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Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

5 

 

Ethical Considerations in Clinical Biochemistry and Laboratory Medicine: A 

Discussion Based on ‘The Belmont Report’ 

 

Miliva Mozaffor1, Mariya Tabassum2, Mohammad Tipu Sultan3, Shamima Parvin4 

1. Clinician Researcher, Biomedical Research Foundation (BRF), Dhaka & Laboratory Consultant and Head, 

Department of Biochemistry, Ashiyan Medical College Hospital, Dhaka-1229, Bangladesh.  

Email: miliva17@yahoo.com  (corresponding author) 

2. Assistant Professor, Department of Biochemistry, Pabna Medical College, Pabna-6600, Bangladesh. 

3. Postgraduate student, Department of Forensic Medicine & Toxicology, Dhaka Medical College, Dhaka-1000, 

Bangladesh. 

4. Professor and Head, Department of Biochemistry & Vice-Principal, Mugda Medical College, Dhaka-1214, 

Bangladesh. 

 

Abstract: With technical sophistication and innovation in the field of medical science, a considerable 

proportion of medical diagnosis now rely on laboratory analyses, which emphasises the crucial role of 

laboratory physicians in patient care. Sustaining high ethical standards remains crucial in both clinical 

biochemistry and laboratory medicine, and several ethical dilemmas are faced by laboratory physicians in 

day-to-day practice. In a low-resource country like Bangladesh, formal ethics education or ethical 

framework in laboratory practice is still absent; ethics has not received that much attention it this field. This 

paper has considered ethical issues encountered during the daily routine work of laboratory physicians and 

specially focused on the ethical issues encountered during the pre-analytical, analytical and post-analytical 

phases of laboratory medicine practice and discuss those issues in light of ‘The Belmont Report’ (1978) 

perspective. It is not intended to be a comprehensive one, rather it aims to complement existing guidelines 

and documents that are available in some institutions and to offer a framework for addressing ethical issues 

encountered in the practice of clinical biochemistry and laboratory medicine in Bangladesh. 

Key words: The Belmont Report, ethics, clinical biochemistry, laboratory medicine, Bangladesh. 

Introduction: With technical sophistication 

and innovation in the field of medical 

science, a considerable proportion of medical 

diagnosis now rely on laboratory analyses, 

which emphasises the crucial role of 

laboratory physicians in patient care1. In 

laboratory medicine, there is usually no direct 

or minimal contact with patients; however, 

the laboratory physicians’ first and foremost 

duty is to act in the best interests of the patient 

who is often “just a number” (as coded)2. 

Although personal knowledge of the patient  

is often lacking, the laboratory physician 

does have intimate knowledge of at least a 

part of the patient – “the labelled specimen” 

– and an unusual but traditional three-way 

contract is made between clinician, 

laboratory physician and patient2,3. This is the 

case in particular where a life-altering event 

may occur on the basis of the definitive 

decision of a laboratory physician and the act 

of faith with which this is accepted by the 

patients1-3.  

The evolution of medical ethics over the 

years is well documented and evolved 



Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

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through the Nuremberg Code from 19474, the 

Declaration of Geneva from September 1948, 

with its continual amendment until October 

20175, the Declaration of Helsinki from June 

1964, with its continual amendment until 

October 20136 and ‘The Belmont Report’ 

from 19787. While many of these documents 

focus on medical research, concepts in the 

Declaration of Geneva and The Belmont 

Report are also applicable to the practice of 

clinical medicine to date. Moreover, ‘The 

Belmont Report’ remains one of the key 

milestones concerning ethics in biomedical 

research. Created in 1978 by the National 

Commission for the Protection of Human 

Subjects of Biomedical and Behavioral 

Research of the United States, it outlines 

ethical principles and guidelines for the 

protection of human subjects. It identifies 

three core principles; those are as follows:7  

a) Respect for persons: To ensure autonomy 

of the subjects/patients as well as to protect 

autonomy of those with diminished capacity 

to consent and make decision by themselves.  

b) Beneficence: Acting in the best interests of 

patients or study subjects as well as maximize 

benefits and minimize harm. It is also termed 

as non-maleficence. 

c) Justice: Moral obligation to treat all the 

patients equally disregarding age, sex, and 

race, and to ensure fair allocation of 

resources, e.g. treatment facilities and 

medications/vaccines, what is rightly due in 

terms of benefits, risks and cost. 

As practicing physicians in the field, we have 

felt that sustaining high ethical standards 

remains crucial in both clinical biochemistry 

and laboratory medicine, and several ethical 

dilemmas are faced by laboratory physicians 

in day-to-day practice2. The importance of 

ethics in clinical biochemistry and laboratory 

medicine can never be ignored; however, 

there is variability in ethics education 

worldwide, focusing on the ethics in the 

laboratory procedure and practice. In a low-

resource country like Bangladesh, formal 

ethics education or ethical framework in 

laboratory is still absent; ethics has not 

received that much attention it this field. As 

we have stated earlier, the three basic 

principles of ‘The Belmont Report’ can be 

applied to both research and clinical settings. 

In this paper, these three principles will 

mostly be highlighted to clarify the ethics in 

clinical biochemistry and laboratory 

medicine. This paper aims to focus on the 

ethical issues encountered during daily 

routine work of laboratory physicians and 

will consider the pre-analytical, analytical 

and post-analytical phases in laboratory 

medicine and discuss those in ‘The Belmont 

Report’ perspective. 

 

Ethical Issues in the Pre-analytical Phase: 

Usually it is assumed that the referring 

clinician has ordered the appropriate tests to 

support his/her provisional diagnosis, not for 

any financial gain, discussed the risks and 

benefits of the tests to the patients, referred 

testing to an appropriate laboratory (one that 

is that is properly certified and approved by 

the corresponding authority and in which the 

referring individual has no financial interest) 

and practiced those three ethical principles to 

the best of his/her ability. The maintenance of 

ethical standards in the pre-analytical phase 

is the collaborative responsibility of the 

laboratory, the health care provider, 



Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

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researcher, phlebotomist, nurse, or whoever 

collects the specimen8. In pre-analytical 

phase, their roles include proper 

identification of the patient, collection of the 

appropriate sample using the appropriate 

technique, accurate identification and 

labeling of the sample so that the right tests 

are performed, and proper handling of the 

specimen until testing is performed8,9. In this 

stage, the application of those three principles 

is as follows:  

a) Respect for persons: Consent should be 

obtained prior to sample collection, 

preferably a written one, and this consent 

should be informed (the patient knows what 

testing is being performed and why)10-12. 

However, the consent may be implied when 

a patient provides a requisition from the 

clinician and willingly sits in a collection 

chair and allows a sample to be taken. 

However, implied consent is nuanced as a 

patient who is sitting to have blood collected 

may have been told what to do and may not 

actually understand that they had a choice8. 

Informed consent may pose an ethical 

problem if the patient is incompetent to make 

any decision due to age, mental status, or 

critical illness10-12. However, who may be 

allowed to give consent on behalf of the 

patient may vary among regions, may be 

influenced by different cultural practices12. 

Besides, the patient’s right to refuse to be 

tested or the methods of collection of 

samples, should be respected7. However, 

there are certain situations in which patient 

autonomy is not absolute. For example, a 

patient may be deemed incompetent to make 

a decision about his/her health, as when the 

patient is unconscious, mentally ill, or under 

the influence of drugs11,12. Children are 

generally considered as incompetent in 

decision-making for themselves until and 

unless they are legally emancipated from 

their parents; however, the status of children 

and adolescents under 18 years of age 

remains an area of controversy and is viewed 

differently in different parts of the world12. 

There are cases of compulsory testing in 

certain groups such as intravenous drug users 

and prisoners. In these exceptional cases, 

healthcare professionals have an obligation to 

consult the guidelines provided by the 

institution in which they practice, and they 

must weigh the risks of loss of a patient’s 

autonomy versus the benefits of the testing11. 

Confidential information about patient 

demographics, the visit of a patient to a 

testing facility, which tests were ordered, and 

the reasons for those tests, should be given 

only to appropriate persons8,9,13. 

Confidentiality is a must at every step of the 

process – specimen transportation, data entry 

and report delivery13. 

b) Beneficence: All tests should benefit the 

patient based on the best medical evidence. In 

addition, sample collection should not cause 

harm. Examples of harm in the preanalytical 

phase include infection or pain from the 

collection process (e.g. inadvertent puncture 

of an artery and other adverse events). 

Therefore, standard operating procedures and 

trained personnel should be in place8,9. 

Besides, the collection procedure should be 

carried out using universal precautions to 

protect both the patient and healthcare 

worker. Additional specimens shall not be 

collected for research procedures without 



Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

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informed consent from the patient and 

approval from the appropriate ethics board14.  

c) Justice: The clinical laboratory should, as 

far as it is able, provide access to a wide 

variety of laboratory tests at reasonable cost. 

There should be no preference given to 

individuals to facilitate or expedite the 

collection process at the expense of other 

patients8-10. 

 

Ethical Issues in the Analytical Phase: 

Confidentiality, quality assurance and 

competence are vital for all laboratories and 

settings. In the analytical phase, 

confidentiality may be maintained through 

automation that uses automated bar code 

readers, automated analysis, and auto-

verification, as the patient names are deemed 

by codes15. Nevertheless, challenges of 

ensuring confidentiality are often greater in 

small laboratories with low-resources that 

perform manual testing and in operations that 

conduct near-patient (point-of-care) testing. 

Now we look at those three principles:  

a) Respect for persons: Patient have 

the right to decline to have their specimens 

analyzed even after the specimens have been 

collected and processed8,9. Confidentially 

should be respected and maintained13,15. 

However, in point-of-care settings, it is really 

difficult because testing is often conducted in 

a common room with access by trained and 

non-trained personnel8. 

b) Beneficence: The aim of the 

laboratory in the analytical phase is to 

provide the best possible analytical result. 

This is achieved through good laboratory 

practice and maintenance of professional 

standards. Good laboratory practice should 

involve the establishment of a rigorous 

quality assurance program encompassing 

quality control testing, proficiency testing 

and laboratory accreditation8,9,15. The maxim 

“a wrong result is worse than no result” is a 

guiding principle in this regard8,15,16. Good 

laboratory practice includes refusal to 

analyze or report a result when there is 

evidence of poor sample integrity, incorrect 

or poor labeling or other deficiencies that 

may compromise the test result8,9,17. 

Laboratories should maintain proper 

certification and only qualified, properly 

trained personnel should perform point-of-

care testing2,8.  

c) Justice: Discrimination in the analysis of 

patient samples based on gender, age or racial 

origin is an injustice17. Laboratories should 

develop appropriate operating procedures for 

each type of testing. It is expected that all 

specimens are analyzed accurately and in a 

timely manner8,9,17. 

 

Ethical Issues in the Post Analytical Phase: 

The post analytical phase includes reporting 

and interpretation of results, residual 

specimen storage, and access to data. 

Laboratories should have a policy for 

specimen storage and data protection8,9. 

Archiving of results in either electronic or 

hard copy format is an important aspect of 

good laboratory practice15. Now we will 

discuss those three principles here:  

a) Respect for persons: There are substantial 

differences in the world regarding the 

confidentiality of results. In some areas, the 

patient and the referring clinician are the sole 

legitimate recipients of laboratory data11. 

Exceptions are made if the patient is a 

juvenile or is incapable of receiving or 

understanding laboratory results. However, 



Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

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in other areas, the patient's family is regarded 

as legitimate recipients of a patient's 

laboratory results12. In addition, the patient 

should be allowed to give consent for access 

by others (such as family members) as 

required12,13. Respect for local customs as to 

legitimate recipients of laboratory data 

should be taken into account as laboratories 

develop a policy on dissemination of 

results13. In some areas, there may be 

exceptions regarding who may access results; 

access is affected by legal requirements and 

government regulations, especially in 

forensic cases12,13. Patients have a reasonable 

expectation that their samples will be used 

solely for the laboratory testing requested by 

the clinician. Individuals have the right to 

decide when and if their records or specimens 

shall be used outside the normal medical care 

to which they have consented12,14. Further 

testing of residual samples (except for 

method validation or in cases where samples 

are completely anonymized) should be 

approved by a local ethics committee or 

board, and patient consent may be required14.  

b) Beneficence: Misinterpretation of results 

can lead to patient harm; to minimize this 

harm, only qualified personnel should 

interpret reports15,16. It is expected that results 

should include an appropriate name for the 

test performed, an appropriate reference 

interval, which may be age and gender 

specific, the unit of measurement and, when 

possible, a designation that the test is within 

or above the reference interval. Timely 

access to results is important; withholding of 

results because of non-payment might lead to 

harming the patient especially in emergency 

situations17. Delays in reporting should be 

avoided. It is very crucial that ordering 

clinicians should be notified of errors as soon 

as those are identified, and test results should 

be corrected as soon as possible16.  

c) Justice: The reporting of results should be 

consistent for all patients. Rapid reporting 

may be required for some results, such as for 

"critical" and "significant-risk" results;8 

however, the rules for rapid reporting must 

apply regardless of the source of the sample 

and the patient’s ability to pay17. Sometimes 

residual samples are often used without the 

patient’s knowledge, which is quite 

unethical. However, there are many 

discussions and debates on who owns patient 

specimens and whether patients should share 

in profits, if financial gains are derived from 

leftover samples18,19. Rules and practices 

vary by region and institution. In current 

discussion, bio-banking of leftover 

specimens and the ethical issues associated 

with it are beyond its scope. 

 

Conclusion: This paper is not intended to be 

a comprehensive one; however, we have tried 

to complement existing guidelines and 

documents that are available in some 

institutions and to offer a framework for 

addressing ethical issues encountered in the 

practice of clinical biochemistry and 

laboratory medicine in Bangladesh. As 

laboratory-based physicians, it is our utmost 

duty to uphold the standards of 

professionalism, be honest in all professional 

endeavors, and maintain a high level of 

personal integrity as well as maintain the 

existing professional code of ethics. We 

should also maintain a high level of quality in 

the product(s) of our professional endeavors, 

including validity and reliability of 

laboratory test results, interpretive opinions, 



Bangladesh Journal of Bioethics 2019; 10(3): 5-10 

 

 

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scientific research, publication of data, and 

different forms of knowledge dissemination.  

Moreover, we should ensure promotion of 

safety and welfare of patients, employees, co-

workers, colleagues, the public, and the 

environment. 

 

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Authors’ contribution: M Mozaffor and S Parvin 

were involved in conception of the paper; M Mozaffor, 

M Tabassum, MT Sultan and S Parvin were equally 

involved in the literature search, manuscript writing 

and revision. 

 

Conflict of interest: None to disclose. 


