Research Ethics, Misconduct, Fabrication, and Plagiarism-2024-Prof. dr. Mohammad Hakimi, Sp.Og.pdf

Research Ethics, Misconduct, Fabrication, and Plagiarism Prof. dr. Mohammad Hakimi, SpOG. Subsp. Obginsos., PhD. Center for Bioethics and Medical Humanities Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada...

Research Ethics, Misconduct, Fabrication, and Plagiarism Prof. dr. Mohammad Hakimi, SpOG. Subsp. Obginsos., PhD. Center for Bioethics and Medical Humanities Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada 1  Research Ethics – What is Research – What is Research Ethics – History of Research Ethics – The 3 Basic Ethical Principles Research Misconduct – Research Fraud – Plagiarism – Other Topics in Publication Ethics 2 Research Ethics 3  What is Research? “Research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. A determination that research is the intended purpose of the undertaking, is key for differentiating activities that require ethics review by an ethics review committee and those that do not. Systematic methodological scientific approach for basic facts around a certain problem in order to find solutions based on these facts. 4 What Makes a Good Research? 5 When Paradigms Collide Research can yield valuable information Difficulties in implementation because of sensitive issues 6 Scientific Design and Conduct of Study Case: – A study to examine whether and how women involved in the sex trade negotiate condom use by their male partners. Ethical Question: – Was the study justified in using a form of participant-observation that depended on deception? 7 Scientific Design and Conduct of Study The research would produce reliable information on the views of these women about HIV/AIDS, their sexual practices, and their condom negotiation skills, and that this information would provide a basis for better policy-making. The research method breaches the ethical code – the fake customers had misled research participants. 8  What is Research Ethics? Research involving human subjects can raise difficult and important ethical and legal questions. The field of research ethics is devoted to the systematic analysis of such questions to ensure that study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole. (Weijer, Dickens & Meslin, 1997) 9  What is Research Ethics? It is the field of ethics that systematically analyze the ethical and legal questions raised by research involving human subjects. It main focus is to ensure that the study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole. It works when and only when it is applied before the research is conducted. 10  Jurisdiction Basically, all research involving human subjects – Research: “a systematic investigation designed to develop or contribute to generalizeable knowledge.” – Human subject: “living individual(s) about whom an investigator obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” 11 11 Why is research ethics important? First, norms promote the aims of research, such as knowledge, truth, and avoidance of error. Second, ethical standards promote the values that are essential to collaborative work, such as trust, accountability, mutual respect, and fairness. Third, many of the ethical norms help to ensure that researchers can be held accountable to the public. Fourth, people more likely to fund research project if they can trust the quality and integrity of research. Finally, many of the norms of research promote a variety of other important moral and social values, such as social responsibility, human rights, animal welfare, compliance with the law, and health and safety. (Resnik, 2013) 12 13  History of Research Ethics Pre-World War II Research standards left up to the discretion of the individual researcher. 14  Pre WWII Edward Jenner (1789) Smallpox Vaccine Claude Bernard (1865) Ethical Maxims Louis Pasteur (1885) Rabies Vaccine Walter Reed (1900) Yellow Fever 15 Nazi War Crimes In order to ensure the supremacy of the Aryan race, the Nazi Party in Germany desired to find a secret way of sterilizing large populations. Three experiments involving sterilization were in progress when World War II ended in 1945. 1. Dried plant juice was put into flour that was fed to the general population. This was supposed to sterilize women predominantly. 2. Intra-uterine injections of a silver nitrate solution were given to women, without their consent, during routine physical examinations. 3. Men stood at a counter to complete forms while being exposed, without their knowledge, to sterilizing doses of X-radiation. 16 16 17  Nuremberg Trial The horrors of the preceding and many other "experiments," were exposed during and after World War II. The people who conducted these experiments were tried separately from other Nazi war criminals because of their professional status as physicians and the atrocious nature of their crimes. 18 18  The 10 Points of the Nuremberg Code 1. Participation must be voluntary, and subjects should have the capacity to give consent. Further, subjects should be fully informed of the purposes, nature, and duration of the experiment. 2. The research should yield results that are useful to society and that cannot be obtained in any other way. 3. The research should have a sound footing in animal research and be based on the natural history of the problem under study. 4. Steps should be taken in the research to avoid unnecessary physical or psychological harm to the subjects. 5. Research should not be conducted if there is reason to believe that death or disability will occur in the subjects. 19 19  The 10 Points of the Nuremberg Code 6. The risk involved in the research should be proportional to the benefits to be obtained. 7. Proper plans should be made and facilities provided to protect the subject from harm. 8. Research should be conducted by highly qualified scientists only. 9. The subject should have the freedom to withdraw at any time if he or she has reached the conclusion that continuing in the experiment is not possible. 10. The researcher must be prepared to discontinue the experiment if it becomes evident that continuing will be harmful to the subject. 20 20  Declaration of Helsinki Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects Adopted by the 18th World Medical General Assembly, Helsinki, Finland, 1964 and amended in Tokyo, Japan, 1975, Venice, Italy, 1983, Hong Kong, 1989, Somerset West, Republic of South Africa, 1996, Edinburgh, Scotland, 2000, Washington DC, USA, 2002, Tokyo, Japan, 2004, Seoul, Republic of Korea, 2008 and Fortaleza, Brazil, 2013. Concern for the interests of the subject must always prevail over the interests of science and society. It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject. 21  The Declaration of Helsinki Consent should be in writing. Use caution if participant is in dependent relationship with researcher. Limited use of placebo Greater access to benefit. 22  The most infamous observational epidemiologic study ever undertaken: 1932-1972: Tuskegee Syphilis Study 23  The Tuskegee Syphilis Study US Public Health Service funded study to evaluate the natural history of untreated syphilis. Over 400 black men with syphilis and about 200 men without syphilis, who served as the controls, were the subjects. 24  The Tuskegee Syphilis Study The men were recruited without informed consent. In fact, they were misinformed and told that some of the procedures done in the interests of research (e.g., spinal taps) were actually "special free treatment." 25  The Tuskegee Syphilis Study By 1936, it was apparent that many more infected men than controls had developed complications. Ten years later a report of the study indicated that the death rate among those with syphilis was about twice as high as it was among the controls. 26  The Tuskegee Syphilis Study In the 1940's, when penicillin, known to be effective in the treatment of syphilis, became available, the men were neither informed of this, nor treated with the antibiotic. The study continued until the first accounts of it appeared in the national press in 1972, at which time an ad hoc advisory panel was formed by the government to give advice on how to assure that such experiments would never again be conducted. 27 The Tuskegee Syphilis Study The government continues to pay millions of dollars yearly to surviving subjects and the families of deceased subjects. 28  The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects in Research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979)) 29  The Belmont Report Boundaries Between Practice and Research – IRB must determine that the researcher (and through informed consent, the subject) distinguishes practice from experiment in both social science and medical science research. 30  The Belmont Report The 3 Basic Ethical Principles 1. Respect for persons 2. Beneficence/nonmaleficence 3. Justice 31  Respect for Persons Definition: Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection Application: Voluntary Informed Consent 32 Beneficence/nonmaleficence Definition: Do not harm Maximize possible benefits Minimize possible harms Application: Assessment of risks and benefits 33  Justice Definition: Who ought to receive the benefits of research? Who ought to bear its burdens? Application: Equitable selection of subjects 34  What Makes Clinical Research Ethical? (Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA. 2000; 283:2701-2711. ) 1) Social or scientific value  Evaluation of a treatment, intervention, or theory that will improve health and well- being or increase knowledge 2) Scientific validity  Use of accepted scientific principles and methods, including statistical techniques, to produce reliable and valid data 35 35  What Makes Clinical Research Ethical? (Emanuel, Wendler & Grady, 2000) 3) Fair subject selection  Selection of subjects so that stigmatized and vulnerable individuals are not targeted for risky research and the rich and socially powerful not favored for potentially beneficial research 4) Favorable risk-benefit ratio  Minimization of risks; enhancement of potential benefits; risk to the subject are proportionate to the benefits to the subject and society 36 36  What Makes Clinical Research Ethical? (Emanuel, Wendler & Grady, 2000) 5) Independent review  Review of the design of the research trial, its proposed subject population, and risk-benefit ratio by individuals unaffiliated with the research 6) Informed consent  Provision of information to subjects about purpose of the research, its procedures, potential risks, benefits, and alternatives, so that the individual understands this information and can make a voluntary decision whether to enroll and continue to participate 37 37  What Makes Clinical Research Ethical? (Emanuel, Wendler & Grady, 2000) 7) Respect for potential and enrolled subjects  Respect for subjects by a. Permitting withdrawal from the research b. Protecting privacy through confidentiality c. Informing subjects of newly discovered risks or benefits d. Informing subjects of results of clinical research e. Maintaining welfare of subjects 38 38 Research Misconduct 39 Introduction Whether you are just starting out in your career or are a more seasoned researcher, you are no doubt very much aware of the importance of ethical conduct. 40  Introduction Plagiarism, research fraud, undisclosed conflicts of interest... these are just a few of the violations that can threaten not only the integrity of the science, but also one's standing in the scientific community. An understanding of the ethical boundaries and "rules" is paramount to ensuring your work and career get off to the best start possible. 41  Research Fraud 1/6 Research fraud is publishing data or conclusions that were not generated by experiments or observations, but by invention or data manipulation. There are two kinds in research and scientific publishing: Fabrication. Making up research data and results, and recording or reporting them. Falsification. Manipulating research materials, images, data, equipment, or processes. Falsification includes changing or omitting data or results in such a way that the research is not accurately represented. A person might falsify data to make it fit with the desired end result of a study. 42  Research Fraud 2/6 Both fabrication and falsification are serious forms of misconduct because they result in a scientific record that does not accurately reflect observed truth. 43  Research Fraud 3/6 Certain instances of fraud can be easy to spot–for example if a referee knows for a fact that a particular laboratory does not have the facilities to conduct the research that was published. Or, if it's obvious an image looks manipulated or is made up from several different experiments. The data from the control experiments might be "too perfect". In such situations, an investigation would be conducted to determine if an act of fraud was committed. Digital image enhancement is acceptable. However, a positive relationship between the original data and the resulting image must be maintained to avoid creating unrepresentative data or the loss of meaningful signals. If a figure has been significantly manipulated, you must note the nature of the enhancements in the figure legend or in the 'Materials and Methods' section. 44  Research Fraud 4/6 What about unintentional error that comes across as misconduct? According to the U.S. Office of Research Integrity, research misconduct does not include honest error or differences of opinion. But it's best never to have the integrity of your work come into question. As a researcher and author, it is essential to understand what constitutes appropriate data management (including data collection, retention, analysis and reporting) in accordance with responsible conduct of research. To help prevent fraud, most publishers have strict policies on manipulation of images and access to the reported data. It's a good idea to familiarize yourself with them before you submit a paper. 45  Research Fraud 5/6 Some general guidelines (which may vary from field to field, publisher to publisher) include: Manipulation of images Images may be manipulated for improved clarity only. No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. Adjustments of brightness, contrast, or color balance are usually acceptable as long as they do not obscure or eliminate any information present in the original. 46  Research Fraud 6/6 Some general guidelines (which may vary from field to field, publisher to publisher) include: Data access & retention – Authors maybe asked to provide the raw data in connection with a paper for editorial review. Therefore all data for a specific paper should be retained for a reasonable time after publication. There should be named custodian for the data. – Studies undertaken in human beings, e.g. clinical trials have specific guidelines about the duration of data retention. 47 48  Plagiarism 1/5 One of the most common types of publication misconduct is plagiarism–when one author deliberately uses another's work without permission, credit, or acknowledgment. Plagiarism takes different forms, from literal copying to paraphrasing some else's work and can include: – Data – Words and Phrases – Ideas and Concepts 49  Plagiarism 2/5 Plagiarism has varying different levels of severity, such as: – How much of someone's work was taken–a few lines, paragraphs, pages, the full article? – What was copied–results, methods, or introduction section? 50  Plagiarism 3/5 When it comes to your work, always remember that crediting the work of others (including your advisor’s or your own previous work) is a critical part of the process. You should always place your work in the context of the advancement of the field, and acknowledge the findings of others on which you have built your research. 51  What is self-plagiarism? 4/5 Roig (2016) identifies a few types of self-plagiarism: Republishing the same paper that is published elsewhere without notifying the reader nor publisher of the journal Publishing a significant study as smaller studies to increase the number of publications rather than publishing one large study Reusing portions of a previously written (published or unpublished text) Roig, Miguel (2006) 52  What is self-plagiarism? 5/5 Self-plagiarism is any attempt to take any of your own previously published text, papers, or research results and make it appear brand new. Self-plagiarism can also refer to the publication of identical papers in two places (sometimes called “duplicate publication”). 53  Other Topics in Publication Ethics Authorship Conflict of interest Simultaneous submission Salami slicing 54  Authorship Naming authors on a scientific paper ensures that the appropriate individuals get credit, and are accountable, for the research. Deliberately misrepresenting a scientist's relationship to their work is considered to be a form of misconduct that undermines confidence in the reporting of the work itself. Three basic criteria must collectively be met to be credited as an author: 1. Substantial contribution to the study conception and design, data acquisition, analysis, and interpretation. 2. Drafting or revising the article for intellectual content. 3. Approval of the final version. 55  Conflict of Interest Transparency and objectivity are essential in scientific research and the peer review process. When an investigator, author, editor, or reviewer has a financial/personal interest or belief that could affect his/her objectivity, or inappropriately influence his/her actions, a potential conflict of interest exists. Such relationships are also known as dual commitments, competing interests, or competing loyalties. The most obvious conflicts of interest are financial relationships such as: – Direct: employment, stockownership, grants, patents. – Indirect: honoraria, consultancies to sponsoring organizations, mutual fund ownership, paid expert testimony. 56  Simultaneous Submission Authors have an obligation to make sure their paper is based on original–never before published–research. Simultaneous submission occurs when a person submits a paper to different publications at the same time, which can result in more than one journal publishing that particular paper. Duplicate/multiple publication occurs when two or more papers, without full cross-reference, share essentially the same hypotheses, data, discussion points, and/or conclusions. This can occur in varying degrees: literal duplication, partial but substantial duplication, or even duplication by paraphrasing. 57  Salami Slicing The “slicing” of research that would form one meaningful paper into several different papers is called "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 referred to as "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 practice. The same "slice" should never be published more than once. 58 59  References Conner TD. Nazi Medical Experiments. 1917. Elsevier. Ethics in Research & Publication. ethics.elsevier.com Emanuel EJ, Wendler D, Grady C. (2000) What makes clinical research ethical? JAMA 283:2701-2711. Federman DD, Hanna KE, and Rodriguez LL (Editors). (2003) Responsible Research - A Systems Approach to Protecting Research Participants. Washington DC: The National Academies Press. Resnik DB. (2013) What is Ethics in Research & Why is it Important? www.niehs.nih.gov/research/bioethics/whatis/index.cfm. Roig, Miguel. (2006). Avoiding plagiarism, self-plagiarism, and other questionable writing practices: A guide to ethical writing. Retrieved from http://facpub.stjohns.edu/~roigm/plagiarism.doc The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. 1979. Weijer CW, Dickens B, Meslin EM. (1997) Bioethics for clinicians: 10. Research ethics. CMAJ 156:1153-1157. 60