Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 19

Right of Injured Subjects to Treatment and Compensation

Investigators should ensure that research subjects 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. Subjects must not be asked to waive the right to compensation.

Commentary on Guideline 19

Guideline 19 is concerned with two distinct but closely related entitlements. The first is the uncontroversial entitlement to free medical treatment and compensation for accidental injury inflicted by procedures or interventions performed exclusively to accomplish the purposes of research (non-therapeutic procedures). The second is the entitlement of dependants to material compensation for death or disability occurring as a direct result of study participation. Implementing a compensation system for research-related injuries or death is likely to be complex, however.

Equitable Compensation and Free Medical Treatment. Compensation is owed to research subjects who are disabled as a consequence of injury from procedures performed solely to accomplish the purposes of research. Compensation and free medical treatment are generally not owed to research subjects who suffer expected or foreseen adverse reactions to investigational therapeutic, diagnostic, or preventive interventions when such reactions are not different in kind from those known to be associated with established interventions in standard medical practice. In the early stages of drug testing (Phase I and early Phase II), it is generally unreasonable to assume that an investigational drug holds out the prospect of direct benefit for the individual subject; accordingly, compensation is usually owed to individuals who become disabled as a result of serving as subjects in such studies.

The ethical review committee should determine in advance:

(1) the injuries for which subjects will receive free treatment and, in case of impairment, disability, or handicap resulting from such injuries, be compensated; and

(2) the injuries for which they will not be compensated.

Prospective subjects should be informed of the committee's decisions, as part of the process of informed consent. As an ethical review committee 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.

Subjects must not be asked to waive their rights to compensation or required to show negligence or lack of a reasonable degree of skill on the part of the investigator in order to claim free medical treatment or compensation. The informed consent 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 subjects would waive their right to seek compensation for impairment, disability, or handicap. Prospective subjects 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.

Obligation of the Sponsor with Regard to Compensation. Before the research begins, the sponsor, whether a pharmaceutical company or other organization or institution, or a government (where government insurance is not precluded by law), should agree to provide compensation for any physical injury for which subjects are entitled to compensation, or come to an agreement with the investigator concerning the circumstances in which the investigator must rely on his or her own insurance coverage (for example, for negligence or failure of the investigator to follow the protocol, or where government insurance coverage is limited to negligence). In certain circumstances it may be advisable to follow both courses. Sponsors should seek adequate insurance against risks to cover compensation, independent of proof of fault.

The Islamic Point of View Concerning Guideline 19

Right of Injured Subjects to Treatment and Compensation

1. Research subjects are entitled to free medical treatment when they catch any disease as a result of their involvement and to equitable compensation for any impairment, disability, or handicap that results from their participation. Their entitlement is based on the following:

a. The principles of justice and equity advocated by Islam and all divine creeds must be observed and firmly established in people's lives. God says, "God enjoins justice" (Al-Nahl XVI: 90). He also says, "We have sent Our messengers with explicit signs, and sent down with them the Book and the Scale, that people may stand in justice" (Al-Hadeed LVII: 25).

b. The Islamic legal rule of reparation, which makes it an obligation for a person who causes any damage to another to make equitable compensation for the loss.

c. The implicit agreement between research sponsor(s) and involved subjects entails a religious responsibility on the part of the former party to make up for the damages suffered by a subject as a result of participation in the research.

2. Therefore, no investigator should ask subjects to waive, or be indifferent to, their rights to treatment and/or compensation, as that involves injustice, inequity, departure from fairness, and denial of rights. There is, however, no conflict between an individual's right to waive his right voluntarily, as long as he is not subjected to any pressure, enticement or deception practiced after the injury.

3. When a subject dies as a result of his participation in research, his heirs are entitled to the compensation due to him as stipulated in Islamic Legislation. Islamic Center of Southern California