Chapter 1: Introduction

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.(1)

In the present context, "research" includes both medical and behavioural studies pertaining to human health. Usually "research" is modified by the adjective "biomedical" to indicate its relation to health. In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential objective of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research (2).

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 participant is defined by WHO as " any social science, biomedical, behavioral or epidemiological act that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human being are involved”.

1.1 Research involving human subjects includes:

· Studies of physiological, biochemical or pathological processes, 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.

· Studies concerning human health-related behavior in a variety of circumstances and environments (1).

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

Biomedical research involving human subjects is to be 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 to be conducted simultaneously, as when research is designed to obtain new information about the efficacy of a drug or other therapeutic, diagnostic or preventive modality.

1.2 What is ethics in research?

“Ethics is the study of morality – careful and systematic reflection on analysis of moral decisions and behaviour” (2). Ethics and ethical principles extend to all spheres of human activity (3).

The Declaration of Helsinki issued by the World Medical Association in 1964, is the fundamental document in the field of ethics in biomedical research and has influenced the formulation of international, regional and national legislation and codes of conduct. The declaration, amended several times, most recently in 2000, is a comprehensive international statement of the ethics of research involving human subjects. It sets out ethical guidelines for physicians engaged in both clinical and non-clinical biomedical research (4).

Research involving 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 involvement of human subjects; 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.

The mere formulation of ethical guidelines for biomedical research involving human subjects will hardly resolve all the moral doubts that can arise in association with much research, but the Guidelines can at least draw the attention of sponsors, investigators and ethical review committees to the need to consider carefully the ethical implications of research protocols and the conduct of research, and thus conduct of high scientific and ethical standards of biomedical research..

References:

1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.

2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964.

3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212 Ferney-Voltaire Cedex, France.

4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research Involving Preamble: 28 June 1999.