Research Ethics and Misconduct: Research Reproducibility Baraka Malaki Morris (BSc.N, RN, MBE) Jon F. Merz (MBA, JD, PhD) Objectives By the end of this presentation participants should be able to: Describe the research misconduct Describe Reproducibility in research Describe factors that contribute research misconduct (Compromising reproducibility) Effects of research misconducts Discuss ways to improve research reproducibility (Research Integrity) Introduction What is Research Misconduct? Research Misconduct (RM) Research misconduct is defined as fabrication (making up results), falsification (manipulating process- es and results), and plagiarism (stealing other’s work) Research misconduct is intentional/irresponsible research practices that falls short of good ethical and scientific standards It does not include accidental error or honest misinterpretation of results Other Questionable research practices Publishing the same data or results in two or more publications Failing to declare conflicts of interest, Inappropriately assigning authorship credit Withholding details of methodology or results in papers or proposals Using inadequate or inappropriate research designs Dropping observations or data points from analyses based on a gut feeling that they were inaccurate Inadequate record keeping related to research projects Contributing factors for RM Pressure to publish (Publish or Perish pressure) Pressure of severe competition for fund Requirements to get significant positive results for future funding and promotion Pressure to get desire results in the case of sponsored study Lack or Poor preparation about the realities and stresses of a scientific career Contributing factors for RM cont… Lack of awareness of rules and standards for proper scientific conducts e.g. students Expectation and pressure from the supervisors and sponsors Poor relationship with colleagues Too much work/responsibilities in a given timeline Lack of good communication and documentation Research Reproducibility Research findings/results are considered as reproducible once an independent researcher conducts an experiment under similar conditions to a previous study, and achieves commensurate results. Causes Irreproducibility Poor study design, methodologies and/or practices. Inappropriate data analysis. Incomplete reporting of research methods and results Inadequate quality control. Factors associated to Irreproducibility 1. 2. 3. False discovery rate and small sample sizes (affect the statistical power of the research) Small effect size (a large proportion of the most easily observed phenomena have already been discovered). Exploratory analyses (positive results are likely to be published than negative ones or inconclusive) Factors associated to Irreproducibility 4. 5. 6. 7. Flexible study designs (the greater the flexibility the less likely the research findings are to be true) Conflicts of interest and introduction of bias High – profile scientific field Poor study design and lack of standardization Factors associated to Irreproducibility 8. 9. 10. Lack of research training among researchers Insufficient information about materials, method and data analysis Failure to disclose full results including raw data Whistleblowers Is there a duty to whistle blow? (Discussion) Whistleblowers Institutions must provide protection/support to individuals who report research misconduct About 60% of whistleblowers has experienced negative consequences of whistleblowing including: Loss of job (fired or denied contract renewal) Denied promotion Loss of research opportunity Pressured to drop allegations Threats of being sued Ostracized by colleagues Consequences of Misconduct It jeopardizes the good name of the institution Misconduct in a clinical trial places all subjects in that trial at possible safety risk Misconduct jeopardizes the reliability of submitted and/or published findings hence undermines the country’s mission to protect and promote the public health Consequences of Misconduct cont… Failure to publish (withdrawal or correction of all pending and published papers and abstracts affected by the misconduct) Reprimand, removal from project, rank and salary reduction, dismissal Restitution of funds to the granting agency Ineligibility to apply for grants for years The end of your research career Strategies to Promote Research Integrity Training and Mentorship Developing an appropriate institutional culture Adopting and developing research codes and policies at institutional level References 1. 2. 3. 4. 5. 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