Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 1

Ethical Justification and Scientific Validity of Biomedical Research Involving Human Beings

Islamic Perspective

The ethical justification of biomedical research involving human subjects is the prospect of discovering new ways of benefiting people's health. Such research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out. Moreover, because scientifically invalid research is unethical in that it exposes research subjects to risks without possible benefit, investigators and sponsors must ensure that proposed studies involving human subjects conform to generally accepted scientific principles and are based on adequate knowledge of the pertinent scientific literature.

Commentary on Guideline 1

Among the essential features of ethically justified research involving human subjects, including research with identifiable human tissue or data, are that the research offers a means of developing information not otherwise obtainable, that the design of the research is scientifically sound, and that the investigators and other research personnel are competent. The methods to be used should be appropriate to the objectives of the research and the field of study. Investigators and sponsors must also ensure that all who participate in the conduct of the research are qualified by virtue of their education and experience to perform their roles competently. These considerations should be adequately reflected in the research protocol submitted for review and clearance to scientific and ethical review committees (Appendix I).

Scientific review is discussed further in the Commentaries to Guidelines 2 and 3: Ethical review committees and Ethical review of externally sponsored research. Other ethical aspects are discussed in the remaining guidelines and their commentaries. The protocol designed for submission for review and clearance to scientific and ethical review committees should include, when relevant, the items specified in Appendix I, and should be carefully followed in conducting the research.

The Islamic Point of View Concerning Guideline 1 (Ethical Justification and Scientific Validity of Biomedical Research Involving Human Beings)

The Islamic Point of View

From the point of view of Islamic jurisprudence, justification and rationalization of such research is contingent on the following:

1. The purpose of conducting it is to secure an absolute benefit, which enhances human health; prevent an instance of absolute harm, which impairs that health; or give priority to securing an outweighing benefit over preventing a less substantial instance of harm, if they are in conflict and only one of them can be realized, for "The majority [of scholars] agree that a less substantial harm is forgiven when coupled with an outweighing benefit." 16 Ibn Taimiyah says, "Islamic Law is built upon the recognition and completion of benefits and prevention and reduction of harm. It is required that the better of two good things should be given priority by abandoning the inferior one, and the worse of two evil things be prevented, even if the inferior one does take place." 17

2. The [absolute or outweighing] benefit must be real in the sense that it does not violate a legal stipulation made in the Quran or in the Prophet's Sunna, nor contradicts any of the firmly established, absolute principles or rulings of Islamic jurisprudence.

3. The means to reach the goal, i.e. the research itself, should be legitimate, as the end does not justify the means, and both means and end must be legally permissible.

4. The design of the research must be scientifically sound, which means that it should be more likely to achieve the sound purpose it is expected to accomplish. Otherwise, it would be in vain that man is honored and protected from being a guinea pip used in experiments. God says, "We have honored Adam's children" (Al-Israa XVII: 70). One rule of Islamic jurisprudence is that "Every action that ceases to pursue its objective is unacceptable." 18

5. The research team members must be qualified and competent enough to conduct their research successfully, since the desired end is contingent on their being so. A rule of Islamic Law is that, "Anything vital for the discharge of an obligation is itself an obligation."

In addition, a rule of Islamic Law says that "the person placed to be placed in charge in every situation is the one most capable of achieving the interests involved in that situation." 19

16. As Al-Qarfi says Al-Akheerah, XIII: 322.

17. Majmou' Fataawa Ibn Taimiyah, XXX: 193, and Mukhtasar Al-Fataawa Al-Masriyah, p. 383.

18. Al-'Iz Ibn 'Abd Al-Salaam, Al-Qawaa'ed Al-Kubra, II: 249.

19. Ibid., II: 337. Islamic Center of Southern California