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.

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.

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.

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.

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.

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.

Students' vulnerability in educational research.

Dental teaching institutions in South Africa recently implemented "learner-centred" curricula and expected educators to alter their teaching styles accordingly, but perhaps without providing adequate training in this paedagogical philosophy. At the same time, the lecturers were required to conduct evidence-based research to evaluate the outcomes. Thus, clinicians/lecturers also became researchers, using their own students or student material for assessment purposes. Previously, this form of educational research, which was carried out in normal academic settings, was not subject to review by Institutional Review Boards (IRB). However, concerns have risen that learners may be a vulnerable population due to their position in the academic institution, and the power and knowledge differentials that exist between them and the lecturer/researcher. This raises ethical concerns regarding their autonomy and ability to provide free, voluntary, informed consent to be research participants. This paper questions whether educational research may lead to student vulnerability, and proposes some recommendations for educators and institutions involved in educational research.

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.

In vitro and in situ erosion models for evaluating tooth substance loss.

Because of the difficulties in measuring erosion in vivo, a number of in vitro and in situ models have been developed and validated. These models are flexible and informative, allowing single as well as multiple variables to be examined under specific conditions using accurate measurement techniques over defined timelines, thus yielding useful data without harmful effects on individuals. This information, together with clinical findings, is essential for clinicians advising susceptible patients appropriately regarding the management of their condition. Little guidance is available, however, on the standardisation of in vitro and in situ protocols for erosive tooth wear studies, so it is difficult to make meaningful comparisons between investigations as experimental variables differ widely from study to study. The aim of this review was to collate the available data on models designed to assess erosive challenges which are severe enough to cause tissue loss as opposed to just softening of the surface structure. The different types of models, with their merits and pitfalls, are documented. Test substrates, disinfecting regimens and ethical considerations are discussed. The aims of this paper are to give guidance to the researcher on evidence-based in vitro and in situ erosive tooth wear methodology and to suggest best practice given current knowledge.

Institutional review board and regulatory solutions in the dental PBRN.

OBJECTIVES: Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network called "DPBRN" (http://www.DPBRN.org) comprises dentists in two health maintenance organizations, several universities, seven US states, and three Scandinavian countries. Our objectives are to describe: a) the various human participants and regulatory requirements and solutions for each of DPBRN's five regions; b) their impact on study protocols and implementation; and c) lessons learned from this process. METHODS: Following numerous discussions with IRB and grants administrative personnel for each region, some practitioner-investigators are attached to their respective IRBs and contracting entities via sub-contracts between their organizations and the network's administrative site. Others are attached via Individual Investigator Agreements and contractually obligated via Memoranda of Agreement. RESULTS: IRBs approve general operations under one approval, but specific research projects via separate approvals. Various formal IRB and grants administrative agreements have been arranged to customize research to the network context. In some instances, this occurred after feedback from patients and practitioners that lengthy written consent forms impeded research and raised suspicion, instead of decreasing it. CONCLUSIONS: Instead of viewing IRBs and institutional administrators as potentially adversarial, customized solutions can be identified by engaging them in collegial discussions that identify common ground within regulatory bounds. Although time-intensive and complex, these solutions improve acceptability of practice-based research to patients, practitioners, and university researchers.

Conflicts of interest in research: is clinical decision-making compromised? An opinion paper.

Lack of transparency in funded research can compromise clinical decision-making in an evidence-based practice. Transparency can be defined as full disclosure of all financial assistance and support to authors and investigators. There is a perception that ethical principles are eroding and that research data can be biased due to conflicts of interest. These research outcomes biased or not, are used for clinical decision-making in the evidence-based practice. One suggested solution to this common ethical dilemma is to continue the dialogue on transparency in research and to create oversight bodies which include representatives from business and industry, private practice, academia, and research. There is increasing evidence of the need for more ethics education at all levels.

Human rights and ethical considerations in oral health research.

Although international agreements set the framework for research ethics, countries vary in their interpretation and execution. The Government of Canada guidelines are based on the Tri-council policy statement: ethical conduct for research involving humans (2005) and the new CIHR guidelines for health research involving Aboriginal people (2007). In this critical review, we address 3 areas of educational value to practitioners who care for the oral health needs of the public, research trainees and research investigators who advance knowledge pertaining to oral health: protection of human study participants, conflicts of interest and investigator integrity. Its main message is that ethical health care should be supported by a strong foundation of ethical research.