This document discusses various bioethical issues related to patient safety in clinical practice and research. It begins by defining bioethics and describing when an issue becomes an ethical one. It then discusses key principles like autonomy, beneficence and justice. Specific issues covered include informed consent and its components, disclosure, capacity, voluntariness and exceptions. Research ethics guidelines and principles are also summarized, including issues like clinical equipoise, dual role of doctors, informed consent in research, and managing conflicts of interest.
This powerpoint covers the topics that pertain to the ethics of the medical fields and how they are used. We have provided articles, videos, and pictures for better understanding.
Concepts and principles of bioethics for the students of health professionsK Raman Sethuraman
Students and many educators have difficulty in differentiating among Legal, Ethical and Moral viewpoints. After explaining these terms, the concept of biomedical ethics, a brief history of its origin in the post-War period and the components of ethics are explained. The final part is on Nursing ethics, attributes of an ethical nurse and ethical challenges faced by the nursing profession.
The Presentation explains basic models of disease causation, to understand the etiology or causes of disease & altered production and helps to understand the applicability of causal criteria applied to epidemiological studies.
Introduction to ethical issues in public health, Public Health Institute (PHI...Dr Ghaiath Hussein
An introduction to ethical issues in public health practice and research I gave to master students in the Public Health Institute in Sudan -- My Home Country. This was on Jan. 5, 2012.
This powerpoint covers the topics that pertain to the ethics of the medical fields and how they are used. We have provided articles, videos, and pictures for better understanding.
Concepts and principles of bioethics for the students of health professionsK Raman Sethuraman
Students and many educators have difficulty in differentiating among Legal, Ethical and Moral viewpoints. After explaining these terms, the concept of biomedical ethics, a brief history of its origin in the post-War period and the components of ethics are explained. The final part is on Nursing ethics, attributes of an ethical nurse and ethical challenges faced by the nursing profession.
The Presentation explains basic models of disease causation, to understand the etiology or causes of disease & altered production and helps to understand the applicability of causal criteria applied to epidemiological studies.
Introduction to ethical issues in public health, Public Health Institute (PHI...Dr Ghaiath Hussein
An introduction to ethical issues in public health practice and research I gave to master students in the Public Health Institute in Sudan -- My Home Country. This was on Jan. 5, 2012.
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Ethical Issues in Obtaining Informed Consent.pptxAhmed Mshari
Medical ethics is a set of moral principles, beliefs and values that guide decisions about patient care.
It is an integral part of good medical practice.
The health care professional uses knowledge, experience, and judgment and considers the ethical principles to make decisions on management recommendations.
In the present days of increasing consumer awareness and distrust among the public towards the medical profession its time to introspect & rectify ....
In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.
نظرية التطور عند المسلمين (بروفيسور محمد علي البار
ويقدم فيها سردا تاريخيا لنظريات نشأة الخلق وخلق آدم وكيف ان نظرية التطور هي نظرية علمية وليس دينية لكن تم استغلالها لمحاربة الكنيسة
Ethical considerations in research during armed conflicts.pptxDr Ghaiath Hussein
My talk @AUBMC Salim El-Hoss Bioethics Webinar Series. In this webinar, we have discussed the following points:
1- How armed conflicts affect the planning and conduct of research?
2- What is ethically unique about research during armed conflicts?
3- How did my doctoral project approach these ethical issues both at the normative and the empirical levels?
4- What are the lessons learned from the conflicts in the middle east (Sudan, Syria, Yemen, etc.) and how do they differ from the situation in Ukraine?
Acknowledgement: This talk is based on my doctoral thesis (http://etheses.bham.ac.uk/8580/), which was fully funded by Wellcome Trust, UK.
Research or Not Research? This Is Not the Question for Public Health Emergencies
November 17, 2021 @ 4:00 pm - 5:00 pm EST
Speaker:
Ghaiath Hussein, Assistant Professor, Medical Ethics and Law, Trinity College Dublin, Ireland
About this Seminar:
Public health emergencies, whether natural or man-made, local or global, in peacetime or during armed conflicts are always associated with the need to collect data (and sometimes biological samples) about and from those affected by these emergencies. One of the central questions in the relevant literature is whether the activities that involve the collection of data and/or biological samples are considered ‘research’, with the subsequent endeavour to define what ‘research’ is and whether they should be submitted for ethical approval or not. In this seminar, I will argue that this is not the central question when it comes to research/public health/humanitarian ethics. Using the findings of a systematic review on the research conducted in Darfur and findings from a qualitative project that aimed at defining what constitutes ‘research’ in public health emergencies I will, alternatively, present what I refer to as the ‘ethical characterization’ of these research-like activities and how they can be ethically guided.
Ethical Issues in Patients’ Safety Practice &research
1. Bioethical Issues in Patients’ Safety Practice & Research Ghaiath M.A. Hussein MBBS, MHSc. (Bioethics) Patients’ Safety Proposal Development Workshop July 29, 08
45. Before enrolling patients As part of the completed protocol, PI details safety monitoring plans and procedures including assessing, documenting, and reporting adverse events. PI sends to program officer or medical officer for approval. Program officer or medical officer review Does the PO or MO have concerns about patient safety? Yes, concerned PO or MO sends recommendations to the PI for collaborative revisions. No concerns Approval PO or MO approves safety plan and adverse event reporting plan. Patients may be enrolled once the trial meets all approval requirements. Needs IRB approval of complete protocol as well as approval by other parties such as the DSMB, FDA, and division regulatory staff. After peer review NIAID commits funds. During a clinical trial PO monitors compliance with monitoring plan and adverse event reporting requirements. IRB, FDA, and NIAID address DSMB and SAE reports PO must email or fax PI within 10 days and send official letter within 30 days of receipt. NIAID can terminate award or take other action if PI does not comply with monitoring plan. Serious adverse events PI provides reports of serious adverse events following NIAID Clinical Terms of Award Guidance . For multi-site trials, PI also sends DSMB summary reports to all IRBs and program officer. Last reviewed June 27, 2007 (jlg) Relevant Extramural SOP: Adverse Events Reporting Requirements Example of Clinical Trial Safety Monitoring and Reporting Requirements
When there is conflict of moral values , beliefs, and objectives e.g. between the health care providers and the patients. For instance, the classical example of blood transfusion to a severely bleeding Jehovah Witness who refuses to take blood, even this refusal can lead to severe life threat and eventually death. When there is conflict of commitments and responsibilities : for example at one hand there is the commitment of the health care provider to preserve his/her patients' lives, however there is the responsibility to "rationally" use the resources available to him/her on the other hand. The classical example of which is "one ICU bed, and two patients: whom to choose?" When there is the concern that our patients rights/values are not respected . When the issue in focus is related to justice in allocating the available resources . A classical example is which of the cancer drugs should be funded publicly. Should we choose a drug which efficiently improves the quality of life of few patients? Or a drug that makes little improvement for a larger number of patients. Finally, when we, as care providers feel that we are not sure what we should do .
this is usually the hardest exercise, and commonly known in the bioethics literature as "moral reasoning". There are 10s of ethical approaches, theories, principles etc. to make a sound ethical/moral reasoning.
Community care ethics is now being developed as a subset of this category;
Prospective IC: This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.
The easiest answer to overcome the ethics bore is to say, “ok. You’re talking about research ethics. This is not research”
This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed.
Incompetent: who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor
it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.