Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 19

Ethical Obligation of External Sponsors to Provide Health-Care Services

External sponsors are ethically obliged to ensure the availability of:

health-care services that are essential to the safe conduct of the research;

treatment for subjects who suffer injury as a consequence of research interventions; and,

services that are a necessary part of the commitment of a sponsor to make a beneficial intervention or product developed as a result of the research reasonably available to the population or community concerned.

Commentary on Guideline 21

Obligations of external sponsors to provide health-care services will vary with the circumstances of particular studies and the needs of host countries. The sponsors' obligations in particular studies should be clarified before the research is begun. The research protocol should specify what health-care services will be made available, during and after the research, to the subjects themselves, to the community from which the subjects are drawn, or to the host country, and for how long. The details of these arrangements should be agreed by the sponsor, officials of the host country, other interested parties, and, when appropriate, the community from which subjects are to be drawn. The agreed arrangements should be specified in the consent process and document.

Although sponsors are, in general, not obliged to provide health-care services beyond that which is necessary for the conduct of the research, it is morally praiseworthy to do so. Such services typically include treatment for diseases contracted in the course of the study. It might, for example, be agreed to treat cases of an infectious disease contracted during a trial of a vaccine designed to provide immunity to that disease, or to provide treatment of incidental conditions unrelated to the study.

The obligation to ensure that subjects who suffer injury as a consequence of research interventions obtain medical treatment free of charge, and that compensation be provided for death or disability occurring as a consequence of such injury, is the subject of Guideline 19, on the scope and limits of such obligations.

When prospective or actual subjects are found to have diseases unrelated to the research, or cannot be enrolled in a study because they do not meet the health criteria, investigators should, as appropriate, advise them to obtain, or refer them for, medical care. In general, also, in the course of a study, sponsors should disclose to the proper health authorities information of public health concern arising from the research.

The obligation of the sponsor to make reasonably available for the benefit of the population or community concerned any intervention or product developed, or knowledge generated, as a result of the research is considered in Guideline 10: Research in Populations and Communities with Limited Resources.

The Islamic Point of View Concerning Guideline 21

Ethical Obligation of External Sponsors to Provide Health-Care Services

1. The ethical commitment of institutions sponsoring research and studies to provide free essential medical care services, so that the research will proceed safely, falls under the concept of justice and charity, which are enjoined by Islamic Law.

2. The commitment of those institutions to provide treatment for patients who suffer injury as a result of their participation in research falls under the Islamic rule of reparation, which makes it an obligation for a person who causes any damage to another to make repair for it by removing it and its effects and making equitable compensation for the loss suffered by the injured party. Islamic Center of Southern California