17. Compensation for injury in commercially sponsored intervention studies

Introduction

The Accident Compensation Act 2001(external link) limits the circumstances in which a participant can receive treatment injury cover for personal injury suffered as a result of treatment given as part of a clinical trial. Participants who suffer a personal injury in a clinical trial may be eligible for treatment injury cover only under two conditions.

The two conditions are:

• an ethics committee, which is approved by the Health Research Council of New Zealand or the Director-General of Health, has approved the trial and was satisfied the trial was not to be conducted principally for the benefit of the manufacturer or distributor of the medicine or item being trialled; or
• the participant did not agree, in writing, to participate in the trial, for example if the participant was unconscious.

Therefore, consenting participants are excluded from compensation in the event of an injury if it was conducted principally for the benefit of the manufacturer or distributor of the medicine or item being trialled (‘commercially sponsored research’), regardless of whether it has been approved by an ethics committee.

Many academic studies rely on manufacturers or distributors to supply products and/or provide funding. The line between commercially-sponsored and academic research may therefore be difficult to establish. Researchers should consider the ultimate aim of the research programme (for example, whether it is to support the approval or marketing of a product) and the degree of involvement of the manufacturer or distributor of the product.

Factors such as input into study design and documents; expectation of being able to monitor and/or audit study source documents and data (including identifiable medical records); and access to study results (especially the ability to publish independently of the researcher) should be considered when deciding whether a study is commercially sponsored.

For commercially-sponsored research to be conducted ethically, researchers must satisfy an ethics committee that participants have access to compensation for injury to at least the equivalent of any Accident Compensation Corporation (ACC) compensation that would be available to them if they had been injured in research that was not commercially sponsored. Such compensation includes earnings-related compensation and compensation for surviving partners, children and dependants in the event of death (‘alternative compensation’). For commercially-sponsored clinical trials, researchers and sponsors must comply with the following standards.

ACC-equivalent compensation

17.1 Researchers must make ACC-equivalent alternative compensation available to participants for the whole period of the clinical trial.

17.1.a This compensation may include treatment costs, weekly compensation for wages a participant has lost because of injury, personal help such as home help or childcare, and other types of assistance depending on the circumstances.

17.2 Participants’ claims for alternative compensation must be resolved in a timely manner. If timely resolution is not achieved, claims should be referred to independent mediation.

17.3 As part of the informed consent process, researchers must clearly inform participants of:

• whether alternative compensation arrangements are legally enforceable, and the process that will occur
• how the researcher and their employer would support the participant in making a claim
• whether participants may need to engage their own lawyer to lodge an alternative compensation claim
• whether the amount of the alternative compensation, if any, is at the sole discretion of the study sponsor or their insurer
• the jurisdiction in which any entitlement to, and amounts of, alternative compensation will be determined
• details of mediation, appeal or review processes
• whether the alternative compensation is ‘no-fault’ compensation, or whether fault on the part of the participants or researchers may impact on the availability and amount of the alternative compensation
• whether any other material limitations apply to the availability of the alternative compensation, including the timing of payments.

17.4 Study protocols or associated documents must provide details of the availability of alternative compensation.

17.5 Researchers or sponsors must provide evidence to an ethics committee of appropriate levels of insurance to ensure they are able to pay out alternative compensation to participants if necessary.

17.5.a In determining whether a level of insurance is appropriate, ethics committees will consider the type of research, including whether it involves vulnerable people or infants or children who, if injured, may require long-term compensation.

17.6 Researchers must provide evidence to an ethics committee of appropriate professional indemnity.