The classification of laparoscopy assisted hysterectomy.
\r\n\tIt is a relatively simple process and a standard tool in any industry. Because of the versatility of the titration techniques, nearly all aspects of society depend on various forms of titration to analyze key chemical compounds.
\r\n\tThe aims of this book is to provide the reader with an up-to-date coverage of experimental and theoretical aspects related to titration techniques used in environmental, pharmaceutical, biomedical and food sciences.
The invention of Veress needle by Sir Janos Veres, an internist working in Hungary on tuberculosis, launched the era of laparoscopy [1]. The first laparoscopic hysterectomy was performed by Reich in 1989 [2]. Laparoscopic hysterectomy carries an edge over open hysterectomy as it provides a better magnification of anatomy and pathology [3, 4, 5, 6].
\nThe three main considerations are ergonomics, task analysis and minimizing injury and adhesions. When we apply the baseball diamond concept of trocar placement, the target in total laparoscopic hysterectomy is the uterine artery.
\nThe goal of preoperative evaluation is to identify and modify risk factors that might adversely affect anesthetic care and surgical outcome.
\n\n
Pulmonary disease—either obstructive or restrictive lung disease.
Cardiac disease
History of previous abdominal surgeries
History of coagulation disorders in self or in family
Previous history of anesthesia related complications
History of dentures or prosthetic devices
Previous operative records if any
\n
Assessment of head and neck
Assessment of lungs and heart
Vascular and neurological examination
Airway evaluation by anesthetist
Vital signs
Abdominal examination to look for scar site and to decide on alternate port site and to assess the extent of adhesions.
\n
Hemoglobin
Blood urea and creatinine
Serum electrolytes
Liver function test
Coagulation profile
ECG and chest X-ray
Serology testing
Ultrasound abdomen and pelvis
Urine analysis
Tests obtained within 6 months of surgery are acceptable if there is no significant change in patient medical history.
\nThe expectations with regard to the surgery should be clearly discussed with the patient. Anesthetic and surgical procedure and complications should be clearly explained to the patient. Risk of perioperative morbidity and mortality, post op pain, recovery, length of stay everything in detail should be counseled to the patient prior to surgery. Detailed informed consent regarding chance of conversion to laparotomy, chance of visceral injury should be obtained.
\nThe laparoscopic hysterectomy is classified depending on the extent of dissection done laparoscopically (Table 1). The knowledge of anatomy is essential before hysterectomy (Figure 1). The sterile precautions are maintained to arrange and assemble the laparoscopy instruments (Figure 2).
\nThe classification of laparoscopy assisted hysterectomy.
A sagittal section of a cadaveric specimen of female pelvis showing the anterior and posterior relation of the uterus.
The laparoscopy instruments required are arranged in a sterile cart: grasper, bipolar, scissors, suction irrigation, trocars and cannula. One 10 mm and three 5 mm ports are necessary.
The patient is given general anesthesia, with oral tracheal intubation. The patient is positioned in dorsal decubitus position Loyd Davis Position. The legs are positioned in the low lithotomy position with thighs flexed at 30°and knees supported, the arms are positioned along the body, and the buttocks extending slightly over the edge of the surgical table. The bladder is catheterized. The surgeon is positioned to the left of the patient. The first assistant is on the right side of the patient. The second assistant does the uterine manipulation and he stands between the legs of the patient. A foam mattress is placed directly under the patient to prevent sliding during steep Trendelenburg. The table is kept in a low position to enable wrist movements for intracorporeal knotting. The monitor to directly face each surgeon at the angle of resting eye, i.e., 30°, to promote an ergonomic working environment. The surgeon, the target tissue and the monitor should be in straight line. The height of the table should be about the half of surgeons’ height to enable wrist movements.
\nUterine cannulation is performed with a specific instrument named The Clermont-Ferrand type Karl Storz Uterine Manipulator or RUMI - Uterine Manipulator (Figure 3).
\nThe uterine manipulator is used to antevert the uterus and delineate the fornixes for laparoscopic colpotomy. The pneumoperitoneum is maintained by the soft silastic parts of the instrument that prevent the air leak after colpotomy.
First, a Sims speculum is placed into the vagina. Cervix is held with a tenaculum and the uterus is sounded. The cervix is dilated to Hegar number 9. RUMI tip used should be selected according to the patient after sounding the uterine cavity with a uterine sound. If the uterine cavity is 7, a 6-cm tip should be selected. The sizes available are 6, 8, or 10 cm. The distal end of the shaft may be dipped in the in lubricant prior to attaching the tip. This greatly facilitates the insertion into the uterine cavity. The pneumo-occluder is now slided over the tip and the shaft. Now the Koh cup (3, 3.5, and 4 cm in width) is attached. The Koh cup should be appropriately sized according to the cervix of the patient. This is important because a small ring will not mark the vaginal fornices exactly and only push up the cervix. The delineation of fornices is important because it serves as a landmark till the surgery is complete. A large ring will increase the risk of a ureteral injury. Insert the tip of the RUMI as far into the cervix as it will go. The correct placement is confirmed by palpation or direct visualization. Inflate the Uterine balloon with 5 cc of normal saline to manipulate the uterus and facilitate specimen removal through the vagina at the end of the case. The bladder is catheterized with Foleys catheter. The pneumo-occluder is now inflated with 60 to 100 cc of saline. RUMI II and RUMI arc are recent modifications that fascilate easy manipulation.
\nThe stomach should be deflated by Ryle’s tube insertion and aspiration. First step is to insert the Veress needle following the double click sound at subumbilical incision or the Palmer’s point in the left upper quadrant, about 2 to 3 cm below the left costal margin, in the left midclavicular line [7]. Now, CO2 insufflation is done to create pneumoperitoneum to achieve an intra-abdominal pressure of 12 to 14 mmHg [8, 9]. An easy way to confirm intraperitoneal entry is to look for the pressure reading on the insufflator. If the pressure reading is high the Veress needle is likely to be impinging on the omentum. A slight gentle movement will dislodge it. Alternatively bubble test can be done.
\nFour trocars are positioned: one 10 mm umbilical trocar with a 30° optic and three 5 mm trocars, with one 2 cm medial to the right superior iliac crest, another 2 cm medial to the left anterior superior iliac crest, and a third in the midline, 8–10 cm below the umbilical port. These trocars are placed lateral to the rectus abdominis muscles, 2 cm above and 2 cm medial to the anterior superior iliac spine (Figure 4). The last 5 mm trocar can be substituted by a 10–15 mm trocar during surgery for the introduction of suture needles and for suturing of the vaginal vault. A complete survey of the abdomen to rule out any visceral injury at the time of entry is done. The lower quadrant trocar sleeves are placed under direct vision. In the case of very voluminous uteri, the trocars can be positioned more cephalad using the diamond baseball concept.
\nLaparoscopic port positions for total laparoscopic hysterectomy with ipsilateral ports. The infraumbilical port is the telescopic port. The right iliac fossa port is the traction port and the two left iliac fossa ports are the operating ports.
After inserting the ports the trocars are withdrawn and instruments are inserted. The patient is placed in 15° head low position to move the bowel loops away from pelvis. The small intestine loops are mobilized upwards to visualize the uterus, tubes, ovaries, round ligaments and infundibulopelvic ligaments. The surgeon uses a grasper and a bipolar and follows the manipulation angle of 60°. The Azimuth angle is maintained at 30°. Manipulation angle is the angle between the two operating instruments. Azimuth angle is the angle between the scope and the operating instrument. The first assistant holds the scope with the left hand and uses the Maryland grasper forceps in the right hand. If adhesions are seen they should be gently released. Releasing adhesions between sigmoid colon and utero-ovarian ligament permits the correct exposure of the infundibulopelvic ligament and posterior surface of the uterus. The sequence to be followed is look, hook, coagulate and cut. Thick tissue should be cauterized in small steps with coagulating cautery set at 35 W to prevent charring. The uterus is mobilized by the second assistant and is maintained cranially and anteriorly.
\nThe round ligament is secured with traction by the first assistant, making possible its exposure for the start of the surgery. The round ligament is coagulated at a distance of 2 to 3 cm from the lateral pelvic wall using a bipolar cautery (Figure 5). The coagulation of the round ligament near the uterus is difficult as there is an artery to the round ligament which may bleed. This is followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection.
\nThe round ligament is held 2–3 cm from the lateral pelvic wall. The ligament is coagulated with bipolar and cut with scissors.
The first assistant should secure the adnexa and apply traction in a direction opposite to the operating side (Figure 6). The coagulation and sectioning of the ligament should be progressive, plane to plane (peritoneum, followed by the vessels and connective tissue). The infundibulopelvic ligament or the tubo-ovarian ligament are now coagulated and with a bipolar grasper and scissors. The infundibulopelvic ligament should be coagulated close to the ovary (hug the ovary) as this helps to avoid injury to the vital structures in the pelvic sidewall. The tubo-ovarian ligament should also be coagulated close to the ovary to prevent injury to the uterine vessel during ovarian conservation. When you want to preserve the adnexa, the coagulation and section is performed proximal to the fallopian tubes and the utero-ovarian ligament. The posterior leaf of broad ligament is opened with incision extending till the internal os being careful not to injure the uterine artery and vein (Figure 7). The peritoneum is opened, coagulated and cut till the attachment of the utero-sacral ligaments. The capillaries in the posterior leaf of broad ligament and the parametrial veins that run between the ovary and round ligament should be taken care of.
\nThe infundibulopelvic ligament is identified by gentle traction. It is also coagulated with bipolar and cut with scissors.
The peritoneum in the broad ligament is opened and uterine vessels are identified at the level of internal os.
The assistant uses an atraumatic forceps to grasp the peritoneum and the bladder in the midline, applying vertical and cranial traction (Figure 8). The peritoneum and the adjacent connective tissue are coagulated and sectioned, thus accessing the vesico-vaginal plane and posteriorly to expose the bottom of vesico-uterine sac. The dissection continues in a caudal direction, initially in the midline and then laterally, performing the coagulation and section of the vesico-uterine ligaments thereby mobilizing the bladder off the lower uterine segment. The plane of loose areolar tissue should be identified and opened avoiding injury to the vessels. In women with previous cesarean delivery, there are adhesions between bladder and lower uterine surface and so dissection should be a little high as close to the uterus as possible to avoid bladder injury.it is important to identify and pick small bits of tissue close to the uterus and coagulate and cut them gradually moving down towards the cervix [10]. Alternatively a lateral approach of opening the broad ligament may be the preferred route [11, 12]. During laparoscopic hysterectomy, if the patient has significant adhesions from prior cesarean deliveries, a reverse inferior to superior vesico-uterine fold dissection can be used to dissect the bladder from the uterus [13]. This lateral dissection and accessing the bladder from below can be used as an alternative to the commonly practiced technique of mobilizing the bladder in a superior to inferior fashion at the time of laparoscopic hysterectomy. The anatomy of the space of Seth can be helpful in identifying the lateral structures of bladder. Space of Seth is bounded laterally by the tangential line joining the maximum bulging on the uterine body and cervix, medially the bladder comes in contact with the uterocervical surface thickening at the level of bladder pillars. Anteriorly there is the undersurface of bladder and anterior leaf of broad ligament, posteriorly there is the uterocervical surface [14].
\nThe loose vesicouterine fold of peritoneum is held with grasper and scissors used to dissect the bladder. The bladder is gently dissected downwards by laparoscopic pledgets or applying traction from the jaws of bipolar.
A reevaluation of the route of dissection is advised if fat is encountered because the fat belongs to the bladder and this may indicate that the dissection is moving too close to the bladder. With this the ureter is kept out-of-the-way, since it is mobilized along with the peritoneum.
\nDesiccate the ascending uterine vessels with the bipolar grasper at the level of internal cervical os. The RUMI uterine can be pushed upwards to increase the distance between uterine artery and. The uterine vessels should coagulate till there is vaporization and bubble formation. The uterine vessels should be grasped perpendicularly to coagulate the 7 mm lumen efficiently. If the uterine are grasped obliquely the lumen to be coagulated becomes wider. Grasping the uterine artery perpendicularly is made easier by the new articulating instruments which can change direction and allow the uterine artery to be grasped and coagulated perpendicularly (Figure 9). After the coagulation and cutting of uterine arteries the vascular pedicles are deflected laterally and dissection is continued in the avascular plane over the cervix towards the delineated vaginal fornices (Figure 10). The ureters should be reconfirmed and the dissection continued close to the uterus [15].
\nThe uterine vessels are secured with endocorporeal knotting or harmonic.
Uterosacral ligaments are identified and the peritoneal incision is extended to the pouch of douglas. The peritoneal incision is above the uterosacral ligaments.
While pushing cephalad with the uterine manipulator, vaginal fornices are identified. It is identified by indentation of the Rumi Koh colpotomizer or by palpation with a laparoscopic instrument. The Harmonic scalpel or laparoscopic monopolar hook is then used to cut circumferentially around the cup, thus uterus with cervix is separated from vaginal apex (Figures 11 and 12). In patients with limited vaginal access, the uterus can be morcellated using an electronic morcellator and specimen removed abdominally. It is important to keep the tip of the morcellator in clear view at all times.
\nThe vaginal vault is incised with a harmonic or laparoscopy monopolar hook after delineating the fornixes. The vaginal vault is incised above the attachment of uterosacral ligaments.
The posterior lip of cervix is seen after vaginal vault is incised. The pneumoperitoneum leakage is prevented by the RUMI manipulator in the vagina.
Vaginal cuff should closed beginning at the margins of angle of the vaginal canal. The barb sutures are continued in running manner. The vaginal mucosa and the pubocervical and rectovaginal fascia are included in the suture line. Each suture should be placed at 1 cm in distance from vaginal cuff margins. This is important and can be guessed as a comparison to the wide open jaw of grasper which is 2 cm wide. Distances can be easily underestimated because of the magnification of the laparoscope. Irrigation and suction is performed and hemostasis rechecked. The bidirectional barbed suture is available in which wound tension is evenly distributed across the length of the suture line rather than at the knotted end. No knots are required with bidirectional barbed suture. Since uterosacral ligament attachment to vagina is undisturbed in Total Laparoscopic hysterectomy the vaginal vault fixation is not required.
\nNo routine cystoscopy is needed to ensure ureteral patency and bladder injury except in cases of dense bladder adhesions. However cystoscopy does not identify delayed thermal injury to ureters and bladder.
\nThe pneumoperitoneum is deflated.
\nThe fascial defect of the 10 mm trocar in the midline is sutured and the skin is sutured with 3–0 monofilament absorbable suture.
\nLaparoscopic direct visualization fascial closure methods provide more accurate placement of sutures under direct vision.
\nRecommendations regarding port wound closure:
All ports greater than 10 mm either in midline or lateral should be closed at fascial level.
5 mm ports if manipulated extensively or enlarged significantly during the procedure need to be closed
Port closure should include fascia and peritoneum.
The LigaSure Vessel Sealer, The EnSeal—Advanced Tissue Sealing Technology and the Ultracision ® harmonic scalpel are newer advances in laparoscopic surgery. Articulating vessel sealer helps to grasp and coagulate the vessel at right angle to the course of the vessel, thereby minimizing the diameter of vessel to be coagulated. Each surgeon should develop his own routine and use the available materials and technology to facilitate the surgical procedure.
\n\n
Small surgical wound
Short hospital stay
Quick recovery
No abdominal wound
Decrease in intra op bleeding
Decrease in post op pain and infection
Low incidence of DVT.
Early return of bowel activity
Less risk of adhesion formation
\n
Failure to progress
Dense or extensive lower abdominal or pelvic adhesions
Acute or chronic inflammatory changes causing increased vascularity resulting in tethering or tearing of tissues.
Difficulty to maintain pneumoperitoneum due to gas leaks in and around the ports.
Poor or inadequate exposure—obesity may preclude placement of ports
Altered or aberrant or unclear anatomy
Inexperience of the surgeon
\n
Technical problem/instrument malfunction
Anesthesia related issues like—poorly tolerating pneumoperitoneum
Complex viscus injury
The surgeon should keep in mind the time of dissection and the progress made as well as the remaining tasks to be completed. Also the surgeon’s threshold for conversion should be low while gaining experience.
\n\n
Minimize tissue damage
Perfect hemostasis
Minimize length of insufflation
Minimize intra-abdominal pressure
Adequate irrigation to avoid desiccation
Gentle tissue manipulation
Physical barriers like Seprafilm/Intercede
There is a documented reduction in the narcotic requirement after laparoscopic Hysterectomy when compared to open procedure. It is also associated with earlier return of bowel function, earlier discharge, and improved pulmonary function.
\nPost op pain is due to irritation of somatic nerve fibers by overdistension of the diaphragm and carbon dioxide pneumoperitoneum related acidic intraperitoneal environment. Peritoneal ischemia, distension neurapraxia are other mechanisms that account for post op pain.
\nMethod of reducing postoperative pain:
Infiltration of abdominal wall incision with local anesthetics
Intra peritoneal instillation of saline at the end of the procedure
Epidural analgesia
Complete removal of insufflated gas
Postoperative non-steroidal anti-inflammatory drugs
The addition of deep vein thrombosis prophylaxis should be at the discretion of the operating surgeon based upon the earlier recommendations and risk assessment of that particular patient.
\n\n
Optimize the patient and iatrogenic risk factors.
Appropriate use of systemic perioperative antibiotics.
Adequate operative site preparation.
Avoid unnecessary trauma from hair removal techniques.
Avoid wiping off antiseptic after the skin preparation
Strict adherence to principles of sterility
Wide preparation of skin in case of conversion to laparotomy.
Adequate sized skin incisions will prevent ischemia and marginal wound necrosis.
Occlusive dressings to be released after 48 h because they might be conducive to bacterial overgrowth.
How to avoid Port site bleeding complications?
The trocar and the port should enter the abdomen at 90° to skin surface.
Dermal incision should be complete before using the trocar to penetrate the fascia.
Surgeon should be familiar with the mechanics of the given trocar.
Port placement should be made either in the midline or lateral to the edge of rectus sheath to avoid inferior epigastric artery.
Blunt tip ports are preferable to sharp tipped ones.
\n
Advice to start on liquids after 6 h and to a regular light diet as tolerated on first day.
Bath after 48 h—for skin incision to re-epithelialize.
No restriction to walking from first post op day.
Resumption to preoperative activity by second week.
Regular exercise encouraged after 4 weeks.
Resumption of driving depends on mobility, reaction time, patient ability to respond to any road hazard. Usually resumes by 1–2 weeks.
Return to work by 2 weeks.
Continue Hematinics and Calcium supplements for 3 months.
Abstinence for 6 weeks.
\n
Minimum number of ports with smallest possible diameter.
Violent torqueing of port which can enlarge fascial defect.
Slow desufflation of abdomen while removing the ports—rapid removal of ports may draw bowel and omentum into port sites.
Before closure of ports shake the abdomen to dislodge the stuck bowel.
Closure of fascial defects before patient is extubated.
It is a painless ballotable swelling at a healing port site. It usually occurs within 1–5 days postoperatively. There is no evidence of inflammation. It usually resolves spontaneously within days unless complicated by secondary bacterial infection.
\nPort site tumor is common when an unexpected malignant specimen is retrieved through one of the ports. Serious complication has been noted in setting of ovarian cancer and to lesser extent in patients with endometrial cancer and rare in cervical cancer patients. The presence of 10–15 mm Hg pneumoperitoneum may facilitate the dispersion of liberated tumor cells throughout the abdomen and to port site during insufflation events. The employment of specimen bags is recommended to retrieve the specimen. Laparoscopic skill level of the surgeon also plays a critical factor.
\nLaparoscopy offers the advantage of clear magnified anatomy and pathology. The adhesions can be dissected carefully under vision. To minimize complications the basic principles that should be kept in mind can be summarized.
Proper patient selection
Adequate experience of the surgeon and assistants
Proper port placement
Avoid gas leaks
Sound surgical techniques
Adequate sized incisions
Thorough irrigation of port and abdomen before closure
Fascial and peritoneal wound closure for 10 mm or larger ports
Authors thank the nursing staff of Department of Obstetrics and Gynecology, Department of Radiology and Department of Anesthesiology, Saveetha Medical College, Chennai, for the care given to the women. We also thank the staff of Operation theaters and staff of blood bank. We thank the Biotechnical Department of Saveetha Medical College and hospital.
\nWe also acknowledge the funds provided by Saveetha University, Chennai for the laparoscopy surgical care for women.
\nThe authors declare that there is no conflict of interest.
Biomedical ethics has made giant strides over the past decades and has come to be recognised as integral to medical education. This has encouraged the growing inclusion of the teaching of medical ethics, together with that of the human sciences, in the syllabi of medical and nursing schools. In the 1980s, increased awareness of ethical issues shone a light on some excesses of medical research and medical paternalism which conflicted with ethical principles. The 1990s saw the establishment of the first medical ethics committees in hospitals, overseeing both research and clinical practice. Since the 2000s, the various bodies regulating the doctors’ right to practice have issued regulations, guidelines and recommendations laying down formal ethical rules for medical practice, together with a system of penalties for infringement of these rules.
Many social and cultural factors have contributed to the increase in ethical concerns. The increase in individual civil liberties, codified in various Charters of Citizens’ Rights, has fuelled a growing drive to claim new rights in previously unexplored areas. The development of biomedical technologies has created new frontiers, such as the attempt to shape one’s own medical fate, as in the case of the actress Angelina Jolie, who chose to undergo preventive double mastectomy and subsequent ovariectomy because she carried a gene that greatly increased (over 80%) her risk of developing an aggressive and often fatal type of breast cancer, or the decision of a British manager to have his prostate removed for the same reason. In the meantime, the constant budget cuts have increased the need to make very complex choices.
Recently, the Covid-19 pandemic has confronted us with specific ethical dilemmas, in particular the choice about who to treat or not to treat in a health emergency with scarce resources.
The growing ethical concerns have highlighted the fact that doctors only receive very basic training in medical ethics during their studies and practical training. Some studies even show that the awareness of ethical issues of students and trainees decreases as they advance in their studies [1, 2].
Most doctors trust their ethical judgement and believe that their decisions are morally sound. Yet most doctors lack adequate training and theoretical knowledge of ethical issues to support their beliefs and choices in a manner that stands up to scrutiny. The ethical judgement of most doctors is based on their professional life experience, personal opinions, beliefs and values, but few know the theoretical foundations of biomedical ethics and moral decision-making.
The first part of this paper outlines the key theoretical concepts framing ethical decision-making by physicians. Next, the principles governing the ethical decision-making process are presented. This is important because ethics is not only about the medical decision, but also about the process for reaching that decision. Certain issues in the application of ethical principles and the challenges brought by current events to medical ethics are also discussed.
The birth of bioethics as understood today is closely linked to the giant strides made by the biomedical sciences and technologies (most notably molecular biology and genetic engineering) around the 1970s.
The gradual unlocking of the mechanisms of life, coupled with the possibility of manipulating and modifying living beings, enabled a number of procedures that gave rise to widespread ethical concerns: medically assisted reproduction, tissue and organ transplantation, genetic intervention, the possibility of artificial life independent of ‘natural’ life, euthanasia, cloning, etc.
The word Bio-Ethik was coined by German Protestant pastor and ethicist Fritz Jahr, who used the term to propose a new bioethical imperative that extended to all living beings Kant’s categorical imperative of respect for all persons [3, 4].
However, the current meaning of bioethics can be ascribed to American oncologist Van Rensselaer Potter, who used this term in a paper entitled Bioethics: the science of survival [5] and later in his best-known work Bioethics: a bridge to the future [6].
According to Potter, building an ethic based on scientific knowledge is necessary to ensure the very survival of Homo sapiens, which could be threatened if research were allowed to proceed unchecked and unfettered. Potter rejected merely speculative knowledge and stressed the need to connect ethical values, traditionally confined to the realm of the humanities, with biological facts and thus build a ‘bridge to the future’.
Potter himself defined bioethics as the ‘knowledge of how to use knowledge’, to highlight the distinctive nature of this discipline as a dialogical meeting point between the natural sciences, the social sciences and philosophy.
In his subsequent book, entitled Global Bioethics, Potter made the by now well-established subdivision of bioethics into three branches: medical ethics, environmental ethics and animal ethics [7].
It is interesting to note that originally, the scope of bioethics was not restricted to medical practice, even though in subsequent years this came to be considered its main, if not exclusive, area of concern. Indeed, differently from Potter’s definition of bioethics (later followed by Jonas in his work The Responsibility Principle [8]) the term has mostly been applied in the narrower sense given to it by Dutch obstetrician Andre E. Hellegers, co-founder of the Kennedy Institute, who considered bioethics as ethics applied to the biomedical sciences [9]. This narrowing of the scope of bioethics from its original reflection on the ethical problems relating to life, ‘bios’ in all its complexity, is partly due to the fact that the two centres where bioethics research and teaching were first developed (the Kennedy Institute in Washington and the Hastings Center in New York) focused on medical issues, specifically, on medically assisted reproduction. This meant that issues such as the treatment of animals or environmental risks were not considered to fall within the scope of bioethics proper.
The close links between the different facets of bioethics and the high complexity of the problems addressed require constant cross-disciplinary dialogue among scientists and scholars from a range of disciplines such as philosophy, law, economics, sociology, ethology, psychology and anthropology [10].
The interdisciplinary nature of bioethics is also in evidence in the current definition of this discipline, contained in the 2nd edition of the Encyclopedia of bioethics: ‘Bioethics is the systematic study of the moral dimensions - including moral vision, decisions, conduct, and policies - of the life sciences and health care, employing a variety of ethical methodologies in an interdisciplinary setting’ [11].
The relationship between ethics and science is certainly at the heart of philosophical reflection and may be summed up in one question: should we do everything we can do?
In the United States, the debate on ethical issues had already started long before the breakthroughs in genetics: it was prompted by news of gross abuses committed in several clinical trials, namely at the Jewish Chronic Disease Hospital in Brooklyn, the Willowbrook State Hospital in New York and in the famous ‘Tuskegee Study of Untreated Syphilis in the Negro Male’ which began in 1932 and continued until 1972 [12].
However, the historical roots of bioethics and, in particular, of medical ethics, can be traced further back in time by a deeper examination of the relationship between science and ethics.
The atrocities committed in the experiments on concentration camp prisoners in Nazi Germany dramatically revealed, well before the later events that prompted the appearance of the term ‘bioethics’ in the literature, the need to investigate the relationship between ethics and science.
The Nuremberg Code was the first document to enshrine in specific rules the ethical principles that govern research on human subject. The Code, which although it never attained legal value has a universal moral value, established for the first time the following standards for human experiments:
The voluntary consent of the human subject is absolutely essential: this means that the person involved must be given detailed prior information about the nature, purpose, duration, means and risks of the experiment;
the experiment must be justified in terms of necessity, anticipated results and avoidance of injury;
the risks of the experiment must be carefully weighed against the expected benefits;
the personnel conducting the experiment must be appropriately trained and qualified;
appropriate equipment and facilities must be used;
it must be possible to bring the experiment to an end at any time on the initiative of either the human subject or the scientist.
Thus, the Nuremberg Code is a landmark document in the development of medical ethics, paving the way for a gradual and profound revision of the doctor-patient relationship in order to shed the traditional paternalistic approach in favour of the principles of consent, shared decision-making and therapeutic alliance.
Following the Nuremberg trial and the consequent drafting of the Nuremberg Code (1946), several international instruments on human rights were drafted, starting from the Universal Declaration of Human Rights (1948), which laid down the first legal principles of bioethics. The Declaration contains strong statements on the right to life and physical integrity, together with other fundamental civil and political freedoms. In so doing, it opened up a new legal and regulatory path for bioethics and inspired and influenced the subsequent development of international legislation.
The global and regional documents, charters, declarations and conventions that followed explicitly refer to the Universal Declaration of Human Rights as the foundation of their statutes and precepts, including the WMA Declaration of Geneva and the International Code of Medical Ethics of 1948 and the WMA Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects of 1964 (with its several subsequent amendments.
However, with regard to the aims of bioethics, it would be reductive and historically incorrect to limit its statutory, founding aims to the need to fix the ethical boundaries for the technical progress of science. As Mori [13] pointed out, what the Nuremberg trial itself so dramatically exposed is the need to set limits not to the technological advances of science but to the abuse of those advances. Thus, Mori reminds us that the core problem of bioethics is not to trace the boundaries of technological advancement, pitting science against ethics, but to identify the reasons that justify a specific moral judgement. Thus, as remarked by Schiavone [14], a crucial premise for any ethical approach to be legitimate and justified is that any critical reflection on scientific areas and disciplines should originate and develop within science itself and the scientific and technical advances achieved by it, instead of referring to a source of regulation outside science.
Far from being a system distinct from science and which attempts to stem its progress, bioethics aims to pursue critical and coherent reflection on human dignity, as an instrument of moral control (in the secular sense) over science in terms of its impact on human beings and the environment.
The subject matter of bioethics (which concerns itself with the sphere of ‘bios’, i.e. living beings) is associated with the theme of the destiny of human beings, and thus is an emotionally charged topic, inevitably subject to strong pressures. Bioethics is constantly at risk of sliding from the role of neutral and unbiased observatory – to the extent that such a role can effectively be achieved and maintained – onto the dangerous terrain of ideology and its associated dogmatic views.
Returning to the question of the origins of bioethics, it should be noted that ethical reflection in medicine dates back to long before Potter’s text. The Hippocratic oath is significant evidence of this. The oath, which evidently reflects the philosophy and culture of a time when the medical profession had a hieratic character, contains the seed bioethics in its principles of non nocere (i.e. ‘do no harm’ to the patient) and ‘beneficence’ as cornerstones of the doctor’s activity.
The Western world has adopted this approach and has formulated codes of medical ethics and laws inspired by ethical principles to regulate the exercise of the medical profession. These sets of rules are regularly updated in response to cultural and ethical developments and to the growing demand for professional standards to safeguard not only the interests of medical professionals, but also, and most importantly, those of their patients.
In this regard, medical ethics and standards of professional conduct play a major role in the physician-patient relationship. This is the setting where protecting the patient’s fundamental rights is crucial and where the risk that medical practice may infringe the individual’s rights protected by the Constitution is highest. Indeed, since ancient times, the power imbalance inherent in the patient-provider relationship has required a framework of principles and rules specifying the physician’s duties, in order to protect the patient (Figure 1).
Main documents on medical ethics.
Ethical theories can be grouped for simplicity into two main currents.
One is teleological ethics. Teleological theories focus on the purpose of the decisions taken and on their positive and negative impacts, and assess the consequences of the action [15]. These theories are deductive and pragmatic. Among the best known are John Stuart Mill’s utilitarianism [16] and American principlism [17]. The latter is undoubtedly one of the most widespread currents in medical ethics, at least in the United States, and will be discussed below. These theories focus on doing good for each individual, but also for the community.
The second current is deontological ethics; this differs fundamentally from the teleological approach in that its focus is not on achieving a good outcome but on doing what is morally right. The deontological approach is based on a series of ‘prima facie’ principles; it is an inductive principle focused on processes rather than on the final decision and it refers to the theories of Kant and Habermas [18]. Deontological ethics recognises absolute prohibitions, which admit no exceptions for any reason, override other duties, are fixed ‘a priori’ and are unchangeable. However, since conflict may arise between different duties, priorities must be identified in the hierarchy. Thus, a shift occurs from a hierarchy with absolute ‘a priori’ duties to an ethics with ‘prima facie’ duties, which also requires examination of the circumstances.
Teleological ethics and deontological ethics are two alternative ethical theories that determine the moral good or evil of an action.
The key difference between the two theories is that teleological ethics weighs the good or evil of an action according to its consequences. By contrast, deontological ethics determines the good or evil of an action on the basis of an examination of the action itself. Its vision is based on rules that determine the action.
Application of these two theories to end-of-life care can help to clarify the difference between them. Under the teleological framework, doctors who practice assisted dying focus on the purpose of decisions. They respect the patient’s choice to end her suffering when there is no hope of improvement. By contrast, under the deontological approach, doctors may refuse to provide assisted dying care on the basis of the a priori principle that doctors are trained to treat and not to take life. These are two diametrically opposed positions, which require different ethical frameworks.
General principles that state universal values of common morality also contribute to the basic reasoning on medical ethics . Beauchamp and Childress [17] have identified a model consisting of four moral principles that constitute the most common framework for achieving what is ‘good’ and what is ‘right’ in healthcare. ‘Principlism’ is a basic framework because it identifies four fundamental principles that come into play in most medical decisions, across the different medical specialities, countries and continents. These principles do not constitute a moral system or theory, but offer a framework for reflection on the moral problems encountered, and provide a starting point for making a moral judgement and assessing the procedure to be followed. The main principles are:
respect for autonomy/the individual
beneficence
non maleficence
justice.
The principle of autonomy refers to liberal thought, which has always emphasised individual rights and freedom of choice as an expression of the individual’s free will. The patient is recognised as possessing critical thinking and decision-making skills that must be respected. The model that emphasises the autonomy principle aims to oppose and overcome the paternalistic approach that has long dominated the doctor-patient relationship. The paternalistic model was based on an asymmetric relationship between the doctor (acting as a good parent) and the patient, who was treated as a ‘child’, unable to make decisions because of his lack of scientific and, especially, medical knowledge. This model has been discarded by reversing the patient’s role, from a passive one, to that of an autonomous person, capable of self-determination according to the principle of individual autonomy. The principle of autonomy ensures that the patient is involved in the medical decision-making process and protects his right to choose, accept, refuse or stop treatment. This is an absolute right of the individual, even where the refusal or interruption of treatment might cause adverse health consequences or even death. Autonomy implies respect for an individual’s physical and mental integrity. A person cannot be forced to receive treatment against her will. The patient cannot be subjected to any physical or mental coercion. The principle of autonomy also underpins the patient’s right to accurate and exhaustive information on the proposed treatment. Recognition of this right has led to development of the informed consent procedure. However, for certain specifically identified medical conditions that pose a public health threat, the government has the coercive power to impose treatment; this can occur, for instance, in the case of acute psychiatric patients or highly infectious diseases. However, even in these cases, the dignity of the person must always be respected. To apply these rules, doctors must know the legislation in force in the country in which they work; in any case, they must take all proper actions to minimise the need for coercion and maximise the patient’s consent.
The principle of beneficence states that the patient’s well-being is the ultimate goal of care. This principle lies at the heart of medicine, whose mission is precisely to prevent, diagnose and treat illness in order to promote the patient’s health. It is a question of proposing a treatment that is proportionate to the patient’s needs and whose benefits for the patient outweigh its possible harms. This principle means that doctors may act in the patient’s best interest also by refraining from acting and/or by acting prudently, always from the viewpoint of the benefit for the patient. Traditionally, this principle has been focused on ‘objective’ good, i.e. the outcome considered to be good by the doctor. However, cultural and ethical developments have gradually led to add to this principle that of autonomy, supporting a more subjective interpretation of the patient’s ‘best interest’.
The principle of non-maleficence has been well known to doctors since the time of the Hippocratic precept of primum non nocere. Non-maleficence encompasses two key concepts. The first is that of not causing harm to patients, even before doing them good. The second is the need to properly assess the risks and the benefit/risk balance of a treatment, and hence to refrain from prescribing a treatment that, although effective, could be harmful to the patient.
The non-maleficence principle is reflected in a number of legal provisions regarding wilful medical malpractice, where the patient was intentionally injured, or negligent malpractice, where the harm was caused by negligence, inexperience, recklessness or failure to comply with laws, regulations, orders or standards.
The principle of justice requires that all people be treated fairly. It is difficult to provide a single definition of justice, as various theories have produced different versions. Egalitarian theories stress the importance of universal access to basic necessities [19]. Libertarian theories affirm the right to social and economic freedom [19]. Utilitarian doctrines require the balancing of the two principles in order to maximise public and private utility [17]. Moreover, the principle of justice includes the concept of distributive justice, which states that resources should be allocated so as to ensure that access to care is not affected by socio-economic, ethnic or other factors which could favour certain sectors of the population to the detriment of others. The problem of resource allocation arises at different levels. For example, a national government decides which share of funding to allocate to finance social and healthcare relative to other sectors such as education, labour, transport. Moreover, the healthcare budget is in turn distributed differently among the different specialties. Thus, in practice, implementing the distributive principle raises complex issues; for instance, to what extent can expensive experimental treatments be justified in patients who have not responded to conventional approaches? Some of these treatments can cost more than €100,000 per year and clearly erode the sums available to treat other patients.
These four principles are not independent of each other. Rather, they interact in all medical situations of varying complexity, engaging in a dialectical relationship which requires their careful balancing. The clinician’s art is to fully understand how to best weigh these factors on a case-by-case basis, to reach the most appropriate decision for the individual patient.
In modern biomedical ethics, the process by which a decision is reached is as important as the decision itself. This is why it is necessary to have a clear approach that takes into account the problems to be addressed and all the persons concerned.
Figure 2 shows a decision making process according to Jonsen’s four box model for decision making which evaluates four fundamental variables: medical indications, patient and family preferences, quality of life and contextual features [20].
Jonsen’s four box for medical decision-making.
The approach proposed here is one example, among the many available, of a framework to guide the decision-making process. The approach is based on a series of questions, which are set out and explained below.
What are the facts, the circumstances? This question prompts a description of the clinical problem, concurring factors and psychosocial and environmental aspects. The starting point is awareness that the interaction is not with an illness, but with a sick person with a life history, family, affections, job and deep personal, existential and ideological values. Each participant will, in their own way, experience the impact of the decision. Clearly, at the centre of the decision is the patient, being the person that will ultimately make the decision and bear the consequences. The available options should be assessed from a clinical standpoint, considering the likelihood of success of the option chosen. For example, what are the chances that a patient with aggressive cancer will survive mutilating surgery which may have major adverse effects? Besides the purely clinical assessment, the human and emotional costs involved must also be considered.
What is the ‘spontaneous’ option? What do the patient, their family members, the treating physician, the nursing staff and the medical team want? What is the impact of pressure from fellow doctors or hospital managers, for instance in the event of a shortage of inpatient beds. What is the possible impact of pressure from the media?
What are the values at stake for each of the parties concerned? To answer this question it is necessary to draw up a personalised list of the hierarchy of values at stake, in the specific clinical situation, for the main parties concerned, mainly the patient, but also her family members (clearly where they have a say) and the medical team. For example, in the case of surgery entailing the risk of serious adverse effects and disability, the patient might refuse the surgery if she feels that the degree of beneficence, as perceived by her, is not adequate; the patient might instead wish to retain her current physical status, refusing a procedure that she considers to be invasive and destructive; this because the patient fears that after surgery, she might not recognise herself as the person she was before. On her part, the doctor may feel that the surgery will enable the patient to survive with what the doctor considers an acceptable quality of life (beneficence/maleficence). In other cases, the reverse may happen: the patient and his family members may want the surgery to be performed no matter what, even if its positive impact may be minimal or zero (patient autonomy vs. doctor autonomy vs. fair allocation of resources).
What is the moral dilemma? The matter here is not to choose the best course of action, but to identify clearly the moral dilemma faced by the doctor and the whole team, spelling it out in the most explicit and detailed way. What must be decided is not whether to operate on a patient who demands a treatment that will yield little or no benefits, but whether to prioritise the patient’s autonomy, and what he considers to be beneficial, or to prioritise the professional autonomy of the doctor, expressed through his clinical judgement on a procedure that he considers to be maleficent (a useless operation that will cause suffering to the patient) and to entail an unfair allocation of resources.
What are the alternatives? All too often, emotionally charged situations lead to a polarisation of views between just two possibilities. In the example in point 3, the only two options considered are surgery versus non-surgery. Instead, all options should be considered and presented to both the patient and his family members: chemotherapy, palliative care, home care, etc.
Which was the initial spontaneous choice? It is always advisable to return to the first spontaneous choice and assess whether the position of the main parties has evolved, and whether they have moved closer or farther apart from each other or have otherwise changed their views. If a change of position did happen, it should be considered whether this could help to reduce the conflict.
Making the decision. The decision must be made after consultation with the main parties involved, first and foremost the patient, but also his family members (where their involvement is authorised by the patient), the medical team, etc. It is important to have an open attitude and to truly listen. The patient must be seen not only from a medical point of view, but as an all-round individual with a life story, beliefs and concerns. As J. F. Malherbe [21] said, the patient remains the protagonist of his illness and not just the object of treatment. One should not hesitate to consult a colleague to get a second opinion, or even the hospital’s ethics committee. After exhausting all these steps, a decision must be made. The decision must be justified by taking into account the medical evidence for each situation, but also the ethical issues specific to the situation. It is essential to specify which elements justify the principles that were given priority in the decision-making process.
In theory, the description of ethical principles seems to give a clear overview of medical ethics and the procedures to be followed when making treatment decisions.
However, in clinical practice, the application of ethical principles is increasingly complex and is often affected by issues that complicate the decision-making process and come into conflict with ethical principles. Some issues arise when different principles clash with each other; others are linked to patient-specific situations, while yet others are linked to the organisation of services.
With regard to the conflict between principles, a common opposition may arise between the principles of autonomy and beneficence, for example in terminal cancer patients. According to the principle of autonomy, the patient should be told that her condition is now terminal, to allow her to freely choose among treatment options and decide what to do with the time she still has to live. However, under the principle of beneficence, one might argue that providing such accurate information might cause deep pain, and hence be harmful to the patient, affecting negatively her will to live and her quality of life in the time left to her. Moreover, the conflict between the two principles is not an abstract one; on the contrary, it is experienced by the parties to the decision-making process, with real consequences. The principle of autonomy can be interpreted in very different ways by doctors. For example, some doctors might resort to the legacy of medical paternalism and feel authorised to deliver all the bad news to the patient; other doctors could rely on the principle of autonomy to avoid making difficult decisions by shifting the responsibility onto the patient and/or her family members, placing a heavy emotional burden on the patient; still other doctors may not provide the full set of options to their patient to prevent her from making decisions that the doctor does not consider beneficial to her, resorting to a sort of ‘palliative paternalism’ [22] and thereby arbitrarily reducing the patient’s free choice.
Conflict may also occur between the principles of beneficence and non-maleficence. An example is found in pain management for terminal patients, where the use of opioids relieves pain and meets the beneficence principle, but may shorten life, thereby violating the non-maleficence principle. Both principles are not absolute and are often combined, as in the above example, giving rise to the ‘double effect’ phenomenon, a term that in bioethics refers to an action that can have more than one result and contrasts two principles [17].
Other issues in the application of ethical principles arise when healthcare systems have to contend with limited resources. In these cases, the first ethical problem is patient selection for access to and discharge from care, which clashes with the principles of beneficence, non-maleficence and justice [23, 24]. The American Medical Association [25] has provided guidance on the ethical implications of the allocation of organs for transplant, which may be helpful in the task of determining priority of access to scarce and costly medical resources. The AMA paper has identified five criteria related to the patient’s Medical Needs, which should be considered when making resource allocation decisions: likelihood of benefit
the improvement in quality of life
the duration of the benefit to the patient
the urgency of the patient’s condition
only in some cases, the amount of resources required for successful treatment
These criteria help to maximise three primary goals of medical treatment: number of lives saved, number of years saved and improvement in quality of life. A hierarchy of objectives prioritises the goal of saving the greatest number of lives. [25] While the AMA document makes an important contribution to ethical decision-making, many questions about distributive justice and discrimination against older people remain open.
Furthermore, major social changes have affected the organisation of health systems and have further complicated the application of ethical principles. The globalisation of modern society, with its marked contradictions, inequalities and injustices has also inevitably affected healthcare systems. The undoubtedly successful McDonaldization phenomenon, [26], characterised by efficiency, productivity, cost reduction, procedural standardisation and control, has also influenced the organisation of healthcare services. The double pressure to cut costs and make a profit has impoverished the healthcare system, hitting hardest the most vulnerable and deprived citizens and generating major inequalities in the access to healthcare services: this has deeply affected the ethical principle of justice and beneficence and has altered the doctor-patient relationship [27].
In 2020, the whole world was struck by the Covid-19 pandemic. The pandemic disrupted life for every person with an unexpected, novel situation and caused an unprecedented humanitarian emergency. Its sudden outbreak has put the health systems under massive strain, causing a number of ethical problems for healthcare staff and managers, and giving rise to real challenges to basic ethical principles.
Compounding the existing problems in applying ethical principles, the pandemic has brought about new complex scenarios and issues, which have not always been addressed appropriately and in line with ethical principles.
The first moral dilemma posed by the pandemic relates to the strain on healthcare quality caused by the surge in demand. The pandemic has spread quickly, catching the health structures unprepared to handle the rapid increase in workload. At the height of the crisis, the number of patients rose dramatically and the hospitals soon ran out of beds. The number of healthcare workers (doctors and nurses) was also insufficient to deal with the surge in cases. Many health workers faced the additional workload with great dedication and sense of responsibility, aware that their patients’ lives also depended on their willingness to put in the extra hours. They prioritised the beneficence for their patients over their personal well-being. Many healthcare workers fell ill and many died [28]. At the peak of the pandemic, medical and nursing staff worked 12–14 hours a day wearing uncomfortable face masks, visors and coveralls. It is fair to assume that fatigue and stress at work may have affected the quality of care, hence the actual beneficence for patients. It can also be presumed that the quality of the care provided at the start of a work shift was higher than that provided by the same worker after 12 hours of gruelling work. Thus, the actual working conditions undermined both the principle of beneficence and the principle of justice, according to which all patients must be treated equally.
Moreover, the spike in patient numbers was so high that it produced an imbalance between the healthcare needs of the population and the availability of intensive care resources. The situation that came about was and still is an exceptional one, to the extent that it has been classified as ‘disaster medicine’ [29]. With regard to intensive care, in addition to the criteria for access to and termination of care, traditionally based on the appropriateness and proportionality of care, the criteria of distributive justice and appropriate allocation of limited health resources had to be applied. The ‘first-come, first-served’ criterion for access could not be applied. Healthcare workers were forced to carry out an unusual triage, in which they often had to apply the criterion of ‘greater life expectancy’. In Italy, SIAARTI (the Italian Society of Anaesthesiology, Analgesia, Resuscitation and Intensive Care) issued ‘Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances’ [29]. The recommendations are solidly grounded in ethical principles, to relieve clinicians from the burden of making subjective decisions, and establish explicit resource allocation criteria [29]. (SIAARTI). Robert et al. highlighted the ethical issues in patient management in intensive care units during the pandemic in France [30]. Despite the guidance provided, the dramatic pressure of the situation often forced physicians to grapple alone with the final decision about who should get life-saving care. While admittedly it was necessary to make a selection among the patients, we must also note that a dramatic discrimination occurred by age group, comorbidity and patient type. Elderly patients, patients with comorbidities and frail patients were often denied access to the ICU.
The pandemic emergency also gave rise to other issues. Many patients could not even reach the hospital and died at home while waiting for an ambulance that never arrived. In those cases, the decision was not guided by any particular and specific recommendations, but was simply left to chance: the lottery of life decided for them.
For the patients’ protection, during their stay in hospital, the patient-family and healthcare worker-caregiver connection was severed, counter to more than 20 years of research and care practice aimed at improving those relationships for the patient’s benefit [30]. Many patients were left to face death alone, without the comfort of family members, without any spiritual or religious care. As hospitals were overwhelmed, much was attempted to provide the benefit to the body but little was done to provide psychological and emotional care; healthcare moved back from caring for the whole person to focusing on the illness alone.
Yet other decisions have impacted ethical principles and good clinical practice in the management of chronic patients. For a long time now, the healthcare system has placed emphasis on prevention and early diagnosis programmes, educating the public about the importance of health screening and monitoring. The emergency has deeply disrupted this approach. Many cancer patients have been unable to attend their routine checks, and the same has happened to patients with heart conditions or diabetes. The principles of beneficence and non-maleficence have been severely compromised. An increase in deaths due to cardiovascular diseases has already been recorded, and the number of deaths secondary to cancer is also expected to rise [31].
The above overview confirms that the practical application of ethical principles in medicine is fraught with difficulties that may complicate the decision-making process. The current pandemic is confronting us with novel organisational, social and ethical challenges.
As a rule, major changes in healthcare occur at a much slower pace, giving us enough time to process them, adapt and make decisions. Today’s explosive crisis calls instead for urgent emergency measures. The assessment tools we have used so far have been made obsolete by the extraordinary pace of the crisis. In the health sector, clinical guidelines have traditionally been the gold standard for good clinical practice, in addition to providing some protection from medical liability. However, many guidelines have lost their relevance in the pandemic, which has created an unprecedented health situation for which no specific guidance could be prepared. The dramatic developments have put ethical principles under strain in various circumstances and cases. Moral dilemmas have severely affected the emotional resilience of clinical staff; in the near future we will have to deal with the moral distress they experienced.
Ethics, once a discipline of interest to scholars, has nowadays taken on a prominent role in the social debate. However, moral questions must be addressed and analysed critically, in order to define not only what is right, but also why it is right. [32]
Hopefully, we can draw some lessons from this tragedy.
The rationalisation of healthcare resources – through major budget cuts, the push for standardised care processes according to the McDonaldization model, the emphasis on hi-tech and highly specialised care – has not withstood the test of the pandemic. While of course it is hard to say which model would withstood the Covid crisis, it remains a fact that the current one failed, and this requires some reflection.
First, we should strengthen the human dimension of the physician-patient relationship. The focus on performance and profit has reduced the time available for listening to patients and their family members; as medical professionals, we have contributed to the achievement of the productivity targets set by the health authorities, but we have not always respected the ethical principles of an authentic doctor-patient relationship based on caring for the individual as opposed to simply treating a medical condition. Health professionals should take the brave step of fostering the relationship with their patients and prioritising quality over quantity, eschewing the industrial assembly line model: people are not machines and do not function like machines.
Social systems as a whole should revisit their resource allocation models. For a long time now, policy makers from all sides have made major cuts to health care; the pandemic has shown that ‘sick countries’ with difficulties in the delivery of healthcare are also countries with persistent economic problems. The share of public spending allocated to healthcare should be fairer, instead of treating the health service as the poor relation.
During the pandemic, we helped the patients with the greatest chance of survival, but we were unable to help the frailest ones. We went back to the model of Sparta, the ancient Greek city where frail male infants were tossed off a cliff, to train the others to become strong and valiant warriors. However, the Spartan model was not the one that prevailed in ancient Greece, nor the one that produced the greatest protagonists of classical culture. Healthcare systems, with the contribution of medical ethics, should develop care models that protect the frailest and shelter them from ‘competition’ for survival in which they would be doomed from the start.
We should also send the message that medical ethics is not just a matter for the individual health professional but is the responsibility of the whole community. The pandemic is teaching us that the responsible behaviour of each of us plays a key role in preventing the spread of the infection. The principles of medical ethics, beneficence and non-maleficence should be better known, understood and applied not only by health workers but by all persons.
Last but not least, the expectations placed on doctors today are very high, if not excessive, as concerns both clinical skills and patient relations. Although ethical issues are now on the front line, there is still very little training in biomedical ethics for health professionals. The development of science and technology require that physicians be knowledgeable of ethical issues pertinent to end-of-life care [33, 34]. It is crucial to invest more in this of training, to ensure that the new generations of doctors and other health professionals, within their respective roles, are better equipped to face the new challenges for medical ethics.
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\\n\\n6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\\n\\n7. MISCELLANEOUS
\\n\\n7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
\\n\\n7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\\n\\n7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
\\n\\n7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\\n\\n7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
\\n\\n7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
\\n\\nAny modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\\n\\n7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
\\n\\n7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
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The Corresponding Author (acting on behalf of all Authors) and INTECHOPEN LIMITED, incorporated and registered in England and Wales with company number 11086078 and a registered office at 5 Princes Gate Court, London, United Kingdom, SW7 2QJ conclude the following Agreement regarding the publication of a Book Chapter:
\n\n1. DEFINITIONS
\n\nCorresponding Author: The Author of the Chapter who serves as a Signatory to this Agreement. The Corresponding Author acts on behalf of any other Co-Author.
\n\nCo-Author: All other Authors of the Chapter besides the Corresponding Author.
\n\nIntechOpen: IntechOpen Ltd., the Publisher of the Book.
\n\nBook: The publication as a collection of chapters compiled by IntechOpen including the Chapter. Chapter: The original literary work created by Corresponding Author and any Co-Author that is the subject of this Agreement.
\n\n2. CORRESPONDING AUTHOR'S GRANT OF RIGHTS
\n\n2.1 Subject to the following Article, the Corresponding Author grants and shall ensure that each Co-Author grants, to IntechOpen, during the full term of copyright and any extensions or renewals of that term the following:
\n\nThe aforementioned licenses shall survive the expiry or termination of this Agreement for any reason.
\n\n2.2 The Corresponding Author (on their own behalf and on behalf of any Co-Author) reserves the following rights to the Chapter but agrees not to exercise them in such a way as to adversely affect IntechOpen's ability to utilize the full benefit of this Publication Agreement: (i) reprographic rights worldwide, other than those which subsist in the typographical arrangement of the Chapter as published by IntechOpen; and (ii) public lending rights arising under the Public Lending Right Act 1979, as amended from time to time, and any similar rights arising in any part of the world.
\n\nThe Corresponding Author confirms that they (and any Co-Author) are and will remain a member of any applicable licensing and collecting society and any successor to that body responsible for administering royalties for the reprographic reproduction of copyright works.
\n\nSubject to the license granted above, copyright in the Chapter and all versions of it created during IntechOpen's editing process (including the published version) is retained by the Corresponding Author and any Co-Author.
\n\nSubject to the license granted above, the Corresponding Author and any Co-Author retains patent, trademark and other intellectual property rights to the Chapter.
\n\n2.3 All rights granted to IntechOpen in this Article are assignable, sublicensable or otherwise transferrable to third parties without the Corresponding Author's or any Co-Author’s specific approval.
\n\n2.4 The Corresponding Author (on their own behalf and on behalf of each Co-Author) will not assert any rights under the Copyright, Designs and Patents Act 1988 to object to derogatory treatment of the Chapter as a consequence of IntechOpen's changes to the Chapter arising from translation of it, corrections and edits for house style, removal of problematic material and other reasonable edits.
\n\n3. CORRESPONDING AUTHOR'S DUTIES
\n\n3.1 When distributing or re-publishing the Chapter, the Corresponding Author agrees to credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen. The Corresponding Author warrants that each Co-Author will also credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen, when they are distributing or re-publishing the Chapter.
\n\n3.2 When submitting the Chapter, the Corresponding Author agrees to:
\n\nThe Corresponding Author will be held responsible for the payment of the Open Access Publishing Fees.
\n\nAll payments shall be due 30 days from the date of the issued invoice. The Corresponding Author or the payer on the Corresponding Author's and Co-Authors' behalf will bear all banking and similar charges incurred.
\n\n3.3 The Corresponding Author shall obtain in writing all consents necessary for the reproduction of any material in which a third-party right exists, including quotations, photographs and illustrations, in all editions of the Chapter worldwide for the full term of the above licenses, and shall provide to IntechOpen upon request the original copies of such consents for inspection (at IntechOpen's option) or photocopies of such consents.
\n\nThe Corresponding Author shall obtain written informed consent for publication from people who might recognize themselves or be identified by others (e.g. from case reports or photographs).
\n\n3.4 The Corresponding Author and any Co-Author shall respect confidentiality rights during and after the termination of this Agreement. The information contained in all correspondence and documents as part of the publishing activity between IntechOpen and the Corresponding Author and any Co-Author are confidential and are intended only for the recipient. The contents may not be disclosed publicly and are not intended for unauthorized use or distribution. Any use, disclosure, copying, or distribution is prohibited and may be unlawful.
\n\n4. CORRESPONDING AUTHOR'S WARRANTY
\n\n4.1 The Corresponding Author represents and warrants that the Chapter does not and will not breach any applicable law or the rights of any third party and, specifically, that the Chapter contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy. The Corresponding Author warrants and represents that: (i) the Chapter is the original work of themselves and any Co-Author and is not copied wholly or substantially from any other work or material or any other source; (ii) the Chapter has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) they themselves and any Co-Author are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) they themselves and any Co-Author have not assigned and will not during the term of this Publication Agreement purport to assign any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
\n\nThe Corresponding Author also warrants and represents that: (i) they have the full power to enter into this Publication Agreement on their own behalf and on behalf of each Co-Author; and (ii) they have the necessary rights and/or title in and to the Chapter to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licenses expressed to be granted in this Publication Agreement. If the Chapter was prepared jointly by the Corresponding Author and any Co-Author, the Corresponding Author warrants and represents that: (i) each Co-Author agrees to the submission, license and publication of the Chapter on the terms of this Publication Agreement; and (ii) they have the authority to enter into this Publication Agreement on behalf of and bind each Co-Author. The Corresponding Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each such Co-Author.
\n\nThe Corresponding Author agrees to indemnify and hold IntechOpen harmless against all liabilities, costs, expenses, damages and losses and all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of or in connection with any breach of the aforementioned representations and warranties. This indemnity shall not cover IntechOpen to the extent that a claim under it results from IntechOpen's negligence or willful misconduct.
\n\n4.2 Nothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
\n\n5. TERMINATION
\n\n5.1 IntechOpen has a right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Corresponding Author or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Corresponding Author or any Co-Author (being an individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Corresponding Author or any Co-Author (being a company) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors.
\n\nIn case of termination, IntechOpen will notify the Corresponding Author, in writing, of the decision.
\n\n6. INTECHOPEN’S DUTIES AND RIGHTS
\n\n6.1 Unless prevented from doing so by events outside its reasonable control, IntechOpen, in its discretion, agrees to publish the Chapter attributing it to the Corresponding Author and any Co-Author.
\n\n6.2 IntechOpen has the right to use the Corresponding Author’s and any Co-Author’s names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Chapter and has the right to contact the Corresponding Author and any Co-Author until the Chapter is publicly available on any platform owned and/or operated by IntechOpen.
\n\n6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\n\n7. MISCELLANEOUS
\n\n7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
\n\n7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\n\n7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
\n\n7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\n\n7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
\n\n7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
\n\nAny modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\n\n7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
\n\n7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
\n\nLast updated: 2020-11-27
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