Compensation for research-related injury

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Hello Everybody,

The rapid increase in litigation related to biomedical research on human participants has highlighted the importance of developing policies addressing compensation for research-related injuries.

Compensation is owed to research participants who are disabled as a consequence of injury from procedures performed solely to accomplish the purposes of research.

Investigators should ensure that research participants who suffer injury as a result of their participation are entitled to free medical treatment for such injury and to such financial or other assistance as would compensate them equitably for any resultant impairment, disability or handicap. In the case of death as a result of their participation, their dependants are entitled to compensation. Participants must not be asked to waive the right to compensation.

The EC should determine in advance: i) the injuries for which participants will receive free treatment and, in case of impairment, disability or handicap resulting from such injuries, be compensated; and ii) the injuries for which they will not be compensated. Prospective participants should be informed of the committee’s decisions, as part of the process of informed consent.

As the EC cannot make such advance determination in respect of unexpected or unforeseen adverse reactions, such reactions must be presumed compensable and should be reported to the committee for prompt review as they occur.

The IC process or form should contain no words that would absolve an investigator from responsibility in the case of accidental injury, or that would imply that participants would waive their right to seek compensation for impairment, disability or handicap.

Prospective participants should be informed that they will not need to take legal action to secure the free medical treatment or compensation for injury to which they may be entitled. They should also be told what medical service or organization or individual will provide the medical treatment and what organization will be responsible for providing compensation.

Source: International Ethical Guidelines for Biomedical Research Involving Human Participants

Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) Geneva (Guideline 19)