**Abstract**

Several ethical issues exist within the diagnostic medical laboratory. The major ethical challenges such as; consent, confidentiality, codes of conduct, conflict of interest, lab utilisation, proficiency, and direct access testing are some times more prevalent in resource-limited settings. Presently, decisions regarding diagnosis and patient's treatment are commonly taken on the basis of outcomes and interpretations of laboratory test results. Therefore, ethics plays a significant role in laboratory medicine. Apart from the lab results, laboratory staff is another important aspect of the laboratory. Hence, it is highly recommended that knowledge of ethics helps to protect confidence; operational integrity, capability, impartiality, and safety of the staff. Many countries and their professional societies have developed policies and guidance material with regard to ethical issues in the area of laboratory medicine. The organizations specially; International of federation of clinical chemistry (IFCC), American Association of Clinical Chemistry (AACC) and International Organization for Standardization (ISO) have defined ethical recommendations for clinical laboratories. They are, in general, outlined the responsibilities of laboratory professionals towards their profession, the patient, and the society. However, implication of ethical standards and guidelines are vary between different cultures, geographies, and according to available resources. In this chapter, we have mentioned the ethical consideration of IFCC, AACC and ISO 15189:2012 with regard to laboratory medicine and also addressed the various ethical issues that arises day to day in laboratory medicine in the current scenario.

**Keywords:** laboratory, ethics, issues, principles

### **1. Introduction**

In the current time, ethical concerns exist everywhere whether it is a medical field or life science. Lab Medicine and biomedical research, both fields are interconnected by laboratory testing where new results, remaining patient's blood sample, and genetic testing, etc. are some of the major ethical issues that commonly exist. Ethical issues plays very crucial role in laboratory medicine. Therefore, it is required for laboratories to strictly follow ethical principles.

The field of ethics involves 'a set of principles of right conduct' [1] and bioethics is well-defined as a branch of applied ethics that studies the philosophical, social and legal issues arising in medicine and life sciences. IFCC-task force has suggested that all the area of medicine to fulfill with ethical standards and guidelines and the field of lab medicine is no exemption. According to the IFCC verdict, prognosis as well as medications associated with certain medical conditions is usually determined by outcome, results and analysis of laboratory tests [2]. When we talk about the laboratory system, staff comes at first as they are directly linked in interaction with patients and their care. Apart from laboratory staff, everyone who is involved on the way is equally responsible for maintaining laboratory ethical values. Henceforth, it is highly obligatory to evade any such activity that would downgrade the expertise, neutrality, outcomes, operational truthfulness or patient's confidence in laboratory. Laboratory staff 's behavior and etiquettes also comes in this category, thus, their actions should be in a professional way for example, wearing laboratory coat/apron, proper dressedup, phones should be turned silent/OFF during the time of testing and not discussing any report with clients and others. Hence, various international and national guidelines and declarations have been evolved with time to time and thus critically upgraded the practice of bio-ethics in the field of biomedical research. Compliance with these guidelines confirms the autonomy, dignity and well-being of participants as well as the integrity and credibility of research results [3].
