Indemnity by benbenzhou

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									                                      Indemnity paragraphs for COREC form and PIS
                                                    (07/08/06 version)


                            COREC A35. What arrangements                   A36. What arrangements have                      Patient Information Sheet.
                Indemnity   have been made to provide                      been made to provide indemnity                   Paragraph under 'What if
                            indemnity and/or compensation in               and/or compensation in the event                 something goes wrong?’
Sponsor                     the event of a claim by, or on                 of a claim by, or on behalf of,
                            behalf of, participants for negligent          participants for non-negligent
                            harm?                                          harm?
QMUL                        "The Joint Research Office has arranged for    “The insurance that Queen Mary University of     “Queen Mary University of London has
                            suitable indemnity concerning negligent harm   London has in place provides "No Fault           agreed that if you are harmed as a result of
                            to be in place for this study."                Compensation" for participants which             your participation in the study, you will be
                                                                           provides an indemnity to participants for non-   compensated, provided that, on the balance
                                                                           negligent harm.”                                 of probabilities, an injury was caused as a
                                                                                                                            direct result of the intervention or procedures
                                                                                                                            you received during the course of the study.
                                                                                                                            These special compensation arrangements
                                                                                                                            apply where an injury is caused to you that
                                                                                                                            would not have occurred if you were not in
                                                                                                                            the trial. These arrangements do not affect
                                                                                                                            your right to pursue a claim through legal
                                                                                                                            action.”
BLT                         "The Joint Research Office has arranged for    "When the NHS sponsors research there is no      "If you are harmed by taking part in this
                            suitable indemnity concerning negligent harm   provision to offer compensation in advance       research project, there are no special
                            to be in place for this study."                for non-negligent harm to participants. A        compensation arrangements. If you are
                                                                           person suffering injury as a result of having    harmed due to someone’s negligence, then
                                                                           taken part in research will need to pursue a     you may have grounds for a legal action but
                                                                           claim for negligence through litigation, or      you may have to pay for it. Regardless of
                                                                           may be offered an ex gratia payment by the       this, if you wish to complain, or have any
                                                                           Trust. Each case will be considered on its       concerns about any aspect of the way you
                                                                           merits."                                         have been approached or treated during the
                                                                                                                            course of this study, the normal National
                                                                                                                            Health Service complaints mechanisms
                                                                                                                            should be available to you." (standard COREC
                                                                                                                            guidance)
Commercially sponsored      Sponsor will complete this on behalf of the    Sponsor will complete this.                      Sponsor will complete this.
                            investigator.




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