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, including financial interests, and how institutions are responsible for managing conflicts. It also briefly discusses scientific misconduct and the importance of transparency and oversight in protecting the integrity of research.
Publication misconduct refers to unethical behavior in publishing, such as fabrication, falsification, plagiarism, inappropriate authorship, and duplicate or overlapping publications. It undermines the integrity of research. Reasons for misconduct include career pressures, lack of training, and inadequate supervision. Consequences include losing one's career and destroying public trust in researchers. Key types of misconduct are fabrication, falsification, plagiarism, inappropriate authorship, duplicate submission, overlapping publication, and salami publishing. Retractions can help make misconduct visible but have limitations as they may not provide full details or be widely disseminated. More transparency is needed regarding misconduct to help prevent and address it.
This document discusses various types of academic misconduct, including fabrication, falsification, and plagiarism. It defines fabrication as the construction of data that was never actually observed or measured. Falsification is changing or omitting results to support a claim. Plagiarism involves using others' work and ideas without proper citation. The document provides several examples of academic misconduct, such as conducting research on humans without informed consent, ghost authorship, and image manipulation. It emphasizes the importance of ethical research practices.
The presentation discusses research and publication ethics as well as scientific misconduct. It defines scientific misconduct as fabrication, falsification, or plagiarism in research. The three elements of scientific misconduct are then defined: fabrication is making up false data, falsification is manipulating research materials/processes to misrepresent results, and plagiarism is using other's work without credit. Potential reasons for misconduct are then outlined along with consequences such as career ending and blacklisting. Methods to prevent misconduct through policy, supervision, and research integrity offices are also presented.
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.
This document discusses the moral foundations of research ethics and various issues that can arise, such as research misconduct, collaboration problems, peer review conflicts, and conflicts of interest. It explains that research ethics is about imperfect people making mistakes unintentionally as well as intentionally unethical actions. Research ethics violations can occur through fabrication, falsification, plagiarism, issues with authorship, data ownership, rigor of experiments, and conflicts of interest with funders. Thinking about research ethics provides tools for handling tricky ethical situations that may have unclear right answers.
This document discusses various publication ethics issues including duplicate publication, authorship, scientific misconduct, and conflicts of interest. It provides definitions and examples of these issues, noting that journals exist to enhance the scientific database but also other interests like profits. The document cites a study that found around 0.04% of papers involved plagiarism and 1.35% involved duplicate publication. It discusses best practices for authorship including determining order upfront and documenting responsibilities. Conflicts of interest can mislead readers and include financial, personal, political or academic interests. The Committee on Publication Ethics was founded to address integrity concerns in medical journal publishing.
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.
Scientific integrity and avoiding misconduct are important issues discussed by governments, universities, and the scientific community. Upholding high ethical standards in research helps ensure reliable results and safety. Some examples of misconduct include falsifying or fabricating data, plagiarism, and failing to maintain confidentiality. Consequences for misconduct can be severe, such as job termination, fines, and bans from research. Maintaining integrity through practices like careful record keeping, peer review, and consulting advisors protects scientists and the legitimacy of their work.
Publication misconduct refers to unethical behavior in publishing, such as fabrication, falsification, plagiarism, inappropriate authorship, and duplicate or overlapping publications. It undermines the integrity of research. Reasons for misconduct include career pressures, lack of training, and inadequate supervision. Consequences include losing one's career and destroying public trust in researchers. Key types of misconduct are fabrication, falsification, plagiarism, inappropriate authorship, duplicate submission, overlapping publication, and salami publishing. Retractions can help make misconduct visible but have limitations as they may not provide full details or be widely disseminated. More transparency is needed regarding misconduct to help prevent and address it.
This document discusses various types of academic misconduct, including fabrication, falsification, and plagiarism. It defines fabrication as the construction of data that was never actually observed or measured. Falsification is changing or omitting results to support a claim. Plagiarism involves using others' work and ideas without proper citation. The document provides several examples of academic misconduct, such as conducting research on humans without informed consent, ghost authorship, and image manipulation. It emphasizes the importance of ethical research practices.
The presentation discusses research and publication ethics as well as scientific misconduct. It defines scientific misconduct as fabrication, falsification, or plagiarism in research. The three elements of scientific misconduct are then defined: fabrication is making up false data, falsification is manipulating research materials/processes to misrepresent results, and plagiarism is using other's work without credit. Potential reasons for misconduct are then outlined along with consequences such as career ending and blacklisting. Methods to prevent misconduct through policy, supervision, and research integrity offices are also presented.
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.
This document discusses the moral foundations of research ethics and various issues that can arise, such as research misconduct, collaboration problems, peer review conflicts, and conflicts of interest. It explains that research ethics is about imperfect people making mistakes unintentionally as well as intentionally unethical actions. Research ethics violations can occur through fabrication, falsification, plagiarism, issues with authorship, data ownership, rigor of experiments, and conflicts of interest with funders. Thinking about research ethics provides tools for handling tricky ethical situations that may have unclear right answers.
This document discusses various publication ethics issues including duplicate publication, authorship, scientific misconduct, and conflicts of interest. It provides definitions and examples of these issues, noting that journals exist to enhance the scientific database but also other interests like profits. The document cites a study that found around 0.04% of papers involved plagiarism and 1.35% involved duplicate publication. It discusses best practices for authorship including determining order upfront and documenting responsibilities. Conflicts of interest can mislead readers and include financial, personal, political or academic interests. The Committee on Publication Ethics was founded to address integrity concerns in medical journal publishing.
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.
Scientific integrity and avoiding misconduct are important issues discussed by governments, universities, and the scientific community. Upholding high ethical standards in research helps ensure reliable results and safety. Some examples of misconduct include falsifying or fabricating data, plagiarism, and failing to maintain confidentiality. Consequences for misconduct can be severe, such as job termination, fines, and bans from research. Maintaining integrity through practices like careful record keeping, peer review, and consulting advisors protects scientists and the legitimacy of their work.
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.
This document discusses ethics in research. It covers key principles like voluntary participation, informed consent, avoiding harm, and maintaining privacy, anonymity and confidentiality. It discusses proper data gathering and storage procedures. It also addresses issues like plagiarism, fabrication, misleading authorship, and non-publication of data. The document provides guidelines from organizations like ESRC on ensuring research integrity and quality, informing participants, respecting confidentiality, avoiding coercion, and minimizing harm to participants. It discusses balancing risks and benefits in research.
This document provides an overview of research ethics and principles. It discusses the history of research ethics including the Nuremberg Code established in 1948 requiring voluntary consent. The Belmont Report issued in 1978 summarizes ethical principles of respect for persons, beneficence, and justice. The report established informed consent requiring information, comprehension, and voluntariness. The document also discusses ethical guidelines in Nigeria and tips for conducting 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 document discusses several topics related to research methodology and biostatistics including cultural concerns, truth-telling, online business practices, and control resolution. Cultural concerns involve understanding a patient's culture, language, beliefs, and removing barriers to equal participation. Truth-telling focuses on honesty with patients about diagnoses and errors while balancing autonomy and mental stability. Online business practices emphasize making medical practices mobile-friendly and directly connecting patients to providers through online booking and medical centers. Control resolution ensures ethical considerations in hospitals through effective accreditation addressing integrity, interests, research, and organ ethics.
The document discusses several key issues regarding ethics in research:
- Research is not objective and researchers must recognize how their own biases and worldviews can influence the research process. They must actively manage power dynamics and potential biases.
- Researchers have a responsibility for the production of knowledge and must ensure accurate reporting of results, obtaining informed consent, protecting confidentiality of participants, and avoiding harm.
- Important considerations include recognizing one's own position and identity, being aware of dichotomization and power differentials, and understanding how language and cultural worldviews can impact research. Overall researchers must balance responsibilities to knowledge production with minimizing harm or abuse of participants.
COPE Asia-Pacific Workshop 2018 will feature an interactive cases workshop on publication ethics. The agenda includes an introduction to COPE, case presentations, table discussions of the cases, and a review of the cases. COPE promotes integrity in research and publication by assisting editors through policies and practices reflecting transparency and integrity principles. COPE describes its core practices for preserving scholarly integrity. The workshop will use real cases submitted to COPE's forum to demonstrate how editors can handle ethics issues like authorship disputes, plagiarism allegations, and data manipulation claims. Attendees will discuss potential responses to each case in small groups.
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
This document discusses research ethics and plagiarism. It presents four cases involving ethical issues in research: 1) Authorship disputes between a professor and PhD student on a grant-funded study. 2) A doctor considering manipulating data from an interim analysis of a clinical trial. 3) A doctor unsure about participating in an international drug trial. 4) Issues with the informed consent process for a drug safety study. It also provides background on regulations put in place after tragic human experiments and discusses principles of ethical research from the Nuremberg Code.
This document discusses scientific misconduct and defines key related terms. It begins by defining science and scientific conduct, noting science involves establishing cause and effect relationships through logic. Scientific conduct requires objectivity, impartiality, willingness to change beliefs based on evidence, verification of findings, and precision. The document then defines scientific misconduct as fabrication, falsification, or plagiarism, noting these behaviors violate ethical standards and risk one's career. Several common types of misconduct are outlined, including falsification of data. Key organizations that define misconduct are also mentioned.
This document discusses research ethics. It defines ethics and research ethics, and explains the importance of ethics in promoting valid research, building trust, and accountability. Key stakeholders in research like participants, researchers, funding agencies are discussed. Important ethical issues related to participants include informed consent, privacy and preventing harm. Ethical issues for researchers include honesty, objectivity, and appropriate methodology. Ethical issues for funders include restricting research and potential misuse of findings. The conclusion emphasizes balancing these issues, following guidelines, and acting ethically despite challenges to uphold scientific integrity.
This document discusses research ethics and the ethical issues involved in conducting research. It outlines three approaches to ethics: universal moral code, individual conscience, and weighing costs and benefits. It identifies three stakeholders in research: participants, researchers, and funding bodies. The document then examines several ethical issues concerning research participants, such as obtaining informed consent, avoiding harm, maintaining confidentiality and anonymity of data. It also discusses ethical responsibilities of researchers, such as avoiding bias and misuse of data, and of funding bodies, such as not imposing restrictions or misusing data.
Publication ethics: Definitions, Introduction and ImportanceVasantha Raju N
The document provides an overview of publication ethics and discusses its importance. It defines publication ethics as the principles and standards associated with publishing scientific research results. This includes giving proper credit and authorship, avoiding plagiarism and duplicate publication, managing conflicts of interest, and not falsifying or fabricating research data. The document highlights various unethical practices like plagiarism, gift authorship, and predatory journals. It also discusses guidelines from organizations like COPE, ICMJE and reporting standards to promote ethical research practices.
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.
I explain plainly what is salami silcing, a practice of fragmenting single research into as many publications as possible. Salami publishing and hazards
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.
This document discusses research ethics and the ethical issues researchers must consider. It defines research ethics as principles guiding how researchers interact with participants, colleagues, and society. Researchers must get informed consent, avoid pressure on participants, respect participant autonomy, protect vulnerable groups, ensure anonymity and confidentiality, avoid harm, be objective, not take advantage of easy groups, and be open. Following ethics promotes respecting participants, advancing knowledge, trust, accountability, and public support. Violations can damage participant cooperation, public confidence, and researcher integrity. Ethics apply to all research stages and contribute to quality.
Dr. Sarika Sawant presented on research ethics at a seminar. She discussed the definition of research ethics as regulating scientific activity to protect human participants and serve societal interests. She covered objectives like ensuring consent and oversight. Issues discussed included plagiarism, data handling, and research with humans and animals. National guidelines in India were also presented, as well as UNESCO's ethical guidelines focusing on informed consent, confidentiality, and integrity.
This document discusses ethics in research and provides guidelines for ethical standards. It outlines some unethical historical studies and describes codes of conduct including obtaining informed consent and protecting participants. The document discusses functions of Institutional Review Boards and informed consent procedures. It provides examples of questionable research practices and groups requiring special protections. Overall, the document establishes the importance of ethical research and outlines policies and procedures to ensure participant safety, privacy and welfare.
Conflicts of interest can arise whenever a researcher stands to gain financially or career-wise from a particular study outcome. While not inherently problematic, conflicts of interest may compromise study design, conduct, or findings if not properly disclosed. Researchers should consider how their own interests or those of sponsors align with public welfare using the six Ps framework. Journals require conflict of interest disclosures to maintain integrity and transparency, as non-disclosure can damage credibility and result in paper retraction if biases are later discovered.
Conflict of interest, Confidentiality, InformedconsentAman Ullah
This document discusses several topics related to ethics in research including conflict of interest, informed consent, and confidentiality. It defines conflict of interest as secondary interests that may distort primary research interests. Researchers have a duty to disclose conflicts to prevent harming participants or public trust. Informed consent requires fully informing participants of a study's risks, benefits and alternatives. Consent may be implied in emergencies when patients cannot consent. Confidentiality is a set of rules limiting access to private medical information, though it can be overridden if disclosure protects public health.
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.
This document discusses ethics in research. It covers key principles like voluntary participation, informed consent, avoiding harm, and maintaining privacy, anonymity and confidentiality. It discusses proper data gathering and storage procedures. It also addresses issues like plagiarism, fabrication, misleading authorship, and non-publication of data. The document provides guidelines from organizations like ESRC on ensuring research integrity and quality, informing participants, respecting confidentiality, avoiding coercion, and minimizing harm to participants. It discusses balancing risks and benefits in research.
This document provides an overview of research ethics and principles. It discusses the history of research ethics including the Nuremberg Code established in 1948 requiring voluntary consent. The Belmont Report issued in 1978 summarizes ethical principles of respect for persons, beneficence, and justice. The report established informed consent requiring information, comprehension, and voluntariness. The document also discusses ethical guidelines in Nigeria and tips for conducting 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 document discusses several topics related to research methodology and biostatistics including cultural concerns, truth-telling, online business practices, and control resolution. Cultural concerns involve understanding a patient's culture, language, beliefs, and removing barriers to equal participation. Truth-telling focuses on honesty with patients about diagnoses and errors while balancing autonomy and mental stability. Online business practices emphasize making medical practices mobile-friendly and directly connecting patients to providers through online booking and medical centers. Control resolution ensures ethical considerations in hospitals through effective accreditation addressing integrity, interests, research, and organ ethics.
The document discusses several key issues regarding ethics in research:
- Research is not objective and researchers must recognize how their own biases and worldviews can influence the research process. They must actively manage power dynamics and potential biases.
- Researchers have a responsibility for the production of knowledge and must ensure accurate reporting of results, obtaining informed consent, protecting confidentiality of participants, and avoiding harm.
- Important considerations include recognizing one's own position and identity, being aware of dichotomization and power differentials, and understanding how language and cultural worldviews can impact research. Overall researchers must balance responsibilities to knowledge production with minimizing harm or abuse of participants.
COPE Asia-Pacific Workshop 2018 will feature an interactive cases workshop on publication ethics. The agenda includes an introduction to COPE, case presentations, table discussions of the cases, and a review of the cases. COPE promotes integrity in research and publication by assisting editors through policies and practices reflecting transparency and integrity principles. COPE describes its core practices for preserving scholarly integrity. The workshop will use real cases submitted to COPE's forum to demonstrate how editors can handle ethics issues like authorship disputes, plagiarism allegations, and data manipulation claims. Attendees will discuss potential responses to each case in small groups.
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
This document discusses research ethics and plagiarism. It presents four cases involving ethical issues in research: 1) Authorship disputes between a professor and PhD student on a grant-funded study. 2) A doctor considering manipulating data from an interim analysis of a clinical trial. 3) A doctor unsure about participating in an international drug trial. 4) Issues with the informed consent process for a drug safety study. It also provides background on regulations put in place after tragic human experiments and discusses principles of ethical research from the Nuremberg Code.
This document discusses scientific misconduct and defines key related terms. It begins by defining science and scientific conduct, noting science involves establishing cause and effect relationships through logic. Scientific conduct requires objectivity, impartiality, willingness to change beliefs based on evidence, verification of findings, and precision. The document then defines scientific misconduct as fabrication, falsification, or plagiarism, noting these behaviors violate ethical standards and risk one's career. Several common types of misconduct are outlined, including falsification of data. Key organizations that define misconduct are also mentioned.
This document discusses research ethics. It defines ethics and research ethics, and explains the importance of ethics in promoting valid research, building trust, and accountability. Key stakeholders in research like participants, researchers, funding agencies are discussed. Important ethical issues related to participants include informed consent, privacy and preventing harm. Ethical issues for researchers include honesty, objectivity, and appropriate methodology. Ethical issues for funders include restricting research and potential misuse of findings. The conclusion emphasizes balancing these issues, following guidelines, and acting ethically despite challenges to uphold scientific integrity.
This document discusses research ethics and the ethical issues involved in conducting research. It outlines three approaches to ethics: universal moral code, individual conscience, and weighing costs and benefits. It identifies three stakeholders in research: participants, researchers, and funding bodies. The document then examines several ethical issues concerning research participants, such as obtaining informed consent, avoiding harm, maintaining confidentiality and anonymity of data. It also discusses ethical responsibilities of researchers, such as avoiding bias and misuse of data, and of funding bodies, such as not imposing restrictions or misusing data.
Publication ethics: Definitions, Introduction and ImportanceVasantha Raju N
The document provides an overview of publication ethics and discusses its importance. It defines publication ethics as the principles and standards associated with publishing scientific research results. This includes giving proper credit and authorship, avoiding plagiarism and duplicate publication, managing conflicts of interest, and not falsifying or fabricating research data. The document highlights various unethical practices like plagiarism, gift authorship, and predatory journals. It also discusses guidelines from organizations like COPE, ICMJE and reporting standards to promote ethical research practices.
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.
I explain plainly what is salami silcing, a practice of fragmenting single research into as many publications as possible. Salami publishing and hazards
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.
This document discusses research ethics and the ethical issues researchers must consider. It defines research ethics as principles guiding how researchers interact with participants, colleagues, and society. Researchers must get informed consent, avoid pressure on participants, respect participant autonomy, protect vulnerable groups, ensure anonymity and confidentiality, avoid harm, be objective, not take advantage of easy groups, and be open. Following ethics promotes respecting participants, advancing knowledge, trust, accountability, and public support. Violations can damage participant cooperation, public confidence, and researcher integrity. Ethics apply to all research stages and contribute to quality.
Dr. Sarika Sawant presented on research ethics at a seminar. She discussed the definition of research ethics as regulating scientific activity to protect human participants and serve societal interests. She covered objectives like ensuring consent and oversight. Issues discussed included plagiarism, data handling, and research with humans and animals. National guidelines in India were also presented, as well as UNESCO's ethical guidelines focusing on informed consent, confidentiality, and integrity.
This document discusses ethics in research and provides guidelines for ethical standards. It outlines some unethical historical studies and describes codes of conduct including obtaining informed consent and protecting participants. The document discusses functions of Institutional Review Boards and informed consent procedures. It provides examples of questionable research practices and groups requiring special protections. Overall, the document establishes the importance of ethical research and outlines policies and procedures to ensure participant safety, privacy and welfare.
Conflicts of interest can arise whenever a researcher stands to gain financially or career-wise from a particular study outcome. While not inherently problematic, conflicts of interest may compromise study design, conduct, or findings if not properly disclosed. Researchers should consider how their own interests or those of sponsors align with public welfare using the six Ps framework. Journals require conflict of interest disclosures to maintain integrity and transparency, as non-disclosure can damage credibility and result in paper retraction if biases are later discovered.
Conflict of interest, Confidentiality, InformedconsentAman Ullah
This document discusses several topics related to ethics in research including conflict of interest, informed consent, and confidentiality. It defines conflict of interest as secondary interests that may distort primary research interests. Researchers have a duty to disclose conflicts to prevent harming participants or public trust. Informed consent requires fully informing participants of a study's risks, benefits and alternatives. Consent may be implied in emergencies when patients cannot consent. Confidentiality is a set of rules limiting access to private medical information, though it can be overridden if disclosure protects public health.
This document discusses the importance of research bioethics. It notes that bioethics deals with ethical issues in biomedicine and biomedical research, including research ethics, medical ethics, dental ethics, and environmental ethics. It emphasizes three core principles of ethical research: informed consent, welfare of participants, and confidentiality/anonymity of participants. The document stresses that research ethics aims to protect human subjects and ensure research is conducted safely and for the benefit of society. It also discusses the roles and responsibilities of researchers to obtain proper consent and oversight and disseminate research results in an ethical manner.
Research ethics addresses the ethical principles and values applied to research. This includes ethical treatment of human and animal subjects, preventing misuse of research results, and addressing scientific misconduct. The key principles of research ethics are respect for persons, beneficence, and justice. Respect for persons means respecting individual autonomy and protecting vulnerable populations. Beneficence means research should do no harm and maximize benefits while minimizing risks. Justice means fairness in who bears risks and benefits from research. Research ethics aims to ensure ethical and responsible conduct of research through guidelines, oversight bodies, and codes of conduct.
The document discusses conflicts of interest in health research. It defines what constitutes a conflict of interest, which can be financial interests or personal biases that could unduly influence research. It outlines different levels of conflicts of interest, from individual researchers to institutional interests. While conflicts of interest are common, they could compromise research integrity if not properly managed. The document provides examples of conflicts of interest and discusses practical steps researchers can take to avoid or mitigate conflicts, such as disclosure, transparency and independent oversight.
The document discusses ethics in medical research and provides guidelines. It discusses key concepts like informed consent, minimizing risks and protecting vulnerable groups. Research must have essentiality and voluntary participation. Conflicts of interest can occur at various levels between researchers, sponsors and participants. Guidelines aim to balance research needs with ethical standards like accountability and transparency. Informed consent requires comprehension of risks/benefits and free, voluntary choice. Utility and respect for persons are foundations for ethics in research involving humans.
The document outlines best practices for responsible and ethical scientific conduct. It discusses several key practices including intellectual honesty in proposing, performing and reporting research; accuracy in representing contributions; fairness in peer review; collegiality in scientific interactions and sharing of resources; transparency in conflicts of interest; protection of human subjects; humane care of animals; adherence to responsibilities within research teams; and mentoring and advising. The goal is to exemplify and transmit the values associated with ethical scientific conduct to maintain trust in science.
This document discusses conflict of interest issues related to a clinical drug trial called Coughgone. It provides definitions and examples of conflict of interest, noting that conflicts can arise when secondary interests like financial gain influence professional judgments meant to primarily serve patients or scientific knowledge. The document analyzes potential conflicts in the Coughgone trial, including issues with the scientific credibility of the researchers, oversight and monitoring by the review board, and financial compensation structures. It concludes by discussing ways to minimize conflicts, such as disclosure and external review processes, as well as broader issues like potential bias and reliability of publications regarding drug effectiveness.
Research methodology ethical issues in research an assignmentMaiJoy
This document discusses six key ethical considerations in research: 1) informed consent, 2) invasion of privacy and maintaining confidentiality, 3) deception, 4) protection from harm, 5) data protection, and 6) managing conflicts of interest and affiliation. Violating any of these ethics can have negative consequences like jeopardizing future participation in research, damaging the reputation of the researcher and sponsor, and weakening public trust in the research process. Upholding strong ethical standards is important for conducting research responsibly and building trust.
This document discusses various topics relating to ethics in agricultural research. It begins by defining ethics and outlining the main areas of study within ethics. It then discusses ethical issues that can arise in scientific research, including research ethics frameworks like the Nuremberg Code and examples of scientific misconduct. It also addresses agricultural ethics and sustainability concerns, as well as ethics around initiating research, intellectual property rights, research administration, and guidelines for ethical behavior in scientific research. Overall, the document provides an overview of key ethical considerations that are important for conducting agricultural research.
Highlights from ExL Pharma's 4th Clinical Billing & Research ComplianceExL Pharma
This document summarizes key topics from ExL Pharma's 4th Clinical Billing & Research Compliance conference in March 2010. It discusses the distinction between regulatory misconduct and scientific misconduct in research. It also covers legal standards, investigator responsibilities, privacy regulations, clinical research billing, and technology solutions for research compliance. Hot topics included HIPAA, ARRA, genetic privacy laws, Medicare billing rules, and conflicts of interest. The document stresses the importance of education, understanding current systems and processes, and choosing integrated technology solutions to help assure research compliance.
The document discusses several key issues regarding research ethics:
1. Ethical norms in research promote goals like knowledge, truth, and cooperation between researchers. They also help ensure accountability and build public support.
2. Many professional organizations and government agencies have established codes and policies on research ethics to address issues like honesty, objectivity, integrity, and protecting human and animal subjects.
3. Researchers must make ethical decisions by carefully applying rules and considering how their actions may affect others. They should avoid misconduct but also recognize unwritten norms around attribution, conflicts of interest, and sharing information and resources.
Presentation about research and research ethicsnaribarbon
The document discusses research ethics and its principles. It outlines the objectives of ethical research which are to protect human participants, ensure research benefits society, and ensure research is ethically designed. The principles of research ethics discussed include honesty, integrity, informed consent, respect for persons, beneficence, justice and protecting privacy. Adhering to research ethics promotes trust, accountability and social values. However, research also poses limitations such as risks to participants' physical and psychological well-being. Ensuring ethics at all stages of research involves considering stakeholders, risks, responsibilities and resolving ethical issues.
Presentation about research and research ethicsnaribarbon
The document discusses research ethics and its principles. It outlines the objectives of ethical research which are to protect human participants, ensure research benefits society, and ensure research is ethically designed. The principles of research ethics discussed include honesty, integrity, informed consent, respect for persons, beneficence, justice and protecting privacy. Adhering to research ethics promotes trust, accountability and social values. However, research also poses limitations such as risks to participants' physical and psychological well-being. Ensuring ethics at all stages of research involves considering stakeholders, risks, responsibilities and resolving ethical issues.
This document discusses ethical issues related to research involving human participants. It outlines the principles of informed consent, beneficence, and justice that should guide such research. Informed consent involves providing participants with adequate information about the research, ensuring their voluntary participation, and respecting their autonomy. The principle of beneficence means maximizing benefits and minimizing harms for participants. Justice requires fair selection of participants and equitable distribution of both risks and benefits. Researchers have responsibilities to protect participants and comply with ethics requirements, while research sponsors must oversee studies and ensure local relevance.
Research ethics outlines principles to ensure research involving people is conducted safely and for the benefit of society. It requires researchers to obtain informed consent, protect privacy and confidentiality, avoid deception and harm, disclose conflicts of interest, and protect personal data. Upholding these ethical standards promotes collaborative work, accountability, and builds public trust and support for research.
This document discusses several key issues around recruiting participants for consumer perspectives research:
1. Recruitment strategies must be sensitive to the needs and characteristics of diverse populations and avoid unfair exclusion or targeting of vulnerable groups.
2. Motivating participation through compensation or other benefits requires balancing risks and undue influence, while also recognizing social and economic pressures facing potential participants.
3. A collaborative approach involving community partners and viewing participants as collaborators rather than subjects can help address issues of fairness in recruitment.
Don’t Show Me The Money" Non-Financial Conflicts of InterestIvan Oransky
This document discusses non-financial conflicts of interest in medicine and research. It notes that non-financial conflicts such as personal, political, or ideological beliefs may influence work more than financial interests alone. Examples given include disciplinary rivalries, cronyism, geographic biases, religious and political beliefs. Transparency and separation of roles are suggested to help manage some non-financial conflicts. While messy, understanding non-financial interests is still important to establish unbiased research and healthcare.
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
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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- 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
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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.
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
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.