The document discusses the importance of protecting human participants in medical research. It notes that while research with human subjects is sometimes necessary, guidelines like the Declaration of Helsinki are needed to ensure participants are not exploited and their welfare and autonomy are prioritized. Certain groups like children, the mentally ill, and the elderly are especially vulnerable to exploitation without such protections in place. Consent is also crucial for research even after a person's death to maintain public trust.
Anxiety, uncertainty, and resilience of medical students worldwide during the...Ahmad Ozair
The COVID-19 pandemic significantly impacted medical education worldwide. While healthcare professionals labored to ensure proper care for COVID-19 patients, medical students suffered from high rates of anxiety, uncertainty, burnout, and depressive symptoms. Whilst students in the pre-clinical phase of education faced disruption of didactic lectures and laboratory training, senior medical students faced uncertainty regarding their clinical rotations and internships, which are vital for practical exposure to healthcare. Several studies across the world demonstrated that clinical learning was significantly affected, with students in many countries completely cut off from in-person rotations. The disruption of the clinical curriculum coupled with a sense of failure to contribute at a time of significant need often led to despair. Reforms proposed and/or implemented by governments, medical advisory boards, medical schools, and other administrative bodies were felt to be insufficient by the medical student fraternity at large. Consequently, these students continue to face high rates of anxiety, depression, and a general sense of cynicism. In this student-authored perspective, we highlight the challenges faced by and the psychological impact on medical students directly or indirectly from the pandemic.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
Identify the ethical issue related to vaccination
Analyse the arguments that support and that reject making vaccination mandatory.
Outline an ethical framework to vaccination in the EMR context
Ethics in Clinical Research and Historical Perspective of Nazi Trials, Nuremb...ShantanuThakre3
What is Ethics ?
The word ‘ethics’ is derived from the Greek word,
ethos, which means custom or character. Ethics is
the systematic study of values, so as to decide
what is right and what is wrong. Ethics is concerned
with what is good for individuals and society.
What is Clinical Research ?
Clinical Research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Importance of Ethics in Clinical Research :-
1. Ethics is important in clinical research because it keeps the researcher from committing errors while seeking knowledge and truth.
2. Ethical guidelines for clinical research were formulated only after discovery of inhumane behavior with participants during research experiments.
3. In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the object of study.
4. It focuses on improving human health and well-being, typically by identifying better methods to treat, cure or prevent illnesses.
5. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government
• The goal of clinical research is to generate useful knowledge about human health and illness, and ways to prevent, diagnose and treat diseases.
• The goal is not benefit to the individuals who participate (although there is sometimes benefit).
• People are the means to developing useful knowledge; and are thus at risk of exploitation.
Anxiety, uncertainty, and resilience of medical students worldwide during the...Ahmad Ozair
The COVID-19 pandemic significantly impacted medical education worldwide. While healthcare professionals labored to ensure proper care for COVID-19 patients, medical students suffered from high rates of anxiety, uncertainty, burnout, and depressive symptoms. Whilst students in the pre-clinical phase of education faced disruption of didactic lectures and laboratory training, senior medical students faced uncertainty regarding their clinical rotations and internships, which are vital for practical exposure to healthcare. Several studies across the world demonstrated that clinical learning was significantly affected, with students in many countries completely cut off from in-person rotations. The disruption of the clinical curriculum coupled with a sense of failure to contribute at a time of significant need often led to despair. Reforms proposed and/or implemented by governments, medical advisory boards, medical schools, and other administrative bodies were felt to be insufficient by the medical student fraternity at large. Consequently, these students continue to face high rates of anxiety, depression, and a general sense of cynicism. In this student-authored perspective, we highlight the challenges faced by and the psychological impact on medical students directly or indirectly from the pandemic.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
Identify the ethical issue related to vaccination
Analyse the arguments that support and that reject making vaccination mandatory.
Outline an ethical framework to vaccination in the EMR context
Ethics in Clinical Research and Historical Perspective of Nazi Trials, Nuremb...ShantanuThakre3
What is Ethics ?
The word ‘ethics’ is derived from the Greek word,
ethos, which means custom or character. Ethics is
the systematic study of values, so as to decide
what is right and what is wrong. Ethics is concerned
with what is good for individuals and society.
What is Clinical Research ?
Clinical Research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Importance of Ethics in Clinical Research :-
1. Ethics is important in clinical research because it keeps the researcher from committing errors while seeking knowledge and truth.
2. Ethical guidelines for clinical research were formulated only after discovery of inhumane behavior with participants during research experiments.
3. In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the object of study.
4. It focuses on improving human health and well-being, typically by identifying better methods to treat, cure or prevent illnesses.
5. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government
• The goal of clinical research is to generate useful knowledge about human health and illness, and ways to prevent, diagnose and treat diseases.
• The goal is not benefit to the individuals who participate (although there is sometimes benefit).
• People are the means to developing useful knowledge; and are thus at risk of exploitation.
Vaccines are valuable and specialized products, of great diversity have already achieved great success in controlling many diseases of economics importance in farm and companion animals, but present they do not cover all infections, access to modern techniques are used for designing to new vaccine ,not only prolongation of immunity, but also to better practical aspects, such as product stability and less dependence on cold-storage.
Ethical and Human Rights Concerns in Global HealthChapter Fou.docxdebishakespeare
Ethical and Human Rights Concerns in Global Health
Chapter Four
Chapter four: Ethical and human rights concerns in global health.
As with any area of health, global health is affected by the issues of ethics and right for sound health outcome. In this chapter we will explore ethical and human rights concerns, some of the central treaties and conversions related to human rights, some historically significant cases in human subject research and key principles for making critical decisions in health research.
1
Failure to respect human rights is often associated with harm to human health
Health research with human subjects puts people at risk for the sake of other people’s health
Health investments must be made in fair ways since resources are limited
The Importance of Ethical and Human Rights Issues in Global Health
Access to the health care is human right and failure to respect this right might causes harm for health. For example, the stigma associated with HIV, TB and leprosy makes it difficult for the patient to obtain necessary health care, it not only cause harm to individual health but as a whole community health even. For example, if a TB patient remains untreated by the health care workers, then that individual could be a source of infection for other people.
Health research with human subject in particular in low income countries where study participants may not have other option to obtain the medication might become a proxy of clinical trial for other people .Lastly, fair decision in health investment is critical because in low income countries where health resources are scare difficult decisions need to be made depending on the priority and severity of disease.
2
The Foundations for Health and Human Rights
Universal Declaration of Human Rights and other legally binding multilateral treaties
Governments are obliged to respect, protect, and fulfill the rights they state
International Bill of Human Rights is the cornerstone for human rights. This bill include couple of documents including the Universal declaration of human rights that was officially declared in 1948, that place obligation on Government to respect , protect, and fulfill the rights of the state.
3
Selected Human Rights
The Rights-Based Approach
Assess health policies, programs, and practices in terms of impact on human rights
Analyze and address the health impacts resulting from violations of human rights when considering ways to improve population health
Prioritize the fulfillment of human rights
In considering human right, first we are going to examine the issue of right based approach. Some global health advocates argue that this approach, which thinks that fulfillment of people’s human right is conducive to their health, should be followed in global health. This means we need to assess health policies, programs or practices in terms of its impact on human right and analyze the health impacts from the perspective of violation of human rights
.
Ethical Conduct of Researchpower point from this document, 1.docxdebishakespeare
Ethical Conduct of Research
power point from this document, 15 slides
Introduction
Depending on the context of the study, researchers often encounter ethical dilemmas that are associated with respect for privacy, establishment of honest and open interactions, and avoidance of misrepresentation. From an ethical standpoint, such challenging circumstances may surface if researchers are grappling with conflicting issues and have to choose between different methodological approaches in complex circumstances. In such circumstances, disagreements among different components including participants, researchers, researchers’ disciplines, the financing organization, and the society might be inevitable. Therefore, there are numerous ethical concerns that should be taken into account when undertaking studies that deal with human subjects. Understanding ethical principles can guide researchers to conduct studies that safeguard the wellbeing of human subjects.
Overview of the Research
In a research work titled
Resilience of People Living with HIV/AIDS in Indonesia: a Phenomenological Study
, Kumboyono et al. (2018) observe that HIV/ AIDS is among the most prevalent and expanding communicable diseases on the planet. The number of individuals who are diagnosed with HIV/AIDS continues to skyrocket every year in Indonesia and other parts of the world. According to Kumboyono et al. (2018), individuals who suffer from HIV/AIDS often plunge themselves into a series of crises, which indicate the challenges of living with the chronic pathological condition. As such, resilience is one distinct phenomenon that is common among persons living with the diseases Indonesia, a pattern that indicates the results of current health management and expectations of HIV/AIDS patients for better and improved health outcomes. In light of this concern, Kumboyono et al. (2018) undertook a study that sought to examine the mechanism of resilience in Indonesian people living with HIV/AIDS and the factors that influence their specific mechanisms.
Using qualitative phenomenological design, the researchers sampled a total of 27 people living with HIV/AIDS from a primary health care institution in Malang City, East Java, Indonesia. The participants were selected from different socioeconomic, gender, and sexual orientations. The researchers informed participants about the conduct and processes involved in the study, resulting in their consent to participate in the interview process. The findings of the study indicated that the diagnosis of HIV/AIDS reflects the onset of psychological and social distress. Moreover, Kumbomoyo et al. (2018) found that the spiritual response that follows diagnosis is a state that is characterized by crises. As a consequence, the coping strategies and understanding of life by HIV patients is a definite sign on resilience. Based on these findings, Kumbomoyo et al. (2018) infer that HIV/AIDS is a chronic infection that has the potential to induce the unique .
Running head WEEK THREE ASSIGNMENT .docxtoltonkendal
Running head: WEEK THREE ASSIGNMENT
1
WEEK THREE ASSIGNMENT
6
Week Three Assignment
PHI445: Personal & Organizational Ethics
Week Three Assignment
The case that I chose was Pharmaceuticals (Merck). The pharmaceutical industry is a multi-billion dollar industry that has evolved over decades developing, producing, and marketing various medications to the masses. They deal with increasing criticism in this industry due to the multiple side effects and drug interactions that occur. “In fact, research has shown that more than 100,000 deaths are caused by drug reactions each year in the United States (Null, 2010)” (Fieser, 2015). An ethical and moral dilemma for the pharmaceutical industry is that many drug companies are caught deceiving the public. The pharmaceutical industry continues to face controversy due to their advertising techniques. Pharmaceutical companies began to bypass the healthcare professionals and advertise directly to the patients. This tactic is called direct-to-consumer advertising which began in 1982. In our text is says, “Such advertising, it argued, is problematic “because of the inability of patients to understand medical information and make a rational, informed choice of medication from an array of drugs making similar claims.” The DEA was further concerned about “the messages conveyed to our youth” through such advertising” (Fieser, 2015).
The Food and Drug Administration (FDA) which is the government agency that ensures the safety and effectiveness of medicines available to Americans. The FDA pushes guidance, compliance, and regulatory information onto the pharmaceutical industry. The FDA publishes regulations in the federal government’s official publication for notifying the public in accordance with the U.S. law, Executive Orders (EO) and memoranda issued by the President. The Center for Drug Evaluation and Research (CDER) has been tasked from the FDA with evaluating new drugs before they could be sold to consumers. They also oversee the type of advertising that the pharmaceutical companies use to market their products to consumers to ensure that false or misleading information is not presented.
Utilitarianism is the theory that focuses on the cost-benefit analysis which believes that and action is morally right as long as the consequences of some do not out weight the benefits of the majority. They also emphasize goodness and badness in decision making by focusing on how our actions affect human happiness. “An action is morally right if the consequences of that action are more favorable than unfavorable to everyone” (Fieser, 2015). The pharmaceutical companies contend that the drugs they create save thousands of lives worldwide on a daily basis. They live and work under a Pharmacist Code. The Pharmacist Code of Ethics and Oath ...
HCM 3304, Principles of Epidemiology 1 Course Learn.docxaryan532920
HCM 3304, Principles of Epidemiology 1
Course Learning Outcomes for Unit VIII
Upon completion of this unit, students should be able to:
11. Describe the importance of epidemiology for local, state, national, and international health policy-
making.
11.1 Explain the role of epidemiology in disease prevention, and contrast two possible strategies for
such preventive efforts.
11.2 Describe risk assessment and discuss the role of epidemiology in such assessments.
11.3 Discuss how epidemiology can shape public policy through the courts.
11.4 Explain the role of meta-analysis as a tool for summarizing epidemiologic evidence and
creating public policy.
12. Articulate the key ethical issues which are associated with epidemiology and the use of
epidemiological data today.
12.1 Consider how privacy and confidentiality of health records are protected in epidemiological
studies.
12.2 Describe the scientific and ethical implications of classifying race and ethnicity in epidemiologic
studies.
Reading Assignment
Chapter 19:
Epidemiology and Public Policy
Chapter 20:
Ethical and Professional Issues in Epidemiology
Unit Lesson
Crossing the Ethical Line in Epidemiology – The Tuskegee Experiment
Certainly one of the world’s leading professional organizations in community health is the American College of
Epidemiology (ACE). Founded in 1979, ACE is involved in formal education of epidemiologists, continuing
education conferences, setting of professional standards, and also establishing ethical guidelines for practice.
That last piece is where we will focus in the Unit VIII lecture. This is so important because the opportunity
exists for epidemiologists to step over the ethical line while trying to prove their point about a particular cause
of disease, a particular natural history of disease, or a particular form of treatment (ACE, 2014).
Conflict - Research and Ethics
Perhaps you have by now heard of the Tuskegee Experiment, an example of truly horrible research ethics
that will hopefully be remembered for a long time, and which will hopefully cause modern medical researchers
to think twice about how they treat the subjects in their studies. What really happened?
UNIT VIII STUDY GUIDE
The Epidemiology Profession
HCM 3304, Principles of Epidemiology 2
UNIT x STUDY GUIDE
Title
The United States Public Health Service designed and performed a study of syphilis beginning in 1932 and
ending in 1972. The study included 600 black men, and 399 of them were positive for late stage syphilis.
Participants in this study were promised free medical care, and were told that they were being treated for "bad
blood." These poor and uneducated subjects were evaluated to learn about the effects of syphilis on black
people. At the time, medical professionals held a theory that white people were affected neurologically by
syphilis, whereas, black people suffered only cardiovascular effects ...
KAFKAS ÜNİVERSİTESİ/KAFKAS UNIVERSITY
SOCIOLOGY
Course
LECTURE NOTES AND POWER POINT PRESENTATIONS
Prof.Dr. Halit Hami ÖZ
Kars, TURKEY
hamioz@yahoo.com
Similar to In research involving human participants as trial subjects or tissue (20)
Prof.dr. halit hami öz sociology-chapter 19-health and medicine
In research involving human participants as trial subjects or tissue
1. “In research involving human participants as trial subjects or tissue
donors, the wishes and wellbeing of the human participants should always
be paramount.”
Why do we need human participants?
Medical research is a required necessity to further scientific knowledge and to gain better
understanding of new treatments, preventative measures, drugs actions, pain management and
disease knowledge.
Unfortunately sometimes in the process of bettering our understanding, human research is often an
undesirable but required necessity. Strict guidelines that cover the ethics and human rights of
participants have been in place for many years to protect not only the people taking part but the
researchers too. Following World War Two and the many atrocities carried out during the Holocaust
involving human experimentation, the Declaration of Helsinki was adopted by the World Health
Authority in June 1964. It was designed as a set of guidelines for physicians worldwide regarding the
involvement of human subjects in scientific research. It was aimed to protect the welfare, privacy,
dignity and personal autonomy of the participant and their choice to participate or withdraw from the
research at any time (Woods and McCormack, 2013). Within these guidelines, the declaration details
reasons for carrying out research and why it may be necessary. For example if the objective of the
research has more weighting than any risks associated with it or if it could have serious benefits to
prevent loss of life or suffering in the future, this is deemed to be a good reason for proceeding with
research involving human participants. Equally if risks are found to be too high, the physician must
make the decision whether it is suitable to continue and if necessary forfeit the research for the benefit
of the participants (WHA, 2013).
Vulnerability
Some have deemed these guidelines altogether too restricting, outdated and paternalistic, even
though they have been revised several times, the latest revision being in 2000. It is even suggested
that they presume vulnerability of the research subject, with researchers having the potential to use
exploitative measures to further knowledge in the name of science (Woods and McCormack, 2013).
Whether guidelines are deemed too restricting or not, they are a definitive necessity for the wellbeing
and wishes of the human participant. Without guidelines subjects deemed vulnerable or those unable
to make decisions for themselves or people unaware and uneducated in the research they are taking
part in, would become at risk of being exploited for medical research. Vulnerability can stretch to many
different groups of people including, the mentally ill, children and elderly, but what if the research
being proposed could benefit many others?
2. In a study published in the British Medical Journal in 1998, a study was conducted on babies to
discover the effects of exposure to 15% oxygen on breathing patterns. The hypothesis for the
research originated following several incidents of Sudden Infant Death Syndrome (SIDS), which had
occurred following travel on intercontinental flights. Normal oxygen levels within air are around 21%
however, within an aeroplane cabin, “The partial pressure of inspired oxygen…is only 110 to 130 mm
Hg; this corresponds to a fraction of inspired oxygen of 0.15 to 0.17 at sea level” (Cottrell, 1988). It
was felt research using 34 infants (13 of which has siblings who had died of SIDS) would be beneficial
(Parkins et al., 1998). But how can an infant make a conscious decision to take part in such a
research study? It is obviously the decision of the parent to put forward their child to take part; but can
this really be justified as being ethical? The authors of the SIDS study answered criticism to the ethical
implications, by explaining their study was no more harmful to the child than taking them on a
commercial flight. However, this study purposely exposed the infants to a known possible danger in
the interests of research and not necessity to their own wellbeing (Leavitt, 2006).
Within the Declaration of Helsinki, it states that any vulnerable group “should stand to benefit from the
knowledge, practises or interventions that result from the research” (WHA, 2013), but how can the
infants within the Cottrell study benefit from a study about a disease process that may or may not
happen to them and which could expose them to danger? It could be argued that if the infants were
suffering from a disease and the research carried out could offer up potential curative benefits, that
this is a good enough reason to conduct it.
Children are not the only ones in danger of vulnerability, other groups such as the mentally ill, elderly
or uneducated can all be in danger of becoming involved in something they either do not fully
understand or are not in position to make a decision about.
Research into neurodegenerative and mental disorders is particularly challenging when it comes to
consent. In the case of progressive disorders such as dementia, medical practitioners make use of
advanced directives; legal documentation drawn up whilst the disease is in its early stages and the
person suffering from it can make an informed decision regarding taking part in medical research. But
what about mental disorders such as schizophrenia and depression which do not necessarily have a
steady disease progression? Patient’s suffering from these disorders may never be considered to be
in a state of competence to consent, especially is the risks outweigh any benefits to them as an
individual (Helmchen, 2012).
Do the dead have a say?
Vulnerability can clearly be seen in people who are alive but what about people who have died? A
change to UK legislation in 2004 was enforced, following inquiries at The Alder Hey Hospital and
Bristol Royal Infirmary, which found they had been retaining tissue without consent (Parker, 2011).
This scandal caused public outcry and resulted in a divide between the medical community the
3. general public (Plomer, 2005). But how does a medical practitioner class a piece of tissue and when
does consent need to be established? It is understandable when the tissue in question is of a sensitive
nature such as the brain or the heart, but what about pathological samples? Research on these
samples could be of great benefit to the general public’s health and the requirement of consent a
detail that hampers this. However beneficial the proposed medical research is, consent is still an
essential requirement in safeguarding human tissue samples after death and ensuring the continued
confidence of the general public in medical research.
Conclusion
When embarking upon medical research, it must be established, whether the use of human subjects
will give rise to benefits. All other avenues to the research must have been explored and the only way
to progress is with the use of human participants.
Establishing consent and guidelines to safeguard participants is essential, not only for the welfare of
the participants but also in ensuring that public confidence in the medical community is maintained so
that research of this nature can continue.
4. Reference List
COTTRELL, J. J. 1988. Altitude exposures during aircraft flight - flying higher. Chest, 93, 81-84.
HELMCHEN, H. 2012. Ethics of clinical research with mentally ill persons. European Archives of
Psychiatry and Clinical Neuroscience, 262, 441-452.
LEAVITT, F. J. 2006. Is any medical research population not vulnerable? Cambridge Quarterly of
Healthcare Ethics, 15, 81-88.
PARKER,L. 2011. Usinghumantissue:when do we need consent? Journal of Medical Ethics, 37, 759-
761.
PARKINS, K. J., POETS, C. F., O'BRIEN, L. M., STEBBENS, V. A. & SOUTHALL, D. P. 1998. Effect of
exposure to 15% oxygen on breathing patterns and oxygen saturation in infants:
interventional study. British Medical Journal, 316, 887-891.
PLOMER, A. 2005. The law and ethics of medical research : international bioethics & human rights,
London, Cavendish.
WHA 2013. WHA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human
Subjects. In: AUTHORITY, W. H. (ed.). France.
WOODS, S. & MCCORMACK, P. 2013. Disputing the ethics of research: the challenge from bioethics
and patient activism to the interpretation of the declaration of helsinki in clinical trials.
Bioethics, 27, 243-250.