Lecture 4 Research Ethics PDF

Dent 4407 Research Methods in Dentistry Associate Professor Banu Öter, DDS,PhD Bahçeşehir University School of Dentistry Department of Pediatric Dentistry Course Resources Research Ethics 24.10.2023 Assoc Prof Banu Öter What is Ethics The English word ethics is derived from the Ancient Greek...

Dent 4407 Research Methods in Dentistry Associate Professor Banu Öter, DDS,PhD Bahçeşehir University School of Dentistry Department of Pediatric Dentistry Course Resources Research Ethics 24.10.2023 Assoc Prof Banu Öter What is Ethics The English word ethics is derived from the Ancient Greek word ēthikós (ἠθικός), meaning "relating to one's character", which itself comes from the root word êthos (ἦθος) meaning "character, moral nature". This word was transferred into Latin as ethica and then into French as éthique, from which it was transferred into English. Research Ethics 24.10.2023 Assoc Prof Banu Öter What is Ethics Research Ethics 24.10.2023 Assoc Prof Banu Öter Why Do We Need Ethics in Research? Dentistry is advancing in various fields such as - genetics and gene therapy, - tissue engineering, - organs-on-a-chip, - biomaterials with immunomodulatory properties, - smart biomaterials, - nanotechnology, and - artificial intelligence. Research Ethics 24.10.2023 Assoc Prof Banu Öter Why Do We Need Ethics in Research? New questions are being asked about the moral responsibility of using these techniques in animal and human research with these advances. In addition, many of the ethical challenges already posed have not yet been addressed (such as the time required to follow up with patients who have participated in a study involving a new material or technique or using animals to overcome aging). Research Ethics 24.10.2023 Assoc Prof Banu Öter Moral principles 1. Honesty: Observance of honesty concerning patients who have participated in the research, collected data, and reported results 2. Neutrality: Observance of neutrality and lack of prejudice in justifying patients and interpreting and writing results, disclosing personal and fnancial interests that may affect research 3. Accuracy: Observance of accuracy in the process of performing research, collecting data, and writing results 4. Criticism: Sharing data and ideas and willingness to accept criticism Research Ethics 24.10.2023 Assoc Prof Banu Öter Moral principles 5. Respect for the rights of others: The rights of patients, other researchers, copyright, and other individual rights 6. Responsibility: Conducting research in the interests of society, performing wellorganized animal research, and not publishing similar articles for personal gain 7. Observance of justice: Lack of discrimination between patients, fairness towards the article’s authors Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies At present, placing absolute confidence in animal models as indicators of physiological, pharmacological, or toxicological effects in humans is impossible. In most cases, the harmlessness effect of a new material or treatment in animal studies does not guarantee that it is safe for humans. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies At present, placing absolute confidence in animal models as indicators of physiological, pharmacological, or toxicological effects in humans is impossible. In most cases, the harmlessness effect of a new material or treatment in animal studies does not guarantee that it is safe for humans. Whether diagnostic, prophylactic, or therapeutic, all innovative scientific interventions should ultimately be evaluated in human subjects. ADA’s seal of acceptance requires carrying out clinical trials before marketing products in the USA. Human subject means “...a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifable private information”. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies Human studies are not limited to clinical trials but also saliva, gingival crevicular fuid, stem cells, tooth, tissue samples, and histological slides. It is undoubtedly essential to observe ethics in human research; the question is: What rules and regulations are needed to comply with ethical considerations in human studies? Several codes to ensure the protection of human subjects, the Nuremberg Code, the Declaration of Geneva, and the Declaration of Helsinki [4]. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies In dentistry, the Committee on Ethics in Dental Research of the International Association for Dental Research (IADR) adopted the Code of Ethics in May 2009. This code of ethics includes human research, animal research, conflict of interest, and dissemination of information. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies The general spirit of the international statements on the observance of ethical standards is respect for the free will of the subject, dignity, rights and welfare, avoidance of possible harm to the subjects or justifying the potential damage by derived benefits, honest and fair treatment of the subject, and commitment of researchers to the confidentiality of the information they receive at the beginning of or during research on the subject. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies Voluntary participation in the study is the key to the moral debate in human research. The patient should be fully aware of the treatment or intervention and consciously accept this participation. Ethical research involves obtaining the informed consent of those you intend to interview, question, or experiment with. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies The Institutional Review Board (IRB) should review and approve the research proposal, informed consent forms, and documentation of “Research Compliance Training” and no “Conficts of Interest” before conducting research. All proposals related to human subjects should include the results of relevant laboratory and animal research, the expected benefits and potential risks to participants, the full details of the informed consent procedure, the evidence of the researcher’s qualification and experience, the arrangements for protecting the confidentiality of information, and research’s accordance with the Helsinki Declaration. The researchers cannot deviate from the proposal approved by the IRB. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Human Studies Accordingly, the final report or manuscript must mention that the study was conducted according to the Declaration of Helsinki, the local ethical committee approved the proposal, and the patient’s informed consent was received. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Animal Studies We need to establish the relevance of in vitro experiments by in vivo studies. Laboratory animals are special specimens in approved suppliers used for the pathogenesis of oral diseases, the biocompatibility of new dental materials, or the appropriateness of new treatments. Until the mid-nineteenth century, animals were mainly used to learn the anatomy and physiology of the body. With the advancement of microbiology, the discovery of hormones, vitamins, and the pharmaceutical industry, more research has begun on animals. Millions of animals are currently being used in research laboratories. Ethics in animal studies is more dependent on the personal moral responsibility of the researcher. However, individual conscience and responsibility do not seem to be effective alone. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Animal Studies Russell and Burch suggested that any animal research should be evaluated in terms of compliance with the three principles: replacement, reduction, and refinement. • Replacement: Animal experiments should be replaced—as much as possible— by developing alternative methods (such as laboratory tests, 3D in vitro models, or computer programs). Sensitive animals (such as vertebrates) can be replaced with less sensitive animals (non-vertebrates) or tissue-engineered models. Current advances in three-dimensional tissue engineering, lab-on-a-chip, and organ-on-a-chip can be effective in this aspect. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Animal Studies • Reduction: With careful planning before testing, the minimum number of animals required to get valid results can be tested. • Refinement: Good laboratory conditions should be provided for the animal to reduce its suffering and increase its well-being (adequate living conditions, minimizing pain on distress, developing anesthesia methods, using non-invasive techniques, and providing postoperative care). Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Animal Studies In addition to these three principles, the following points must also be considered: • Animal experiments should only take place when no alternative is possible. • The choice of animal species to be tested should be based on the purpose of the research. • Endangered animal species (in the red list) should only be tested with the purpose of conserving the species. • The suitability of the experimental proposal should be proven (by reviewing articles and discussing with colleagues from other disciplines). • At the end of the experiment, wild animals should be released into the prey if they can survive. Otherwise, the death of the animal must be in a completely moral way. • It is essential to write an accurate proposal before starting work. Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Animal Studies It is estimated that 115 million animals, including rodents, such as mice and rats, as well as dogs, pigs, and monkeys, are used for dental research purposes worldwide each year The required tests (cytotoxicity, genotoxicity, sensitization, and implantation) could be selected based on the nature of the contact of biomaterials with the body and the contact duration. A new orthodontic bracket that is a surface device in contact with teeth does not need to be evaluated by implanting in an animal’s body. Also, an impression material that is in contact with prepared teeth (external communicating devices) does not need genotoxicity and implantation tests due to limited exposure Research Ethics 24.10.2023 Assoc Prof Banu Öter Ethics in Manuscript writing Research ethics is dependent not only on the way we treat humans or animals but also on how results are reported. A nonproft organization called the Committee on Publication Ethics (COPE) was set up in 1997 to investigate and report on ethical issues of scholarly publishing . It is important to note that in many cases, insuffcient awareness leads to non-compliance with moral issues. For example, many students do not know the correct way to refer, leading to plagiarism. Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Authorship Observance of ethical principles in writing authors’ names based on their participation in a project is one of the basic principles for writing a scientific article. Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results According to the International Committee of Medical Journal Editors (ICMJE), you must play a role in all three of the following areas and be included as an author in a manuscript: 1. Presenting ideas, research design, implementation, data collection, data analysis, or data interpretation 2. Drafting the manuscript or revising it critically 3. Approving the final version for publication in the journal and agreeing to be accountable for the full content of the article Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Remember that playing a role in only one of the three authorship requirements (such as data analysis), funding research, research group supervision, technical help, or writing assistance is not an excuse to add names to the list of authors. A person who does not confirm to all three conditions should not be mentioned as an author but could be mentioned in the Acknowledgment section of the manuscript. Nowadays, some journals call for defining the role of authors and their contributions to the manuscript by submitting an “author statement file. Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results What about Chat GPT ? Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Fraud (Data Fabrication/Data Falsification/Omission of Data) Lack of honesty in research includes data fabrication (making up the data), manipulation of results (changing or adding data), or failure to provide all the results obtained. You can neither falsify nor exclude data in favor of your hypothesis. Do not exclude some data, which are inconsistent with others, from the analysis unless you doubt their credibility based on a valid reason (you should report this omission). Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Undeclared Confict of Interest (COI) Confict of interest (COI) includes situations that can affect the judgment of reviewers or the editorial board. Any result or discussion mentioned in the article that benefits one of the authors is part of the confict of interest. Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Plagiarism Plagiarism is derived from the Latin word “plagiarius,” meaning “kidnapper.” According to the Merriam-Webster dictionary, plagiarism is “the act of using another person’s words or ideas without giving credit to that person.” It is not morally acceptable to present the work of other researchers without referring to them. Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Plagiarism Plagiarism is derived from the Latin word “plagiarius,” meaning “kidnapper.” According to the Merriam-Webster dictionary, plagiarism is “the act of using another person’s words or ideas without giving credit to that person.” It is not morally acceptable to present the work of other researchers without referring to them. Currently, journals have various anti-plagiarism software such as WCopyfind, iThenticate, CrossCheck, or Turnitin to detect plagiarism. The decision of a journal will vary based on the degree of plagiarism. Copying a figure or a table from a published work is also illegal and is called copyright infringement. Before taking such an action, the authors must contact the publisher or the author concerned and obtain permission (copyright permission). Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Research Ethics 24.10.2023 Assoc Prof Banu Öter the most critical ethical issues in reporting research results Duplicate Submission/Redundant Publication It is not morally appropriate for an author to simultaneously submit a manuscript to more than one journal or publish a similar article (resemblance in hypothesis, data, discussion, or conclusion). When submitting a manuscript to a journal, the corresponding author declares that they did not submit it to another journal at the same time. You can send the manuscript to another journal after receiving the rejection letter or withdrawing your manuscript from the first one. Presenting a summary of a manuscript during conferences or meetings does not include this ethical problem. Research Ethics 24.10.2023 Assoc Prof Banu Öter