AMANET Web-based Basic Health Research Ethics Course Module 1: Evolution of Biomedical Research Ethics Lecture Notes, Part

1 By Roma Chilengi BSc. MBcHB. DHTM. Clin. Research

This module has two parts. The first establishes a clear foundation of the players central to research ethics. It defines ethics themselves, the researcher and the participants. The ethical issues raised in biomedical research hinge mainly on the question: How can the rights of individual persons be reconciled with the need for scientific/medical advancement? The goal of medical research is to improve is to improve human well being.

Ethics The word is derived form Greek ethos meaning the set of moral principles or a system of moral principles or rules of behaviour. It is a branch of philosophy that deals with moral principles that may be connected to beliefs about what may be considered wrong or right. An ethical behaviour is therefore one that is deemed to be morally correct or acceptable. Research ethics is the application of this concept to the conduct of research.

What is research? It is important at this point to draw the line between research and practice. This though, is a very hard task as the two often occur together. Research is a systematic investigation (including development, testing, and evaluation) designed to discover or contribute to a body of generalisable knowledge. Generalisable knowledge consists of theories, principles, or relationships (or the accumulation of data on which they may be used), that can be corroborated by accepted scientific observation and inference. Not all research involves human participants, but when they are involved, researchers and their teams are legally and ethically obligated to protect them.

A researcher is the individual who undertakes to study. This term may be used synonymously with Investigator, who according to GCP is: the person who takes responsibility for the conduct of the trial or study and the study site. www.amanet-trust.org http://elearning.amanet-trust.org 1

AMANET Web-based Basic Health Research Ethics Course Module 1: Evolution of Biomedical Research Ethics Lecture Notes, Part 1 By Roma Chilengi BSc. MBcHB. DHTM. Clin. Research

The practice of medicine or behavioural therapy on the other hand refers to a class of activities designed solely to enhance the well-being of an individual patient or client. The purpose of practice is to provide diagnosis, preventive or treatment therapy.

WHO is the research participant? The human participant is a living individual about whom a researcher obtains either: (1) data through intervention or interaction with the individual; or (2) identifiable private information. In other words, this is the individual upon whom the investigator performs research; the following terms are used interchangeably: subject, volunteer, respondent or participant. In the course of participating in a research study, a participant may provide information to investigators about other persons, such as a spouse, relative, friend, or social acquaintance. The information may be sensitive (e.g., regarding alcohol or drug use, diet, or lifestyle) and personal. These other persons are referred to as third parties. There are still unresolved ethical questions around third parties and whether they should be considered human subjects. If information is obtained about a third party from a research participant, then these third parties may be considered human subjects under certain circumstances. However, if no private and individually identifiable information is obtained about third parties, then they may not generally be considered as human subjects. Nevertheless, investigators should treat all research information about individuals as confidential. Identifying information, whether about a human subject or a third party, should be kept secure and protected from inappropriate disclosure.

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AMANET Web-based Basic Health Research Ethics Course Module 1: Evolution of Biomedical Research Ethics Lecture Notes, Part 1 By Roma Chilengi BSc. MBcHB. DHTM. Clin. Research

WHEN does research include human participation? The term research may be very general. Some research may not actually involve living human beings, but may be considered as such. For example, research that involves tissue specimens, medical records, genetic material, behavioural and/or biomedical assessments, and treatments. In addition to the traditional understanding of research participation, legal obligations to protect human participants apply to research that uses: Bodily materials, such as cells, blood or urine, tissues, organs, and hair or nail clippings, even if the researcher did not collect these materials. Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research. Private information, such as medical data, that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals falls into this category.

Benefits of research The goal of all medical research is generally to improve human well-being. Medical research with humans is justifiable because it seeks knowledge that not only is of theoretical interest, but also will benefit many people and society as a whole.

Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. (Declaration of Helsinki, Intro, Paragraph 6) The collection, analysis and interpretation of information obtained from research involving human beings contribute significantly to the improvement of human health. (CIOMS 11) There are very many benefits that have arisen from research, too numerous to be listed. An African example cited in this regard is from the work of David Ross etal on their Vitamin A supplementation studies in northern Ghana which unequivocally showed great

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AMANET Web-based Basic Health Research Ethics Course Module 1: Evolution of Biomedical Research Ethics Lecture Notes, Part 1 By Roma Chilengi BSc. MBcHB. DHTM. Clin. Research

benefits of the supplementation. Their findings led to policies that realised fortification of food with multi-nutrients. Risks of research Unfortunately the successes of research have come with a cost. Historically, even well intended research has resulted into disasters which not infrequently cost life. The list of historical atrocities of research is very long. The major land mark events are described in part II of this module.

What makes research morally acceptable? Some people think that ethics is purely a matter of individual opinion. However, ethical analysis needs to be firmely based on rationality and logic. In a society where different groups of people use different systems of morals, there is a need for a systematic approach in order to understand and balance rival positions so as to come to a reasonable conclusion. Broadly speaking, there are three different approaches to examining what makes an action morally acceptable.

1. Goal-based approach Using this approach, an action is good if the goal or outcome is good. You can express this simply as the end justifies the means. In philosophy, this is also called utilitarian approach.

2. Duty-based approach This approach asks if an action is consistent with moral principles. If an action violates moral principles, such as cheating or lying, then the action is wrong, even if the outcome is good. This approach is underpinned by theories such as those proposed by philosopher Emmanuel Kant.

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AMANET Web-based Basic Health Research Ethics Course Module 1: Evolution of Biomedical Research Ethics Lecture Notes, Part 1 By Roma Chilengi BSc. MBcHB. DHTM. Clin. Research

3. Rights-based approach Right-based thinkers stress the freedoms of the individual protected in a given society by the concept of rights. For example, most societies recognize the right of an individual to refuse a medical intervention. So you must find out, and respect, the views and feelings of individuals. Tension can develop between the good of protecting and promoting respect of such individual rights and the good and benefit to the community.

All the three approaches to one extent or the other make health care research morally acceptable.

References for further reading Declaration of Helsinki, World Medical Association (2000) CIOMS guidelines for biomedical research ICH GCP guidelines; E-6 series 2005.

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