Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

(An Islamic Perspective)

Preamble

Preamble

The term "research" refers to a class of activity designed to develop or contribute to general knowledge. General knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, "research" includes both medical and behavioral studies pertaining to human health. Usually "research" is modified by the adjective "biomedical" to indicate its relation to health.

Progress in medical care and disease prevention depends upon an understanding of physiological and pathological processes or epidemiological findings, and requires in some cases research involving human subjects. The collection, analysis, and interpretation of information obtained from research involving human beings contribute significantly to the improvement of human health.

Research involving human subjects includes:

- studies of a physiological, biochemical, or pathological process, or of the response to a specific intervention - whether physical, chemical or psychological - in healthy subjects or patients;

- controlled trials of diagnostic, preventive, or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;

- studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and

- studies concerning human health-related behavior in a variety of circumstances and environments.

Research involving human subjects may employ either observation or physical, chemical, or psychological intervention; it may also either generate records or make use of existing records containing biomedical or other information about individuals who may or may not be identifiable from the records and information. The use of such records and the protection of the confidentiality of data obtained from those records are discussed in International Guidelines for Ethical Review of Epidemiological Studies (CIOMS, 1991).

The research may be concerned with the social environment, manipulating environmental factors in a way that could affect incidentally-exposed individuals. The definition of research is made in broad terms in order to embrace field studies of pathogenic organisms and toxic chemicals under investigation for health-related purposes.

Biomedical research with human subjects is distinguished from the practice of medicine, public health and other forms of health care, which is designed to contribute directly to the health of individuals or communities. Prospective subjects may find it confusing when research and practice are conducted simultaneously, as when research is designed to obtain new information about the efficacy of a drug or other therapeutic, diagnostic, or preventive modality.

As stated in Paragraph 32 of the Declaration of Helsinki,

In the treatment of a patient, where proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic, and therapeutic measures, if in the physician's judgment it offers hope of saving life, re-establishing health, or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.

Professionals whose roles combine investigation and treatment have a special obligation to protect the rights and welfare of the patient-subjects. An investigator who agrees to act as physician-investigator undertakes some or all of the legal and ethical responsibilities of the subject's primary-care physician. In such a case, if the subject withdraws from the research owing to complications related to the research or in the exercise of the right to withdraw without loss of benefit, the physician has an obligation to continue to provide medical care, to see that the subject receives the necessary care in the health-care system, or to offer assistance in finding another physician.

Research with human subjects should be carried out only by, or strictly supervised by, suitably qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research, the reasons for proposing the involvement of human subjects in it, the nature and degree of any known risks to the subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects' consent will be adequately informed and voluntary. The protocol should be scientifically and ethically appraised by one or more suitably constituted review bodies, independent of the investigators.

New vaccines and medicinal drugs, before being approved for general use, must be tested on human subjects in clinical trials; such trials constitute a substantial part of all research involving human subjects. Islamic Center of Southern California