This document discusses the importance of ethics in medical research. It begins by defining ethics and research, and identifies human subjects. It then reviews some unethical medical experiments from history, like the Tuskegee Syphilis Study, that lacked informed consent and caused harm. This led to various codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report to protect subjects. The three main principles of research ethics are respect for persons, beneficence, and justice. Special protections are needed for vulnerable groups. Overall, ethics aim to balance scientific advancement with subject welfare and rights.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
This is a presentation I gave to the Research Coordinators in the Federal Ministry of Health, Sudan (04.03.2015).
It included the following topics:
• Overview on the Knowledge Management Cycle and how research fits in it
• Brief historical background on research ethics
• What makes research ethical?
• Definition and examples of scientific misconduct
• How to make your research ethical and avoid scientific misconduct?
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
This is a presentation I gave to the Research Coordinators in the Federal Ministry of Health, Sudan (04.03.2015).
It included the following topics:
• Overview on the Knowledge Management Cycle and how research fits in it
• Brief historical background on research ethics
• What makes research ethical?
• Definition and examples of scientific misconduct
• How to make your research ethical and avoid scientific misconduct?
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
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
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This week, reflect on what you learned from the NIH materials abouTakishaPeck109
This week, reflect on what you learned from the NIH materials about protecting the rights of human research participants.
·
·
·
· Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.
· Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?
· The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.
· Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.
3 pages only
2 scholarly articles
Protecting Human Research Participants
NIH Of fic e of E xt ramural R e se a rc h
Introduction
Research with human subjects can occasionally result in a dilemma for investigators. When the
goals of the research are designed to make major contributions to a field, such as improving the
understanding of a disease process or determining the efficacy of an intervention, investigators
may perceive the outcomes of their studies to be more important than providing protections
for individual participants in the research.
Although it is understandable to focus on goals, our society values the rights and welfare of
individuals. It is not considered ethical behavior to use individuals solely as means to an end.
The importance of demonstrating respect for research participants is reflected in the principles
used to define ethical research and the regulations, policies, and guidance that describe the
implementation of those principles.
Who?
This course is intended for use by individuals involved in the design and/or conduct of National
Institutes of Health (NIH) funded human subjects research.
What?
This course is designed to prepare investigators involved in the design and/or conduct of
research involving human subjects to understand their obligations to protect the rights and
welfare of subjects in research. The course material presents basic concepts, principles, and
issues related to the protection of research participants.
Why?
As a part of NIH's commitment to the protection of human subjects and its response to Federal
mandates for increased emphasis on protection for human subjects in research, the NIH Office
of Extramural Research released a policy on Required Education in the Protection of Human
Research Participants in June 2000. This course is specifically designed for extramural
investigat ...
Principles of essentiality
Principles of voluntariness, informed consent and community agreement
Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
1. Why Ethics In Medical
Research?
Tamer Hifnawy. MD. Dr (PH)
Associate Professor of Public health
Faculty of Medicine, Beni Suef University, Egypt
College of Dentistry, Taibah University, KSA
Vice Dean for Quality and Development
Certified Trainer in International Research Ethics
2. Points Covered Today
Define ethics
Define Research
Identify Human Subjects in research
Overview of history of research ethics
Identify evolution of codes of ethics
Identify three fundamental principals of
research ethics
4. WHAT IS: ETHICS ?
The word is derived form the Greek
word “ethos” meaning;
“the set of moral principles”
5. What do we mean by ethics?
Morality or ethics represents a code of
conduct that governs how people treat each
other.
In essence, it is concerned with the way
people act or behave.
The term ‘ethics’ usually refers to the moral
principles, guiding conduct, which are held
by a group or even a profession”
(Wellington, 2000: 54)
6. WHAT IS: ETHICS ?
Ethics are ways of understanding and
examining the moral life, or of right and wrong
human conduct.
Bioethics is a way of understanding and
examining the moral aspects of biomedical
research and practice
7. WHY WORRY ABOUT
RESEARCH ETHICS ?
The science itself
Other scientists
The research participant
The public
The future
Ourselves
8. WHY WORRY ABOUT
ETHICS ?
The science itself
Other scientists
The research participant
The public
The future
Ourselves
10. WHO IS A HUMAN SUBJECT?
“a living individual about whom an
investigator (professional or student)
conducting research obtains;
1. Data or
2. Identifiable private information
Through intervention or interaction
with the individual.”
45 CFR 46.102(f)
12. It is important at this point to
draw the line between
“research” and “practice”.
13. WHAT IS RESEARCH ?
Research is defined as;
“a systematic investigation,
including research
development, testing and
evaluation, designed to
develop or contribute to
GENERALIZABLE knowledge.”
45 CFR 46.102(d)
14. HUMAN SUBJECT RESEARCH
A research Involving living
individuals about whom the
researcher obtains:
Data through
intervention
or interaction
Identifiable
Human Material
+/Private
Information
AND
OR
17. During The Islamic
Era
Islamic Rules included all the basic
ethical principles known in modern
history which include:
Respect for persons
Non-maleficence
Beneficence
Justice
18. History of Research Ethics
Codes, guidelines & regulations
developed to guide research
involving human participants.
Guidelines were created in response to:
1. An ethical lapses in research.
2. Provide answers to new problems and
challenges in research.
19. By 1833 William Beaumont records
what some consider to be the oldest
American document dealing with
research ethics. Which identified key
issues which may be summarized as
follows:
Experimentation is needed;
Investigator must be
conscientious and responsible;
20. Investigations must have good
methodological approach and there should
be no random studies;
Voluntary consent is necessary;
Discontinuation of experiment when it causes
distress to the subject or the subject objects
or becomes dissatisfied
21. HISTORY OF RESEARCH
ETHICS
Before 20th century
Small scale, involving few individuals
Edward Jenner -- Small pox vaccine
Beginning of 20th century
Larger scale clinical trials
Collect Systematic data
Groups of individuals
Vulnerable groups
Prisoners
Orphans
Mentally ill
No Formal Codes of Research
Ethics
22. RESEARCH HISTORY
TRAGEDIES
Albert Neisser, discoverer of the
gonococcus
In order to find a method of syphilis
prevention he injected cell free serum from
patients with syphilis into patients who
were admitted for other medical conditions.
Most of these patients were commercial
sex workers, who were neither informed
about the experiment nor asked for their
consent.
23. Neisser Case Cont.
When some of them contracted syphilis
Neisser concluded that the
“vaccination did not work”.
However, he argued that the women did
not contract syphilis as a result of his
serum injections but contracted the
disease because they were commercial
sex workers.
24. Neisser Case Cont.
Most academic physicians at the time
supported Neisser.
In 1898 the public prosecutor investigated
the case.
25. The court ruled that, though Neisser as a
well known medical authority may have
been convinced that the trials were
harmless, he should have sought the
patients' consent.
Not questionable science but lack of
patients' consent was the main principle
for the legal judgment.
27. Nazi Experiments
Hypothermia Experiments
The goal of this type
of experiments was
to determine how
long German pilots
would survive after
parachuting into the
cold north sea.
A prisoner is submerged in a
tank filled with cold water.
28. High Altitude Experiments
• High altitude experiments were performed to test how long
pilots would survive after being ejected from their planes.
Prisoners were put into low-pressure tanks with little oxygen.
• Many of those who did not die immediately were put under
water until they died.
29. Tuskegee Syphilis Study
(1932 - 1972)
Tuskegee, Alabama
High prevalence of syphilis
Although treatment existed, blacks in the rural
southern town were not receiving treatment
Lack of funds/Lack of doctors
Study natural course of syphilis
Enrolled 400 black males infected with
syphilis
Not an experiment but rather a “study in
nature”
30. Tuskegee Syphilis Study
(1932 - 1972)
Ethical Issues Inadequate disclosure of
information
Subjects believed they were
getting free treatment
Told that spinal taps was therapy
US Gov’t actively prevented
men from receiving penicillin
1972 press reports caused the
U.S. Gov’t to stop the study
31. Ethical issues in Tuskegee
study:
Inadequate disclosure of
information
Subjects believed they
were getting free treatment
Told that spinal taps was
therapy
US Gov’t actively
prevented men from
receiving penicillin
1972 press reports caused
the U.S. Gov’t to stop the
study
32. Problems with research include;
Lack of informed consent
Use of vulnerable population
Exploitation of vulnerable population
Withholding information and / or treatment
Putting subjects at risk
Risks outweigh benefits
Deception and violation of rights
33. The Willowbrook Study
(1963-1966)
Research done at a state school of mentally
handicapped children
Deliberate infection with live Hepatitis virus
Institution could only take in those accepting
to participate in the study
Poor public had no other institutional choice
Parents were not completely told what study
involved
34. The Willowbrook Study cont.
Researchers defended the
deliberate injection of these
children by pointing out that
the vast majority of them
would acquire the infection
anyway while at
Willowbrook, given the
crowded and unsanitary
conditions, and
Only children whose
parents had given consent
were included
35. Nuremburg Nazi Doctors’ Trial
(1947)
Nazi doctors & scientists
put on trial for the murder
of concentration camp
inmates who were used
as research subjects
15 of 23 guilty, 7 hanged, 5 life sentences
36. How Could This Happen?
German physicians had sworn to
“DO NO HARM” by the Hippocratic Oath
Science corrupted by politics?
37. Relevance of Hippocratic Ethics to Human
Experimentation
Medical Practice
Ethics: guided by Hippocratic Oath
Doctor’s primary obligation is patient’s welfare
Doctor acts in the patients’ best interest
Research
Lies outside of the context of the physician-patient
relationship
Two Interests
Test a hypothesis
Subject welfare
Two different types of practices
38. Ends, means, subjects and
objects
There is a danger of reducing
research subjects
to
research objects
39. Balancing Two Goals
Without an Adequate Framework of Research Ethics
Advancement
of Science
Protection of
Subject Welfare/Rights
>>>
40. In the context of research
Could not protect human welfare
Could not respect human rights
Hippocratic Oath
Expand on Hippocratic Ethics to
Protect Research Subjects
42. Nuremberg Code (1947)
First Codification of Research Guidelines
Human Rights + Welfare of Subjects
The first and longest
principle
Article (9)
Subjects have the right to
withdraw at any time
“The voluntary consent
of the human subject is
absolutely essential.”
43. The Declaration of Helsinki
Developed by the World Medical
Association in Finland in 1964.
Provide guidance for physicians and
participants in medical research.
Many updates were introduced in
1975, 1983, 1989, 1996, 2000 and in
2008.
44. The Declaration of Helsinki
It indicates:
o The well-being of the subject should
take precedence over the interests of
science and society.
o Physician should obtain the subject’s
freely given informed consent in
writing.
o Ethical review committee approval is a
must.
45. The Belmont Report
• In 1974, the National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research was
established.
• In 1978, it submitted The Belmont Report
that sets the fundamental ethical principles
1. Respect for persons
2. Beneficence
3. Justice
46. The first step in the evolution of ethics is a
sense of solidarity with other human beings.
Albert Schweitzer
47. VULNERABLE POPULATIONS
Pregnant women / fetuses
Children
Elderly
Mentally disabled
Sick persons
Unconscious persons
Prisoners
Persons with little/ no education
Poor persons
48. CIOMS 2002
Council for International Organizations of
Medical Sciences: International Ethical
Guidelines for Biomedical Research
Involving Human Subjects
Dealt with issues involving international
clinical trials
49. CIOMS Guideline 10:
Research in populations and communities with
limited resources
“…the sponsor and the investigator must
make every effort to ensure that:
The research is responsive to the health
needs and priorities of the population or
community; and
Any intervention or product developed,
or knowledge generated, will be made
reasonably available for the benefit of
that population or community.
50. CONCLUSIONS
All ethical codes and principals
advocate three fundamental principals;
Respect for persons
Beneficence
Justice
Research is a privilege, not a right
The well-being of participant is a priority
54. Case 1: Research with autopsy
specimens
An application describes the following
proposed activities:
An investigator receives autopsy
specimens from a pathologist at the
same institution.
The investigator will receive and
record identifiable private information
about the individuals from medical
records
55. Case 1: Is the investigator conducting
human subjects research?
No:
Research involving only specimens and
data from dead individuals is not human
subjects research
Investigator is neither interacting nor
intervening with living individuals for
research
Definition of “human
subject” is not met
56. Case 2: Discarded Tumor Specimens
An application describes the following
proposed activities:
Investigators will obtain human specimens
for basic research from a pathologist who
has previously collected tumor specimens
from cancer patients.
The pathologist will de-identify the data so
that he/she and the investigators will not
know the identities of the samples.
57. Case 2: Are the recipient investigators
conducting human subjects research?
The recipient investigators are not
conducting human subjects
research, because
They have received existing de-
identified data
There is no way they can ever
access the identities of the samples
Data has been anonymized
58. What is meant by existing
data?
Data has already been collected at the
time the proposal was conceived
Existing data had been collected for
purposes other than the proposed research
Applies to retrospective studies involving
already collected data where data must be
“on the shelf” when the protocol is
initiated.
59. THANK YOU
Tamer Hifnawy MD. Dr PH.
Associate Professor of Public Health & Community Medicine
Faculty of Medicine, Beni Suef University, Egypt
College of Dentistry, Taibah University, KSA
Vice Dean for Quality and Development
Certified Trainer in International Research Ethics
Email: tamer.hifnawy@bsu.edu.eg
thifnawy@yahoo.com
Mobile: +201114130107 Egypt
+966564356123 KSA