Regulation 19

that the trial involves research;

the purpose of the trial;

the treatments or procedures to be administered in the trial and the probability for random assignment of each treatment or procedure;

the procedures to be followed in the trial, including all invasive procedures;

the responsibilities of the subject;

the aspects of the trial which are experimental;

the reasonably foreseeable risks or inconveniences to the subject and, where applicable, to any embryo, foetus or nursing infant;

the reasonably expected benefits, including whether there is any intended clinical benefit to the subject;

any alternative procedures or treatments available to the subject, and their potential benefits and risks;

any compensation and treatment available to the subject in the event of injury arising from participation in the trial;

the circumstances which may result in the pro-ration of payment to the subject for participating in the trial;

any anticipated expenses to the subject from participating in the trial;

that the subject’s participation in the trial is voluntary and that the subject’s participation in the trial may be refused, or the subject withdrawn from the trial, at any time without penalty or loss of benefits which the subject would be entitled;

the persons who will be granted access to the subject’s medical records and the extent of such access, including the possibility that the Authority may inspect the records;

the extent to which records identifying the subject will be kept confidential;

that —

any person whose consent is required under regulation 16 or 17 (including a subject who regains capacity to consent); or

the family member contacted under regulation 17(5), in circumstances where the consent of neither the subject nor the legal representative has been obtained,will be informed in a timely manner of any information which becomes available and which may be relevant to the decision of the potential subject being, or the subject continuing to be, a subject (as the case may be);

the persons to contact for further information relating to the trial and the rights of subjects in the event of injury arising from participation in the trial;

any foreseeable circumstances under or reasons for which a subject’s participation may be terminated;

the expected duration of the subject’s participation in the trial;

the approximate number of subjects involved in the trial;

any other information which the Authority may require to be given.

the person whose consent is required in order for the subject to continue being a subject in the trial (including a subject who regains capacity to consent); or

the family member contacted under regulation 17(5), in circumstances where the consent of neither the subject nor the legal representative has been obtained,as the case may be.