Introduction
Every profession that contracts with human rights and freedom ultimately develops a professional code of ethics to direct the responsible behavior of its members. A code of ethics can be defined as the moral boundaries within which professional services may be ethically delivered. The concept of dental ethics includes ethics in dental practice as well as in research. Ethics in practice includes the duties and obligations of the dentist towards his patients, professional colleagues, and society whereas ethics in research include the code of conduct that should be followed while conducting research, analyzing the data, and publication of the report. The college instructs its staff and students to stand by the highest standards of integrity in their conduct of academic research.
Code of Ethics
Research conducted at our institution is purely adherent to the principles of veracity, accountability, and professionalism. Regarding the code of ethics, the IGIDS ethics committee has adopted the core principles put forward by the Dental Council of India (DCI), the Indian Council of Medical Research (ICMR), the World Medical Association International Code of Medical Ethics, The Nuremberg Code (1947) and Helsinki Declaration (1964). This code applies to all research conducted by our faculty, students, interns, visiting researchers of the institute, and other individuals who conduct research within or on behalf of the institution.
1. Purpose of Code of Ethics
The prime purpose of the development of a code of ethics is to enable the researcher related to our institution to keep professional standards in research, guided by ethical and legal policies.
The researchers are independently accountable to guarantee that their work is steered by the institutional values and policies as well as the terms and conditions of service or study.
2) Responsibilities of the Ethics Committee
2.1 From the submitted proposals, identify and promote novel research activities with social values
2.2 Analyse the risk-benefit ratio involved in the study and approve only those studies where the benefits outweigh the risks
2.3 Cross-check with the assistance of the Institutional Review Committee, the quality and internal validity of the study including feasibility, sample size estimation, sampling, and methodology followed
2.4 Assess the ethical concerns of the conduct of the study counting the matters related to informed consent. Careful assessment of the ethical issues related to reporting the results (eg: falsification, fabrication, plagiarism) should also be taken care of. The authenticity of the report should be checked using plagiarism software. In case of alleged research misconduct, an inquiry committee (2-3 members with one external) should be appointed to enquire about the situation and disciplinary action should be taken against the culprit.
Plagiarism Check Software used by the institution includes
- Queten (https://www.quetext.com/)
- Duplichecker (https://www.duolichecker.com/)
- Edubirdie (https://edubirdie.com/free-plagiarism-checker )
- Grammarly (https://www.grammarly.com/plagiarism-checker )
2.5 Ensure that the investigator has informed the participants about their right to withdraw at any point in time, research benefits and risks, and maintenance of confidentiality
2.6 Give respect to the enrolled participants
2.7 Attend to the complaints related to research ethics and publication ethics
2.8 Record keeping: The committee has to maintain the details of a clinical trial for a minimum of 5 years after its completion
2.9 Periodic training and continued education should be provided for the researchers for a better appraisal of research integrity.
3) Terms and conditions of the Ethics Committee
3.1 Generally, the ethics committee meets once a year. However, meetings will be scheduled as and when the research proposals are received.
3.2 Once a study proposal is submitted, considering the Research Committee’s report and the study’s ethical and legal aspects, the Ethics Committee decides whether approval should be given.
3.3 The approved proposals will carry a validity time of 2 years.
3.4 The investigators have to take re-approval after the end of the term if necessary.
3.5 The investigators are generally requested to submit the progress report after 1 year to IEC for review.
3.6 Any change, modification, or deviation in the protocol, or an adverse event should be informed to the ethics committee. Any protocol modification or amendment must receive IEC approval.
3.7 The premature cessation of study or the appearance of any adverse events occurring during the process of trials should be informed to the committee at the earliest.
3.8 Investigator once receives the approval, should conduct the study as per the recommended Good Clinical Practice guidelines.
3.9 Regarding decision-making, to attain the consensus of the members, extensive discussions are entertained. In case of failure to reach a consensus, a decision will be taken considering the opinion/voting of the majority present.
4) Proposal submission
4.1 The research proposals can be submitted to the ethics committee through
iecigids@gmail.com
4.2 At the time of submission, the following documents should be uploaded
- Research protocol
- Patient information sheet
- Informed consent sheet (in both English and local language)
- Copy of questionnaire and tools
- Curriculum vitae of the principal investigator
- Statutory permissions if needed
- Official authentication by the investigator, guide, Head of the institution, and/or Head of the Department
- Documents ensuring compensation to the participant in case required
5) Review policies
5.1 All the reviewers should take seriously their commitment to the research community by participating in refereeing, reviewing, and evaluation.
5.2 Primary and secondary reviews should be done based on the review policies of the institution in a justifiable and time-bound manner.
5.3 Reviewer board or ethics committee members with a conflict of interest should withdraw from involvement in decisions on approval, publication, funding, and reward.
5.4 Under no circumstance, copying of ideas, data, or interpretations presented are allowed to be publicized to others. Strict confidentiality should be maintained unless there is prior approval for disclosure.
5.5 Due respect should be given to the authors and their intellectual properties.
6) Responsibilities of the researcher
6.1 Conduct of research
6.1.1 Investigator follows the principles of non-maleficence, doing good to the participants, truthfulness, and justice throughout the research.
6.1.2 Qualified, proficient persons with adequate training and experience in data collection, analysis, and interpretation should carry out research.
6.1.3 The health research undertaken should follow ICMR National Ethical guidelines
6.1.4 Depending upon the type of study, before its initiation, approvals must be obtained from the Institutional Research/ Scientific Committee (lRc), institutional Human Ethics Committee (loc), Central Drug Standard Control Organization (CDSCO), and Animal Ethics Committee. In the case of clinical trials, registration with Clinical Trial Registry-India (CTRt) is obligatory.
6.1.5 Only quality and fruitful research works where benefits outweigh risks should be undertaken
6.1.6 At every step of the study from the very beginning, confidentiality should be maintained
6.1.7 Researchers, guides, and EC must declare any Conflict of Interest (COl) if present.
6.1.8 Bias in experimental design, data interpretation, peer review, grant writing, and other aspects of the research should be avoided.
6.2 Report writing, submission, and publication
6.2.1 Researchers should follow the guidelines put forward by an international committee of MedicaI JournaI Editors (ICMJE), the Committee on Publication Ethics (COPE) on publication
6.2.2 Authenticity of the work should be ensured by the researcher before submission
6.2.3 Research misconduct in any form- falsification, fabrication, or plagiarism should never be encouraged. Redundant publications and salami slicing should be avoided.
6.2.4 Authorship should be awarded only to those deserving candidates who have substantially contributed to the research. The practice of adopting ghost/guest/gift author should not be encouraged.
6.2.5 Finished research works should be published at the earliest. Extra care must be exercised to avoid publishing in predatory journals.
