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200216P - ETHICO-LEGAL ISSUES IN RESEARCH GRANTS

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Presentation at a Course on Bioethics Alfaisal University on 16 February 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 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]


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? 


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. 


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]?


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? 


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.


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. 


INFORMED CONSENT

• Description of information to be given to subjects

• Description of the process of informed consent

• Attach documents to be used 


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. 


FINANCIAL INTEGRITY / COI

• Mention other sources of funding.

• Conflict of interest regarding the expected sponsor.

• Paying someone to write part or all the proposal. 


REGULATORY AFFAIRS

• IRB requirements 

• SFDA requirements

• GCP requirements

• Others e.g. NIH 


REFERENCE:

  1. DuBois JM1, Anderson EE, Chibnall J.Assessing the need for a research ethics remediation program.Clin Transl 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 research grant 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. Sci Eng Ethics. 2013 Sep;19(3):775-97. 
  16. Garner HR. Combating unethical publications with plagiarism detection services. Urol Oncol. 2011 Jan-Feb;29(1):95-9. 
  17. Bischoff WR1, Abrego PC. Rapid assessment of assignments using plagiarism detection 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