Dr. Pletser’s experience includes 30 years of working with the European Space Agency as a Senior Physicist/Engineer and coordinating their parabolic flight campaigns, and he is the Guinness World Record holder for the most number of aircraft flown (12) in parabolas, personally logging more than 7,300 parabolas.
\\n\\n
Seeing the 5,000th book published makes us at the same time proud, happy, humble, and grateful. This is a great opportunity to stop and celebrate what we have done so far, but is also an opportunity to engage even more, grow, and succeed. It wouldn't be possible to get here without the synergy of team members’ hard work and authors and editors who devote time and their expertise into Open Access book publishing with us.
\\n\\n
Over these years, we have gone from pioneering the scientific Open Access book publishing field to being the world’s largest Open Access book publisher. Nonetheless, our vision has remained the same: to meet the challenges of making relevant knowledge available to the worldwide community under the Open Access model.
\\n\\n
We are excited about the present, and we look forward to sharing many more successes in the future.
\\n\\n
Thank you all for being part of the journey. 5,000 times thank you!
\\n\\n
Now with 5,000 titles available Open Access, which one will you read next?
Preparation of Space Experiments edited by international leading expert Dr. Vladimir Pletser, Director of Space Training Operations at Blue Abyss is the 5,000th Open Access book published by IntechOpen and our milestone publication!
\n\n
"This book presents some of the current trends in space microgravity research. The eleven chapters introduce various facets of space research in physical sciences, human physiology and technology developed using the microgravity environment not only to improve our fundamental understanding in these domains but also to adapt this new knowledge for application on earth." says the editor. Listen what else Dr. Pletser has to say...
\n\n\n\n
Dr. Pletser’s experience includes 30 years of working with the European Space Agency as a Senior Physicist/Engineer and coordinating their parabolic flight campaigns, and he is the Guinness World Record holder for the most number of aircraft flown (12) in parabolas, personally logging more than 7,300 parabolas.
\n\n
Seeing the 5,000th book published makes us at the same time proud, happy, humble, and grateful. This is a great opportunity to stop and celebrate what we have done so far, but is also an opportunity to engage even more, grow, and succeed. It wouldn't be possible to get here without the synergy of team members’ hard work and authors and editors who devote time and their expertise into Open Access book publishing with us.
\n\n
Over these years, we have gone from pioneering the scientific Open Access book publishing field to being the world’s largest Open Access book publisher. Nonetheless, our vision has remained the same: to meet the challenges of making relevant knowledge available to the worldwide community under the Open Access model.
\n\n
We are excited about the present, and we look forward to sharing many more successes in the future.
\n\n
Thank you all for being part of the journey. 5,000 times thank you!
\n\n
Now with 5,000 titles available Open Access, which one will you read next?
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1. Introduction
Mycobacterium tuberculosis exists exclusively as a pathogen of humans and in some cases of animals. It is not thought to exist in the environment other than for brief periods during transfer from an infected host to an uninfected contact. Thus M. tuberculosis must adapt to an in vivo environment by modifying gene expression. Differential expression can occur in immune cells such as macrophages, larger immune structures such as granulomas, and within liquefied lesions of the lung. Within the human body tubercle bacilli experience reactive oxygen intermediates as well as acidity within the phagosomes of macrophages. In addition within the centers of caseating granulomas bacilli experience low oxygen tension as well as toxic lipases and proteases released by dead immune cells. High temperature is present within the body of a person with active tuberculosis in the form of a fever. There may be other unrecognized signals and stresses that modulate gene expression within invading M. tuberculosis bacilli as well. Examination of gene expression during in vivo growth, within macrophages, or during application of specific stresses can illuminate which critical pathways in the mycobacterium are upregulated that lead to an M. tuberculosis bacillus exquisitely adapted to in vivo survival.
2. Adaptation to growth in the phagosomal compartment of macrophages
Macrophages are the preferred intracellular location for M. tuberculosis\n\t\t\t\tin vivo. Infected individuals cough and expel droplet nuclei which contain M. tuberculosis bacilli and remain suspended in the air. After inhalation and within the body, the bacilli are transported to the small alveoli in the lungs where they encounter alveolar macrophages which are relatively nonactivated (Dannenberg, 1993; Dannenberg, 1997). These nonactivated macrophages are not efficient at killing or retarding growth of invading microbes. Initially bacilli are taken up into phagosomal compartments and may replicate. As the immune system becomes activated, macrophages are stimulated with INF-γ to increase their efficiency of mycobacterial killing, becoming more efficient at producing reactive oxygen intermediates and acidic stress. In response, M. tuberculosis pushes back against the macrophages and differentially regulates key genes. Within macrophages M. tuberculosis increases its lipid metabolism which may reflect an environment in the phagosome which lacks available carbohydrates (Table. 1). In addition the enzyme isocitrate lyase (icl) is strongly induced in vivo, and icl is upregulated in all macrophage models. Icl is a key enzyme in the glyoxylate shunt and utilizes fatty acids as an energy source. When icl and other genes in the glyoxylate shunt are mutated this results in attenuation in vivo. In addition within macrophages, genes involved in stress responses, cell wall component production, anaerobic respiration, siderophore production to scavange iron, diverse sigma factor production, and tranposases that may mutate the genome are all upregulated (Schnappinger et al, 2003, Beste et al, 2007, Ward et al, 2010).
3. Adaptation to granulomas and caseation
Once infection has progressed, tubercle bacilli replicate within incompletely activated macrophages. Additional macrophages arrive to the site of infection, and engulf newly liberated mycobacteria. The immune cells, T-cells, arrive to this location and an immune structure, the granuloma, composed of macrophages and a mantel of T-cells develops. If the host is resistant, and can robustly activate the body’s macrophages, then M. tuberculosis infection is likely controlled. If the host immune system is weak, or is weakened, M. tuberculosis can replicate in the incompletely activated macrophages. Genes of M. tuberculosis required to resist macrophages will be important in resisting the environment of the granuloma as well. As the infection progresses in susceptible individuals, the centers of the granulomas degenerate and form a caseous, or cheesy, center. At the heart of this is an elevated lipid metabolism of the host that produces a variety of lipids including cholesterol, cholesteryl esters, triacyglycerol and others (Kim et al, 2010). Interestingly M. tuberculosis infection has been shown to induce elevated lipid metabolism in the host (Table 1.). The cell wall lipid of M. tuberculosis, trehalose dimycolate or cord factor, induces a granulomatous response in mice, and this was accompanied by foam cell formation which contains elevated lipids (Kim et al, 2010). It is intriguing to speculate that M. tuberculosis infection can induce elevated host lipid metabolism, and as discussed previously as part of adaptation to in vivo growth, M. tuberculosis also switches to lipid metabolism and lipids as a preferred carbon source (Eisenreich et al, 2010). Thus M. tuberculosis induces the host to produce what the microbe has evolved to utilize as an energy source.
4. Liquefied lesions and sputum
Later in infection caseating granulomas continue to breakdown. At a certain point these granulomas begin to liquefy, and host lipases and proteases are present which damage host tissues. Dead macrophages release lytic enzymes, and bacterial products may also result in host tissue damage and liquefaction ensues. As tissue is damaged, a cavity erodes into the lung airspace. In rabbit studies, M. tuberculosis can replicate to extremely high levels in this liquefied environment (Dannenberg 1993, Dannenberg et al 1997, Dannenberg 2006). For the first time in vivo\n\t\t\t\tM. tuberculosis is capable of replicating extracellularly. Liquid containing free M. tuberculosis is expelled through cavities in the lung by coughing.
M. tuberculosis within sputum contains elevated levels of lipid bodies and tends to be inhibited in its replicative process ( Table 1.) (Garton et al, 2008). In addition, sputum transcriptome analysis of M. tuberculosis reveals that triacylglycerol synthase, tgs1 part of the DosR regulon, is induced and lipid bodies may be composed of increased stores of triacylglycerol (Garton et al, 2008). Lipid bodies are correlated in vitro with nonreplicating persistence, and may help M. tuberculosis survive the harsh environment ex vivo before it encounters another human host.
5. Mycobacterium tuberculosis and dormancy
One third of the world’s population is infected with M. tuberculosis in part because it causes a latent or dormant infection in a majority of those infected. If therapies are to be developed which can eradicate M. tuberculosis, a better understanding of dormancy is required. M. tuberculosis can persist for decades in a dormant state within hypoxic granulomas in the lung. Studies have suggested that in a dormant state M. tuberculosis is occupied mainly with maintaining cell wall integrity, membrane potential, and protecting its DNA structure. The mycobacterium must also resist the host’s immune system. A number of in vivo and in vitro models have been used to investigate dormancy. These models include exposing mycobacteria to environments that are likely encountered within the host. In one model cultures are stirred slowly and sealed so that oxygen is gradually consumed. In another model nutrient starvation of the bacteria may induce dormancy. In addition, infection of mice, partial treatment with antibiotics, and exposure to immune suppression can lead to dormancy and reactivation (Murphy and Brown, 2007).
The gene encoding a transcriptional regulator, dosR (devR), part of a two component system that responds to low oxygen seems to be very important in a shift from replicating M. tuberculosis to a nonreplicating form (Table 1.). Carbohydrate limitation also upregulated dosR and there is indeed an overlap of genes upregulated in phagosomes of macrophages and low carbohydrate availability. In dormancy models aerobic respiratory metabolism was down regulated while anaerobic respiration was upregulated as were DosR controlled genes (Murphy and Brown, 2007). Amino acid and carbon starvation results in the activation of the stringent response. RelA (Rv2583c) mediates this stringent response in M. tuberculosis and can globally down regulate components necessary in protein translation, and thus conserve badly needed resources in the mycobacterium during times of stress. RelA may be a target to prevent M. tuberculosis from entering dormancy or a target to force M. tuberculosis out of dormancy (Murphy and Brown, 2007).
The ability of M. tuberculosis to survive in a dormant state relies on maintaining cell integrity, viability, and a proton motive (Rustad et al, 2008). Entry into a dormant state may be followed later by reactivation and growth of this microorganism, and may occur due to waning immunity, age, or disease. T-cells originally controlling infection may become less activated and numbers of T-cells may decrease allowing mycobacteria increased ease of replication in host macrophages. M. tuberculosis needs energy to exit this dormant phase, and this may be found in the form of triacylglycerol which is known to accumulate in response to acidic stress, nitric oxide exposure, and lowered oxygen tension (Table 1.) (Sirakova et al, 2006; Garton et al, 2008). In fact triacylglycerol has been shown to be important to transition from dormancy to active growth (Low et al, 2009). The highly pathogenic strain of M. tuberculosis, the Beijing lineage strain, over produces triacylglycerol perhaps giving the microorganism a competitive edge in resisting hypoxic stress and dormancy (Fallow et al, 2010).
6. Mycobacterium tuberculosis responses to acidic stress
M. tuberculosis encounters acidity in the body in a number of locations including within immune cells, macrophages. When macrophages phagocytose tubercle bacilli, phagosomes of unactivated macrophages are limited in their ability to acidify due to the presence of live M. tuberculosis. Bacilli can inhibit phagosomal maturation and also inhibit phagosome lysosome fusion (Armstrong and Hart, 1971; Sturgill-Koszycki et al, 1994; Huynh and Grinstein, 2007). Virulent M. tuberculosis can exclude a proton ATPase from the phagosome in non-activated macrophages. Exposure to the cytokine INF-γ can result in increased activation of macrophages and these macrophages that phagocytose live virulent M. tuberculosis can lower the intra phagosomal pH (Schaible et al,1998; Via et al, 1998; MacMicking et al, 2003; Ehrt and Schnappinger, 2009). This pH’s can be toxic to bacilli either killing them, or inhibiting their growth. The robustness of the response seems to lie in the activation and efficiency of the host’s immune response. Anything that interferes with the host\'s immune status can negatively impact acidic modulation within phagosomes, and lead to more mycobacterial replication. In addition, the tubercle bacillus\' ability to respond to acidic stress will likely affect the outcome of the infection.
Mycobacteria seem to bear an intrinsic ability to resist acidic stress. They have a thick waxy cell wall as well as an outer membrane that can resist acidic stress. This physical barrier may serve to inhibit entry of toxic protons, and anything that interferes with this barrier could increase acid susceptibility. Many mutants that are acid susceptible lie in genes that affect cell wall and lipid metabolism (Table 1.). Environmental mycobacteria are found in conditions that may be acidic and can grow at pHs as low as 4.0 (Santos et al, 2007). Pathogenic mycobacteria have evolved to resist acidic stress, and potentially share similar mechanisms with their environmental cousins (Kirschner et al, 1992; Kirschner et al, 1999).
Although Mycobacterium smegmatis has been found to have an acid tolerance system it is not known if M. tuberculosis also possesses one. However, a large number of genes are upregulated due to acidic stress in M. tuberculosis. Interestingly when M. tuberculosis is engulfed by the phagosomes of macrophages many genes are upregulated, and when cocanamycinA is added which interferes with the development of acidity, 80% of genes in M. tuberculosis that are normally upregulated in the phagosomes fail to do so (Rohde et al; 2007). This is an indication that acidity is one of the main environmental signals M. tuberculosis experiences in vivo.
A number of genes that are upregulated by acidic stress have been identified in previous studies. Looking at rapid response to acidity at 15 or 30 minutes it was found that genes involved in cell wall ultrastructure were induced (Fisher et al, 2002). The mymA operon was induced in this study, and is under the control of VirS which is an AraC/XylS family transcription factor (Singh et al, 2005). The lipF promoter of M. tuberculosis is upregulated, but requires a longer time frame (Saviola et al, 2001). It fails to be upregulated at 30 minutes, instead needing more extended exposure to acidic stress of 1.5 hours. LipF is annotated to be an esterase and may also function to alter the cell wall structure. LipF has been shown to be part of the two component system phoP/R regulon. In fact many genes involved in the PhoP/PhoR regulon including pks2, pks3, and pks4 are responsive to acidic stress (Table 1.) (Gonzalo-Asensio et al, 2009; Rohde et al, 2007). Thus PhoP/R may be responding to acidic stress or conversely PhoP/R controls a downstream regulator that responds to acidity. The ompATb gene encodes a porin that is active specifically at low pH and functions to pump ammonia into the phagosomal environment which serves to neutralize acidity (Song et al, 2011). Longer term exposure to acidic stress seems to stimulate production of triacylglycerol. Tgs1 is not upregulated by short term acid exposure but exposure of three weeks duration or more (Sirakova et al, 2006; Low et al, 2009; Deb et al, 2009). Triacylglycerol production may be important for mycobacteria to resist stress and survive a dormant period which is induced by stress conditions. An energy source such as triacylglycerol may be needed to reanimate from dormancy once stresses such as acidity are removed. Mutatagenesis studies also revealed genes involved cell wall/cell envelope synthesis when mutated resulted in mycobacteria which were unable to maintain neutral pH within their microbial cytoplasm in the presence of acidic stress (Vandal et al, 2008; Vandal et al, 2009, Biswass et al, 2010).
The type VII secretion system, Esx-1, may also may be involved in response to acid stress (Abdallah et al, 2007). The 6 kDa early secreted antigenic target (Esat-6) and the 10kDa culture filtrate protein (CFP-10) are secreted by Esx-1. These two proteins form a heterodimer that can dissociate at acidic pH. Esat-6 is capable of lysing membranes, and M. tuberculosis has been identified to reside extraphagosomally in the cytoplasm of macrophages in some cases. In addition when the esx-1 gene was mutated it could result in an M. tuberculosis strain that fails to escape from the phagosomal compartment into the cytoplasm (Simeone et al, 2009). Thus Esat-6 may be involved in mycobacterial responses to acidity and adaptation to in vivo stressors.
7. Response to oxidative damage
Inside phagosomes of activated macrophages tubercle bacilli are exposed to reactive oxygen intermediates. M. tuberculosis traffics to phagosomes, and a large number of genes are upregulated by oxidative stress indicating this is an important stress in vivo (Wu et al, 2007). In addition nutrients are limited in the phagosome which may cause M. tuberculosis to enter a stationary phase of growth, which has been shown to induce internal oxidative damage. The gene whiB1 is more active during stationary phase, and the protein produced by this gene has been shown to reduce cellular disulphide bridges that may predominate during this adaptational phase (Garge et al, 2009).
Mycobacteria contain a unique substance, mycothiol, which combats oxidative stress. Other bacterial species utilize glutathione which can also neutralize oxidative stress. Mycothiol contains cysteine residues which are oxidized when that condition predominates thus forming disulfide bonds, creating mycothione, and preventing other molecules in the mycobacterial cell from becoming oxidized (Table 1.). Human cells produce glutathione to combat oxidative damage, and glutathione is toxic to mycobacterial cells perhaps due to a redox imbalance generated by this substance in the mycobacteria (Venketaraman et al, 2008; Connell et al, 2008)). Mycobacteria also contain other molecules to detoxify oxidative damage including superoxide dismutase (SOD) and catalase (KatG) which can inactivate superoxide (Table 1.) (Shi et al, 2008). SOD and KatG are upregulated early in infection indicating an increase in oxidative damage due to superoxide. Oxidative damage is capable of harming DNA, and histone like proteins (LSR2) can protect against damage by compacting DNA and acting as a physical barrier. UvrB which repairs mycobacterial DNA damage also protects against oxidative damage (Darwin and Nathan, 2005; Colangeli et al, 2009).
8. Heat shock
One of the hallmarks of tuberculosis is fever and night sweats in which body temperature increases and is suboptimal for Mycobacterium tuberculosis replication and survival. This allows the immune system a competitive edge over the invading microbes. Heat stress can cause damage to M. tuberculosis by causing proteins to unfold which may then be degraded. In response, M. tuberculosis can upregulate chaperonins which complex with unfolded proteins and help them refold (Table 1.). The α-crystalline protein, or Acr-2, is activated by heat shock, and has demonstrated chaperonin activity (Pang and Howard, 2007).
Many proteins that are upregulated in M. tuberculosis in vivo are heat shock proteins that have chaperonine activity. While these proteins may benefit the organism by complexing with and refolding heat damaged proteins, they are also recognized by the immune system. Both the 65Kd heat shock protein and the HSP70 protein can be found extracellularly to M. tuberculosis, and are potent stimulators of an inflammatory response (Anand et al, 2010).
9. Low iron
Normally iron taken up by intestinal epithelial cells and bound to transferrin circulates within the body. This complex binds to cell surface receptors, and is internalized where it releases its iron to be bound by the host cellular factor ferritin. Infection and inflammation are natural signals to the host to limit availability of iron. Proinflammatory cytokines stimulate hepcidin production, decrease iron uptake from the gut, and inhibits the iron efflux protein ferroportin (Johnson and Wessingling-Resnick, 2012). Inflammation thus inhibits iron uptake by the intestinal epithelium thus preventing iron from being loaded onto transferrin. Interfering with uptake limits iron availability in the host, and M. tuberculosis has been shown to be severely growth restricted in a low iron environment. It has been demonstrated in African studies that iron supplementation increases incidence of tuberculosis. Thus being anemic may be protective against infectious processes. Within human macrophages, Nramp1 (natural resistance associated macrophage protein) is produced and localizes to the phagosomal compartment where it reduces iron within this site possibly by extrusion. This function confers resistance to M. tuberculosis infections and mutations in the nramp1 gene can result in increased susceptibility to active disease due to M. tuberculosis infection (Johnson and Wessingling-Resnick, 2012).
Mycobacteria have a variety of systems which aid in the uptake of iron and the regulation of iron responsive genes. As mycobacteria have been shown to be somewhat novel among gram positive bacteria, they possess an outer mycolic acid based membrane, as well as an inner membrane and periplasmic space. Porins in the outer membrane appear to transport iron in the presence of high iron conditions (Jones and Niederweis, 2010). M. tuberculosis under low iron conditions can produce the siderophore carboxymycobactin as well as mycobactin (Table 1.) (Banerjee et al, 2011). These molecules bind with a higher affinity to iron than the human host’s storage proteins and steal iron from the host. Mycobactin is present within the inner membrane and thus can only bind iron imported into the periplasmic space. Interestingly lipid membranes with associated mycobactins may diffuse out, travel to lipid vesicles in the host cell, and sequester iron. These structures may recycle back to interact with the mycobacterium. Disruption of the genes responsible for production of mycobactins can cause these mutant mycobacteria to replicate less well in macrophages (Banerjee et al, 2011). Carboxymycobactins are excreted possibly by the type VII secretion or ESX system. Externally the carboxymycobactins bind available iron from transferrin (Banerjee et al, 2011). Porins and also ABC transporters may allow import of these iron loaded carboxymycobactins (Banerjee et al, 2011). The host cell, in response to infection and inflammation, produces siderocalins such as lipocalin-2 that can bind to and inactivate mycobactin from M. tuberculosis thus interfering with mycobacterial iron acquisition (Johnson and Wessingling-Resnick, 2012). In fact mice deleted for genes involved in production of siderocalin are much more susceptible to mortality due to M. tuberculosis infection (Johnson and Wessingling-Resnick, 2012). Inside the mycobacterial cell, iron is stored in bacterioferritin and a ferritin like protein. These proteins are required for replication in human macrophages and guinea pigs, act to store iron, and also to limit excess iron in the cells that can lead to iron mediated oxidative damage due to the Fenton reaction (Reddy et al, 2011).
Iron responsive genes in M. tuberculosis are controlled in part by the iron dependent regulator IdeR. This protein can act both as an activator and a repressor depending on where it binds within a mycobacterial promoter region (Manabe et al, 1999; Banerjee et al, 2011). Within promoters of genes involved in mycobactin synthesis it acts as a repressor, inhibiting expression of these genes at high iron concentrations. In promoters of iron storage proteins it acts as an activator, stimulating expression of these genes at high iron concentrations and thus avoiding iron stimulated oxidative damage.
10. Hypoxic growth
In vivo M. tuberculosis experiences low oxygen tension that may be encountered in the centers of granulomas as previously described. Studies have shown that tuberculous granulomas are hypoxic in a variety of animal models including rabbits, guinea pigs, and nonhuman primates (Via et al, 2008). The response to low oxygen tension is biphasic. There is an initial response that predominates and is controlled by the two component system DosS/DosT-DosR (Table 1.). This two component system upregulates genes that are known to be part of the "dormancy regulon". DosR is the transcriptional regulator, and Dos T and DosS are the sensor kinases that respond to low oxygen tension as well as nitric oxide (Park et al, 2003; Kumar et al, 2007). hspX ( acr, Rv2031c) is upregulated by low oxygen, is regulated by DosR, and has chaperonin activity that may aid in refolding proteins which are damaged by low oxygen tension (Vasudeva-Rao and McDonough, 2008; Florczyk et al, 2003). It is known that this protein is expressed in vivo as latently infected individuals possess T-cells that are reactive to the HspX protein (Geluk et al, 2007). Interestingly one half of the genes in the DosR regulon return to their baseline level after 24 hours. After this initial 24 hour period other regulators play a role in hypoxic responses such as sigE and sigC (Table 1.). An enduring hypoxic response begins after the initial response, and this may be important for M. tuberculosis to enter and stay in a dormant state (Rustad et al, 2008).
11. Toxin-antitoxin systems
Interestingly there are many toxin-antitoxin systems within the M. tuberculosis genome. These systems seem to provide a mechanism by which bacteria can alter growth rate rapidly, potentially in response to environmental stressors. The toxin is not a protein secreted and targeted against the human host, but targeted against mycobacterial cellular components. The toxin is a stable protein which may be complexed with an antitoxin forming a toxin-antitoxin pair. The antitoxin is relatively unstable and environmental stressors can inactivate it causing release of a free toxin. The toxin is then available to interact with cellular components, and may function to cleave mRNA thus inhibiting subsequent translation and rapidly halting growth of the bacterium. As static bacteria are more resistant to environmental stressors and antibiotics, this system may allow M. tuberculosis to survive in the face of external stressors. M. tuberculosis possesses 88 toxin-antitoxin systems and four of these have been shown to be activated by phagocytosis of bacilli, by macrophages, or hypoxia (Table 1.). It appears that the toxin in these systems acts by cleaving mRNA (Rapage et al, 2009).
Table 1.
Mycobacterial responses to in vivo stressors and conditions.
12. Two component systems
Two components systems are common in many bacteria. These systems are comprised of a sensor kinase which phosphorylates the response regulator as a result of an environmental signal, which is often a stress. The sensor kinases are trans membrane proteins which are embedded into membranes. They sense external stresses and transmit these signals internally into the bacterial cell by phosphorylating a response regulator that binds to its cognate promoter DNA, and regulates transcription. The mycobacterial genome contains 11 two component systems (Hett and Rubin, 2008). The large number of these systems in the mycobacterial coding regions is likely the result of evolution to accommodate bacterial responses to diverse stresses.
DosS/DosT-DosR was previously described, and responds to initial hypoxic stress (Table 1.) (Park et al, 2003). Some of the genes controlled by the transcriptional regulator DosR are upregulated by hypoxic stress, and are also part of the transcriptional regulator PhoP regulon, a member of the PhoP/R two component system. While it is unknown what environmental signal PhoP or the sensor kinase PhoR are responding to, genes controlled by PhoP either directly or indirectly are upregulated by such stresses as acidity and low oxygen (Table 1.) (Gonzalo-Asensio et al, 2008).
13. Sigma factors
Mycobacterial RNA polymerase catalyzes RNA synthesis from specific promoter sequences. This RNA polymerase is composed of subunits that comprise the core holoenzyme, and include two α subunits, a β, a β\' and a ω subunit. The core enzyme, however, cannot target specific promoter sequences. A sigma factor is required for this function, and can bind and recognize specific -10 and -35 promoter sequences. As the mycobacterial genome possesses many different sigma factors, these RNA polymerase components can recognize diverse mycobacterial promoter sequences to activate a whole class of genes. This activity is in addition to specific transcription factors which bind to promoters, regulate transcription, and are not part of the RNA polymerase enzyme.
The mycobacterial genome possesses many different sigma factors that belong to different categories. The M. tuberculosis σA is responsible for regulating housekeeping genes, and is also an essential gene for mycobacterial growth in vitro and in vivo. While the sigma factor σB is highly similar to σA, it is nonessential and is induced by a variety of stresses including oxidative stress, heat shock, cold shock, stationary phase, and low aeration (Lee et al, 2008). There are a number of sigma factors designated to have extracellular function, and some respond to environmental stresses and are involved in the synthesis of the mycobacterial envelope. These sigma factors are SigC, SigE, SigF, SigG, SigH, SigI, SigJ, SigK, SigL, and SigM. One sigma factor that is known to respond to nutrient starvation is SigF. The sigma factor SigE is involved in response to heat shock and SDS exposure (Manganelli et al, 2004). Both SigJ and SigF are induced in response to antibiotic exposure (Manganelli et al, 2004). The sigma factor SigH also responds to heat shock and oxidative stress (Manganelli et al, 2004). Thus the use of sigma factors by the mycobacterial cell is a manner in which "master regulators" can control whole classes of genes to rapidly facilitate gene regulation in response to specific environmental stresses (Table 1.).
14. Summary
As mycobacteria invade their human hosts they must respond to a plethora of stresses many of which are generated by the host\'s immune system. Under this selective pressure, M. tuberculosis has evolved mechanisms to combat the toxic insults of the host. Although mycobacteria are inherently resistant to environmental stresses due to their thick waxy cell envelope, upregulation of genes further reinforce this defense. In addition there are proteins upregulated by environmental stressors which can detoxify the mycobacterial cell as is the case of acidic stress and upregulation of ammonia extruding pumps that neutralize acidic pH of the macrophage phagosome. Thus inducible systems allow M. tuberculosis to resist environmental stresses and persist in the human body to cause active or latent disease.
Understanding the specific steps in infection, the stresses associated with each step, and the mycobacterial response may be of clinical relevance. The knowledge that oxidative stress and acidic stress may predominate as adaptive immunity makes the host’s macrophages more activated, may lead to the development of chemotherapeutic agents that target mycobacterial components produced by these stressors during this infective stage. In addition, the knowledge that mycobacteria may utilize toxin-antitoxin systems to slow their growth and to enhance their innate antibiotic resistance may spur the development of therapies that target these systems which could be used in conjunction with traditional antibiotic treatments. Chemotherapeutic agents given to decrease activity of triacylglycerol synthase may decrease infectivity of sputum positive individuals by inhibiting lipid body production in the bacilli while antibiotic treatment lags in its sterilizing activity. Ultimately treatments may be developed which target inducible systems upregulated by stresses, and may interfere with mycobacterial responses to these stressors. By thwarting these adaptive responses potentially with chemotherapeutic agents, mycobacteria may be rendered more fragile and susceptible to the host\'s immune system. In addition a greater understanding of how M. tuberculosis enters a latent state of persistence could lead to treatments that prevent this microbe from reactivating from the dormant state, or from becoming dormant to begin with. Greater understanding of M. tuberculosis responses to in vivo growth will hopefully lead to the development of technologies that lessen M. tuberculosis\' global impact on human health.
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Adaptation to growth in the phagosomal compartment of macrophages",level:"1"},{id:"sec_3",title:"3. Adaptation to granulomas and caseation",level:"1"},{id:"sec_4",title:"4. Liquefied lesions and sputum",level:"1"},{id:"sec_5",title:"5. Mycobacterium tuberculosis and dormancy ",level:"1"},{id:"sec_6",title:"6. Mycobacterium tuberculosis responses to acidic stress",level:"1"},{id:"sec_7",title:"7. Response to oxidative damage",level:"1"},{id:"sec_8",title:"8. Heat shock",level:"1"},{id:"sec_9",title:"9. Low iron",level:"1"},{id:"sec_10",title:"10. Hypoxic growth",level:"1"},{id:"sec_11",title:"11. Toxin-antitoxin systems",level:"1"},{id:"sec_12",title:"12. Two component systems",level:"1"},{id:"sec_13",title:"13. Sigma factors",level:"1"},{id:"sec_14",title:"14. Summary",level:"1"}],chapterReferences:[{id:"B1",body:'Abdallah A, Gey van Pittius N, Champion P, Cox J, Luirink J, Vandenbroucke-Grauls C, Appelmelk B, and Bitter W. 2007. Type VII secretion-mycobacteria show the way. 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Basic Medical Sciences, College of Osteopathic Medicine, Western University of Health Sciences, Pomona CA, USA
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Christophides",authors:[{id:"154007",title:"Dr.",name:"Mathilde",middleName:null,surname:"Gendrin",fullName:"Mathilde Gendrin",slug:"mathilde-gendrin"},{id:"154008",title:"Prof.",name:"George",middleName:"K",surname:"Christophides",fullName:"George Christophides",slug:"george-christophides"}]},{id:"43829",title:"Bacterial Biodiversity in Midguts of Anopheles Mosquitoes, Malaria Vectors in Southeast Asia",slug:"bacterial-biodiversity-in-midguts-of-anopheles-mosquitoes-malaria-vectors-in-southeast-asia",signatures:"Sylvie Manguin, Chung Thuy Ngo, Krajana Tainchum, Waraporn\nJuntarajumnong, Theeraphap Chareonviriyaphap, Anne-Laure\nMichon and Estelle Jumas-Bilak",authors:[{id:"50017",title:"Prof.",name:"Sylvie",middleName:null,surname:"Manguin",fullName:"Sylvie Manguin",slug:"sylvie-manguin"},{id:"75315",title:"Prof.",name:"Theeraphap",middleName:null,surname:"Chareonviriyaphap",fullName:"Theeraphap Chareonviriyaphap",slug:"theeraphap-chareonviriyaphap"},{id:"88985",title:"Prof.",name:"Anne-Laure",middleName:null,surname:"Michon",fullName:"Anne-Laure Michon",slug:"anne-laure-michon"},{id:"88986",title:"Prof.",name:"Estelle",middleName:null,surname:"Jumas-Bilak",fullName:"Estelle Jumas-Bilak",slug:"estelle-jumas-bilak"},{id:"156016",title:"MSc.",name:"Chung Thuy",middleName:null,surname:"Ngo",fullName:"Chung Thuy Ngo",slug:"chung-thuy-ngo"},{id:"156018",title:"MSc.",name:"Krajana",middleName:null,surname:"Tainchum",fullName:"Krajana Tainchum",slug:"krajana-tainchum"},{id:"156019",title:"Dr.",name:"Waraporn",middleName:null,surname:"Juntarajumnong",fullName:"Waraporn Juntarajumnong",slug:"waraporn-juntarajumnong"}]},{id:"43899",title:"Distribution, Mechanisms, Impact and Management of Insecticide Resistance in Malaria Vectors: A Pragmatic Review",slug:"distribution-mechanisms-impact-and-management-of-insecticide-resistance-in-malaria-vectors-a-pragmat",signatures:"Vincent Corbel and Raphael N’Guessan",authors:[{id:"152666",title:"Dr.",name:"Vincent",middleName:null,surname:"Corbel",fullName:"Vincent Corbel",slug:"vincent-corbel"},{id:"169017",title:"Dr.",name:"Raphael",middleName:null,surname:"N'Guessan",fullName:"Raphael N'Guessan",slug:"raphael-n'guessan"}]},{id:"43851",title:"Perspectives on Barriers to Control of Anopheles Mosquitoes and Malaria",slug:"perspectives-on-barriers-to-control-of-anopheles-mosquitoes-and-malaria",signatures:"Donald R. Roberts, Richard Tren and Kimberly Hess",authors:[{id:"151439",title:"Prof.",name:"Donald",middleName:null,surname:"R. Roberts",fullName:"Donald R. Roberts",slug:"donald-r.-roberts"},{id:"151656",title:"Mr.",name:"Richard",middleName:null,surname:"Tren",fullName:"Richard Tren",slug:"richard-tren"},{id:"154152",title:"Ms.",name:"Kimberly",middleName:null,surname:"Hess",fullName:"Kimberly Hess",slug:"kimberly-hess"}]},{id:"43874",title:"Residual Transmission of Malaria: An Old Issue for New Approaches",slug:"residual-transmission-of-malaria-an-old-issue-for-new-approaches",signatures:"Lies Durnez and Marc Coosemans",authors:[{id:"152754",title:"Prof.",name:"Marc",middleName:null,surname:"Coosemans",fullName:"Marc Coosemans",slug:"marc-coosemans"},{id:"169018",title:"Dr.",name:"Lies",middleName:null,surname:"Durnez",fullName:"Lies Durnez",slug:"lies-durnez"}]},{id:"44330",title:"Vector Control: Some New Paradigms and Approaches",slug:"vector-control-some-new-paradigms-and-approaches",signatures:"Claire Duchet, Richard Allan and Pierre Carnevale",authors:[{id:"151662",title:"Dr.",name:"Pierre",middleName:null,surname:"Carnevale",fullName:"Pierre Carnevale",slug:"pierre-carnevale"},{id:"169000",title:"Dr.",name:"Richard",middleName:null,surname:"Allan",fullName:"Richard Allan",slug:"richard-allan"},{id:"169008",title:"Dr.",name:"Claire",middleName:null,surname:"Duchet",fullName:"Claire Duchet",slug:"claire-duchet"}]},{id:"43870",title:"New Salivary Biomarkers of Human Exposure to Malaria Vector Bites",slug:"new-salivary-biomarkers-of-human-exposure-to-malaria-vector-bites",signatures:"Papa M. Drame, Anne Poinsignon, Alexandra Marie, Herbert\nNoukpo, Souleymane Doucoure, Sylvie Cornelie and Franck\nRemoue",authors:[{id:"151515",title:"Dr.",name:"Papa Makhtar",middleName:null,surname:"Drame",fullName:"Papa Makhtar Drame",slug:"papa-makhtar-drame"},{id:"151648",title:"Dr.",name:"Franck",middleName:null,surname:"Remoué",fullName:"Franck Remoué",slug:"franck-remoue"},{id:"154034",title:"Dr.",name:"Anne",middleName:null,surname:"Poinsignon",fullName:"Anne Poinsignon",slug:"anne-poinsignon"},{id:"154035",title:"MSc.",name:"Alexandra",middleName:null,surname:"Marie",fullName:"Alexandra Marie",slug:"alexandra-marie"},{id:"154037",title:"Dr.",name:"Souleymane",middleName:null,surname:"Doucoure",fullName:"Souleymane Doucoure",slug:"souleymane-doucoure"},{id:"154038",title:"MSc.",name:"Herbert",middleName:null,surname:"Noukpo",fullName:"Herbert Noukpo",slug:"herbert-noukpo"},{id:"154039",title:"Dr.",name:"Sylvie",middleName:null,surname:"Cornélie",fullName:"Sylvie Cornélie",slug:"sylvie-cornelie"}]},{id:"44149",title:"Transgenic Mosquitoes for Malaria Control: From the Bench to the Public Opinion Survey",slug:"transgenic-mosquitoes-for-malaria-control-from-the-bench-to-the-public-opinion-survey",signatures:"Christophe Boëte and Uli Beisel",authors:[{id:"98400",title:"Dr.",name:"Christophe",middleName:null,surname:"Boëte",fullName:"Christophe Boëte",slug:"christophe-boete"},{id:"167749",title:"Dr.",name:"Uli",middleName:null,surname:"Beisel",fullName:"Uli Beisel",slug:"uli-beisel"}]}]}]},onlineFirst:{chapter:{type:"chapter",id:"74571",title:"Medical Ethics",doi:"10.5772/intechopen.95382",slug:"medical-ethics",body:'
“Without ethics, everything happens as if we were all five billion passengers on big machinery that nobody handles, and its going faster and faster but we don’t know where”.
‘Jacques Cousteau’
1. Introduction
Every profession has guidelines, rules and regulations guiding its practice, this is what ethics is all about. It has to do with the professional conduct of the practice of medicine including conducting research for the advancement of medicine and the making of new discoveries. One of the necessary aspects of human life is health [1] and it is the duty clinicians to care for the health needs of the populace [2]. Medical ethics has been from time immemorial. In medical education, medical ethics is taught at both the undergraduate and postgraduate levels to equip a new graduate in the dental and medical profession. Clinicians’ face various challenges in the course of their work some of which may have ethical issues, worst are when there is poor clinical state and death is anticipated [3]. Decision making on patients care is a critical responsibility of every physician practicing medicine [4]. Physicians who err in their practice may be tried by the medical council. Each national medical council has guidelines for erring doctors who derail in their practice of medicine. Medical councils have a panel of enquiry and disciplinary boards for doctors who do not practice medicine without the application of the medical ethics. Various disciplinary measures include apology to the patient, suspension from practice for a period of time, or the extreme of which is the permanent seizure of the medical practicing license and striking off the doctors’ name from the medical practicing register. Due to the importance of ethics the World Health Organization in 2002 established an ethics team known as the global health ethics unit, a unit dedicated to ethics [5]. Through this ethics team, the World Health Organization works in close collaboration with the United Nations interagency committee, non-governmental organizations and other international organizations [5].
2. Overview of ethics
Ethics is a concept in the field of philosophy. The word ethics is derived from the Greek word ‘Ethnos’ which means character, customs and habits. It is closely linked to the word ‘moral’ which is derived from the Latin word ‘Mos’ (mores) but they are different. Both ethics and morals generally mean the customs and socially accepted norms. Ethics is a branch of philosophy and includes the values, guidelines, rules and regulations and the justification for these values, and guidelines [6, 7]. Hence ethics is required in our daily lives in making choices from various available options and alternatives [8]. Ethics guides various professions in carrying out their duties while morals have to do with the way of life. Ethics is concerned in the concept of right and wrong. This was first conceptualized and structured by many Greek scholars and established by Aristotle by the third century BC. Various factors have affected the concept hence it has evolved over many centuries. It is the systematical philosophical study of morality. Ethics guides human beings where they are as it is the set of principles and values governing a group or even an individual. It also extends to the consequences of wrong misdoings. The application of values and moral to human activities also constitute ethics [9]. The conduct of right and wrong are both related to ethics and morals. The principles developed by an individual regarding what is perceived as right or wrong are morals. Morality can sometimes transform to cultural and regional norms while ethics is not affected by societal, cultural or religious norms. The standard of conduct which guides and governs an occupation or profession is knowns as professional ethics. Ethics is connected to the code of conduct, it guides how employees and employers to conduct themselves at the workplace. The understanding of moral values is related to ethics hence the relationship between ethics and morals [10]. Ethics is widespread in all areas of life as decision making is a part of life [11].
3. Overview of medical ethics
Medical ethics is a type of professional ethics. In modern medicine, ethics is believed to have started in the 18th century; a physician by name Thomas Percival authored a book on medical ethics which is believed to be the beginning and development of medical ethics code of conduct [7, 12, 13]. It is Dr. Thomas Percival who coined the term medical ethics after publishing his book in 1803. Medical ethics is the conduct required from any medical practitioner, it is necessary for the physician as it acts as a guide in making clinical decisions [14]. Medical ethics is the ethical, morals and values aspect that guides the medical profession and its allies and it consists of interdisciplinary knowledge [15, 16]. It guides decision making, medical practice, medical education and research in medicine [10, 12, 17]. There have been ethical guidelines which must be followed by healthcare workers in the history of the medical profession [6]. In 1949, the international code of medical ethics has been adopted by the World Medical Association in London [17]. Every national medical board has a code of conduct to guides the practice of medicine in that country. For instance, in Nigeria, medical ethics is governed by the Medical and Dental Council of Nigeria (MDCN) which published a booklet titled ‘A Code of Conduct’ which is handed over to every new medical and dental graduate at the time of induction into the medical and dental profession. Medical ethics is a type of applied ethics. The basis of the medical ethics is centred on the Hippocratic Oath [7] which is an oath is taken by every dental and medical graduate at the time of been inducted into the medical and dental profession. They are set of rules, regulations and guidelines that guides and governs physicians in carrying out their duties [18]. Medical ethics focuses on the relationship that exists between the doctor and their patient, which includes the legal and ethical implications. Hospitals also ensure that their employees practice medical ethics to prevent litigations which can cause loss of resources to the health facilities. Medical ethics guides decision making of medical practitioners as patient centred care is based on medical ethics. It is expected that medical practitioners are well equipped with medical skills and knowledge and also they are familiar with the medical ethics and its legal implications [9]. Medical ethics is a branch of applied ethics and bioethics. Medical ethics promotes the respect of patient and confidentiality. Medical ethics is important in the practice of medicine [10] therefore it is taught in most medical and dental schools both at the undergraduate and postgraduate levels. It is applied in all clinical settings as well as the medical workplace and in research; it encompasses other disciplines such as history, philosophy, theology, anthropology and sociology [18]. The different categories of professionals involved in providing healthcare practice medical ethics [19]. Therefore for a better understanding of the concept training in medical ethics should be incorporated into undergraduate and postgraduate education curriculum [10, 15, 20]. It is the duty of every physician to practice medical ethics in every consultation with the patient.
4. Importance of medical ethics
Medical ethics is important both in medical practice which involves the patient doctor relationship and in medical research.
Some of the roles of medical ethics are:
It provides standards in the professional relationship between the physician and their clients or patient hence provides guidelines in the prevention of litigation [17, 21, 22].
The social capital in the professional relationship is established with members of the community [21].
Medical ethics is implemented in decision making by both the physician and the patient [23].
Medical ethics provides moral values necessary in providing solutions to ethical dilemma [23].
It provides privacy, confidentiality and truthfulness in the doctor-patient relationship [19].
Medical ethics promotes health, wellbeing, respect decision making, dignity, justice and accountability in the medical profession [17, 19].
Medical ethics helps in promoting good and quality medical care by identifying, analyzing and attempting to resolve the ethical problems that arise in medical practice [10, 17, 24].
Medical ethics promotes diligence and proper training skills among healthcare professionals [7].
Medical ethics helps in the prevention of unethical practices such as negligence and malpractice.
5. Ethical dilemma
Controversies and conflict sometimes occur in the practice of medicine especially in the decision making process. Sometimes, these conflict occurs in the shared decision making as conflicts arise when the doctors and patient decisions contravenes medical ethical principles. Generally everyday there are ethical dilemma occurs daily in the practice of medicine [14, 25, 26]. Ethical dilemma has been described by the World Health Organization as a dilemma between different values which are seen as necessary particularly in cases and circumstances in conflict with each other [10]. It occurs when all the possible remedy for a clinical care will lead to moral violation [8, 23]. Sometimes, there are no answers to ethical dilemmas [27]. These ethical dilemmas arise when there are options for the decisions which may be compelling reasons and actions [19]. Ethical dilemma consists of a type of ethical problem. From several researchers, there is a relationship between ethical dilemma and ethical principles [28]. No ethical principle can explain adequately ethical dilemma [2]. There is a connection between facts, values and morals conflict, some of the problems associated with ethical dilemma have been there for centuries with medical ethics [29]. Ethical dilemma is a product of conflict arising from ethical principles and options [30, 31]. When ethical dilemma occurs, it can be resolved using individualistic approach as there are no general principles in tackling it [17, 23]. Ethical dilemma is not limited to medical practice only as it also occurs in medical research [14]. The establishment of a comprehensive ethical framework and legal framework will guide medical health care workers in resolving ethical dilemma.
Ethical dilemma can be found in telemedicine, artificial intelligence, COVID-19 testing, management of near end of life care, medical error, priority testing, biotechnology, medical ethics education, e-health and bioethics [10]. Some of the factors and barriers to ethical dilemmas are connected to medical facts, individual characteristics and unclassified factors [31].
Medical Factors: Some of the medical factors associated with ethical dilemmas are the patient’s history, diagnostic results, risks, complications and previous intervention associated with the illness the patient is suffering from.
6. Individual characteristics
There are some characteristics that are peculiar to everyone that can lead to ethical dilemma. These factors affect the decision process of the patient. These include values, culture, religion, relationships and previous experiences [31]. The belief system affects medical care.
7. Unclassified factors
There are some factors not associated with individual characteristics and medical affects that affect decision making process. These include the logistics facility, competing interests and Interprofessional perspectives [31]. In some countries, there have been Interprofessional rivalry between the different categories of health care workers and the clients and patients are the ones who suffer when such occur.
8. Some ethical dilemmas
Healthcare professionals regularly encounter ethical dilemmas while carrying out their duties [3, 17, 27]. Some situations in which ethical dilemma can occur are discussed below:
Near End of Life: End of life is a topic and phenomenon that has been debated for several decades. There is the ethical dilemma if end of life care should be provided or should such patients be abandoned? Is end of life care a waste of resources? Especially in low resource counties where health insurance is not available. Near end of life care is expensive as it may involve artificial nutrition hydration, telling the patient’s care givers the truth and disagreement that may arise in the course of management. Such disagreements may include continuation of artificial ventilation or administration of oxygen, care in the intensive care unit. Moral distress sometimes is experienced by the physician, patient and their caregivers when there are unexpected clinical developments as death approaches [3].
Telemedicine: Telemedicine means “healing from a distance” and it is very beneficial [32]. Telemedicine is becoming popular due to the need for social and physical distancing especially in this time of the COVID-19 pandemic. During telemedicine proper history taking may not be gotten and a comprehensive physical examination may not be done. Physical examination is important in every medical consultant. Ethical dilemma occurs in telemedicine due to the conflict in productivity and patient confidentiality which cannot be obtained. Privacy cannot be attained in the patient-doctor relationship while using telemedicine [30]. This is worst if artificial intelligence is also used. During consultation using telemedicine, it must be done in a secure and safe way so that medical electronic information is not leaked out. Therefore passwords security should be maintained always [32].
Coronavirus-2019 (COVID-19) Testing: The ethical considerations in the management of epidemics are different [16]. This is not different for the Covid-19 pandemic as several ethical principles are affected by the pandemic. This includes autonomy, truthfulness, confidentiality and justice. In the Covid-19 pandemic, testing is done without consent of the patient. This is also to help in the control and to protect others. Also the ethical principle of autonomy is not respected during contact racing [33]. Confidentiality is not maintained in the Covid-19 testing in order to protect the public. This is why it is required before air travel especially international travel and also admission and entry into certain public places such as schools and camps. There is the ethical dilemma in the allocation of the scare resources and medical supplies, therefore question to be answered are who need what? Hence the ethical principle of justice has to be practiced. The physician decides which patient may likely die or lives, which patient should be connected to the ventilator, which is in short supply worldwide. Allocation of these scares medical resources must be done fairly and with justice [16, 34]. This has created a high ethical dilemma which intensivists have to deal with [35]. Rationing of medical equipment is a great dilemma ravaging the world due to the covid019 pandemic [34]. Also coupled with the increase patient load in intensive care units [35]. In other to protect the public, there is the ethical dilemma when a patient with the signs and symptoms of the Severe Acute Respiratory Syndrome-2 refuses to get tested.
Medical Error: Errors can occur in any profession but it can lead to fatalities in some sectors. Some of such sectors are the aviation, architecture and medicine as any mistake can lead to disability and even death. Not all medical errors can lead to disability and death but it may increase hospital stay and loss of work days. This is a serious issue especially as there are increase cases of litigation. There is the ethical dilemma of weather the patient or client should be informed about medical errors when they occur.
Ethical dilemma is also encountered when dealing with “Do Not Resuscitate Order”.
9. Ethical dilemma: case report
A 72 years old woman was brought to the emergency room in a developing country by her children with complaints of unconsciousness and difficulty in breathing of 24 hours duration. She is a known hypertensive not compliant with her medications. On examination, she was not pale, unconscious with a Glasgow Coma Scale of verbal response – 1, eye opening – 1, and motor response – 1 with a total of 3/15. She was not cyanosed, in respiratory distress evidenced by flaring alae nasi and subcostal and intercostal recession. Oxygen saturation was 76%, she was gasping for breathing, auscultation of the chest yielded vesicular breath sounds. Respiratory rate was 60 cycles per minute and pulse rate was 100 beats over minute, regular and full volume. Blood pressure was 150/100 mmhg. A diagnosis of cerebrovascular accident was made. She was placed on oxygen, 20% mannitol and normal saline. After admission, the patient was not improving and the patient’s caregiver was paying out of pocket for the management of the patient. After twenty four hours of hospital admission, the patient’s daughter requested that the patient was in a bad clinical state therefore she wants the oxygen to be discontinued, that she (the daughter) feels that the mother may not survive the illness. She was counseled on her mother’s condition but she still insisted that the oxygen should be discontinued. After much argument, she was asked to write an undertaken that she is the one requesting for the discontinuation of oxygen therapy. At this point she refused to put it down in writing and started crying. The oxygen was never discontinued.
10. Discussion of the case report
This is a case of ethical dilemma on end of life care and care of a patient unable to make decisions. When patients are unable to make decisions for themselves such decisions are made by a legal caregiver who may be patient, child, guardian or legal representative. In some developing countries like Nigeria where the extended family system is practiced and the people live a communal life, the caregiver may be any relative or even a neighbor; the group of people who cannot make decisions for themselves are the unconscious patient, children and minors and the mentally impaired. Some of the decisions made by a caregiver may not always be in the best interest of the patient. For instance in this case, the patient is unconscious and the caregiver is her daughter. Even though the patient was in bad clinical state, oxygen therapy was necessary for her management hence the dilemma of whether or not to discontinue the intranasal oxygen. There is conflict between the ethical principles of autonomy and maleficence. This can lead to litigation against the attending physician. If the physician decides to obey the wish of the caregiver, even though she takes an undertaken, the conflict of maleficence in which a doctor is required not to do harm may arise. The physician will have no justification to discontinue the administration of oxygen if taken to a court of law as he or she has received medical training.
11. Institutional review boards
In the practice of medicine, research is an important and essential tool [36, 37, 38]. Institutional review boards are ethical committees in institutions that analyze and review proposed research protocols, it serves as a deliberation forum in which ethical issues in medical researchers are analyzed (WHO). Some institutions have more than one institutional review board [39]. Institutional review board plays an important role in medical practice. Some of these roles of the institutional review boards are to protect human subjects in the course of any medical research [39]. This is because some researches may have detrimental effects on research participants, some of these effects may lead to morbidity and even mortality. Institutional review board act as risk benefit analysis intermediary between research participants and the researcher. They also determines if the research should be commenced or not [38]. They ensure that the research is conducted as specified by the researcher in the research protocol. Institutional review boards are important in the improvement of medical practice by working with researches to apply good ethical principles in their research [40]. Each institutional review board has its guidelines. Some have documents that must be used while applying for ethical approval for any study. The institutional review boards are made up of persons with expertise in medical ethics and medical specialties. There are different types of institutional review board namely national ethics committee, research ethics committee and clinical ethics committee (WHO). Globally, there are different local and medical national institutional review boards and communities [17]. An example of a national ethics committee is the National Health Research Ethics Committee of Nigeria (NHREC). In medical research, the human subjects are a very valuable resource hence there safety has to be protected [37]. Extra scrutiny is done on research that will be carried out among vulnerable populations [38]. This is to avoid coercion in the recruitment of research participants. The vulnerable populations are children and minors, older persons, the mentally retarded, pregnant women and people in conflict and war zones.
12. Principles of medical ethics
Since the olden days, it is believed that the doctor knows it all and also knows the best [41]. These have been challenging as there is an increase in litigation against doctors, practice and implementation of ethical principles helps as the preventive measure against such medical litigation and jurisprudence. Modern medicine is faced with several ethical problems [29]. Some of these problems can be abated by ethical principles. Clinicians try to do their best for their patients by providing the best medical care available. These ethical principles guide physicians in decision making in the course of their work especially where there are ethical dilemmas and helps in the resolution of ethical conflict [27]. Hence physicians generally act in the best interest of their clients and patient though conflict may sometimes occur as they weigh the risks and benefits of all available choices but act in the best interest of the patient [2, 27]. The principles of medical ethics [3, 4, 10, 27] are:
Autonomy
Justice
Beneficence
Non maleficence
Confidentiality
Truth telling
12.1 Autonomy
The fundamental principle of medical ethics is autonomy [42] Autonomy is the freedom of patients and clients to make their decisions on their conditions without the interference, pressurization and duress. It means giving adequate information to the patient respectfully and disclosure of information about a patient after obtaining informed consent to do so [4, 43, 44]. Trust is always key in every doctor patient relationship as the patient rusts the doctor to the best for him or her therefore the patient is entitled to autonomy. It is the duty of the doctors to counsel and explain to the patient the diagnosis, proposed management and treatment options. The doctor is not expected to impose any decision on the patient. Hence, the freedom of thought, intention and decision making process especially in the new era of shared decision. For this to be complete, the patient should be counseled in simple language so that they understand the risks and benefits of the procedures. This is also the principle for not to do evil or inflict harm. Autonomy allows the freedom of choice and action by the patient. The principle of autonomy requires the physician should provide all available therapeutic options to the client [21]. This also shows that the patient even after all the counseling has the right to refuse and reject treatment [10]. Ethical principles are affected by cultural and traditional beliefs and practices. Some cultures frown against being told that the clinical condition is poor worst is if death is anticipated. Since time immemorial, doctors have been faced with the notion of to what extent and how much clinical information should be released to a patient especially when it is bad news [45]. This is in conflict with the ethical principle of autonomy for which people should be allowed to make their decisions without any influence or been coerced to do so. The other medical ethical principles of truth telling, and confidentiality including informed consent are all based on autonomy [4]. Autonomy allows the patient to choose from every available treatment options depending on their goals and values [41, 44, 46]. Although sometimes doctors are able to convince their patients to accept what they believe is the best for the patient [41]. Autonomy therefore makes patients to be responsible for their health needs and wishes [11].
12.2 Beneficence
The principle of beneficence is that everything done by the medical practitioner should be in the best interest of the patient [4, 10, 47]. Therefore this guides the decision making process of the physician. This means that all negative options which will not be in the best interest of the patient should not be offered to the patient. An example is administering a medication to a patient because of the side effect of the drug. The summary of beneficence is to do good always. Though every physician has to practice the ethical principle of autonomy, options that shall be beneficial to the patient should only be offered to be patient [47]. This ethical principle is implemented in the choice of drugs as all medications have adverse effects some of which may be mild which can be tolerated while some others are severe which can worsen the clinical state and can even cause death.
12.3 Non-maleficence
The ethical principle of non-maleficence is related to beneficence but they are different [44]. The principle of non-maleficence states that no harm should be done to the patient or other people in the community [4, 9, 10, 17, 48]. Implementing the principle of non-maleficence means that any treatment option that will be harmful to the patient should not be offered to the patient [44] as the patient will also exhibit autonomy. Hence the patient’s medical condition may worsen. Violation of non-maleficence can lead to litigation and malpractice. Negligence is a consequence of the violence of non-maleficence. Medical error can result in non-maleficence. This also applies to research in which the research protocol must be reviewed by an institutional review board so that none of the research participants suffer harm. All the benefits, risks and consequences of all treatment are weighed in the course of the medical consultation [49]. It is the duty of the physician to protect their patients [48]. Though all health practitioners encounter ethical challenges in the course of their work, the principle of not to do harm is always a priority [17].
12.4 Justice
Justice requires fairness in the management of patients and distribution of resources especially in the time of scarcity and when priority needs to be maintained such as during mass casualty and pandemics. Individuals at all time should be treated fairly when they visit a health facility [10]. The distribution of health resources requires justice for it to be done fairly and equitably [1, 4, 19, 47]. Justice is also necessary in respecting the rights of patients [19]. In times of scarcity, the ethical principle of justice is used to determine areas of priority in the distribution of health resources [10].
12.5 Confidentiality
Confidentiality and privacy generally is required in any human relationship [43]. A physician is expected to maintain confidentiality of all discussions made with the client or patient [50]. The physician requires permission and consent of the patient before divulging such information to any other person even among fellow physicians and health care professionals. The ethical principle of confidentiality is related to other ethical principles of autonomy and truthfulness. Patients trust their physicians hence that can open up their privacy to the doctor and trust that the doctor will keep secret all information confided in him or her to be private. Patients and their caregivers hold different preference in the disclosure of medical information about them or their loved one to third parties [44]. The ethical principle of confidentiality is based on trust hence patients trust the clinician therefore they tell them the truth and except the doctor to keep it private to themselves only without their authorization or informed consent [4, 43, 51]. Part of a patient’s right dwells on the physician respecting patient confidentiality. Trust in the patient doctor relationship is based on trust confidentiality and trustfulness. This issue of confidentiality is also maintained even after the death of the patient [32]. The doctor patient relationship is strengthened by confidentiality including communication between them [51]. It is ethical and legally binding on doctors to respect patient confidentiality always [50, 52]. Sometimes, the ethical principle of confidentiality is breached when the medical information is required by a court or law or when the illness is a threat or will be harmful to others and the public. Patients put their trust in their physician hence it is importance to maintain this trust to meet all legal requirements [32]. Confidentiality is breached when communicating with patients through an interpreter.
12.6 Truthfulness
Generally, most people say that it is hurtful to be told the truth but it has to be told whether it is palatable or not [45]. The physician is expected at all times to tell the patient the truth about their clinical condition. Truthfulness is also known as truth telling is one of the principles of medical ethics. Truth telling is guided by trust and confidentiality. Every patient expects the physician to tell them the truth about their illness always. It is very important in the advancement of patient autonomy [42]. Trust telling is an important ingredient in the physician doctor relationship as lack of it leads to distrust [4]. It is expected that all healthcare professionals including doctors should always tell their patients the truth always even if it will become bad news [45]. This is why medical ethics and breaking of bad news is incorporated in medical training. Some cultures and religions forbid been told the truth when it is bad news. Sometimes there is a contradiction between respect for the person as an individual and with the patient’s right not to know due to patient autonomy [44, 45]. Therefore the issue of truth telling has been debated in biomedical ethics [2]. This is because truth telling has been a challenge in medical ethics as there is no guideline on the limit to how much information should be given to the patient which sometimes leads to ethical controversies [2, 44]. How the information is relayed to the patient is also very important [2]. Even with all these controversies, challenges and ethical issues associated with truth telling, it is always the right of the patient to be told the truth always [53].
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, 57, 58]. The Code emphasized four basic ethical principles of research which are ‘informed consent’, ‘beneficence’, ‘non-maleficence’, 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].
Article
Code
1
The voluntary consent of the human subject is absolutely essential.
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 knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
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 physicians also serve as subjects.
6
The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
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 engage in the experiment.
9
During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10
During the course of the experiment the scientist in charge must be prepared to terminate 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 to result in injury, disability, or death to the experimental subject.
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 embedded loopholes in the Articles 4, 5, 9 and 10 of the Code (Table 1) [56, 57, 58, 59, 60]. Nonetheless, the Code is still widely regarded as the most important document in the history of medical research ethics [57, 58, 59].
Over the years, many countries had formulated and enacted policies and laws guiding the ethical conduct of medical research within their borders [61, 62, 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:
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:
Medical research should be conducted only if it does not impede emergency response efforts.
When doing collaborative medical research, be it an international or a local collaboration, medical researchers should work as a team to jointly prioritize the challenges faced in the outbreak, determine the best fit research project that will provide answers to those challenges, conduct the research, and ensure that the research ultimately benefits the affected communities.
The affected communities must be meaningfully and fairly engaged in the research process, and they should be involved in inclusive decision making efforts.
Independent research ethics review committee should be strengthened and the ethical review process of research protocols should be expedited.
Appropriate research methodologies should be adopted for all medical research conducted during public health emergencies.
Research participants’ selection and treatment must be done safely, fairly, justifiably, and with respect.
The research participants must be fully aware of the implications of their participation in such research, their participation must be voluntary, and their identity must be treated with strict confidentiality.
Individuals and communities that participated in a research must have access to the benefits accrued from such research.
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 with the study must be able to prove that:
Such patient is in a life-threatening situation.
Available treatment options are unsatisfactory or untested.
Such patient is unable to give his/her informed consent due to his/her current clinical condition.
Such patient might have direct benefits from participating in the clinical study.
The time to seek an informed consent from the LAR prior to the clinical intervention is not available [74, 75, 76]. All the recommendations in this paragraph operate at the clinical level.
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.
Ethical Considerations In Conducting Research On The Vulnerable Population Group: The vulnerable population groups are the disadvantaged sub-segment of the community; they include minors (people below 18 years), the mentally impaired, children, prisoners, pregnant women, fetuses, older persons, displaced persons, and other categories of disadvantaged people [65, 78, 79, 80]. Due to the inherent characteristics of this population group, they are not capable to protect their own interests [80, 81]. Among all medical research types, trials are one of the most crucial types due to its complexity and the inclusion of an intervention in its scope. A study by Welch et al. extensively described the peculiarities and limitations of each particular sub-group in the vulnerable population group, when it comes to the ethical issues surrounding their participation in a clinical trial [80]. Based on these peculiarities and limitations, it was concluded that:
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.
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
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.
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.
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.
There should be regular review of the incremental risk of the study design with respect to the participating vulnerable persons so as to determine if there is a need for the provision of further protections to this peculiar group [80].
14. Informed consent taking in medical research
In medical research involving human subjects, taking consent from the subjects is very necessary. In fact, it is not just about consent taking; rather, it is about taking a consent that is informed. Informed consent refers to the voluntary agreement of a human subject regarding his/her participation in a medical research as a subject. Informed consent taking constitutes a major aspect in the ethical conduct of medical research. As non-coercion is one of the standing pillars in the principles governing medical ethics, all persons participating in a medical research must not be coerced to participate in any way; rather, their participation should be completely voluntary. In the course of recruiting humans into a medical research, they should be given prior information that is of relevance to the protocol and safety profile of the study. However, informed consent taking applies only to adults, i.e. people aged 18 years or above. It is believed that only people in this category are mentally and psychologically capable to make decisions regarding consent. As for children, due to their age and level of psychological development, they can only give assent.
Informed consent can be taken in two ways: written or verbal. In written informed consent, the human subject gives a written documentation of him/her agreeing to participate in a study while in verbal informed consent, the human subject gave his/her agreement verbally. Between the two forms of informed consent, the written type is more reliable.
15. Conclusion
Medical ethics is a branch of ethics is a branch of philosophy that guides all human endeavors. Medical ethics are sets of regulations that guide physicians in their work and protect them against litigation. Ethical principles that guide the medical profession are autonomy, beneficence, non-maleficence, justice, confidentiality and truth telling. Sometimes these ethical principles have to be breached to protect the public and when required by a court of law. These ethical principles also help in there resolution of ethical dilemmas and conflict.
\n',keywords:"medicine, ethics, litigation",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/74571.pdf",chapterXML:"https://mts.intechopen.com/source/xml/74571.xml",downloadPdfUrl:"/chapter/pdf-download/74571",previewPdfUrl:"/chapter/pdf-preview/74571",totalDownloads:38,totalViews:0,totalCrossrefCites:0,dateSubmitted:"July 9th 2020",dateReviewed:"December 5th 2020",datePrePublished:"December 24th 2020",datePublished:null,dateFinished:"December 24th 2020",readingETA:"0",abstract:"Medical ethics is very important at this time of medicine due to the covid-19 pandemic which has caused a lot of mortality and morbidity world wide. Medical is important in guiding clinicians and other healthcare workers not to cause harm while caring out their duties. There are various aspects of medical ethics such as negligence, do not cause harm, beneficent and others. Not practicing medical ethics has caused some physicians to face litigation by their patients and clients and also face medical disciplinary boards. Some have even been suspended from medical practice for a number of months or years or even have their names struck off from the register of the licensing board of their country.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/74571",risUrl:"/chapter/ris/74571",signatures:"Dabota Yvonne Buowari and Kehinde Kazeem Kanmodi",book:{id:"9566",title:"Bioethics",subtitle:null,fullTitle:"Bioethics",slug:null,publishedDate:null,bookSignature:"Dr. Thomas F. Heston and Dr. Sujoy Ray",coverURL:"https://cdn.intechopen.com/books/images_new/9566.jpg",licenceType:"CC BY 3.0",editedByType:null,editors:[{id:"217926",title:"Dr.",name:"Thomas F.",middleName:null,surname:"Heston",slug:"thomas-f.-heston",fullName:"Thomas F. Heston"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:null,sections:[{id:"sec_1",title:"",level:"1"},{id:"sec_2",title:"1. Introduction",level:"1"},{id:"sec_3",title:"2. Overview of ethics",level:"1"},{id:"sec_4",title:"3. Overview of medical ethics",level:"1"},{id:"sec_5",title:"4. Importance of medical ethics",level:"1"},{id:"sec_6",title:"5. Ethical dilemma",level:"1"},{id:"sec_7",title:"6. Individual characteristics",level:"1"},{id:"sec_8",title:"7. Unclassified factors",level:"1"},{id:"sec_9",title:"8. Some ethical dilemmas",level:"1"},{id:"sec_10",title:"9. Ethical dilemma: case report",level:"1"},{id:"sec_11",title:"10. Discussion of the case report",level:"1"},{id:"sec_12",title:"11. Institutional review boards",level:"1"},{id:"sec_13",title:"12. Principles of medical ethics",level:"1"},{id:"sec_13_2",title:"12.1 Autonomy",level:"2"},{id:"sec_14_2",title:"12.2 Beneficence",level:"2"},{id:"sec_15_2",title:"12.3 Non-maleficence",level:"2"},{id:"sec_16_2",title:"12.4 Justice",level:"2"},{id:"sec_17_2",title:"12.5 Confidentiality",level:"2"},{id:"sec_18_2",title:"12.6 Truthfulness",level:"2"},{id:"sec_20",title:"13. Ethical considerations in conducting medical research",level:"1"},{id:"sec_21",title:"14. Informed consent taking in medical research",level:"1"},{id:"sec_22",title:"15. Conclusion",level:"1"}],chapterReferences:[{id:"B1",body:'Widjaja G, Sijabat HH. The importance of bioethics subject in healthcare education in Indonesia. International Journal of Multidisciplinary and Current Educational Research (IJMCER). 2020, 2 (5), 21-26'},{id:"B2",body:'Amer AB. Understanding the ethical theories in medical practice. Open Journal of Nursing. 2019, 9, 188-193'},{id:"B3",body:'McKillip KM, Lott AD, Swetz KM. 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Journal of Medical Ethics. 2003. www.jmedethics.com. doi.10.1136/jme.29.1'},{id:"B53",body:'Amer AB. Understanding the ethical theories in medical practice. Open Journal of Nursing. 2019, 9, 188-193'},{id:"B54",body:'Oddi LF, Cassidy VR. Nursing research in the United States: the protection of human subjects. Int J Nurs Stud. 1990;27(1):21-33. doi: 10.1016/0020-7489(90)90020-j'},{id:"B55",body:'Burns N, Grove SK. The practice of nursing research: Conduct, critique, and utilization, 5th ed. St Louis, MO: Elsevier/Saunders, 2005'},{id:"B56",body:'Ghooi RB. The Nuremberg Code-A critique. Perspect Clin Res. 2011;2(2):72-6. doi: 10.4103/2229-3485.80371'},{id:"B57",body:'Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med. 1997;337(20):1436-40. doi: 10.1056/NEJM199711133372006'},{id:"B58",body:'Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996;313(7070):1445-9. doi: 10.1136/bmj.313.7070.1445'},{id:"B59",body:'Grodin MA, Annas GJ. Legacies of Nuremberg: medical ethics and human rights. JAMA 1996;276:1682-1683'},{id:"B60",body:'Moreno JD. Reassessing the influence of the Nuremberg Code on American medical ethics. J Contemp Health Law Policy 1997;13:347-360'},{id:"B61",body:'Molyneux S, Geissler PW. Ethics and the ethnography of medical research in Africa. Soc Sci Med. 2008;67(5):685-95. doi: 10.1016/j.socscimed.2008.02.023. Epub 2008 May 2'},{id:"B62",body:'Zielinski C, Kebede D, Mbondji PE, Sanou I, Kouvividila W, Lusamba-Dikassa PS. Research ethics policies and practices in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey. J R Soc Med. 2014;107(1 suppl):70-76. doi: 10.1177/0141076813517679. Epub 2014 Mar 18'},{id:"B63",body:'Hedgecoe A, Carvalho F, Lobmayer P, Raka F. Research ethics committees in Europe: implementing the directive, respecting diversity. 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The Origin of COVID-19 and Why It Matters. Am J Trop Med Hyg. 2020;103(3):955-959. doi: 10.4269/ajtmh.20-0849'},{id:"B70",body:'Tuttle KR. Impact of the COVID-19 pandemic on clinical research. Nat Rev Nephrol 2020;16:562-564. doi: 10.1038/s41581-020-00336-9'},{id:"B71",body:'World Health Organization. Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R & D. Available from: https://www.who.int/blueprint/priority-diseases/key-action/liverecovery-save-of-ethical-standards-for-research-during-public-health-emergencies.pdf. Accessed: November 12, 2020'},{id:"B72",body:'Millum J, Beecroft B, Hardcastle TC, Hirshon JM, Hyder AA, Newberry JA, Saenz C. Emergency care research ethics in low-income and middle-income countries. BMJ Glob Health. 2019 Jul 29;4(Suppl 6):e001260. doi: 10.1136/bmjgh-2018-001260'},{id:"B73",body:'Frederick Grant Banting (1891-1941). Codiscoverer of insulin. J Am Med Assoc. 1996;198(6):660-61. doi: 10.1001/jama.1966.03110190142041'},{id:"B74",body:'Tisherman SA. Defining “community” and “consultation” for emergency research that requires an exception from informed consent. AMA J Ethics. 2018;20(5):467-474. doi: 10.1001/journalofethics.2018.20.5.stas1-1805'},{id:"B75",body:'Dutton RP, Stansbury LG, Hemlock B, Hess JR, Scalea TM. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma. 2008;64(4):1106-12. doi: 10.1097/TA.0b013e318165c15c'},{id:"B76",body:'Abramson NS, Safar P. Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. Ann Emerg Med. 1990;19(7):781-4. doi: 10.1016/s0196-0644(05)81703-2'},{id:"B77",body:'Dickert N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005;95(7):1123-7. doi: 10.2105/AJPH.2004.058933. Epub 2005 Jun 16'},{id:"B78",body:'Shivayogi P. Vulnerable population and methods for their safeguard. Perspect Clin Res. 2013;4(1):53-7. doi: 10.4103/2229-3485.106389'},{id:"B79",body:'Waisel DB. Vulnerable populations in healthcare. Curr Opin Anaesthesiol. 2013;26(2):186-92. doi: 10.1097/ACO.0b013e32835e8c17'},{id:"B80",body:'Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clin Trials. 2015;12(5):503-10. doi: 10.1177/1740774515597701. Epub 2015 Sep 15'},{id:"B81",body:'Levine RJ. Ethics and regulation of clinical research. 2nd ed. Yale University Press; New Haven, CT: 1988. Available from: https://yalebooks.yale.edu/book/9780300042887/ethics-and-regulation-clinical-research'}],footnotes:[],contributors:[{corresp:"yes",contributorFullName:"Dabota Yvonne Buowari",address:"dabotabuowari@yahoo.com",affiliation:'
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IDH mutation produces oncometabolite “2-hydroxyglutarate” and induces epigenetic alteration, such as DNA global methylation and histone methylation. As a result, IDH mutation promotes early gliomagenesis. Since IDH mutation is the earliest genomic event and almost always retained during tumor progression, IDH mutation is expected as novel therapeutic target. Herein, we review the clinical characteristics of IDH-mutant gliomas, biological role of IDH mutation for gliomagenesis, and current and future therapeutic approach for IDH mutant tumors.",signatures:"Kensuke Tateishi and Tetsuya Yamamoto",authors:[{id:"280036",title:"Dr.",name:"Kensuke",surname:"Tateishi",fullName:"Kensuke Tateishi",slug:"kensuke-tateishi",email:"ktate12@yokohama-cu.ac.jp"},{id:"291758",title:"Dr.",name:"Tetsuya",surname:"Yamamoto",fullName:"Tetsuya Yamamoto",slug:"tetsuya-yamamoto",email:"y_neuros@yokohama-cu.ac.jp"}],book:{title:"Brain and Spinal Tumors",slug:"brain-and-spinal-tumors-primary-and-secondary",productType:{id:"1",title:"Edited Volume"}}}],collaborators:[{id:"181611",title:"Dr.",name:"Scott",surname:"Turner",slug:"scott-turner",fullName:"Scott Turner",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/181611/images/system/181611.png",biography:"Dr. Scott Turner is a clinical Neuro-oncologist and Associate Professor of Neurology at the University of California, Irvine. He attended graduate school at Cornell University and received his medical degree from the Medical College of Wisconsin in 2003. He completed a Neurology residency at SUNY Stony Brook followed by a Neuro-oncology fellowship at Duke University in 2010. He has served as an Assistant Professor of Neurology at both Temple University and the University of Missouri - Kansas City School of Medicine. He has participated in many clinical trials in the field and is interested in the mechanism of glioma cell invasion.",institutionString:"University of California, Irvine",institution:{name:"University of California, Irvine",institutionURL:null,country:{name:"United States of America"}}},{id:"193557",title:"Ph.D.",name:"Andrew",surname:"Rodgers",slug:"andrew-rodgers",fullName:"Andrew Rodgers",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of New Orleans",institutionURL:null,country:{name:"United States of America"}}},{id:"222671",title:"Ph.D. Student",name:"Breno",surname:"Nery",slug:"breno-nery",fullName:"Breno Nery",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"258451",title:"Dr.",name:"Meenu",surname:"Gupta",slug:"meenu-gupta",fullName:"Meenu Gupta",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"280036",title:"Dr.",name:"Kensuke",surname:"Tateishi",slug:"kensuke-tateishi",fullName:"Kensuke Tateishi",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"280071",title:"Associate Prof.",name:"Meral",surname:"Kurt",slug:"meral-kurt",fullName:"Meral Kurt",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"280157",title:"Ms.",name:"Meredith",surname:"Morgan",slug:"meredith-morgan",fullName:"Meredith Morgan",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"282805",title:"Dr.",name:"Mushtaq",surname:"Ahmad",slug:"mushtaq-ahmad",fullName:"Mushtaq Ahmad",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"289494",title:"Dr.",name:"Candan",surname:"Demiröz Abakay",slug:"candan-demiroz-abakay",fullName:"Candan Demiröz Abakay",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"289496",title:"MSc.",name:"Ali",surname:"Altay",slug:"ali-altay",fullName:"Ali Altay",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null}]},generic:{page:{slug:"careers-at-intechopen",title:"Careers at IntechOpen",intro:"
Our business values are based on those any scientist applies to their research. The values of our business are based on the same ones that all good scientists apply to their research. We have created a culture of respect and collaboration within a relaxed, friendly, and progressive atmosphere, while maintaining academic rigour.
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Integrity - We are consistent and dependable, always striving for precision and accuracy in the true spirit of science.
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Disruptiveness - We are eager for discovery, for new ideas and for progression. We approach our work with creativity and determination, with a clear vision that drives us forward. We look beyond today and strive for a better tomorrow.
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What makes IntechOpen a great place to work?
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IntechOpen is a dynamic, vibrant company, where exceptional people are achieving great things. We offer a creative, dedicated, committed, and passionate environment but never lose sight of the fact that science and discovery is exciting and rewarding. We constantly strive to ensure that members of our community can work, travel, meet world-renowned researchers and grow their own career and develop their own experiences.
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If this sounds like a place that you would like to work, whether you are at the beginning of your career or are an experienced professional, we invite you to drop us a line and tell us why you could be the right person for IntechOpen.
Integrity - We are consistent and dependable, always striving for precision and accuracy in the true spirit of science.
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Openness - We communicate honestly and transparently. We are open to constructive criticism and committed to learning from it.
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Disruptiveness - We are eager for discovery, for new ideas and for progression. We approach our work with creativity and determination, with a clear vision that drives us forward. We look beyond today and strive for a better tomorrow.
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What makes IntechOpen a great place to work?
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IntechOpen is a dynamic, vibrant company, where exceptional people are achieving great things. We offer a creative, dedicated, committed, and passionate environment but never lose sight of the fact that science and discovery is exciting and rewarding. We constantly strive to ensure that members of our community can work, travel, meet world-renowned researchers and grow their own career and develop their own experiences.
\n\n
If this sounds like a place that you would like to work, whether you are at the beginning of your career or are an experienced professional, we invite you to drop us a line and tell us why you could be the right person for IntechOpen.
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I am also a member of the team in charge for the supervision of Ph.D. students in the fields of development of silicon based planar waveguide sensor devices, study of inelastic electron tunnelling in planar tunnelling nanostructures for sensing applications and development of organotellurium(IV) compounds for semiconductor applications. I am a specialist in data analysis techniques and nanosurface structure. 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After obtaining a Master's degree in Mechanical Engineering, he continued his PhD studies in Robotics at the Vienna University of Technology. Here he worked as a robotic researcher with the university's Intelligent Manufacturing Systems Group as well as a guest researcher at various European universities, including the Swiss Federal Institute of Technology Lausanne (EPFL). During this time he published more than 20 scientific papers, gave presentations, served as a reviewer for major robotic journals and conferences and most importantly he co-founded and built the International Journal of Advanced Robotic Systems- world's first Open Access journal in the field of robotics. Starting this journal was a pivotal point in his career, since it was a pathway to founding IntechOpen - Open Access publisher focused on addressing academic researchers needs. Alex is a personification of IntechOpen key values being trusted, open and entrepreneurial. Today his focus is on defining the growth and development strategy for the company.",institutionString:null,institution:{name:"TU Wien",country:{name:"Austria"}}},{id:"19816",title:"Prof.",name:"Alexander",middleName:null,surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/19816/images/1607_n.jpg",biography:"Alexander I. Kokorin: born: 1947, Moscow; DSc., PhD; Principal Research Fellow (Research Professor) of Department of Kinetics and Catalysis, N. Semenov Institute of Chemical Physics, Russian Academy of Sciences, Moscow.\r\nArea of research interests: physical chemistry of complex-organized molecular and nanosized systems, including polymer-metal complexes; the surface of doped oxide semiconductors. He is an expert in structural, absorptive, catalytic and photocatalytic properties, in structural organization and dynamic features of ionic liquids, in magnetic interactions between paramagnetic centers. The author or co-author of 3 books, over 200 articles and reviews in scientific journals and books. He is an actual member of the International EPR/ESR Society, European Society on Quantum Solar Energy Conversion, Moscow House of Scientists, of the Board of Moscow Physical Society.",institutionString:null,institution:{name:"Semenov Institute of Chemical Physics",country:{name:"Russia"}}},{id:"62389",title:"PhD.",name:"Ali Demir",middleName:null,surname:"Sezer",slug:"ali-demir-sezer",fullName:"Ali Demir Sezer",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/62389/images/3413_n.jpg",biography:"Dr. Ali Demir Sezer has a Ph.D. from Pharmaceutical Biotechnology at the Faculty of Pharmacy, University of Marmara (Turkey). 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Focus of his research activity is drug delivery, physico-chemical characterization and biological evaluation of biopolymers micro and nanoparticles as modified drug delivery system, and colloidal drug carriers (liposomes, nanoparticles etc.).",institutionString:null,institution:{name:"Marmara University",country:{name:"Turkey"}}},{id:"61051",title:"Prof.",name:"Andrea",middleName:null,surname:"Natale",slug:"andrea-natale",fullName:"Andrea Natale",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"100762",title:"Prof.",name:"Andrea",middleName:null,surname:"Natale",slug:"andrea-natale",fullName:"Andrea Natale",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"St David's Medical Center",country:{name:"United States of America"}}},{id:"107416",title:"Dr.",name:"Andrea",middleName:null,surname:"Natale",slug:"andrea-natale",fullName:"Andrea Natale",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Texas Cardiac Arrhythmia",country:{name:"United States of America"}}},{id:"64434",title:"Dr.",name:"Angkoon",middleName:null,surname:"Phinyomark",slug:"angkoon-phinyomark",fullName:"Angkoon Phinyomark",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/64434/images/2619_n.jpg",biography:"My name is Angkoon Phinyomark. 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I had been a visiting research student at Faculty of Computer Science, University of Murcia, Murcia, Spain for three months.\n\nI have published over 40 papers during 5 years in refereed journals, books, and conference proceedings in the areas of electro-physiological signals processing and classification, notably EMG and EOG signals, fractal analysis, wavelet analysis, texture analysis, feature extraction and machine learning algorithms, and assistive and rehabilitative devices. I have several computer programming language certificates, i.e. Sun Certified Programmer for the Java 2 Platform 1.4 (SCJP), Microsoft Certified Professional Developer, Web Developer (MCPD), Microsoft Certified Technology Specialist, .NET Framework 2.0 Web (MCTS). 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