**4. Various international ethical considerations**

Similar to other fields of medicine, laboratory medicine is obliged to adhere to high ethical standards. With the advancement of medical science in the area of laboratory medicine, special ethical considerations should be taken in addition to the general ethical framework followed in biomedical research. Various policies and guidelines related to ethical issues are being developed time to time by several countries or related societies.

### **4.1 Ethical consideration in ISO 15189**

The International Organization for Standardization (ISO) that created ISO 15189:2012 "Medical laboratories-Requirements for quality and competence" in 2012 [10]. Its section 4.1.1.3 elaborated the ethical conduct required in laboratories. ISO 15189 is technically applicable for laboratory equipment, personnel, environmental conditions, consumables, pre- and post-examination processes, reporting and release of laboratory results, and lab information management. As per ISO 15189 standards, the core principles that stated in documents are: (i) there should not be participation in any activities that would diminish confidence in the laboratory's competence, impartiality, judgment or operational integrity; (ii) management and personnel are free from any undue commercial, financial, or others pressure and influences that may adversely affect the quality of work; (iii) where potential conflicts in competing interests exist, they shall be openly and appropriately declared; (iv) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements; (v) confidentiality of information is maintained.

**109**

*Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues*

and pursue to change whenever they seem contrary to patient's interests.

Despite the importance of bio-ethics in lab medicine, still there are lacunae in education training focused on ethics in laboratory. To address this issue, IFCC has recently constituted a task force on ethics (TF-E) to rationalize the documents and spread the education and training on ethics [12]. This task force (TF-E) has created a toolkit which serves as a repository of documents developed worldwide in the kingdom of laboratory ethics [13]. Although the members of the IFCC Task Force on Ethics also contribute to achieve the goal of ethics education in the field of laboratory medicine through the publications on the topic of ethics in collaboration with the electronic journal of International Federation of Clinical Chemistry (eJIFCC).

Professional personnel of a medical laboratory are bound by the ethical codes of their respective profession. A code of ethics may be described as an expression of basic values –the principles and standards by which we should conduct ourselves. Several laboratory professional societies and organizations have developed codes of ethics, with common principles of conduct which act as guidelines to professional members of those organizations [14]. The International Federation of Biomedical Laboratory Science (IFBLS) suggests to maintain strict confidentiality of patient information and test results; safeguard the dignity and privacy of patients and above all be accountable for the quality and integrity of clinical laboratory services being provided [15]. In same line, the American Society of Clinical Pathologists (ASCP) has also advised laboratory staff to treat patients and colleagues with respect, care and thoughtfulness; perform duties in an accurate, precise, timely and responsible manner; and safeguard patient information as confidential, within the

There are several ethical issues in laboratory (**Figure 2**). These issues have divided into three phases according to the laboratory work distribution.

The American Association for Clinical Chemistry (AACC) has also recommended fifteen principles of ethical conduct for laboratories. The major highlights are that [11]: (i) to be honest in all professional accomplishments, and retain the high level of personal veracity*;* (ii) need to avoid any scientific or professional delinquency; (iii) should report any professional that is degrading the standards of laboratory and professionalism that would affect patients care; (iv) to maintain high quality reagents, equipments and consumables. Also, they must confirm the reliability of test reports and quality of confidentiality of reports; (v) respect the privacy and confidentiality of protected health information; (vi) continuously endeavor to augment the professional qualifications, knowledge, and skills, and present them accurately; (vii) encourages the safety of patients, staff and the environment; (viii) must disclose the actual conflicts of interests; (ix) encourage open and honest discussion among physicians, other healthcare providers and/or facility managers; (x) fulfill the appropriate laws

*DOI: http://dx.doi.org/10.5772/intechopen.96122*

**4.2 Ethical consideration in AACC**

**4.3 Ethical consideration in IFCC**

**5. Codes of ethics**

limits of the law.

**6. Ethical issues in laboratory**

*Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues DOI: http://dx.doi.org/10.5772/intechopen.96122*

#### **4.2 Ethical consideration in AACC**

*Bioethics in Medicine and Society*

**Figure 1.**

*Core principles of ethics.*

c.**Justice**: It is an obligation to provide all participants with whatever they are deserve. Basically, we have an obligation to treat all people equally, fairly, and impartially. All individuals should have an opportunity to participate in research unless contraindicated and we must not impose unfair burdens. All doubts of research participants should be cleared by concerned staff. We should make available all the safety concerns as demanded by research participants.

Similar to other fields of medicine, laboratory medicine is obliged to adhere to high ethical standards. With the advancement of medical science in the area of laboratory medicine, special ethical considerations should be taken in addition to the general ethical framework followed in biomedical research. Various policies and guidelines related to ethical issues are being developed time to time by several

The International Organization for Standardization (ISO) that created ISO 15189:2012 "Medical laboratories-Requirements for quality and competence" in 2012 [10]. Its section 4.1.1.3 elaborated the ethical conduct required in laboratories. ISO 15189 is technically applicable for laboratory equipment, personnel, environmental conditions, consumables, pre- and post-examination processes, reporting and release of laboratory results, and lab information management. As per ISO 15189 standards, the core principles that stated in documents are: (i) there should not be participation in any activities that would diminish confidence in the laboratory's competence, impartiality, judgment or operational integrity; (ii) management and personnel are free from any undue commercial, financial, or others pressure and influences that may adversely affect the quality of work; (iii) where potential conflicts in competing interests exist, they shall be openly and appropriately declared; (iv) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements; (v) confidentiality of

**4. Various international ethical considerations**

countries or related societies.

information is maintained.

**4.1 Ethical consideration in ISO 15189**

**108**

The American Association for Clinical Chemistry (AACC) has also recommended fifteen principles of ethical conduct for laboratories. The major highlights are that [11]: (i) to be honest in all professional accomplishments, and retain the high level of personal veracity*;* (ii) need to avoid any scientific or professional delinquency; (iii) should report any professional that is degrading the standards of laboratory and professionalism that would affect patients care; (iv) to maintain high quality reagents, equipments and consumables. Also, they must confirm the reliability of test reports and quality of confidentiality of reports; (v) respect the privacy and confidentiality of protected health information; (vi) continuously endeavor to augment the professional qualifications, knowledge, and skills, and present them accurately; (vii) encourages the safety of patients, staff and the environment; (viii) must disclose the actual conflicts of interests; (ix) encourage open and honest discussion among physicians, other healthcare providers and/or facility managers; (x) fulfill the appropriate laws and pursue to change whenever they seem contrary to patient's interests.

#### **4.3 Ethical consideration in IFCC**

Despite the importance of bio-ethics in lab medicine, still there are lacunae in education training focused on ethics in laboratory. To address this issue, IFCC has recently constituted a task force on ethics (TF-E) to rationalize the documents and spread the education and training on ethics [12]. This task force (TF-E) has created a toolkit which serves as a repository of documents developed worldwide in the kingdom of laboratory ethics [13]. Although the members of the IFCC Task Force on Ethics also contribute to achieve the goal of ethics education in the field of laboratory medicine through the publications on the topic of ethics in collaboration with the electronic journal of International Federation of Clinical Chemistry (eJIFCC).

#### **5. Codes of ethics**

Professional personnel of a medical laboratory are bound by the ethical codes of their respective profession. A code of ethics may be described as an expression of basic values –the principles and standards by which we should conduct ourselves. Several laboratory professional societies and organizations have developed codes of ethics, with common principles of conduct which act as guidelines to professional members of those organizations [14]. The International Federation of Biomedical Laboratory Science (IFBLS) suggests to maintain strict confidentiality of patient information and test results; safeguard the dignity and privacy of patients and above all be accountable for the quality and integrity of clinical laboratory services being provided [15]. In same line, the American Society of Clinical Pathologists (ASCP) has also advised laboratory staff to treat patients and colleagues with respect, care and thoughtfulness; perform duties in an accurate, precise, timely and responsible manner; and safeguard patient information as confidential, within the limits of the law.

#### **6. Ethical issues in laboratory**

There are several ethical issues in laboratory (**Figure 2**). These issues have divided into three phases according to the laboratory work distribution.

**Figure 2.** *Ethical issues in laboratory phases.*

Pre-analytical phase issues are related to patient's interaction, specimen collection, sample receiving and its transport. Analytical phase issues are usually related to quality control, whereas, post-analytical phase issues are related to reporting of results, keeping and maintaining records [16].
