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This is the complete lecture note for COM507 Health Research Ethics and Ethics of Good Medical Practice and the Role of Medical and Dental Council of Nigeria. You can read it online below, open it in the full viewer, or download the PDF for offline study. It pairs with the course's video lectures, so you can read and watch together.
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS Course code: COM 507 Course title: Health Research Ethics and Ethics of Good Medical Practice and the Role of Medical and Dental Council of Nigeria Course credit load: 1 Unit Series 1: Health Research Ethics: History, Belmont Report, Helsinki and Geneva Declarations, and Principles of Research Ethics • Part 1.1: Health Research Ethics and the History of Medical Ethics o Sub Part 1.1.1: Definition and scope of health research ethics o Sub Part 1.1.2: Early history of medical ethics o Sub Part 1.1.3: Evolution of medical ethics in the twentieth century • Part 1.2: Key Codes and Declarations in Research Ethics o Sub Part 1.2.1: The Belmont Report o Sub Part 1.2.2: The Declaration of Helsinki o Sub Part 1.2.3: The Declaration of Geneva • Part 1.3: Ethics of Medical Research Involving Human Subjects o Sub Part 1.3.1: Ethical requirements for research involving human subjects o Sub Part 1.3.2: Vulnerable populations in research o Sub Part 1.3.3: Principles of research ethics Introduction Medical research has produced immense benefit to humanity, yet its history also includes episodes of serious harm to research participants, harm that ultimately gave rise to the ethical codes and principles that now govern how health research must be conducted. Picture an institutional research ethics committee carefully reviewing a proposed clinical trial, weighing the scientific value of the study against the welfare and rights of the human participants who would take part in it. Understanding how this careful balance came to be formally required, and the
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS specific historical documents that established it, is the essential foundation for everything that follows in this course, and it is this history that forms the subject of this opening Series. The aim of this Series is to equip you with a clear understanding of health research ethics, the history of the evolution of medical ethics, the Belmont Report, the Declaration of Helsinki, the Declaration of Geneva, and the principles governing ethical research involving human subjects. This Series begins with health research ethics and the history of medical ethics, before turning to the key codes and declarations that shape research ethics today. It concludes with the ethics of medical research involving human subjects. Series Learning Outcomes At the end of this Series, you should be able to: • SLO 1.1: define health research ethics and describe the early history of medical ethics • SLO 1.2: explain the evolution of medical ethics in the twentieth century • SLO 1.3: describe the Belmont Report and the Declaration of Helsinki • SLO 1.4: describe the Declaration of Geneva • SLO 1.5: describe the ethical requirements for medical research involving human subjects and vulnerable populations, and • SLO 1.6: list the principles of research ethics. 1.1 Health Research Ethics and the History of Medical Ethics 1.1.1 definition and scope of health research ethics Protecting the rights and welfare of research participants Health research ethics is the branch of applied ethics concerned with the moral principles that should guide the design, conduct, and reporting of research involving human participants, or, in some cases, animals, seeking to ensure that the pursuit of scientific knowledge never comes at the expense of the fundamental rights, dignity, and welfare of those who take part in a study. The scope of health research ethics extends across the entire research process, from the initial design of a study, through the process of recruiting and obtaining consent from participants, discussed further in a later Series of this course, to the conduct of the research itself and the
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS honest, accurate reporting of its eventual findings, meaning ethical obligations do not end once a study has actually begun. Fill in the blank: Health research ethics seeks to ensure that the pursuit of scientific knowledge never comes at the expense of the rights, dignity, and welfare of research ________. 1.1.2 early history of medical ethics Formal reflection on the ethical obligations of physicians dates back to antiquity, most famously exemplified by the Hippocratic Oath, attributed to the ancient Greek physician Hippocrates, which articulated early principles such as acting for the benefit of the patient and avoiding harm, themes that continue to underpin medical ethics discussions examined in a later Series of this course. For many centuries following antiquity, medical ethics remained largely an informal matter of individual professional conduct and custom, generally passed down through apprenticeship and professional tradition rather than codified in the kind of formal written documents and regulatory oversight that would eventually emerge, discussed further in the remainder of this Series, particularly from the twentieth century onward. Fill in the blank: Formal reflection on the ethical obligations of physicians dates back to antiquity, most famously exemplified by the Hippocratic ________. 1.1.3 evolution of medical ethics in the twentieth century The twentieth century brought a decisive shift toward formal, codified medical and research ethics, driven substantially by the exposure of serious ethical violations, most notably the atrocities committed by Nazi physicians during experiments on concentration camp prisoners, which were prosecuted at the Nuremberg trials following the Second World War and led directly to the Nuremberg Code, one of the earliest formal research ethics documents. Further serious ethical violations, most notably the Tuskegee syphilis study conducted in the United States, in which treatment was deliberately withheld from research participants for decades even after effective treatment became available, provided additional impetus for the more comprehensive ethical frameworks examined in the next Part of this Series, including the Belmont Report. Fill in the blank: The exposure of serious ethical violations, including the atrocities prosecuted at the Nuremberg trials, led directly to the Nuremberg ________.
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS Figure 1.1: A research ethics committee reviewing a study proposal around a conference table. Pilot questions 1.1 1. Define health research ethics. (Linked to SLO 1.1) 2. Describe the scope of health research ethics across the research process. (Linked to SLO 1.1) 3. Identify the earliest example of formal reflection on physicians' ethical obligations. (Linked to SLO 1.1) 4. Explain why medical ethics remained largely informal for many centuries. (Linked to SLO 1.1) 5. Explain how the Nuremberg trials led to the development of formal research ethics documents. (Linked to SLO 1.2) 1.2 Key Codes and Declarations in Research Ethics 1.2.1 the belmont report Three foundational ethical principles for research The Belmont Report, published in 1979 by a United States national commission established in direct response to the Tuskegee syphilis study discussed in the previous Part of this Series, set out
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS three foundational ethical principles for research involving human subjects, respect for persons, beneficence, and justice, principles that continue to underpin research ethics guidance worldwide. Respect for persons requires treating individuals as autonomous agents capable of making their own decisions and providing additional protection to those with diminished autonomy, beneficence requires maximising possible benefits while minimising possible harms, and justice requires the fair distribution of both the burdens and the benefits of research across different groups within society. Fill in the blank: The Belmont Report set out three foundational ethical principles for research: respect for persons, beneficence, and ________. 1.2.2 the declaration of helsinki The Declaration of Helsinki, first adopted by the World Medical Association in 1964 and revised on multiple occasions since, provides ethical principles specifically for medical research involving human subjects, including research using identifiable human material or data, and represents one of the most widely referenced international research ethics documents used by researchers and ethics committees around the world. Among its central provisions, the Declaration of Helsinki emphasises that the interests of the individual research subject must take precedence over the interests of science and society, and that a research protocol must be reviewed by an independent research ethics committee before the study begins, principles closely related to the ethical requirements for human subjects research discussed in the next Part of this Series. Fill in the blank: The Declaration of Helsinki was first adopted by the World Medical Association in the year ________. 1.2.3 the declaration of geneva The Declaration of Geneva, first adopted by the World Medical Association in 1948 and also revised on multiple occasions since, is a modern restatement of the physician's ethical commitments, intended as a contemporary successor to the ancient Hippocratic Oath discussed earlier in this Series, and is widely used as a professional oath recited by newly qualified physicians upon entering medical practice. Unlike the Belmont Report and the Declaration of Helsinki, which focus specifically on research ethics, the Declaration of Geneva addresses the broader ethical commitments of physicians in their general professional practice, including commitments to patient welfare, confidentiality,
la-NET | ONLINE LEARNING VIDEO PLATFORM FOR POST-SECONDARY & HIGHER INSTITUTION STUDENTS and non-discrimination,
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