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200512P - RESEARCH MALPRACTICES: PROPOSALS AND PUBLICATIONS

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Presentation at a Course for Clinical Research Coordinators held at Faculty of Medicine, King Fahad Medical City on May 12, 2020 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 common1
  • Violation of ethics reason for retractions2
  • Research malpractice reflects wrong attitudes
  • Short course can change attitude to fraud3
  • Researchers recognize fraud but do not blow the whistle4,5
  • Poor attitude to plagiarism in Iran6


INTRODUCTION TO RESEARCH MALPRACTICE: Causes

  • Research grants are an avenue for academic promotion and professional growth7
  • Competitive nature of scientific grants may motivate misbehavior
  • Career and reputation from publishing can motivate misconduct8
  • Funding expectations are associated with research misbehavior: public vs private9
  • Research wrongdoing in Nigeria due to knowledge gaps in ethics and the pressure to publish10


PROTOCOL: INVESTIGATORS AND AUTHORSHIP

  • Principal investigator / co-investigators or sub-investigator must be mentioned
  • All names mentioned must have a substantial recorded contribution
  • 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 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 deception12,13,14.
  • 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 plagiarism15?


PROTOCOL: PLAGIARISM: Detection and Avoidance

  • Plagiarism detection services16
  • If in doubt run plagiarism software. 
  • Plagiarism detection can be quick17 or can be sophisticated18. 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*

  • 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.

* A position statement developed at the 2nd World Conference on Research Integrity, Singapore, July 22-24, 2010.


PUBLICATION: INTERNATIONAL STANDARDS FOR AUTHORS

  • 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 (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 (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 (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 (http://publicationethics.org)

  • Self-plagiarism
  • Undeclared COI
  • Undeclared financial support for publication
  • Unethical research or treatments


REFERENCE:

  1. DuBois JM1, Anderson EE, Chibnall J. Assessing the need for a research ethics remediation program. ClinTransl Sci. 2013 Jun;6(3):209-13.
  2. Resnik DB1, Dinse GE. Scientific retractions and corrections related to misconduct findings. Author information. J Med Ethics. 2013 Jan;39(1):46-50.
  3. Vuckovic-Dekic L1, Gavrilovic D, Kezic I, Bogdanovic G, Brkic S. Science ethics education part II: changes in attitude toward scientific fraud among medical researchers after a short course in science ethics.J BUON. 2012 Apr-Jun;17(2):391-5.
  4. Vuckovic-Dekic L1, Gavrilovic D, Kezic I, Bogdanovic G, Brkic S. Science ethics education part II: changes in attitude toward scientific fraud among medical researchers after a short course in science ethics. J BUON. 2012 Apr-Jun;17(2):391-5.
  5. Vuckovic-Dekic L1, Gavrilovic D, Kezic I, Bogdanovic G, Brkic S. Science ethics education part I. Perception and attitude toward scientific fraud among medical researchers. J BUON. 2011 Oct-Dec;16(4):771-7.
  6. Ghajarzadeh M1, Norouzi-Javidan A, Hassanpour K, Aramesh K, Emami-Razavi SH. Attitude toward plagiarism among Iranian medical faculty members. Acta Med Iran. 2012 Nov;50(11):778-81.
  7. Crockett SD1, Dellon ES, Bright SD, Shaheen NJ. A 25-year analysis of the American College of Gastroenterology researchgrant program: factors associated with publication and advancement in academics. Am J Gastroenterol. 2009 May;104(5):1097-105.
  8. Krishnan V.Etiquette in scientific publishing.Am J OrthodDentofacialOrthop. 2013 Oct;144(4):577-82.
  9. Martinson BC1, Crain AL, Anderson MS, De Vries R. Institutions' expectations for researchers' self-funding, federal grant holding, and private industry involvement: manifold drivers of self-interest and researcher behavior. Acad Med. 2009 Nov;84(11):1491-9.
  10. Adeleye OA1, Adebamowo CA. Factors associated with research wrongdoing in Nigeria. J Empir Res Hum Res Ethics. 2012 Dec;7(5):15-24.
  11. López P R[Create or copy... Which is the difference?]. Rev Med Chil. 2009 Jan;137(1):121-6.
  12. Perfect TJ1, Defeldre AC, Elliman R, Dehon H. No evidence of age-related increases in unconscious plagiarism during free recall. Memory. 2011 Jul;19(5):514-28.
  13. Kennedy D. Sherlock Holmes and the case of the plagiarised paper. Nurse Educ Today. 2011 Jul;31(5):525-30.
  14. Sugimori E1, Kitagami S. Plagiarism as an illusional sense of authorship: the effect of predictability on source attribution of thought. Author information. Acta Psychol (Amst). 2013 May;143(1):35-9.
  15. Andreescu L. Self-plagiarism in academic publishing: the anatomy of a misnomer. SciEng Ethics. 2013 Sep;19(3):775-97.
  16. Garner HR. Combating unethical publications with plagiarismdetection services. UrolOncol. 2011 Jan-Feb;29(1):95-9.
  17. Bischoff WR1, Abrego PC. Rapid assessment of assignments using plagiarismdetection software. Nurse Educ. 2011 Nov-Dec;36(6):236-7.
  18. Chow TW1, Rahman MK. Multilayer SOM with tree-structured data for efficient document retrieval and plagiarism detection. IEEE Trans Neural Netw. 2009 Sep;20(9):1385-402.