Presentation at a Course on Bioethics Alfaisal University, Riyadh held on 2 December 2018 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.
INTRODUCTION TO RESEARCH MALPRACTICE: PREVALENCE AND ATTITUDES
• Seeds of research malpractice are in the research proposal
• Research malpractice is common[1]
• Violation of ethics reason for retractions[2]
• Research malpractice reflects wrong attitudes
• Short course can change attitude to fraud[3]
• Researchers recognize fraud but do not blow the whistle[4,5]
• Poor attitude to plagiarism in Iran[6]
INTRODUCTION TO RESEARCH MAL-PRACTICE: CAUSES
• Research grants are an avenue for academic promotion and professional growth[7]
• Competitive nature of scientific grants may motivate misbehavior
• Career and reputation from publishing can motivate misconduct[8]
• Funding expectations are associated with research misbehavior: public vs private[9]
• Research wrongdoing in Nigeria due to knowledge gaps in ethics and the pressure to publish[10]
PROTOCOL: INVESTIGATORS AND AUTHORSHIP
• Principal investigator / co-investigators or sub-investigator must be mentioned.
• All names mentioned must have a substantial recorded contributions.
• The issue of the senior author/boss/friend/colleague?: scratch my back and I scratch yours.
• All names mentioned must have agreed to be part of the study.
• Doubtful cases: students, research assistants, laboratory technicians?
PROTOCOL: ORIGINALITY
• Thorough literature review to make sure this investigation is original.
• Check clearinghouses such as Cochrane and www.clinicaltrials.org.
• Cite and acknowledge all information used in the proposal.
• Why is repeat research is already done? Local experience / training/scientific validation.
• Writing proposals from boilerplates.
PROTOCOL: PLAGIARISM: DEFINITION
• Create or copy? Is it possible to create from nothing?[11]
• Plagiarism is a complex phenomenon that may be related to memory lapses and not always deliberate deception[12,13,14]
• Un-intended plagiarism: ideas gained in discussions or from the classroom?
• What if it is your original idea but someone already thought of it?
• Self-plagiarism [15]?
PROTOCOL: PLAGIARISM: DETECTION AND AVOIDANCE
• Plagiarism detection services[16]
• If in doubt run plagiarism software.
• Plagiarism detection can be quick[17] or can be sophisticated[18]. Even Google can help.
• If you are a research administrator should you write proposals?
PROTOCOL: PROTECTING YOUR IDEAS FROM PLAGIARISTS
• Discuss your research with colleagues / students OR be secretive.
• Departmental review / research committees?
• Carefully document your new ideas and create evidence they are yours.
PROTOCOL: CONFIDENTIALITY AND PRIVACY
• Measures of protecting personal data must be described.
• Access to personal research data: papers and computers must be on a need-to-know basis.
• Use of anonymized data.
PROTOCOL: INFORMED CONSENT
• Description of information to be given to subjects
• Description of the process of informed consent
• Attach documents to be used
PROTOCOL: DISCLOSURE
• Disclose all that you want to do in objectives and methods.
• Do not add secret ideas later for fear they may not be approved if presented upfront.
• If you get additional ideas submit an amendment.
PROTOCOL: FINANCIAL INTEGRITY / COI
• Mention other sources of funding.
• Conflict of interest regarding the expected sponsor.
• Paying someone to write part or all the proposal.
PROTOCOL: REGULATORY AFFAIRS
• IRB requirements
• SFDA requirements
• GCP requirements
• Others e.g. NIH
PUBLICATION: INTERNATIONAL STANDARDS FOR AUTHORS[19]
• The research being reported should have been conducted in an ethical and responsible manner and should comply with all relevant legislation.
• Researchers should present their results clearly, honestly, and without fabrication, falsification, or inappropriate data manipulation.
• Researchers should strive to describe their methods clearly and unambiguously so that their findings can be confirmed by others.
PUBLICATION: INTERNATIONAL STANDARDS FOR AUTHORS, Con’t.
• Researchers should adhere to publication requirements that submitted work is original, is not plagiarized, and has not been published elsewhere.
• Authors should take collective responsibility for submitted and published work.
• The authorship of research publications should accurately reflect individuals’ contributions to the work and its reporting.
• Funding sources and relevant conflicts of interest should be disclosed.
PUBLICATION BIAS (Wikipedia)
• Bias to reporting positive findings
• Bias to significant results
• Investigator refusing to submit results for publication }Solution is registration of the study
• Selective reporting
PUBLICATION PROBLEMS (http://publicationethics.org)
• Author mistakes e.g. unauthorized use of questionnaires
• Authorship e.g. omitted author, ghost author, gift authorship, data monitors as authors
• Lack of consent for publication e.g. publication of family pedigree
• Copyright breaches e.g. unauthorized use of a questionnaire
• Data manipulation/fabrication/falsification
PUBLICATION PROBLEMS, Con’t. - 1 (http://publicationethics.org)
• Dispute over data ownership.
• Image manipulation.
• Impact factors: manipulation of IF by quoting one another unnecessarily.
• Lack of ethical review/approval.
• Multiple submissions: When a manuscript (or substantial sections from a manuscript) is submitted to a journal when it is already under consideration by another journal.
PUBLICATION PROBLEMS, Con’t. - 2 (http://publicationethics.org)
• Overlapping publications: 2 or more publications based on analysis of the same data set
• Failure to respect participant confidentiality
• Lack of participant consent
• Plagiarism (When somebody presents the work of others (data, words, or theories) as if they were his/her own and without proper acknowledgment)
PUBLICATION PROBLEMS, Con’t. - 3 (http://publicationethics.org)
• Failure of protection of subjects (human) or animal subjects.
• Redundant publication: publication of the same material or same
• data in more than one journal without cross-referencing.
• Selective reporting: When unfavorable or inconvenient end-points (e.g. Outcomes that fail to reach statistical significance or do not favor a particular product or hypothesis) are deliberately omitted from publications reporting research.
PUBLICATION PROBLEMS, Con’t. - 4 (http://publicationethics.org)
• Self-plagiarism
• Undeclared COI
• Undeclared financial support for publication
• Unethical research or treatments
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- DuBois JM, Anderson EE, Chibnall J.Assessing the need for a research ethics remediation program.Clin Transl Sci. 2013 Jun;6(3):209-13.
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- A position statement developed at the 2nd World Conference on Research Integrity, Singapore, July 22-24, 2010.