Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 3

Ethical Review of Externally Sponsored Research

An external sponsoring organization and individual investigators should submit the research protocol for ethical and scientific review in the country of the sponsoring organization, and the ethical standards applied should be no less stringent than they would be for research carried out in that country. The health authorities of the host country, as well as a national or local ethical review committee, should ensure that the proposed research is responsive to the health needs and priorities of the host country and meets the requisite ethical standards.

Commentary on Guideline 3

Definition. The term externally sponsored research refers to research undertaken in a host country but sponsored, financed, and sometimes wholly or partly carried out by an external international or national organization or pharmaceutical company with the collaboration or agreement of the appropriate authorities, institutions and personnel of the host country.

Ethical and Scientific Review. Committees in both the country of the sponsor and the host country have responsibility for conducting both scientific and ethical review, as well as the authority to withhold approval of research proposals that fail to meet their scientific or ethical standards. As far as possible, there must be assurance that the review is independent and that there is no conflict of interest that might affect the judgment of members of the review committees in relation to any aspect of the research. When the external sponsor is an international organization, its review of the research protocol must be in accordance with its own independent ethical-review procedures and standards.

Committees in the external sponsoring country or international organization have a special responsibility to determine whether the scientific methods are sound and suitable to the aims of the research; whether the drugs, vaccines, devices, or procedures to be studied meet adequate standards of safety; whether there is sound justification for conducting the research in the host country rather than in the country of the external sponsor or in another country; and whether the proposed research is in compliance with the ethical standards of the external sponsoring country or international organization.

Committees in the host country have a special responsibility to determine whether the objectives of the research are responsive to the health needs and priorities of that country. The ability to judge the ethical acceptability of various aspects of a research proposal requires a thorough understanding of a community's customs and traditions. The ethical review committee in the host country, therefore, must have as either members or consultants persons with such understanding; it will then be in a favorable position to determine the acceptability of the proposed means of obtaining informed consent and otherwise respecting the rights of prospective subjects as well as of the means proposed to protect the welfare of the research subjects. Such persons should be able, for example, to indicate suitable members of the community to serve as intermediaries between investigators and subjects, and to advise on whether material benefits or inducements may be regarded as appropriate in the light of a community's gift-exchange and other customs and traditions.

When a sponsor or investigator in one country proposes to carry out research in another, the ethical review committees in the two countries, by agreement, may undertake to review different aspects of the research protocol. In short, in respect of host countries either with developed capacity for independent ethical review or in which external sponsors and investigators are contributing substantially to such capacity, ethical review in the external, sponsoring country may be limited to ensuring compliance with broadly stated ethical standards. The ethical review committee in the host country can be expected to have greater competence for reviewing the detailed plans for compliance, in view of its better understanding of the cultural and moral values of the population in which it is proposed to conduct the research; it is also likely to be in a better position to monitor compliance in the course of a study. However, in respect of research in host countries with inadequate capacity for independent ethical review, full review by the ethical review committee in the external sponsoring country or international agency is necessary.

The Islamic Point of View Concerning Guideline 3

Ethical Review of Externally Sponsored Research

In regards to research undertaken in a host country but sponsored, financed, and wholly or partly carried out by an external international or national organization or pharmaceutical company, with the collaboration or agreement of the appropriate authorities, institutions and personnel of the host country - from the perspective of Islamic jurisprudence (fiqh), the following should be observed.

1. The scientific and ethical review should be conducted objectively, independently, and honestly in the country of the sponsoring organization, to guarantee that the ethical controls stated in guidelines 1 and 2 are applied. The ethical standards applied should be no less stringent when applied in another country, as all members of the human race should be treated equally and all forms of racial discrimination should be renounced. Equity for all people is the basis of the message of Islam and all divine religions, for God declares to us that "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). Ibn Al-Qayyem explains this principle, saying, "God, the Most Supreme, has sent His messengers and books so that people may apply justice, which is the equity on which the Earth and the Heavens are founded. Where indications of justice are clear and can be seen wherever one turns, God's Law and Creed prevail." 21

2. A similar ethical review should be conducted in the host country to achieve the desired goal and make sure that the proposed research meets the health needs and priorities of that country. It is one of the purposes of Islamic Law is "to place everything in its right place [on the list of priorities], in light of reality and its requirements, so that what needs to take priority is not delayed, and what ought to be delayed is not given priority." In the jurisprudence controls of priorities, it is stipulated that, "A more beneficial thing has priority over a less beneficial one;" "Prevention of what causes more harm has priority over prevention of something less harmful;" "The most outweighing item should be given priority when there is a congestion of benefits and harms;" "What is needed immediately should be given precedence over what is needed without any special hurry;" and "A person with a need should be attended to before one with no need."

3. If the host country is expected to gain very limited or no benefit from certain experiments, then the order of rules of necessity according to Islamic Law would be that decent human life has precedence over expected benefit from the research.

Moreover, if the country where research is conducted has no specialists in the relevant field who can safeguard its rights, the rule in Islamic Law is that the judiciary are guardian of a party with no other guardian. Therefore, the research projects, its purposes, the precautions taken, and the benefit expected should be submitted to the judiciary system to review them as thoroughly as to guarantee that the said rule is complied with.

21. Al-Turuq Al-Hamiyah, p. 13.

22. Al-Wakeeli, Fiqh Al-Awlawiyaat, p. 16.

23. Ibid., p. 197.

24. Ibid., p. 211.

25. Ibid., p. 222.

26. Ibid., p. 256.

27. Ibid., p. 264. Islamic Center of Southern California