This document provides an overview of research ethics and scientific misconduct. It begins with the history of research ethics, covering developments from the 18th century through World War II and the Nuremberg Code. It then discusses key documents and guidelines that shape modern research ethics like the Declaration of Helsinki and Belmont Report. The document defines informed consent and its key components. It also covers conflicts of interest and provides examples of scientific misconduct like fabrication, falsification and plagiarism. Overall, the document provides important context on the evolution of research ethics and outlines the key ethical principles and guidelines that researchers must follow.
One of the most important research ethical issues that should be taken into consideration is “scientific misconduct” such as fabrication, falsification and plagiarism. Plagiarism can occur at any stage of the research activities such as reporting, communicating, authoring, and peer review. The purpose of this workshop is to engage researchers in their responsibility to conduct an ethical research.
A conflict of interest arises whenever there is any potential bias that could affect a researcher’s work. Avoid post-publication headaches by disclosing all conflicts of interest upfront.
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?
One of the most important research ethical issues that should be taken into consideration is “scientific misconduct” such as fabrication, falsification and plagiarism. Plagiarism can occur at any stage of the research activities such as reporting, communicating, authoring, and peer review. The purpose of this workshop is to engage researchers in their responsibility to conduct an ethical research.
A conflict of interest arises whenever there is any potential bias that could affect a researcher’s work. Avoid post-publication headaches by disclosing all conflicts of interest upfront.
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?
Redundant, Duplicate and Repetitive publications are the most important concerns in the scientific research/literature writing. The occurrence of redundancy affects the concepts of science/literature and carries with it sanctions of consequences. To define this issue is much challenging because of the many varieties in which one can slice, reformat, or reproduce material from an already published study. This issue also goes beyond the duplication of a single study because it might possible that the same or similar data can be published in the early, middle, and later stages of an on-going study. This may have a damaging impact on the scientific study/literature base. Similar to slicing a cake, there are so many ways of representing a study or a set of data/information. We can slice a cake into different shapes like squares, triangles, rounds, or layers. Which of these might be the best way to slice a cake? Unfortunately, this may be the wrong question. The point is that the cake that is being referred to, the data/ information set or the study/findings, should not be sliced at all. Instead, the study should be presented as a whole to the readership to ensure the integrity of science/technology because of the impact that may have on patients who will be affected by the information contained in the literature/findings. Redundant, duplicate, or repetitive publications occur when there is representation of two or more studies, data sets, or publications in either electronic or print media. The publications can overlap partially or completely, such that a similar portion, major component(s), or complete representation of a previously/simultaneous ly or future published study is duplicated.
SALAMI SLICING: The slicing of research publication that would form one meaningful paper into several different papers is known as salami publication or salami slicing. Unlike duplicate publication, which involves reporting the exact same data in two or more publications, salami slicing involves breaking up or segmenting a large study into two or more publications. These segments are called slices of a study. As a general rule, as long as the slices of a broken-up study share the same hypotheses, population, and methods, this is not acceptable in general practice. The same slice should never be published more than once at all. According to the United States Office of Research Integrity (USORI), salami slicing can result in a distortion of the literature/findings by leading unsuspecting readers to believe that data presented in each salami slice (journal article) is derived from a different subject sample/source. Somehow this practice not only skews the scientific database but it creates repetition to waste reader's time as well as the time of editors and peer reviewers, who must also handle each paper separately.
The involvement of multiple individuals in different capacities naturally evokes the question of who should be credited and held accountable for the research published, especially since careers, ethics, and scientific integrity are at stake. This article outlines the major concepts pertaining to authorship.
Ethics is a system of moral principles and the rules of conduct recognized in respect to a particular class of human actions or a particular group, culture, etc. research is steady progress by which we have gained a better understanding, greater ability of prediction and ever-increasing control over the world.
Ethics in medical sciences research may not always translate into ethical publications.
Ethical violations in conducting medical research always promote unethical scientific publications.
Published research influences other researchers and establishes credibility for individual or journal.
Open Access (OA) is a system provide access to knowledge resources with free of cost and other restrictions. This PPT answer to the questions what, why, types, benefits etc. and also describes the creative commons licensing, concept of predatory journals, open access journals, and Sharpa RoMeO.
CONTENTS :
INTRODUCTION
TRANSPARENCY
PROMOTING RESEARCH INTEGRITY
EDITORIAL STANDARDS AND PROCESSES
RESPONSIBLE PUBLICATION PRACTICES
OWNERSHIP OF IDEAS AND EXPRESSION
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
Redundant, Duplicate and Repetitive publications are the most important concerns in the scientific research/literature writing. The occurrence of redundancy affects the concepts of science/literature and carries with it sanctions of consequences. To define this issue is much challenging because of the many varieties in which one can slice, reformat, or reproduce material from an already published study. This issue also goes beyond the duplication of a single study because it might possible that the same or similar data can be published in the early, middle, and later stages of an on-going study. This may have a damaging impact on the scientific study/literature base. Similar to slicing a cake, there are so many ways of representing a study or a set of data/information. We can slice a cake into different shapes like squares, triangles, rounds, or layers. Which of these might be the best way to slice a cake? Unfortunately, this may be the wrong question. The point is that the cake that is being referred to, the data/ information set or the study/findings, should not be sliced at all. Instead, the study should be presented as a whole to the readership to ensure the integrity of science/technology because of the impact that may have on patients who will be affected by the information contained in the literature/findings. Redundant, duplicate, or repetitive publications occur when there is representation of two or more studies, data sets, or publications in either electronic or print media. The publications can overlap partially or completely, such that a similar portion, major component(s), or complete representation of a previously/simultaneous ly or future published study is duplicated.
SALAMI SLICING: The slicing of research publication that would form one meaningful paper into several different papers is known as salami publication or salami slicing. Unlike duplicate publication, which involves reporting the exact same data in two or more publications, salami slicing involves breaking up or segmenting a large study into two or more publications. These segments are called slices of a study. As a general rule, as long as the slices of a broken-up study share the same hypotheses, population, and methods, this is not acceptable in general practice. The same slice should never be published more than once at all. According to the United States Office of Research Integrity (USORI), salami slicing can result in a distortion of the literature/findings by leading unsuspecting readers to believe that data presented in each salami slice (journal article) is derived from a different subject sample/source. Somehow this practice not only skews the scientific database but it creates repetition to waste reader's time as well as the time of editors and peer reviewers, who must also handle each paper separately.
The involvement of multiple individuals in different capacities naturally evokes the question of who should be credited and held accountable for the research published, especially since careers, ethics, and scientific integrity are at stake. This article outlines the major concepts pertaining to authorship.
Ethics is a system of moral principles and the rules of conduct recognized in respect to a particular class of human actions or a particular group, culture, etc. research is steady progress by which we have gained a better understanding, greater ability of prediction and ever-increasing control over the world.
Ethics in medical sciences research may not always translate into ethical publications.
Ethical violations in conducting medical research always promote unethical scientific publications.
Published research influences other researchers and establishes credibility for individual or journal.
Open Access (OA) is a system provide access to knowledge resources with free of cost and other restrictions. This PPT answer to the questions what, why, types, benefits etc. and also describes the creative commons licensing, concept of predatory journals, open access journals, and Sharpa RoMeO.
CONTENTS :
INTRODUCTION
TRANSPARENCY
PROMOTING RESEARCH INTEGRITY
EDITORIAL STANDARDS AND PROCESSES
RESPONSIBLE PUBLICATION PRACTICES
OWNERSHIP OF IDEAS AND EXPRESSION
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
Ethical Concerns Regarding Research on Human SubjectsClinosolIndia
Research involving human subjects raises important ethical concerns that need to be carefully addressed to protect the rights, welfare, and dignity of participants. Here are some key ethical concerns regarding research on human subjects:
Informed Consent: Obtaining informed consent is a fundamental ethical principle in research. Participants must be fully informed about the purpose, risks, potential benefits, procedures, and alternatives of the study before voluntarily agreeing to participate. Informed consent should be obtained in a language and format that participants can understand, and they should have the freedom to withdraw from the study at any time without repercussions.
Beneficence and Non-maleficence: Researchers have an ethical obligation to maximize potential benefits and minimize risks and harms to participants. The potential benefits of the research should outweigh any foreseeable risks. Researchers should ensure participant safety, monitor adverse events, and take appropriate measures to mitigate risks.
Privacy and Confidentiality: Participants' privacy must be protected throughout the research process. Personal identifiable information should be kept confidential and handled securely. Data should be anonymized or de-identified whenever possible to ensure participant confidentiality. Researchers should obtain informed consent specifically for data sharing and ensure compliance with applicable data protection regulations.
Protection of Vulnerable Populations: Special protections are required for individuals who may be vulnerable due to age, cognitive impairments, illness, or other factors. Examples include children, pregnant women, prisoners, individuals with disabilities, and economically or socially disadvantaged groups. Additional safeguards should be in place to minimize potential exploitation and ensure their rights and welfare are protected.
Research Ethics Review: Independent research ethics review committees, often called Institutional Review Boards (IRBs) or Ethics Committees (ECs), play a crucial role in evaluating the ethical aspects of research protocols. They assess the study's scientific merit, participant protection measures, and compliance with ethical guidelines and regulations. Research should not proceed without receiving ethical approval from these committees.
Transparency and Integrity: Researchers have an ethical responsibility to conduct research with integrity and honesty. They should accurately report the methodology, results, and limitations of the study, avoiding any fabrication, falsification, or plagiarism. Transparency promotes trust in the research process and allows for scrutiny, replication, and further advancement of knowledge.
Equity and Justice: Research should be conducted in a fair and equitable manner, avoiding any unjust discrimination or exploitation.
MedicReS Winter School 2017 Vienna - Ethics of Cancer Trials - Adil E. ShamooMedicReS
A Comprehensive Introduction to the Ethical Issues at stake in the conduct of Cancer Research
Adil E. Shamoo, Ph.D.
University of Maryland School of Medicine
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
.
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.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
2. Outline
■ 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?
3.
4. History of Research Ethics
Pre-World War II: Research standards left up to the discretion of
the individual researcher
18th and 19th Centuries
■ James Lind “scurvy study in sailors - Salisbury
■ Edward Jenner cowpox vaccine test
■ 1897 Giuseppe Sanarelli yellow fever test
1900 Walter Reed established several [first ever] “safeguards”
■ Self-experimentation
■ Only adults would be enrolled in research
■ Written informed consent
■ Reimbursement (inducement)
5. World War II: Nazi Doctors’ Experimentation
Experiments conducted on inmates of Nazi concentration camps
1945-1949:Trials in Nuremberg, Germany– physicians convicted of crimes against
humanity
6. The Nuremberg Code (1947)
The first provision of the code requires that “the voluntary
informed consent of the human subject is absolutely
essential.”
The code provides other details implied by such a
requirement:
■ Voluntary consent absolutely essential
■ Freedom from coercion
■ Comprehension of the risks and benefits involved
■ Experiment to be conducted by highest qualified persons
■ Risk/Benefit Analysis essential to ethics review
■ Scientific Soundness is important to ethics review
The code on the web: http://ohsr.od.nih.gov/nuremberg.php3
7. The Declaration of Helsinki (DOH)
The World Medical Association created the Declaration of
Helsinki in 1964 and amended regularly since 1975
The main issues emphasized were:
“The well-being of the subject should take precedence over
the interests of science and society”
Respect for Persons – people are not a means to an end;
researchers have duty to protect life, health, privacy and
dignity of research participants
Consent should be in writing
Standard of care must be best available, even for control
group
Greater access to benefit
Use caution if participant is in dependent relationship with
researcher
Limited use of placebo
8. More than 400 African-
American men with latent
syphilis were followed for the
natural course of the
disease rather than receiving
treatment.
Continued after penicillin
available
40 wives infected, 19
children
born with congenital syphilis
TUSKEGEE SYPHILIS STUDY,
ALABAMA ( 1932 – 1972 )
9. The Belmont Report (1979)
1972: the public became aware of the Tuskegee
study
1974: the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral
Research was established.
1978: the commission submitted its report titled,
The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of
Research.
Those principles respect for persons, beneficence and
justice are accepted as the 3 fundamental
principles for the ethical conduct of research
involving human participants.
10. Year Benchmark
2013 WMA updates DOH (Brazil)
2010 TCPS updated
2008 WMA updates DOH (Seoul)
2004 WMA updates DOH (Tokyo)
2002 WMA updates DOH (Washington) CIOMS Guidelines updated
2000 WMA updates DOH (Edinburgh)
1998 Tri-Council Policy Statement (TCPS)published in Canada
1996 WMA updates DOH (South Africa)
1993 CIOMS guidelines for biomedical research involving human subjects
1991 US CFR title 45, Part 46 issued CIOMS Guidelines for Epidemiological studies
1989 WMA updates DOH (Hong Kong)
1983 WMA updates DOH (Venice)
1981 US Common rule updated
1979 The Belmont Report
1975 WMA updates DOH (Tokyo)
1966 Dr. Beecher’s Article “Ethics and Clinical Research”
1964 World Medical Association (WMA) published the Declaration of Helsinki (DOH)
1947 The Nuremberg Code
1900 Walter Reed’s ‘consent’ for yellow fever experiments
Pre-1900 Edward Jenner smallpox vaccines
11. Is it over?... Torvan trial in Kano, Nigeria
Kano Trovan clinical trials in 1996, on pediatric age
group, during the worst ever meningococcal
meningitis.
Lack of proper Governmental authorization and
informed consent during the studies publicized in
2000, by Washington Post.
Court trial and release of investigation panel
reports
stalled in Nigeria.
Suit for 5.8 billion USD moved to the USA and
report leaked there too.
12.
13. Main ethical issues in research
Before
•Benefit/harm
analysis
•Vulnerability
(Risk-
Vulnerability
Matrix)
•Fair selection of
participation
•Conflict of
Interests (COI)
During
•Informed
Consent
•Privacy and
confidentiality
•Risk to
researchers
•Risk to
participants
After
•Sharing results
•Sharing
benefits
•Integrity &
publication
ethics
14. Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters,
WHO (2014))
Ethical
principle/issue
Definition1 Examples of
guidelines
Respect for
people’s
autonomy
The duty to respect people’s ability to make
decisions on issues related to their health and their
body, if they are competent to make such decisions;
and the duty to protect individuals with impaired or
diminished autonomy
CIOMS, General
principles
TCPS, article 1.1
Belmont Report
15. Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and
disasters, WHO (2014))
Ethical
principle/issue
Definition1 Examples of
guidelines
Beneficence The moral duty to pursue actions that promote
the well-being of others and the ethical
obligation to maximize benefit and to minimize
harm
CIOMS, Belmont
Report,
Non-
maleficence
The moral duty not to cause harm to others
through interventions
CIOMS,
DOH (articles 16–18)
Justice Primarily distributive justice, which requires
equitable distribution of benefits and burdens,
i.e. distribution such that no segment of the
population is unduly burdened by the harms of
research or denied the benefits of the
knowledge generated from it
CIOMS (guidelines
10 and 12)
DOH (articles 16–18)
TCPS (article 1.1 and
Chapter 4)
16. Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters, WHO
(2014))
Ethical
principle/issue
Definition1 Examples of
guidelines
Vulnerability A status in which some people may struggle to protect
their interests or be at greater risk of being exploited.
This situation is usually linked to specific physical,
financial, educational or social circumstances.
Groups considered as vulnerable vary by guideline, but
children, mentally retarded and handicapped people,
prisoners, refugees, terminally ill patients and women
are often cited as the prime vulnerable groups.
CIOMS ( guidelines 13–
16), DOH (articles 19 &
20)
Common rule, subparts
B, C and D
TCPS (Chapter 9)
Privacy The right or expectation not to be interfered with or to
be free from surveillance or, more generally, a moral
right to be left alone. In practical terms, privacy is for
instance concerned with the setting in which a person’s
health-related information is acquired.
TCPS (Chapter 5), DOH
(article 24)
17. Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters,
WHO (2014))
Ethical
principle/issue
Definition1 Examples of
guidelines
Confidentiality The principle that ensures that identifiable
information is kept out of reach of others.
All identifiable information about
individuals, whether recorded (written,
computerized, visual, audio) or simply held
in the memory of health professionals, is
subject to the duty of confidentiality.
CIOMS (Guideline
18), TCPS (Chapter 5)
Research
ethics review
A process by which a group of experts in
research, ethics and other disciplines decides
whether a research protocol fulfils the ethical
standards of research before being
undertaken
CIOMS, Guidelines 2
and 20; Common
Rule, subpart A,
(articles 46.107,
46.108 and 46.109);
DOH (article 23);
TCPS (Chapter 6)
19. What is IC?
■ A process whereby potential research
participants decide whether they want to
participate in the proposed study after
receiving information about it.
■ Decisions must be made free from coercion,
by a competent person who can understand
the information given and appreciate the
associated risks.
■ The information given to the participant
should be in a language and format suitable
to the participant’s ability to comprehend it.
20. Components of IC:
1. "Disclosure" refers to the provision of relevant
information by the clinician and its
comprehension by the patient. This refers to the
process during which physicians provide information
about the proposed research to the participant
2. "Capacity" refers to the patient's ability to
understand the relevant information and to
appreciate those consequences of his or her
decision that might reasonably be foreseen.
3. "Voluntariness" refers to the patient's right to
come to a decision freely, without force, coercion
or manipulation.
21. Eight Required Elements
[45 CFR 46.116(a) & 21 CFR 50.25]
1. Statement that study in research and information on
purposes / duration / procedures / experimental
procedures
2. Reasonably foreseeable risks or discomforts
3. Reasonably expected benefits
4. Alternative procedures
5. How confidentiality will be maintained
6. Information on compensation for injuries (unless minimal
risk)
7. Contact persons for information on research, injury,
subject’s rights
8. Voluntary participation, no penalty or loss of benefits for
22. Waiver of Informed Consent
Conditions to waiver IC:
Poses no more than Minimal risk
Waiver or alteration will not adversely
affect the rights and welfare of the
subjects
Research could not practicably be carried
out without the waiver or alteration
Does not involve a therapeutic
intervention
Subjects will be provided with additional
pertinent information
All of the above must apply
23. Documentation of Informed Consent
Written consent document
Language understandable to the subject
or the subject’s Legally Authorized
Representative (LAR), or
Signed by subject or subject’s LAR
Copy SHALL be given to subject
Opportunity to read before signing
24. Principles for Providing Information to Participant:
Make it clear; avoid jargon
Use language appropriate to the
participant’s level of understanding in
a language of their fluency
Invite questions from the patient and
check for understanding
Summarize the imparted information
Provide contact information (and
other resources)
25. 2. Capacity:
Refers to the presence of a group/set of
functional abilities a person needs to possess
in order to make a specific decisions
(Griso and Applebaum, 1998).
These include:
To UNDERSTAND the relevant information
To APPRECIATE the relatively foreseeable
consequences of the various available options
available.
26. 3. Voluntariness:
■ Refers to a participant’s right to make
participation decisions free of any undue
influence.
Influences include:
■ Physical restraint or sedation
■ Coercion involves the use of explicit or
implicit threat to ensure that the
treatment is accepted
■ Manipulation involves the deliberate
distortion or omission of information in
an attempt to induce the subject’s
participation
28. What is an interest?
•An interest may be defined as a
commitment, goal, or value held
by an individual or an institution.
•Examples include a research
project to be completed, gaining
status through promotion or
recognition, and protecting the
environment.
29. What is COI?
• COI exists when two or more contradictory interests relate
to an activity by an individual or an institution.
• Conflicts of interest are “situations in which financial or
other personal considerations may compromise, or have
the appearance of compromising, an investigator’s
judgement in conducting or reporting research.” AAMC,
1990
• “A conflict of interest in research exists when the individual
has interests in the outcome of the research that may lead
to a personal advantage and that might therefore, in
actuality or appearance compromise the integrity of the
research.”
NAS, Integrity in Scientific Research
30. What comprises COI?
• Stock ownership
• Paid employment Board membership
• Patent applications (pending or actual)
• Research grants (from whatever source)
• Travel grants and honoraria for speaking or
participation at meetings
• Gifts Membership of lobbying organizations
• Relationship with the National Research Ethics
Review Committee, or with possible reviewers of
the paper
• Relationship with organizations and funding bodies
Membership of a government advisory board
31. Levels of COI
1- Researchers
•The REC should assess the likelihood that
the researcher’s judgment may be
influenced, or appear to be influenced, by
private or personal interests (TCPS, 2000)
2- Conflicts of Interest by REC Members
•It is of the highest importance that
members of the REC avoid real or apparent
conflicts of interest .
•E.g.: their research are reviewed by their
REC or when they have been in direct
academic conflict or collaboration with the
researcher whose proposal is under review.
32. Levels of COI
3- Institutional Conflicts of Interest
• Situations may arise where the parent
organization has a strong interest in seeing a
project approved before all ethical questions are
resolved.
• The REC must act independently from the
parent organization.
• Institutions must respect the autonomy of the
REC and ensure that the REC has the
appropriate financial and administrative
independence to fulfill its primary duties.
33. Why to worry about COI?
COIs may result in:
1. Loss of objectivity
2. Reordering of priorities towards
applied research
3. Degradation of the nature of
science as a collegial enterprise
4. Exploitation of trainees
5. Transfer of time and interest to
commercial ventures
34. Practical Steps to resolve COI
•Disclosure / transparency
•Stringent analysis of COI,
•Review of contracts between
funders and researchers
•Close external monitoring
•Blinding of study, when possible
•Restrict review of colleague’s work
•Peer review of manuscripts
35. What is Ethical Review?
■ It is a process by which research proposals are
reviewed for their compliance and accordance with
the national/international ethical principles &
guidelines for research involving human subjects.
All research involving living human subjects by collecting
identifiable information or materials including:
Research with human remains, cadavers, tissues,
biological fluids, embryos and fetuses.
Interviews, surveys and questionnaires.
Secondary data analysis of data from living human
subjects.
37. Types of research
misconduct
(Adapted from: Committee on Publication Ethics. The COPE Report, 2000. 2000. &
Research Misconduct, F.J. Gilberta and A.R. Denison, 2002)
■ Fabrication
■ Falsification
■ Plagiarism
■ Failure to get ethical approval
■ Not admitting that some data are missing
■ Ignoring outliers without declaring it
■ Not including data on side effects in a clinical trial
■ Conducting research on humans without informed
consent
■ Publication of post hoc analyses without declaring it
38. Types of research misconduct (2)
(Adapted from: Committee on Publication Ethics. The COPE Report,
2000. 2000. and Research Misconduct, F.J. Gilberta and A.R. Denison,
2002)
■ Gift authorship
■ Not attributing other authors
■ Redundant publication: “Shotgunning” & “Salami-slicing”
■ Not disclosing a conflict of interest
■ Not attempting to publish completed research
■ Failure to do an adequate search of existing research
before beginning new research
39. Research Misconduct (FFP)
Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or
in reporting research results.
– Fabrication is making up data or results and recording or
reporting them.
– Falsification is manipulating research materials,
equipment, or processes, or changing or omitting data or
results.
– Plagiarism is the appropriation of another person’s ideas,
processes, results, or words without giving appropriate
credit.
– Research misconduct does not include honest error or
differences of opinion.
– Research misconduct includes the destruction of, absence
of, or accused person's failure to provide research records
accurately documenting the questioned research.
40. Basic definitions
(Adapted from: Research misconduct: the poisoning of the well, Richard Smith, J R Soc Med May
2006 vol. 99 no. 5232-237, and
http://grants.nih.gov/grants/research_integrity/research_misconduct.htm
■ Fabrication: is making up data or results and recording or
reporting them.
– Example: In order to meet recruitment pressure and expectations, a
study coordinator completed trial enrollment forms using faked names
and participants' information.
– Eric Poehlman made up patients' data that never existed to support his
scientific claims.
■ Falsification: is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
– Example: 'splicing and pasting' together different segments of western
blot images so that the final image presented appeared to have come
from a single western blot procedure.
– Harvard investigator Marc Hauser was found to have fabricated and
manipulated research results.
41. Plagiarism
(Pearson Prentice Hall, understanding Plagiarism, URL:
http://wps.prenhall.com/hss_understand_plagiarism_1/6/1668/427065.cw/index.html)
■ Plagiarism: is the appropriation of another person's ideas,
processes, results or words without giving appropriate credit.
■ Some obvious examples:
– copying someone else's paper.
– taking short or long quotations from a source without identifying the
source.
– turning in a paper you bought over the Internet.
■ Some less-obvious examples :
■ changing a few words around and pretending those words are your own.
■ rearranging the order of ideas in a list and making the reader think you
produced the list.
■ borrowing ideas from a source and not giving proper credit to the source.
■ using information from an interview or an online chat or email, etc.,
without properly citing the source of the information.
42. How to maintain research ethics
and avoid scientific misconduct?
Before conduct of
research
• Develop clear
research plan
(who will do what
when and how)
• Submit protocol
to ethical review
• Prepare
(communicate)
well with your
research
community
• Agree on
authorship
During conduct of
research
• Follow the
approved protocol
• Gain consent
• Involve the
community
• Protect yourself,
your team, & your
participants
• Regularly check
your data
After research
• Share your study
report(s) with
• Return
‘something’ back
to the researched
community
• Publish following
publication ethics
• Use Reference
Management
Software
43. References
1. SCImago. (2007). SJR — SCImago Journal & Country Rank.
Retrieved December 09, 2014, from
http://www.scimagojr.com
2. Training manual: Ethics in research, surveillance and
patient care in epidemics, emergencies and disasters.
Geneva, Switzerland: World Health Organization; 2014.
■ Committee on Publication Ethics. The COPE Report, 2000.
2000.
■ Research Misconduct, F.J. Gilberta and A.R. Denison, 2002
■ Steneck, Science and Engineering Ethics (2006) 12, 53-74
■ Research misconduct: the poisoning of the well, Richard
Smith, J R Soc Med May 2006 vol. 99 no. 5232-237
■ Pearson Prentice Hall, understanding Plagiarism, URL:
http://wps.prenhall.com/hss_understand_plagiarism_1/6/1
668/427065.cw/index.html
44. This presentation and more material can be found online:
http://www.slideshare.net/ghaiath
https://www.youtube.com/ghaiathme