**13. Ethical considerations in conducting medical research**

The Nuremberg Code is a code which was a part of the wins of the famous 'Nuremberg Trial' (1945–1946) and the "Doctors' Trial" (1946–1947) which indicted and tried major World War II (WWII) criminals and lesser WWII criminals, respectively, on war crimes, crimes against peace and other crimes committed against humanity. This trial began shortly after the end of WWII [54, 55]. If not for the Nuremberg Code, the whole world might not have been safer due to abuses against humanity. The Nuremberg Code is a set of 10 ethical principles that guides research involving human experimentation (**Table 1**) [56–58]. The Code emphasized four basic ethical principles of research which are 'informed consent', 'beneficence', 'nonmaleficence', and 'non-coercion' [56, 58]; it was drafted in 1947 during the trial of some German physicians who were indicted of conducting heinous, unethical and invasive experiments on people incarcerated in concentration camps during the WWII [56, 57].

Through the creation of the Nuremberg Code, the whole world became awakened to the urgent need for the creation of policies and laws that guide the ethical conduct of research involving human subjects [57, 59]. However, over the years, many scientists had criticized the Nuremberg Code on issues pertaining to plagiarism and

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**Table 1.**

*Medical Ethics*

**Article Code**

*DOI: http://dx.doi.org/10.5772/intechopen.95382*

and injury.

physicians also serve as subjects.

engage in the experiment.

experiment seems to him to be impossible.

1 The voluntary consent of the human subject is absolutely essential.

results will justify the performance of the experiment.

importance of the problem to be solved by the experiment.

2 The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3 The experiment should be so designed and based on the results of animal experimentation and

4 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering

7 Proper preparations should be made and adequate facilities provided to protect the experimental

8 The experiment should be conducted only by scientifically qualified persons. The highest degree

of skill and care should be required through all stages of the experiment of those who conduct or

experiment to an end if he has reached the physical or mental state where continuation of the

experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely

5 No experiment should be conducted where there is an *a priori* reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental

6 The degree of risk to be taken should never exceed that determined by the humanitarian

9 During the course of the experiment the human subject should be at liberty to bring the

10 During the course of the experiment the scientist in charge must be prepared to terminate the

subject against even remote possibilities of injury, disability, or death.

knowledge of the natural history of the disease or other problem under study that the anticipated

history of medical research ethics [57–59].

*Articles in the Nuremberg code [56, 57].*

involving human subjects.

embedded loopholes in the Articles 4, 5, 9 and 10 of the Code (**Table 1**) [56–60]. Nonetheless, the Code is still widely regarded as the most important document in the

to result in injury, disability, or death to the experimental subject.

Over the years, many countries had formulated and enacted policies and laws guiding the ethical conduct of medical research within their borders [61–63]. In fact, multilateral and globally recognized health organizations like 'World Medical Association', 'World Health Organization', and 'Council for International Organizations on Medical Research' also have their own guidelines on the ethical conduct of biomedical research involving human subjects [57, 64, 65]. This shows the huge gravity of global concerns regarding the ethical conduct of research

Ethical considerations are issues that are widely considered as a keystone part of medical research [66, 67]. In medical research, all stakeholders involved must consider the ethical implications of their conduct. The thoughts on these implications are, in order words, known as ethical considerations. There are so many issues of ethical consideration in the field of Medicine. Ethical considerations regarding the conduct of medical research centre on the basic ethical principles discussed in one of the preceding paragraphs. Pertinently, these considerations apply to all forms of medical research irrespective of where, when, how, and why it was conducted. It is noteworthy to discuss extensively on some peculiar issues of ethical concerns that needs to be considered in medical research carried out at/on some peculiar (or special) periods or population groups. These discussions are below:

#### *Medical Ethics DOI: http://dx.doi.org/10.5772/intechopen.95382*


#### **Table 1.**

*Articles in the Nuremberg code [56, 57].*

embedded loopholes in the Articles 4, 5, 9 and 10 of the Code (**Table 1**) [56–60]. Nonetheless, the Code is still widely regarded as the most important document in the history of medical research ethics [57–59].

Over the years, many countries had formulated and enacted policies and laws guiding the ethical conduct of medical research within their borders [61–63]. In fact, multilateral and globally recognized health organizations like 'World Medical Association', 'World Health Organization', and 'Council for International Organizations on Medical Research' also have their own guidelines on the ethical conduct of biomedical research involving human subjects [57, 64, 65]. This shows the huge gravity of global concerns regarding the ethical conduct of research involving human subjects.

Ethical considerations are issues that are widely considered as a keystone part of medical research [66, 67]. In medical research, all stakeholders involved must consider the ethical implications of their conduct. The thoughts on these implications are, in order words, known as ethical considerations. There are so many issues of ethical consideration in the field of Medicine. Ethical considerations regarding the conduct of medical research centre on the basic ethical principles discussed in one of the preceding paragraphs. Pertinently, these considerations apply to all forms of medical research irrespective of where, when, how, and why it was conducted.

It is noteworthy to discuss extensively on some peculiar issues of ethical concerns that needs to be considered in medical research carried out at/on some peculiar (or special) periods or population groups. These discussions are below:

a.**Ethical considerations in conducting research in public health emergencies (PHEs):** Disease pandemics, flooding, earthquake, tsunamis, etc. are PHEs [6]. The periods of PHEs are tragic periods. They are characterized by chaos, panics, untold economic hardship, movement restrictions, stigmatizations, and other unforeseen irregularities [68]. Public health emergencies have been a public health problem that had been bedeviling humanity for thousands of years; unfortunately, the rate of occurrence of such emergencies has increased in its frequency due to many factors [68]. During PHEs, medical research are being conducted either to solve the problems that are associated with the PHE or other problems that are not related to the PHE. However, irrespective of the aims of the medical research endeavors conducted during PHEs, the point still boils down to the fact that such medical research endeavor is being carried out when a PHE is on.

In 2020, the whole world is battling with the COVD-19 pandemic [69]. In a situation like this, many medical researchers are facing enormous difficulties when it comes to the conduct of medical research [70]. Despite these enormous problems, yet a medical researcher still needs to be very mindful about the ethical implications of his/her conduct in all research endeavors carried out during the period. This issue will take us to have a look at a publication of the World Health Organization (WHO) on the ethical standards to be followed during PHEs [71]. Research is part of the key response to public health emergencies; hence, the conduct of medical research during disease pandemic is an ethical imperative as some research hypotheses can only be best answered during the period of a pandemic [71]. This implies that it becomes necessary, from an ethical point for view, for medical researchers to conduct research that will manage a pandemic.

However, it was further mentioned that:


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*Medical Ethics*

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with the study must be able to prove that:

rent clinical condition.

study.

i.Such patient is in a life-threatening situation.

paragraph operate at the clinical level.

the health and wellbeing of our communities.

ii.Available treatment options are unsatisfactory or untested.

iii.Such patient is unable to give his/her informed consent due to his/her cur-

iv.Such patient might have direct benefits from participating in the clinical

v.The time to seek an informed consent from the LAR prior to the clinical intervention is not available [74–76]. All the recommendations in this

At the community level, it is recommended that medical researchers should engage the communities in inclusive decision making on how best to handle informed consent taking in clinical emergency research, make relevant public disclosures about the scope of their study, work closely with the Institutional Review Board (IRB) to guide the study protocol [74, 77]. This approach at the community level is plausible, since one of the ultimate goals of medical research is to improve

to the benefits accrued from such research.

viii.Individuals and communities that participated in a research must have access

b.**Ethical Considerations in Conducting Research on Clinical Emergencies:** Medical and surgical emergencies are clinical emergencies that often occur in the hospital setting. Some of these conditions include asthma, trauma, cerebrovascular accidents, sepsis, and myocardial infarction [72]. These emergency conditions constitute a large proportion of global disease burden [72]. Through medical research, many clinical emergency problems had been solved. A very good example is the 1922 discovery of insulin by Frederick Banting which has helped in improving the clinical outcomes of diabetic emergencies [73]. There

are also many other examples of great discoveries in medical research.

The ethical conduct of medical research more especially in the area of clinical emergencies is a very crucial one. There are many factors that pose as problems to the proper conduct of medical research in clinical emergencies. These factors are diverse and they range from governmental regulations to time of decision making/ intervention [72]. To start with, many nations do not have a specific regulation regarding clinical emergency research [72]; this is a fundamental problem that needs to be solved. Also, the issue of informed consent taking is an issue central to the ethical conduct of research in clinical emergencies, more especially clinical trials. For instance, in unconscious patients, the decision on what clinical intervention (a trial intervention or an approved intervention) to do on such patient must be made in few minutes; unfortunately, such patients are unable to give their consent [74]. Also, the legally authorized representative (LAR) of such patients are often unavailable or in a state of emotional imbalance [74, 75]. In such kind of situation, some authorities recommended the use of 'deferred consent' taking from the LAR (e.g. next of kin) of such patient while some recommended that the medical researchers involved in such kind of clinical research (such as trials) can proceed


The ethical conduct of medical research more especially in the area of clinical emergencies is a very crucial one. There are many factors that pose as problems to the proper conduct of medical research in clinical emergencies. These factors are diverse and they range from governmental regulations to time of decision making/ intervention [72]. To start with, many nations do not have a specific regulation regarding clinical emergency research [72]; this is a fundamental problem that needs to be solved. Also, the issue of informed consent taking is an issue central to the ethical conduct of research in clinical emergencies, more especially clinical trials. For instance, in unconscious patients, the decision on what clinical intervention (a trial intervention or an approved intervention) to do on such patient must be made in few minutes; unfortunately, such patients are unable to give their consent [74]. Also, the legally authorized representative (LAR) of such patients are often unavailable or in a state of emotional imbalance [74, 75]. In such kind of situation, some authorities recommended the use of 'deferred consent' taking from the LAR (e.g. next of kin) of such patient while some recommended that the medical researchers involved in such kind of clinical research (such as trials) can proceed with the study must be able to prove that:


At the community level, it is recommended that medical researchers should engage the communities in inclusive decision making on how best to handle informed consent taking in clinical emergency research, make relevant public disclosures about the scope of their study, work closely with the Institutional Review Board (IRB) to guide the study protocol [74, 77]. This approach at the community level is plausible, since one of the ultimate goals of medical research is to improve the health and wellbeing of our communities.

	- i.Vulnerable population group should not be unnecessarily excluded from a trial because their participation in a trial will also provide informative outcomes that might benefit their group.
	- ii.When designing a trial, the issues concerning the inclusion of vulnerable people and how the ethical and regulatory requirements of such people will be evaluated and managed must be addressed in the protocol of such study
	- iii.Activities that could result into the stigmatization of vulnerable groups, such as unnecessary exclusion, should be avoided as it could result into the violation of confidentiality and even loss of vital research data about vulnerable groups.
	- iv.The risks associated with the participation of vulnerable people in a trial should be properly evaluated and the protections of such group of people should be properly addressed.
	- v.There should be regular revisits of the laid down regulations of the appropriate authorities governing the ethical conduct of research on vulnerable groups during the course of the trial so as to ensure that the conduct of the study does not violate ethical standards.
