, due to a mental disease or other condition are incapable of making a certain decision on their own. Children which have not reached a legally required age for giving informed consent are also regarded as incompetent. Post mortem authorization for autopsy on incompetent person given by the next of kin does not have to meet any additional standards than those laid down in the Code of Conduct and Chapter II of the Model Brain Bank Regulations. Authorization to register an incompetent person as a brain donor at the Brain Donation Program, however, should comply with additional requirement (please see Chapter II of the Model Brain Bank Regulations, article "Special considerations in case of incompetent persons").

Flowchart

For a detailed explanation of the registration of an incompetent person at the Brain Bank please click on the flowchart on incompetent donor registration.

 



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