This document discusses conflict of interest in academic research. It notes that as academic involvement in research has increased, so too has the potential for conflicts of interest where financial gain could influence research outcomes. It describes how granting agencies require disclosure of potential conflicts. The document outlines different types of conflicts, how institutions should manage them, and the importance of protecting both the integrity of research and human subjects. It also briefly discusses scientific misconduct and the responsibilities of authors.
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.
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.
In academia, the pressure to publish is high and the competition intense. This can lead authors to follow unethical publication practices, such as salami slicing, duplicate publication, and simultaneous submission. This slide deck explains these malpractices and shares tips on how authors can avoid them.
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.
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.
In academia, the pressure to publish is high and the competition intense. This can lead authors to follow unethical publication practices, such as salami slicing, duplicate publication, and simultaneous submission. This slide deck explains these malpractices and shares tips on how authors can avoid them.
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.
Predatory Publications and Software Tools for IdentificationSaptarshi Ghosh
Journals that publish work without proper peer review and which charge scholars sometimes huge fees to submit should not be allowed to share space with legitimate journals and publishers, whether open access or not. These journals and publishers cheapen intellectual work by misleading scholars, preying particularly early career researchers trying to gain an edge. The credibility of scholars duped into publishing in these journals can be seriously damaged by doing so. It is important that as a scholarly community we help to protect each other from being taken advantage of in this way.
In this presentation, the speaker has covered following topics:
What is scientific conduct?
What do we mean by ethics in research? – scientific temperament –
What is Ethical behavior in research?
How to practice Ethics in publication?
On Research Metrics -
Author level metrics to journal level metrics
Research Profile Digital Platforms.
Selective Reporting and Misrepresentation of DataSaptarshi Ghosh
Research integrity means conducting research according to the highest professional and ethical standards, so that the results are trustworthy.
It concerns the behavior of researchers at all stages of the research life-cycle, including declaring competing interests; data collection and data management; using appropriate methodology; drawing conclusions from results; and writing up research findings.
Ethical research and publication practices are essential for honest scholarly and scientific research. Most journals today are keenly aware of this: they publish policies on these issues and expect authors to “be aware of, and comply with, best practice in publication ethics”.This article discusses two widespread and related publishing practices that are considered unethical—duplicate publication and simultaneous submission. It draws on definitive international publication ethics guidelines.
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.
CONTENTS :
INTRODUCTION
TRANSPARENCY
PROMOTING RESEARCH INTEGRITY
EDITORIAL STANDARDS AND PROCESSES
RESPONSIBLE PUBLICATION PRACTICES
OWNERSHIP OF IDEAS AND EXPRESSION
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.
Predatory Publications and Software Tools for IdentificationSaptarshi Ghosh
Journals that publish work without proper peer review and which charge scholars sometimes huge fees to submit should not be allowed to share space with legitimate journals and publishers, whether open access or not. These journals and publishers cheapen intellectual work by misleading scholars, preying particularly early career researchers trying to gain an edge. The credibility of scholars duped into publishing in these journals can be seriously damaged by doing so. It is important that as a scholarly community we help to protect each other from being taken advantage of in this way.
In this presentation, the speaker has covered following topics:
What is scientific conduct?
What do we mean by ethics in research? – scientific temperament –
What is Ethical behavior in research?
How to practice Ethics in publication?
On Research Metrics -
Author level metrics to journal level metrics
Research Profile Digital Platforms.
Selective Reporting and Misrepresentation of DataSaptarshi Ghosh
Research integrity means conducting research according to the highest professional and ethical standards, so that the results are trustworthy.
It concerns the behavior of researchers at all stages of the research life-cycle, including declaring competing interests; data collection and data management; using appropriate methodology; drawing conclusions from results; and writing up research findings.
Ethical research and publication practices are essential for honest scholarly and scientific research. Most journals today are keenly aware of this: they publish policies on these issues and expect authors to “be aware of, and comply with, best practice in publication ethics”.This article discusses two widespread and related publishing practices that are considered unethical—duplicate publication and simultaneous submission. It draws on definitive international publication ethics guidelines.
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.
CONTENTS :
INTRODUCTION
TRANSPARENCY
PROMOTING RESEARCH INTEGRITY
EDITORIAL STANDARDS AND PROCESSES
RESPONSIBLE PUBLICATION PRACTICES
OWNERSHIP OF IDEAS AND EXPRESSION
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 level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct. Government oversight of scientific research is important, but such oversight, in the form of administrative rules, typically stipulates what cannot be done.
Navigating the Ethical Landscape: Unraveling Ethical Issues in Clinical TrialsThe Lifesciences Magazine
Here are Unraveling Ethical Issues in Clinical Trials: 1. Informed Consent 2. Vulnerable Populations 3. Placebo Use 4. Randomization 5. Data Transparency
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.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2. Introduction
Increased involvement of academician in
research has raised potential of conflict of
Interest.
Arises from oppourtunities a faculty or other
members might have to benefit financially from
the outcome of research.
Granting agencies wants assurance from the
institution that member involved in research will
not utilise the funds to promote financial gain for
themselves or for families.
Institution should have written policies
conflict of interest
to provide a mechanism for faculty and staff
to disclose such conflicts.
3. Important aspects
The institutional Conflict of Interest policy must
include”
financial interests, gifts, gratuities and favors,
nepotism,
and other areas such as political participation
and bribery.
These rules must also indicate how outside
activities, relationships, and financial interests are
reviewed by the responsible and objective
institution official(s).
In addition, the institution has the responsibility
for maintaining objectivity in research by ensuring
that the design, conduct, or reporting of research
will not be biased by any conflicting financial
interest of investigator
4. Views
“Conflicts of interest are ubiquitous in academic life,
indeed all professional life; conflicts of interest can
never be eliminated. Moreover, the existence of
conflicts of interest has to be accepted and not
equated with scientific misconduct” (Korn 2000).
“Financial conflicts of interest are not inherent to the
research enterprise. They’re entirely optional –
unlike intellectual or personal conflicts of interest to
which they’re often compared” (Angell 2000)
5. What is a Conflict of Interest?
Situation in which the integrity of academic
activity, especially research, may be, or may be
perceived to be, compromised by financial or
other interests.
A conflict of interest occurs when a secondary
interest distorts or has the potential to distort a
judgment related to a primary interest
A professional’s judgment does not necessarily
have to be biased in order for that researcher
to have a conflict of interest — even the
appearance of a conflict of interest is ethically
worrisome
6. Primary Interests
Professionals have a primary interest—
the goal of their profession
For researchers:
− Producing generalizable knowledge
− Ensuring the safety of research
subjects
− Disseminating research results
7. Secondary Interests
Professional goals
Publishing
Obtaining future research funding
Gaining recognition and fame
Personal goals
Spending time with his/her family
Earning a good income
Other personal interests such as religion,
traveling, social activities, etc.
Political activism
8. Types
Conflicts of interest are of two major types.
Conflicts between the professional’s personal or
financial interests and the interests of a subject/
participant, patient or client, and
Conflicts that involve competing loyalties, to two
or more subjects, patients or clients.
Alternatively,
the conflict may be between a
subject/participant, client or patient and a third
party to whom the professional owes
contractual duties, for example, sponsors of
research, insurance companies, employers, etc.
The term competing interest rather than conflict of interest is preferred
by some as a way of lessening any implicit sense of misconduct
9. Financial Conflicts of Interest
The paradigm conflict of interest is financial interest.
non-financial (or only indirectly financial) forms of bias
can pose serious risks to research and to human safety
and dignity
Significant financial interests must be disclosed to
institutional officials and be appropriately managed
[Title 42 CFR, Section 50, Parts 604 and 605].
A “significant financial interest,” according to the PHS,
is one that that could directly and significantly affect the
design, conduct, or publication of research and thus
bear on issues of human subject’s protection.
The PHS sets a monetary threshold of a $10,000
interest or 5% ownership in an entity that would
reasonably be affected by research, neither PHS nor
FDA regulations specify types of financial interests that
may be held, or those that may not be held.
10. Financial interest
Financial interests include, but are not limited to:
Compensation from employment (by other than
grantee institution)
Paid consultancy, advisory board service, etc.
Stock ownership or options
Intellectual property rights (patents, copyrights,
trademarks, licensing agreements, and royalty
arrangements)
Paid expert testimony
Honoraria, speakers’ fees
Gifts
Trips
11. Ethical Concerns
I. The preservation of sound
science and
II.The protection of human subjects.
Both are integrally related.
Robust protection of human subjects –
and those who use the products of
science – depends on ensuring the
soundness of research.
12. Preservation of Sound Science
Threat to scientific integrity by introducing forms of bias
that affect the enterprise of science itself
Financial relationships among investigators,
academic research centers and private industry
create incentives to serve commercial interests
rather than the advancement of scientific knowledge
Sponsors may seek to restrict publication in order to avoid
advancing the work of competitors.
They may conceal negative study findings by maintaining control
of publication
Restricted or partial publication increases the cost of clinical
progress and can jeopardize the health of future study subjects
and future patients.
It also impedes or disrupts the work of other scientists whose
work would otherwise improve, build on or impeach prior
investigations.
13. Preservation of Sound Science
The soundness of study results can be profoundly
influenced by study design decisions: treatments to
be tested
placebo control or active control,
favorable and adverse endpoints,
the characteristics of eligible and ineligible
participants,
stopping or modifying a trial, and so on.
Without an investigator’s being aware of it,
conflicts of interest may influence the design and
conduct of research in ways that render study
results unsound, with the potential to misinform the
practice of many physicians and to affect the
health of patients
14. Preservation of Sound Science
The availability of capitation payments
fees paid by study sponsors to physicians for
each patient enrolled in a study – may decreases
interest in basic science research
may serve as an inducement for researchers and
research institutions to choose projects that are of
interest to generous sponsors rather than
alternatives that might be of more benefit to
patients or society.
15. Protection of Human Subjects
Multiple roles of clinician in clinical research leading
to compromised loyalties.
Investigators, sponsors, grantee institutions, and
physicians in private practice all stand to benefit by a
patient’s participation in research.
Enrolling sufficient number of subjects to obtain
funding, (conflict between potential subject interests and those of
investigators. )
The concern is that investigators – under pressure to
recruit – may undermine the consent process by
misrepresenting the research
inappropriately influencing patients to participate.
16. Current requirements applicable to
investigators
Before beginning a study,
Investigators
− are required to disclose financial interests
that may be affected by the outcome of
research to designated institutional
officials.
Institutions
− are required to report the existence of
conflicts of interest – but not substantive
details – to funding agencies
− to take steps to reduce, eliminate or
manage conflicts of interest.
17. Institutional Assurance
The regulations state that:
Obtain information regarding financial conflicts of
interest from all investigators according to
institutional policies and procedures.
Research institutions are formally responsible for
developing and communicating a process for
reviewing, authorizing and monitoring arrangements
that present conflicts of interest.
Investigators are advised to ensure compliance with
all of their institution’s policies relating to conflicts of
interest .
Improperly managed conflicts of interest can result
in suspending funding to the offending grantee.
18. Impact of the 2003 Guidance on
current requirements
On March 31, 2003, the Department of Health
and Human Services (DHHS) published revised
“draft guidance”Financial Relationships and
Interests in Research Involving Human
Subjects: Guidance for Human Subject
Protection”
The 2003 guidance defines a “conflicting financial
interest” as “a financial interest related to a
research study that will, or may reasonably be
expected to create a bias.” It continues to rely on
institutional assurance rather than prescription.
19. Managing Conflict of Interest
The 2003 Guidance states: “financial interests may
be managed by eliminating them or mitigating their
potentially negative impact.”
The primary strategies for managing conflicts of
interest are disclosure and prohibition.
A number of influential professional societies,
researchers and institutions have advocated a total
ban on paid consultancies and equity holdings in
entities related to their research; some have
recommended barring investigators from
investments in fields in which they are conducting
research.
20. Managing Conflict of Interest
peer review of the study design
independent oversight of the research
insulating investigator from knowledge about
the impact of financial interests through blind-
trust type devices
insulating the subject/participant from the
influence of financial considerations on
professional judgment by having an
investigator with a conflict abstain from
problematic aspects of the study
disclosure of the financial interest to subjects
on the consent form
21. Managing Conflict of Interest
Acknowledge that some conflicts exist (or may
exist) and must be “managed”
Prevent some relationships
Those of no scientific, academic value
Those for which the conflict is deemed “too great”
Those for which the faculty member has been “irresponsible”,
unethical, unprofessional
Manage those relationships that are determined to be
appropriate/worthwhile to minimize the conflict
Clarify what constitutes a Conflict of Interest
22. Managing Conflicts of Interest
Prohibiting Problematic financial
interest
Eliminate those actions that have inherent
conflicts without obvious benefit
Free gifts, meals, junkets
Equity holding
Drug samples
Conflict free formulary committees
Industry control of educational programs
Speakers bureaus
Consultation relationships and research funding
DRAFT - For discussion purposes only
23. Managing Conflict of Interest
Academic implication
Ensure transparency to all stakeholders
Specify deliverables in all relationships
with industry
Research funding
Consulting agreements
Publication and dissemination of
information (positive and negative)
Intellectual property
24. Managing Conflict of Interest
Implications for Patient Care
Clarify relationships to patients
Informed consent
Role of industry in decisionmaking and
clinical management
Consider participation by Ombudsman
Transfer decision making or care, as
appropriate
25. Conclusion:
How should conflicts of interest be
dealt with?
Several options exist; all require
identifying COIs!
Eliminating conflict
Disclosing conflict (e.g., to participants, to
colleagues or superior)
Introducing intermediaries (e.g., consent
monitor)
What other approaches might be
sensible?
26. Scientific misconduct
It is the violation of the standard codes of scholarly
conduct and ethical behavior in professional
scientific research. The main forms of scientific
misconduct are:
fabrication – the publication of deliberately
false or misleading research, often subdivided
in:
fabrication – v-the actual making up of
research data and (the intent of) publishing
them
falsification – manipulation of research data
and processes or omitting critical data or
results
plagiarism – the act of taking credit (or
attempting to take credit) for the work of
another.
27. Motivation to commit scientific
misconduct
Career pressure
"publish or perish"
Believing that one "knows the right answer"
intend to introduce a fact that they believe is
true, without actually performing the
experiments required.
The ability to get away with it
Consequences:
vary based on the severity of the fraud, the level of
notice it receives, and how long it goes undetected.
Even a case of plagiarism can cause damage through
resources being misdirected to others who may be less
capable of using them effectively and certainly are less
deserving of them.
28. Suppression/non-publication of data
Studies may be suppressed or remain unpublished
because
the findings are perceived to undermine the
commercial, political or other interests of the
sponsoring agent
they fail to support the ideological goals of the
researcher.
It may be possible in some cases to use statistical
methods to show that the datasets offered in relation to a
given field are incomplete
Some cases go beyond the failure to publish complete
reports of all findings with researchers knowingly making
false claims based on falsified data.
29. Responsibility of authors and of
coauthors
All authors, including coauthors, are expected to have
made reasonable attempts to check findings submitted
to academic journals for publication
Simultaneous submission of scientific findings to more
than one journal or duplicate publication of findings is
usually regarded as misconduct, under what is known
as the Ingelfinger rule.
Guest authorship and ghost authorship ( are
commonly regarded as forms of research misconduct
Authors are expected to keep all study data for later
examination even after publication
to provide information about ethical aspects of research
Provision of incorrect information to journals may be
regarded as misconduct
30. Summary
Increased involvement of academic researchers has
raised the potential for Conflict of Interest (CoI).
Professionals have a conflict of interest when their
interests or commitments
compromise their judgments,
compromise their research reports.
compromise their communications to research
subjects, participants, patients, or clients.
Multiple role of clinician has led to compromised
loyalties
Human subject recruitment in industry-sponsored trials
conflicts with the fiduciary role.
Investigators, sponsors, grantee institutions, and
physicians in private practice all stand to benefit by a
patient’s participation in research.
31. Summary
Before beginning a study, investigators are required
to disclose financial interests that may be affected by
the outcome of research
Institutions are required to report the existence of
conflicts of interest – but not substantive details – to
funding agencies and to take steps to reduce,
eliminate or manage conflicts of interest.
The goal of managing conflicts of interest is to
minimize the extent to which the design and conduct
of research is influenced – consciously or
unconsciously – by financial considerations
Scientific misconduct is the violation of the standard
codes of scholarly conduct and ethical behavior in
professional scientific research.