**3. Bioethics in the clinical care of women in menopause/ postmenopause**

## **3.1. Advances in bioethics**

Defining "ethics" or "ethical thinking" is complex and has basically focused on two approaches; one is based on care and prior experience, and the other is on justice, as outlined by Gilligan and Kohlberg, respectively. The first one is manifested by women, while the second one, by men which, of course, should not be generalized, but its foundation is derived from biological traits and the activity of each sex. For example, Gilligan proposes that women understand ethics, based on their role in the family and society, that is, in caring for and supporting family members equally and providing them with care, while men focus on ethics, according to the rights and obligations of people; this means that people should receive the just [17]. Both theories raise divergences and difficulties to define ethics and all the components that integrate it, even if there are different types of ethics (professional, economic, and government, among others).

Conduct clinical studies in doctors and nurses with a gender perspective, who provide medical attention is very important, given that they can influence the ethical treatment received by menopausal patients, who are in the stage of emotional and physiological susceptibility [18].

A study with doctors and nurses of both sexes was carried, to evaluate their impartial reasoning; starting from the assumption that women doctors and nurses have a partial thought (care orientation) and impartial men (focused on justice). The dilemmas presented situations of different severities and urgencies, whether the life of a relative was in danger or not. It was found that the response was partial, if the life of a relative was in danger, both in health professionals and in those who were not, while if it was a less serious situation that did not compromise life, the response was impartial, in both cases. In summary, what conditioned the response was the seriousness of the situation.

This ethical requirement for doctors has been diffused in several centuries and is raised in the "Hippocratic Oath," which connects the responsibility of the doctor, with the result of his intervention. Subsequently, the principles of "first do no harm" and "beneficence and no maleficence" were included. Since then, several researchers have contributed to define "ethics and bioethics" as well as their scope. In 1979, Beauchamp and Childress concretized concepts and focused on "biomedical ethics." On the other hand, in the Belmont report, "principlism" was defined, which focuses on respecting people with justice. In 1847, the American Medical Association began to define the doctors' behavior [19].

In 1980, the teaching of bioethics was implemented in the undergraduate program and later in the specialties. Thus, the first thing that was emphasized was the basic concept of bioethics. Surgery residents surveyed indicated that they felt more confident to face ethical problems, after a training program. A study in pediatric residents indicated that they needed ethical training, especially to make the decision to give or take life support [20].

Several studies indicate that (1) medical women trained in ethics perceive more benefits than men and (2) student women focused more on psychosocial aspects and men were based on the rights of the patients. This shows that women are more based on abstract and personal principles, while men focused on responsibility, authority, and control. It is necessary to make a systematic analysis by the specialty and educational level, considering areas of special interest such as the role of bioethics and the conceptualization of justice, obtaining the informed consent of the patient or from a legal representative, facing the rejection of the signature of the said document, as well as obtaining it from people who speak different languages and care for special people or with a certain degree of vulnerability. Recognizing the training needs of the different specialties and taking into account the evolution of bioethics, better-oriented ethics programs can be designed.

A survey at the School of Medicine of the University of New Mexico to better understand these problems was conducted. The hypotheses were that (1) medical students and residents would support the need for more curricular attention to the principles of bioethics, the issues of informed consent, and the special needs of the population; (2) women would more strongly support these curricular needs; (3) residents of psychiatry would more strongly support curricular needs than other residents; and (4) there would be a greater perceived need in these curricular domains of ethics among apprentices who were in more advanced stages of training (**Table 1**) [21].

#### **3.2. Diseases and ethical considerations**

it has been reported that women who do not accept this stage have more severe symptoms. In targeted studies, women in menopause have expressed that they need to be informed of this

Defining "ethics" or "ethical thinking" is complex and has basically focused on two approaches; one is based on care and prior experience, and the other is on justice, as outlined by Gilligan and Kohlberg, respectively. The first one is manifested by women, while the second one, by men which, of course, should not be generalized, but its foundation is derived from biological traits and the activity of each sex. For example, Gilligan proposes that women understand ethics, based on their role in the family and society, that is, in caring for and supporting family members equally and providing them with care, while men focus on ethics, according to the rights and obligations of people; this means that people should receive the just [17]. Both theories raise divergences and difficulties to define ethics and all the components that integrate it, even if there are different types of ethics (professional, economic, and government, among others). Conduct clinical studies in doctors and nurses with a gender perspective, who provide medical attention is very important, given that they can influence the ethical treatment received by menopausal patients, who are in the stage of emotional and physiological susceptibility [18]. A study with doctors and nurses of both sexes was carried, to evaluate their impartial reasoning; starting from the assumption that women doctors and nurses have a partial thought (care orientation) and impartial men (focused on justice). The dilemmas presented situations of different severities and urgencies, whether the life of a relative was in danger or not. It was found that the response was partial, if the life of a relative was in danger, both in health professionals and in those who were not, while if it was a less serious situation that did not compromise life, the response was impartial, in both cases. In summary, what conditioned the response was

This ethical requirement for doctors has been diffused in several centuries and is raised in the "Hippocratic Oath," which connects the responsibility of the doctor, with the result of his intervention. Subsequently, the principles of "first do no harm" and "beneficence and no maleficence" were included. Since then, several researchers have contributed to define "ethics and bioethics" as well as their scope. In 1979, Beauchamp and Childress concretized concepts and focused on "biomedical ethics." On the other hand, in the Belmont report, "principlism" was defined, which focuses on respecting people with justice. In 1847, the American Medical

In 1980, the teaching of bioethics was implemented in the undergraduate program and later in the specialties. Thus, the first thing that was emphasized was the basic concept of bioethics. Surgery residents surveyed indicated that they felt more confident to face ethical problems,

**3. Bioethics in the clinical care of women in menopause/**

stage through different means [16].

**postmenopause**

62 Reflections on Bioethics

**3.1. Advances in bioethics**

the seriousness of the situation.

Association began to define the doctors' behavior [19].

Among the diseases that affect menopausal women, there are some that are deserved to be explained with ethical focus, for example, osteoporosis, periodontal disease, and vaginal symptoms.

Osteoporosis is a disease that occurs in women in late postmenopausal; in fact, according to the National Osteoporosis Foundation, every second, a woman suffers a fracture due to osteoporosis, and even the risk for this disease is higher than for other gynecological cancers. Therefore, studies have been developed that measure the quality of life of these patients, who are determined by their degree of functionality. This has been confirmed in women with osteopenia and osteoporosis; since they have limited physical activity, they have altered the physical position, suffering, and pain, with mental and emotional alterations [22].

There are many approaches that have been given for the prevention, treatment, and study of osteoporosis. Primary prevention means promoting habits that encourage the formation of good quality bones; also, at this stage, the primary detection is carried out, and the modifiable risk factors are identified, or they can be reduced or eliminated. Secondary prevention implies the opportune diagnosis and its pharmacological and non-pharmacological treatment, before a fracture occurs. Tertiary prevention is directed to limit the damage by osteoporosis.

Vaginal symptoms: Like the vasomotor symptoms, the vaginal symptoms are frequent. The clinical evaluation of these manifestations is not easy, and validated questionnaires are required that can be understood and answered by the same patient, as well as being able to be


**Name Symptoms evaluated Score**

perception of general health

appetite, and feeling lonely

daytime dysfunction

during daytime?"

during your sleep?"

blood pressure?"

Consists of yes/no responses: "Do you snore loudly?"

Physical function, social function, role limitations: physical problems, emotional problems, mental health, vitality, pain, and

Depression, such as restless sleep, poor

Epworth Sleepiness Scale [29] Daytime sleepiness Scores: 0–5 lower normal, 6–10

Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and

"Do you often feel tired, fatigued, or sleepy

"Has anyone observed you stop breathing

"Do you have or are you being treated for high

Categorize co-morbidities: each co-morbidity category has an associated weight (from 1 to 6)

Related to the type of diet with the increase or decrease of inflammatory mediators IL − 1beta,

IL-4, IL-6, IL-10, TNF-alfa, and PCR

functioning and well-being

nonpsychiatric patients

mental attitude

Assessing the impact of vaginal dryness, soreness, itching, irritation, and pain on

Depression and anxiety in hospitalized

Dietary self-management, preventive measures, healthy practices, and positive

Pain, physical function, social function, general perception of health, and mental function

Dimensions of sexual function in women Range: 1.2–36 points

≤ 26.55 is classified as FSD

http://dx.doi.org/10.5772/intechopen.74666

65

High scores reflect better health

High scores indicate greater depressive symptoms

higher normal, 11–12 mild excessive, 13–15 moderate excessive, 16–24

≥3 suggest obstructive sleep apnea

Range: 0–100 points

Range: 0–60 points

severe excessive

Range: 0–21 points < 5 have good sleep quality

Range: 0–8 points

0 = no co-morbidity 3 = severe co-morbidities


Higher score indicates major

The highest score refers to the quality of worse life

The higher score indicates health

inflammatory markers +1 = anti-inflammatory foods

Range: 0–4 points

Range: 0–42 points 0–7 normal 8–10 doubtful >11 clinic problem

Range: 1–5 points

Range: 24–120 points

behaviors

symptoms

status

Ethical Considerations in Research and Medical Care of Menopause

Female Sexual Function Index (FSFI) [26]

[27]

Scale [28]

Index [30]

[31]

[32]

[35]

(DII) [33]

Physical Function Scale (PFS)

Center for Epidemiologic Studies Depression (CESD)

Pittsburgh Sleep Quality

STOP-Bang Questionnaire

Charlson Comorbidity Index

Dietary Inflammatory Index

Day-to-Day Impact of Vaginal Aging (DIVA) [34]

Hospital Anxiety and Depression Scale (HADS)

for Osteoporosis (QUALEFFO) [36]

(HBI) [37]

Quality of Life Questionnaire of the European Foundation

Health Behavior Inventory

**Table 1.** Organizations involved in women's health.

applied in populations of different ethnic origins. For which, an instrument of 100 questions was developed, with a set of 100 structured items, which used ordered 5-point response options to assess the degree to which vaginal symptoms interfered with specific aspects of women's daily activities, sexual function, emotional well-being, self-concept and body image, or interpersonal relationships. The aspects evaluated included sexual function, emotional well-being, the concept of self-perception, and personal interrelationships. According this questionnaire, the main symptoms were dryness, dyspareunia, and itching, and there was a lower prevalence


applied in populations of different ethnic origins. For which, an instrument of 100 questions was developed, with a set of 100 structured items, which used ordered 5-point response options to assess the degree to which vaginal symptoms interfered with specific aspects of women's daily activities, sexual function, emotional well-being, self-concept and body image, or interpersonal relationships. The aspects evaluated included sexual function, emotional well-being, the concept of self-perception, and personal interrelationships. According this questionnaire, the main symptoms were dryness, dyspareunia, and itching, and there was a lower prevalence

patient access to high-quality health services World Medical Association (WMA) WMA was founded in 1947 and is formed by several millions of physicians and

Women's Health Initiative (WHI) Was founded by the US National Institutes of Health (NIH) in 1991. This

• To find practical solutions

the participants in the research"

Dominicana)

Services (HHS)

security

industry

women

Initiative consisted of clinical trials and observational studies in order to conduct the main health issues causing morbidity and mortality in postmenopausal

This study was initiated in 1992 and concluded in 2007, in which the patient was included in a trial clinic or an observational study. Both focused to study the

• To apply the solutions in the countries of the region (Belice, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panamá y República

NRES is one of the functions of the Health Research Authority and is responsible for reviewing and supporting ethical research in the National Health Service "to guarantee the protection of the human rights, safety, dignity, and well-being of

Is the main federal agency for health research in Canada. It is constituted by 13

The Office for Human Research Protections (OHRP) is responsible for protecting the rights and welfare of individuals who participate in research projects conducted under the authorization of the US Department of Health and Human

The Council for International Organizations of Medical Sciences was established in 1949 by the WHO and UNESCO, who are integrated international researchers, academies of science, and medical research councils. CIOMS promotes the public health, applying guides of health research, ethics, new products, and its

CMA was founded in 1867, its members are volunteers, and doctors promote

medical associations, promoting the medical care, ethics, and health education

ESCEO was founded in 2005; it is a not-for-profit organization that meets clinical scientists who study bone, joint, and muscle disorders, as well as pharmaceutical

prevention of cancer, cardiovascular diseases, or osteoporosis

Was constituted in 1949, under three principles: • To identify the nutritional problems

institutes, among which is the "Gender and Health"

**Organization Aim**

Women's Health Initiative Clinical

Institute of Nutrition of Central America and Panama (INCAP)

National Research Ethics Service

Canadian Institutes of Health

Office for Human Research Protections (OHRP)

Council for International Organizations of Medical Sciences

Canadian Medical Association

European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)

**Table 1.** Organizations involved in women's health.

Trial (WHICT)

64 Reflections on Bioethics

(NRES)

Research

(CIOMS)

(CMA)


Physical activity: The index of healthy behavior considers four areas: healthy eating habits, preventive actions, positive mental attitude, and recreational activities. Using this instrument, a comparison was made between young and old women, in which it was found that the elderlies (between 56 and 69 years) have a high level of healthy behavior, although in a particular way the alimentary habits were similar and women with the higher educational level and who are divorced had more healthy habits. Women with some pathology had higher scores; this is expected, since they know that they have an illness and they understand that they must have more care and carry out actions that benefit their health and control the disease. On the other hand, women without pathologies had less healthy habits, a situation derived from their perception of their health, since they considered their health status as good. This type of instrument is of fundamental application in postmenopausal women, since it has been proven that a healthy state will condition symptoms of less intensity or frequency [25]. There are several survey questionnaires or scales to evaluate women's health but, however, is not

Ethical Considerations in Research and Medical Care of Menopause

http://dx.doi.org/10.5772/intechopen.74666

67

Since its inception in 1906, the Food and Drug Administration (FDA) has been committed to the health of women and stablished the Office of Women's Health (FDA OWH) in 1994. The US Food and Drug Administration Guide developed a Guide for the Study and Evaluation of Gender Differences, which made it possible to include women in phase 1, 2, and 3 studies. Later, between 2002 and 2004, trials on hormone therapy were designed to test the effects of estradiol and combined estrogen/progesterone therapy on the prevention of cardiovascular diseases, fractures, and breast and colorectal cancer. The studies found that estradiol did not protect against cardiovascular disease and that the risks outweighed the benefits. In the year 2010, it was recognized that it was necessary to carry out research with female animals with a focus on the study of common diseases. Finally, the inadequate number of women included

In that same year, the NIH Office of Research on Women's Health proposed a strategic planning process with scientists, public policy experts, women's health advocates, healthcare providers, elected officials, and the public to generate priorities research. In 2014, federal agencies collaborated with women's health research. The NIH Office of Research on Women's Health and the Office of Women's Health of the FDA plan to collaborate on a national campaign to promote the importance of participation in clinical trials focusing on women; due to evidence of the effect of estrogen in the secondary prevention of coronary disease, published in *The Journal of the American Medical Association* in 1973, was conducted only with men, enrolling

Three main reasons seem to explain the exclusion of women: (1) experimental exposition to risk during fertile years (2) erroneous perceptions that consider that women are less affected by certain disorders or health problems or that women respond to the same treatment as men; and (3) it is perceived that women provide complexity, increased cost, and the need for

usually used all at the same time (**Table 2**).

**4. Clinical research**

in clinical trials is noteworthy [44].

8341 men and not women [44].

greater analytical capacity.

**Table 2.** Questionnaires, survey and index used to evaluate women's health.

of irritation and pain. The questionnaire was useful to evaluate the vaginal function, since it also evaluates feeling good, sexual function, and self-perception of the image [23].

Periodontal disease: A study carried out in postmenopausal women reported that 97% thought they had healthy gums, but when were evaluated, it was identified that 62% had at least one affected site, with the risk of losing a dental organ. In addition, women were unaware of the effects of periodontitis. Although women reported that they visited their dentist semiannually, in several teeth, the biofilm was observed, but in several teeth, biofilm was observed, which indicated a poor periodontal state; what makes us suppose is that they considered that they had healthy gums, because they did not present abscesses, a symptom that seems to be the best known, not considering important events such as the loss of periodontium and depth of probing. Periodontal disease is not well known among women, although they know the risk factors for developing caries, such as the infrequency of brushing, poor dental technique, and sugary foods. The study showed that most of the patients neither had knowledge about the risk factors nor of all the signs and symptoms, but once it was explained to them, they showed greater interest in self-care and assisted a periodic review by the specialist [24].

Physical activity: The index of healthy behavior considers four areas: healthy eating habits, preventive actions, positive mental attitude, and recreational activities. Using this instrument, a comparison was made between young and old women, in which it was found that the elderlies (between 56 and 69 years) have a high level of healthy behavior, although in a particular way the alimentary habits were similar and women with the higher educational level and who are divorced had more healthy habits. Women with some pathology had higher scores; this is expected, since they know that they have an illness and they understand that they must have more care and carry out actions that benefit their health and control the disease. On the other hand, women without pathologies had less healthy habits, a situation derived from their perception of their health, since they considered their health status as good. This type of instrument is of fundamental application in postmenopausal women, since it has been proven that a healthy state will condition symptoms of less intensity or frequency [25]. There are several survey questionnaires or scales to evaluate women's health but, however, is not usually used all at the same time (**Table 2**).

## **4. Clinical research**

of irritation and pain. The questionnaire was useful to evaluate the vaginal function, since it

Periodontal disease: A study carried out in postmenopausal women reported that 97% thought they had healthy gums, but when were evaluated, it was identified that 62% had at least one affected site, with the risk of losing a dental organ. In addition, women were unaware of the effects of periodontitis. Although women reported that they visited their dentist semiannually, in several teeth, the biofilm was observed, but in several teeth, biofilm was observed, which indicated a poor periodontal state; what makes us suppose is that they considered that they had healthy gums, because they did not present abscesses, a symptom that seems to be the best known, not considering important events such as the loss of periodontium and depth of probing. Periodontal disease is not well known among women, although they know the risk factors for developing caries, such as the infrequency of brushing, poor dental technique, and sugary foods. The study showed that most of the patients neither had knowledge about the risk factors nor of all the signs and symptoms, but once it was explained to them, they showed greater interest in self-care and assisted a periodic review by the specialist [24].

also evaluates feeling good, sexual function, and self-perception of the image [23].

**Name Symptoms evaluated Score**

management (SM)

question

Kupperman Index [40] Hot flashes, paresthesia, insomnia, vertigo,

formication

Health responsibility (HR), spiritual growth (SG), physical activity (PA), interpersonal relations (IR), nutrition (N), and stress

The NEO-FFI is integrated by 60 items, which measures the five main domains (neuroticism, extraversion, openness to experience, agreeableness, conscientiousness)

MENQOL evaluates the quality of life after menopause through: vasomotor, physical, psychosocial, sexual, and global quality of life

nervousness, melancholia, weakness, arthralgia or myalgia, headache, palpitations, and

Anxiety, depressed mood, positive well-being, self-control, general health, and vitality

Work, social activities, leisure activities, sleep, mood, concentration, relations with others,

Hot flushes, heart discomfort, sleep problems, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, dryness of vagina, joint, and

sexuality, and enjoyment of life

muscular discomfort

**Table 2.** Questionnaires, survey and index used to evaluate women's health.

Score: ≥2.50 is considered to be a

Higher scores in neuroticism is related to severe menopausal

positive response

Range: 0–6 points (0 none, 6 severe)

Range: 0–100 points

Range: 0–100 points

Range: 9–21 points

A high score is indicative of high levels of psychological well-being

High score indicates interference

Higher score is related to more postmenopausal symptoms

symptoms

Scores: 15–20 = mild 20–35 = moderate >35 = severe

Health Promoting Lifestyle Profile II (HPLP II) [38]

66 Reflections on Bioethics

Neuroticism-Extroversion-Openness Five-Factor Inventory (NEO-FFI) [12]

Menopause-Specific Quality of Life Questionnaire (MENQOL) [39]

Psychological General Well-

Hot Flash Related Daily Interference Scale (HFRDIS)

Menopause Rating Scale

Being Index [41]

[42]

(MRS) [43]

Since its inception in 1906, the Food and Drug Administration (FDA) has been committed to the health of women and stablished the Office of Women's Health (FDA OWH) in 1994. The US Food and Drug Administration Guide developed a Guide for the Study and Evaluation of Gender Differences, which made it possible to include women in phase 1, 2, and 3 studies. Later, between 2002 and 2004, trials on hormone therapy were designed to test the effects of estradiol and combined estrogen/progesterone therapy on the prevention of cardiovascular diseases, fractures, and breast and colorectal cancer. The studies found that estradiol did not protect against cardiovascular disease and that the risks outweighed the benefits. In the year 2010, it was recognized that it was necessary to carry out research with female animals with a focus on the study of common diseases. Finally, the inadequate number of women included in clinical trials is noteworthy [44].

In that same year, the NIH Office of Research on Women's Health proposed a strategic planning process with scientists, public policy experts, women's health advocates, healthcare providers, elected officials, and the public to generate priorities research. In 2014, federal agencies collaborated with women's health research. The NIH Office of Research on Women's Health and the Office of Women's Health of the FDA plan to collaborate on a national campaign to promote the importance of participation in clinical trials focusing on women; due to evidence of the effect of estrogen in the secondary prevention of coronary disease, published in *The Journal of the American Medical Association* in 1973, was conducted only with men, enrolling 8341 men and not women [44].

Three main reasons seem to explain the exclusion of women: (1) experimental exposition to risk during fertile years (2) erroneous perceptions that consider that women are less affected by certain disorders or health problems or that women respond to the same treatment as men; and (3) it is perceived that women provide complexity, increased cost, and the need for greater analytical capacity.

However, the Institute of Medicine concluded "being male or female is an important basic human variable that must be considered when designing and analyzing studies in all areas and at all levels of biomedicine and health-related research." Until sex and gender differences are routinely investigated, there will be many opportunities to gain a better understanding of the pathogenesis of disease and human health.

**6. Conclusions**

**Conflict of interest**

**Author details**

**References**

Claudia Camelia Calzada Mendoza<sup>1</sup>

Carlos Alberto Jiménez Zamarripa<sup>2</sup>

10.4103/1735-9066.185618

BioMed Research International. 2014;**6**:2014

Menopause is a very important stage in a woman's life, and the attention provided at this stage, whether for research or medical attention, must be carried out by personnel trained in ethics, because the woman is in the stage of major susceptibility; also, several symptoms can be confusing. Moreover, in medical consultation or the clinical studies, do not usually apply all the questionnaires, indexes, or scales, either due to lack of time or to focus on the main symptom, without considering that the symptom that was the reason for consultation may be the result of not treating other minor symptoms. The research clinic based on ethical prin-

Ethical Considerations in Research and Medical Care of Menopause

http://dx.doi.org/10.5772/intechopen.74666

\*, Liliana Anguiano Robledo1

1 Instituto Politécnico Nacional, Escuela Superior de Medicina, México City, México 2 Hospital Psiquiátrico Dr. Samuel Ramírez Moreno-Secretaria de Salud, Instituto

Politécnico Nacional, Centro Interdisciplinario de Ciencias de la Salud, México City, México

[1] North American Menopause Society. Menopause Practice: A Clinician's Guide. 5th ed.

[2] Mahboubeh G, Sedigheh A, Habib AE, Bahram AGH. Investigation of the relationship between personality characteristics and vasomotor symptoms in menopausal women. Iranian Journal of Nursing and Midwifery Research. 2016;**21**(4):441-447. DOI:

[3] Lizcano F, Guzmán G. Estrogen deficiency and the origin of obesity during menopause.

[4] Garvey W, Garber A, Mechanick J, Bray G, Dagogo-Jack S, Einhorn D, Grunberger G, Handelsman Y, Hennekens C, Hurley D, McGill J. American Association of Clinical

3 Benemérita Universidad Autónoma de Puebla, Facultad de Medicina, Puebla, México

Mayfield Heights, OH: North American Menopause Society; 2014

and Marta Elena Hernández Caballero<sup>3</sup>

, Gabriela Lugo Martínez1

,

69

ciples will contribute to obtain specific and reliable results on women's health.

The authors declare that there is no conflict of interest.

\*Address all correspondence to: cccalzadam@yahoo.com.mx

Currently, the review of clinic protocols by the Research Ethics Committees (REC) is the key to the regulation of clinical research. The RECs have to comply with several requirements, such as (1) the minimum members is five; (2) membership must be diverse (by race, gender, cultural background, sensitivity to the problems of the community), with at least one scientist and one nonscientist [45]; (3) there are no rules about how fast decisions should be made or how many times you could apply; (4) the consequences of REC's work for investigators or research funders, in terms of time or resources, were not a consideration of REC; (5) the scientific quality of a project is considered an ethical prerequisite; (6) the legality (to ensure that laws and other regulations are followed and the protection of institutes and responsible researchers); (7) the choice of researchers is determined by the professional location of the principal investigator, which a REC within the health institute could be chosen. The researchers did not choose the REC; (8) the REC had "responsibility of state public officials"; (9) transparency in the selection process to accept protocols; (10) compulsory education of REC members about ethical topics; (11) the variability in the work and decisions of REC had been recognized as a problem, but not solved; and (12) quality assurance investigation complicates the topic, but some defended the exemption from quality assurance studies of the ethical approval requirement.

## **5. Challenges in bioethics research and medical care**

Currently, it is recognized that health is fundamental to development of a society. Most studies describe the costs of poor health in women, particularly the costs of poor maternal health.

There are a lot of challenges that REC and national or international organizations have to solve, for example:


## **6. Conclusions**

However, the Institute of Medicine concluded "being male or female is an important basic human variable that must be considered when designing and analyzing studies in all areas and at all levels of biomedicine and health-related research." Until sex and gender differences are routinely investigated, there will be many opportunities to gain a better understanding of

Currently, the review of clinic protocols by the Research Ethics Committees (REC) is the key to the regulation of clinical research. The RECs have to comply with several requirements, such as (1) the minimum members is five; (2) membership must be diverse (by race, gender, cultural background, sensitivity to the problems of the community), with at least one scientist and one nonscientist [45]; (3) there are no rules about how fast decisions should be made or how many times you could apply; (4) the consequences of REC's work for investigators or research funders, in terms of time or resources, were not a consideration of REC; (5) the scientific quality of a project is considered an ethical prerequisite; (6) the legality (to ensure that laws and other regulations are followed and the protection of institutes and responsible researchers); (7) the choice of researchers is determined by the professional location of the principal investigator, which a REC within the health institute could be chosen. The researchers did not choose the REC; (8) the REC had "responsibility of state public officials"; (9) transparency in the selection process to accept protocols; (10) compulsory education of REC members about ethical topics; (11) the variability in the work and decisions of REC had been recognized as a problem, but not solved; and (12) quality assurance investigation complicates the topic, but some defended the exemption from quality assurance studies of the ethical

Currently, it is recognized that health is fundamental to development of a society. Most studies describe the costs of poor health in women, particularly the costs of poor maternal

There are a lot of challenges that REC and national or international organizations have to

**3.** Good health among women is important for child development and the production of

**4.** The mass and nonprofessional media can be the main source of knowledge about the

**5.** Determining the association of quality of life of the postmenopausal women with that of

**1.** Girls from the United States exhibited physical signs of puberty by age 7.

**6.** Promoting the health and health behavior must be a priority [11, 25, 46].

symptoms and coping methods in postmenopausal women.

**2.** Pollutants of land and livestock can impact on man's reproductive abilities.

the pathogenesis of disease and human health.

**5. Challenges in bioethics research and medical care**

approval requirement.

68 Reflections on Bioethics

health.

solve, for example:

future human capital.

their spouses.

Menopause is a very important stage in a woman's life, and the attention provided at this stage, whether for research or medical attention, must be carried out by personnel trained in ethics, because the woman is in the stage of major susceptibility; also, several symptoms can be confusing. Moreover, in medical consultation or the clinical studies, do not usually apply all the questionnaires, indexes, or scales, either due to lack of time or to focus on the main symptom, without considering that the symptom that was the reason for consultation may be the result of not treating other minor symptoms. The research clinic based on ethical principles will contribute to obtain specific and reliable results on women's health.

## **Conflict of interest**

The authors declare that there is no conflict of interest.

## **Author details**

Claudia Camelia Calzada Mendoza<sup>1</sup> \*, Liliana Anguiano Robledo1 , Gabriela Lugo Martínez1 , Carlos Alberto Jiménez Zamarripa<sup>2</sup> and Marta Elena Hernández Caballero<sup>3</sup>

\*Address all correspondence to: cccalzadam@yahoo.com.mx

1 Instituto Politécnico Nacional, Escuela Superior de Medicina, México City, México

2 Hospital Psiquiátrico Dr. Samuel Ramírez Moreno-Secretaria de Salud, Instituto Politécnico Nacional, Centro Interdisciplinario de Ciencias de la Salud, México City, México

3 Benemérita Universidad Autónoma de Puebla, Facultad de Medicina, Puebla, México

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**Chapter 4**

Provisional chapter

**Bioethics and Palliative Care in Primary Health Care**

DOI: 10.5772/intechopen.76864

In order to respect the patient's right to die at home, with quality and respect, discussions about bioethical problems involving palliative care in the context of primary health care are relevant. Among bioethical problems, communication problems regarding the diagnosis and treatment, the maintenance or discontinuation of futile treatments, the adoption of aggressive and lifelong measures by the emergency mobile service, and the problems involving equal access to care stand out. It is important to emphasize that health systems must incorporate palliative measures in primary care and enable professionals to provide

Keywords: palliative care, bioethics, primary health care, health personnel, health systems

The preferred place to die among people throughout the world is their home; however, many

Thus, it is essential that palliative care (PC) be seen as a responsibility of all health professionals, not only of those in the secondary and tertiary level of care but also in primary health

However, several bioethical problems still persist when it comes to respecting this right of patients. These problems must be debated in order to seek the benefit of patients and their

> © 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and eproduction in any medium, provided the original work is properly cited.

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

still die in hospitals, with at least one admission in the last year of life [1–3].

families, respecting their right to die with dignity.

Bioethics and Palliative Care in Primary Health Care

Juliana Dias Reis Pessalacia, Sandra Pinto,

Juliana Dias Reis Pessalacia, Sandra Pinto,

Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

Juliana Guimarães Lima Munis,

Juliana Guimarães Lima Munis,

Adriano Menis Ferreira

Abstract

this type of care.

1. Introduction

care (PHC) [1].

Adriano Menis Ferreira

Jacqueline Resende Boaventura and

Jacqueline Resende Boaventura and

http://dx.doi.org/10.5772/intechopen.76864

#### **Bioethics and Palliative Care in Primary Health Care** Bioethics and Palliative Care in Primary Health Care

DOI: 10.5772/intechopen.76864

Juliana Dias Reis Pessalacia, Sandra Pinto, Juliana Guimarães Lima Munis, Jacqueline Resende Boaventura and Adriano Menis Ferreira Juliana Dias Reis Pessalacia, Sandra Pinto, Juliana Guimarães Lima Munis, Jacqueline Resende Boaventura and Adriano Menis Ferreira

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.76864

#### Abstract

In order to respect the patient's right to die at home, with quality and respect, discussions about bioethical problems involving palliative care in the context of primary health care are relevant. Among bioethical problems, communication problems regarding the diagnosis and treatment, the maintenance or discontinuation of futile treatments, the adoption of aggressive and lifelong measures by the emergency mobile service, and the problems involving equal access to care stand out. It is important to emphasize that health systems must incorporate palliative measures in primary care and enable professionals to provide this type of care.

Keywords: palliative care, bioethics, primary health care, health personnel, health systems

#### 1. Introduction

The preferred place to die among people throughout the world is their home; however, many still die in hospitals, with at least one admission in the last year of life [1–3].

Thus, it is essential that palliative care (PC) be seen as a responsibility of all health professionals, not only of those in the secondary and tertiary level of care but also in primary health care (PHC) [1].

However, several bioethical problems still persist when it comes to respecting this right of patients. These problems must be debated in order to seek the benefit of patients and their families, respecting their right to die with dignity.
