Assessment of Compensation. 4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English Court in cases where legal liability is admitted. 4.2 Compensation may be abated, or in certain circumstances excluded, in the light of the following factors (on which will depend the level of risk the patient can reasonably be expected to accept): 4.2.1 the seriousness of the disease being treated, the degree of probability that adverse events will occur and their seriousness, any warnings and precautions given; or 4.2.2 the risk and benefits of established treatments relative to those known or suspected of the medical device. This reflects the fact that flexibility is required given the particular patient’s circumstances. As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of an adverse event. Participation in the investigation is then based on an expectation that the risk/benefit ratio associated with participation may be better than that associated with alternative treatment. It is, therefore reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse incident of which he or she was told. 4.3 In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost (and make available to the patient) the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company in reaching its decision on the appropriate payment to be made.
Appears in 23 contracts
Sources: Tripartite Clinical Investigation Agreement, Tripartite Clinical Investigation Agreement, Clinical Investigation Agreement
Assessment of Compensation. 4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English a Court in England and Wales in cases where legal liability is admitted.
4.2 Compensation may be abated, or in certain circumstances excluded, in the light of the following factors (on which will depend the level of risk the patient can reasonably be expected to accept):
4.2.1 the seriousness of the disease being treated, the degree of probability that adverse events will occur and their seriousness, any warnings and precautions given; or
4.2.2 the risk and benefits of established treatments relative to those known or suspected of the medical device. This reflects the fact that flexibility is required given the particular patient’s circumstances. As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of an adverse event. Participation in the investigation is then based on an expectation that the risk/benefit ratio associated with participation may be better than that associated with alternative treatment. It is, therefore reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse incident of which he or she was told.
4.3 In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost (and make available to the patient) the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company in reaching its decision on the appropriate payment to be made.
Appears in 2 contracts
Sources: Clinical Investigation Agreement, Clinical Investigation Agreement
Assessment of Compensation. 4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English Northern Ireland Court in cases where legal liability is admitted.
4.2 Compensation may be abated, or in certain circumstances excluded, in the light of the following factors (on which will depend the level of risk the patient can reasonably be expected to accept):
4.2.1 the seriousness of the disease being treated, the degree of probability that adverse events will occur and their seriousness, any warnings and precautions given; or
4.2.2 the risk and benefits of established treatments relative to those known or suspected of the medical device. This reflects the fact that flexibility is required given the particular patient’s circumstances. As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of an adverse event. Participation in the investigation is then based on an expectation that the risk/benefit ratio associated with participation may be better than that associated with alternative treatment. It is, therefore reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse incident of which he or she was told.
4.3 In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost (and make available to the patient) the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company in reaching its decision on the appropriate payment to be made.
Appears in 2 contracts
Sources: Tripartite Clinical Investigation Agreement, Tripartite Clinical Investigation Agreement
Assessment of Compensation. 4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English a Northen Ireland Court in cases where legal liability is admitted.
4.2 Compensation may be abated, or in certain circumstances excluded, in the light of the following factors (on which will depend the level of risk the patient can reasonably be expected to accept):
4.2.1 the seriousness of the disease being treated, the degree of probability that adverse events will occur and their seriousness, any warnings and precautions given; or
4.2.2 the risk and benefits of established treatments relative to those known or suspected of the medical device. This reflects the fact that flexibility is required given the particular patient’s circumstances. As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of an adverse event. Participation in the investigation is then based on an expectation that the risk/benefit ratio associated with participation may be better than that associated with alternative treatment. It is, therefore reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse incident of which he or she was told.
4.3 In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost (and make available to the patient) the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company in reaching its decision on the appropriate payment to be made.
Appears in 2 contracts
Sources: Clinical Investigation Agreement, Clinical Investigation Agreement
Assessment of Compensation. 4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English Court in cases where legal liability is admitted.
4.2 Compensation may be abated, or in certain circumstances excluded, in the light of the following factors (on which will d depend the level of risk the patient can reasonably be expected to accept):
4.2.1 the seriousness of the disease being treated, the degree of probability that adverse events reactions will occur and their seriousness, any warnings and precautions given; or;
4.2.2 the risk risks and benefits of established treatments relative to those known or suspected of the medical devicetrial medicine. This reflects the fact that flexibility is required given the particular patient’s 's circumstances. As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of an adverse eventreaction. Participation in the investigation trial is then based on an expectation that the riskbenefit/benefit risk ratio associated with participation may be better than that associated with alternative treatment. It is, therefore therefore, reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse incident reaction of which he or she was told.
4.3 In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost (and make available to the patient) the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company in reaching its decision on the appropriate payment to be made.
Appears in 1 contract
Sources: Clinical Trial Agreement