The Profile of Articles on AXIN2 Mutations, Oligodontia, and Ethical Statements in Dental Research.

PURPOSE: Editors often require ethical statements in research publications. This is particularly important with genetic data where discrimination may occur upon data disclosures. The purpose of this research is to determine if there was a positive trend of publishing ethical statements in dental genetic research. The study is limited to AXIN2 mutations which may be associated with oligodontia and cancer. METHODS: A MEDLINE search of 2011-2021 articles concerning AXIN2, oligodontia, and ethical statements was conducted. Reviews, nonhuman subject research, abstracts, and articles not written nor translated into English were excluded. RESULTS: Forty-four studies were found; 10 excluded. There were 25 (75.8%) with ethical statements, and 25 (75.8%) with participant consent statements. There was no significant difference by year in ethical statements over the ten years (p = 0.094). CONCLUSION: There is a need to encourage more ethical statements in publications especially for genetically sensitive topics to reassure readers of ethical practices.

Initiating research in a private dental practice.

Research is an intrinsic part of both academia and clinical best practice. Within an academic environment, this can include access to advice and guidance from trained professionals. Similarly, while sometimes overly risk-averse, within the NHS there is a structured and systematic approach to healthcare research. However, in the UK, a large number of specialist dental procedures take place within the private healthcare system, which does not have access to such support and guidance. How, then, can we generate our own dental research from private dental primary care settings? With a number of phrases becoming part of everyday vocabulary in dental primary care, such as practice-based research, patient-centred outcomes, evidence-based dentistry, it is time to consider this. From research ethics to writing papers, via GCP, IRAS, HEIs and MOOCs, this article summarises the experiences of one non-affiliated (non-academic, non-NHS) private dental practice attempting to enter the world of research. The authors discuss their experiences, share the multiple sources of support encountered along the way, and demonstrate the benefits to everyday practice gained by initiating research studies.

Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

P-hacking.

Due to increasing rate of research articles getting published in recent times, medical science is evolving very fast. Open access policies of the journals make information easily available to the stakeholders for building future research proposal. Blindly having faith in whatever is published in the literature is detrimental for science; however, it is hard to find out the correctness of the data analysis.

Institutional Ethics Committee Regulations and Current Updates in India.

AIM: The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. BACKGROUND: Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. REVIEW RESULTS: The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. CONCLUSION: In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. CLINICAL SIGNIFICANCE: The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

Informed consent in dental care and research for the older adult population: A systematic review.

BACKGROUND: Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue. METHODS: The authors completed this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The authors searched the PubMed (MEDLINE), Web of Science, PsycINFO, and Cochrane Library databases. The authors included studies if they involved participants 65 years or older and discussed topics related to informed consent beyond obtaining consent for health care. The authors explored informed consent issues in dentistry and other biomedical care and research. RESULTS: The authors included 80 full-text articles on the basis of the inclusion criteria. Of these studies, 33 were conducted in the United States, 29 addressed consent issues in patients with cognitive impairment, 29 were conducted in patients with medical conditions, and only 3 involved consent related to dental care or research. CONCLUSIONS: Informed consent is a neglected topic in geriatric dental care and research. Substantial knowledge gaps exist between the understanding and implementation of consent procedures. Additional research in this area could help address contemporary consent issues typically encountered by dental practitioners and to increase active participation from the geriatric population in dental care and research. PRACTICAL IMPLICATIONS: This review is the first attempt, to the authors' knowledge, to identify informed consent issues comprehensively in geriatric dentistry. There is limited information in the informed consent literature covering key concepts applicable to geriatric dentistry. Addressing these gaps could assist dental health care professionals in managing complex ethical issues associated with geriatric dental patients.

Causal inference from observational data.

Randomized controlled trials have long been considered the 'gold standard' for causal inference in clinical research. In the absence of randomized experiments, identification of reliable intervention points to improve oral health is often perceived as a challenge. But other fields of science, such as social science, have always been challenged by ethical constraints to conducting randomized controlled trials. Methods have been established to make causal inference using observational data, and these methods are becoming increasingly relevant in clinical medicine, health policy and public health research. This study provides an overview of state-of-the-art methods specifically designed for causal inference in observational data, including difference-in-differences (DiD) analyses, instrumental variables (IV), regression discontinuity designs (RDD) and fixed-effects panel data analysis. The described methods may be particularly useful in dental research, not least because of the increasing availability of routinely collected administrative data and electronic health records ('big data').

Sugar industry influence on the scientific agenda of the National Institute of Dental Research's 1971 National Caries Program: a historical analysis of internal documents.

BACKGROUND: In 1966, the National Institute of Dental Research (NIDR) began planning a targeted research program to identify interventions for widespread application to eradicate dental caries (tooth decay) within a decade. In 1971, the NIDR launched the National Caries Program (NCP). The objective of this paper is to explore the sugar industry's interaction with the NIDR to alter the research priorities of the NIDR NCP. METHODS AND FINDINGS: We used internal cane and beet sugar industry documents from 1959 to 1971 to analyze industry actions related to setting research priorities for the NCP. The sugar industry could not deny the role of sucrose in dental caries given the scientific evidence. They therefore adopted a strategy to deflect attention to public health interventions that would reduce the harms of sugar consumption rather than restricting intake. Industry tactics included the following: funding research in collaboration with allied food industries on enzymes to break up dental plaque and a vaccine against tooth decay with questionable potential for widespread application, cultivation of relationships with the NIDR leadership, consulting of members on an NIDR expert panel, and submission of a report to the NIDR that became the foundation of the first request for proposals issued for the NCP. Seventy-eight percent of the sugar industry submission was incorporated into the NIDR's call for research applications. Research that could have been harmful to sugar industry interests was omitted from priorities identified at the launch of the NCP. Limitations are that this analysis relies on one source of sugar industry documents and that we could not interview key actors. CONCLUSIONS: The NCP was a missed opportunity to develop a scientific understanding of how to restrict sugar consumption to prevent tooth decay. A key factor was the alignment of research agendas between the NIDR and the sugar industry. This historical example illustrates how industry protects itself from potentially damaging research, which can inform policy makers today. Industry opposition to current policy proposals-including a World Health Organization guideline on sugars proposed in 2014 and changes to the nutrition facts panel on packaged food in the US proposed in 2014 by the US Food and Drug Administration-should be carefully scrutinized to ensure that industry interests do not supersede public health goals.

Animal research as a basis for clinical trials.

Animal experiments are critical for the development of new human therapeutics because they provide mechanistic information, as well as important information on efficacy and safety. Some evidence suggests that authors of animal research in dentistry do not observe important methodological issues when planning animal experiments, for example sample-size calculation. Low-quality animal research directly interferes with development of the research process in which multiple levels of research are interconnected. For example, high-quality animal experiments generate sound information for the further planning and development of randomized controlled trials in humans. These randomized controlled trials are the main source for the development of systematic reviews and meta-analyses, which will generate the best evidence for the development of clinical guidelines. Therefore, adequate planning of animal research is a sine qua non condition for increasing efficacy and efficiency in research. Ethical concerns arise when animal research is not performed with high standards. This Focus article presents the latest information on the standards of animal research in dentistry, more precisely in the field of implant dentistry. Issues on precision and risk of bias are discussed, and strategies to reduce risk of bias in animal research are reported.

How sample size influences research outcomes.

Sample size calculation is part of the early stages of conducting an epidemiological, clinical or laboratory study. In preparing a scientific paper, there are ethical and methodological indications for its use. Two investigations conducted with the same methodology and achieving equivalent results, but different only in terms of sample size, may point the researcher in different directions when it comes to making clinical decisions. Therefore, ideally, samples should not be small and, contrary to what one might think, should not be excessive. The aim of this paper is to discuss in clinical language the main implications of the sample size when interpreting a study.

Knowledge awareness and attitude about research ethics among dental faculties in India.

AIM: The aim of this study was to assess the level of knowledge, awareness and attitude about research ethics and research ethics committees (RECs) among dental faculties. MATERIALS AND METHODS: This cross-sectional questionnaire study incorporated a self administered questionnaire. Descriptive, Chi-square and logistic regression analysis was used to analyze the data. RESULTS: The overall response rate to the study was 85%. More than half were familiar with research ethics, principles and functions of the research ethics committee. Though there were some faculties whose attitude regarding research ethics principle was not optimal. CONCLUSION: The present study revealed a broad acceptance among the faculties acceptance toward RECs and training in research ethics, though there existed certain gap in knowledge about research among the faculties. CLINICAL SIGNIFICANCE: This will help us to understand the knowledge, awareness and attitudes of dental faculties toward research ethics, which will help the institutional officials to develop better educational programs in the field of research ethics in order to help them conduct better research henceforth.

Informed consent in community-based oral health research.

The ethical principle of respect for persons presents multiple dimensions to stimulate debate around issues related to informed consent for participation, data management, confidentiality and privacy. The informed consent process is built on a continuum involving a comprehensive explanation of the proposed study; and the declaration of consent (the right to withdraw from at anytime from the study without any negative consequences). All research involving human participants carry a certain level of risk (physical or informational) and it is not possible for the researcher to know all the consequences of participation before a study commences. This presentation will focus around the key issues of information, consent' and competence in relation to community-based oral health research and outlines some of debates in the informed consent process.

Code of ethics for dental researchers.

The International Association for Dental Research, in 2009, adopted a code of ethics. The code applies to members of the association and is enforceable by sanction, with the stated requirement that members are expected to inform the association in cases where they believe misconduct has occurred. The IADR code goes beyond the Belmont and Helsinki statements by virtue of covering animal research. It also addresses issues of sponsorship of research and conflicts of interest, international collaborative research, duty of researchers to be informed about applicable norms, standards of publication (including plagiarism), and the obligation of "whistleblowing" for the sake of maintaining the integrity of the dental research enterprise as a whole. The code is organized, like the ADA code, into two sections. The IADR principles are stated, but not defined, and number 12, instead of the ADA's five. The second section consists of "best practices," which are specific statements of expected or interdicted activities. The short list of definitions is useful.

Ethical considerations of randomized control trials with human participants in dentistry. A reflective analysis.

A potential conflict is built into the roles of dentists and researchers with regard to ethical principles such as beneficence, nonmaleficence, respect for autonomy, and justice. The practitioner has an obligation to do what is believed to be best for the individual patient: the dentist as researcher has an obligation to use rigorous experimental methods, including randomized control trials (RCTs) to discover what is best for patients generally, including the investigation of experimental modalities. This is the equipoise problem-how can a professional be assured of offering the most beneficial treatment available if only using approaches that have worked in the past? This essay explores the ethical foundations for this challenge and proposes a groundwork for balancing ethical obligations to patients and the needs for scientific and public health advances.