150406P - ETHICO-LEGAL ISSUES IN GRANT WRITING AND PUBLICATION

Presentation at a training program ‘Applying the Principles of Ethics to Clinical Practice:’ held at Aramco Dhahran April 6, 2015 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 malpractice: 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 wrong doing in Nigeria due to knowledge gaps in ethics and the pressure to publish[10]

Investigators and authorship

• Principal investigator / co-investigators or sub-investigators must be mentioned
• All names mentioned must have 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 clearing houses such as Cochrane and www.clinicaltrials.org
• Cite and acknowledge all information used in the proposal
• Why repeat research already done? Local experience / training/scientific validation
• Writing proposals from boiler plates

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 class room?
• What if it is your original idea bit 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 what 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

Case Scenario 1:

A professor of cardiology conducted a well-designed post marketing survey of a drug that had been marketed recently in Saudi Arabia but had been marketed for over 10 years in the US and EU. Preliminary results were against what many researchers had published and seemed even illogical to him. He told the team of researchers to keep this information secret until the study was completed. Analysis of the complete data confirmed the preliminary analysis. The professor decided not to submit the results for publication for fear of his reputation and also not to disturb other cardiologists in the country who were satisfied with the drug.

References:

---

[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] 8. 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 Orthod Dentofacial Orthop. 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 Trans Neural Netw. 2009 Sep;20(9):1385-402.