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ETHICS IN RESEARCH
Yusuff Adebayo Adebisi
Director for Research and Thought Leadership, Global
Health Focus
25 September 2021
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
OBJECTIVES
 Discuss what is meant by and why there
should be ethical standards in Bio-
Medical research
 Identify ethical issues in Bio-Medical
research which would amount to
scientific misconduct
 Explain the role of an ethics review
committee
 Construct a set of guidelines for
members of ethics review committees
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Research Ethics…..
Involves the application of
fundamental ethical principles
to planning, conducting &
publishing of research
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Guiding principles
 Autonomy and respect
 Beneficence
 Non-maleficence
 Justice ( free from exploitation)
 Scientific validity
 Honesty
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Activity
Identify ethical issues in the
following scenarios
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 1
Two graduate students have made some
measurements on a new material. The data
points are as shown. To prove their
hypothesis the results should lie on the
curve shown. The two students considered
omitting the two data points which were off
the theoretical curve.
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as it would amount to
falsification of data
 Should include outliers and give
probable reasons or find out
statistically acceptable ways of
trimming outliers
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 2
A group of medical students conducted a
research on the awareness of diabetic diet
in medical clinic participants. Their
research was recognized as the best
undergraduate research and later they
submitted the same research paper to two
different journals to see which journal
publishes it first.
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as it would result in "inadvertent
double-counting or inappropriate
weighting of the results of a single
study, which distorts the available
evidence
 it would give a false idea of the number of
publications in a given area
 Wasting of resources on the review and
publication process
 Should submit to one journal and wait for
response prior to submitting to another
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 3
Students are required to prepare a
research proposal during their
undergraduate program. Nimal
developed the idea for his project and
discussed with a friend. Several months
later, he found that his idea had been
submitted as a research proposal by his
friend without his knowledge.
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as failure to give credit to the
person whose idea it is (intellectual
property) amounts to plagiarism
 Should discuss and include as co-
author
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 4
Four friends decide to work together on a
research project during the vacation. One
of them went abroad during the vacation
and did not contribute to the research.
The friends include all 4 names in a
presentation made at a scientific
congress.
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as only those who
contributed intellectually should be
cited as authors
 Those who contribute in other ways
may be acknowledged
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 5
A group of undergraduate students
planned a research project on the
detection of fetal abnormalities in the
second trimester, by ultrasound
scanning. They collected data from the
scan room without informing the mothers
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as informed consent was not
taken
 Should have informed mothers of their
intent even though there is no
particular advantage/disadvantage to
the mother in doing so
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Group 6
A group of undergraduate students
collected data from a group of bank
officers, with their consent, regarding their
working hours and salary with regards to
the prevalence of high blood pressure.
Subsequently the researchers gave the
same data to another group who were in
need of same data variables.
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Unethical as violating principles of
consent and confidentiality
 Data can be used for a secondary
purpose which was not first considered
as long as
- informed consent for sharing has been
given
- identities anonymised
- due consideration to access restrictions
 Develop ethical guidelines for data
sharing? Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Why should there be research ethics?
 To protect participants /patients /society
/resources /researcher?
 To ensure accuracy of scientific
knowledge
 To protect intellectual and property rights
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
To protect
participants/patients/society/resources
 Protect from harm
 Show respect -privacy /confidentiality
 -Informed consent
 Refrain from Coercion and undue
inducement When do incentives amount
to coersion/undue inducement?
http://www.ncbi.nlm.nih.gov/pmc/articles/P
MC2600442
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Refrain from exploitation of vulnerable
participants Who are the vulnerable
groups?
 Refrain from indiscriminate use of
resources
 Ensure Favorable Risk-Benefit Ratio: risk
should be minimized & potential benefit to
society must outweigh risks
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Must be of social value: improvement of
health/knowledge for the benefit of
society/science
high social value: use of stem cells to improve
quality of life for Huntington's disease
patients
less social value: drug studies conducted to
obtain data that allows a new drug to compete
in the healthcare marketplace even though
existing effective and often cheaper therapeutics
are already available Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
To ensure accuracy of scientific knowledge
 Should be methodically rigorous -
Scientific validity
 Fair subject selection: with inclusion /
exclusion criteria & a valid number of
subjects in order to project results to the
population
 State research method clearly so that
another person can conduct advanced
study in future by using publication
Is it ethical to copy the methodology from a
published paper? Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Do not gloss research method
 Should not falsify/modify/omit data
 Use actual data for analysis/cannot
include someone else's data
 Report errors
 Be aware of conflict of interest
 Should not withhold and/or ‘vaguing up’
information
 Keep data and material for 5 years
 Data and material should be available to
others Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Do not present/publish paper from
incomplete research or from anticipated
outcomes
 Should not duplicate publications and
submissions
 Avoid piecemeal publication
 Should be reviewed Independently by
unaffiliated individuals
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
To protect intellectual and property
rights
 Citation and authorship
inclusion-Writing and significant
scientific contribution
order- order of contribution
-actual researchers
-approval must be sought to
include a name
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Whenever somebody else’s work is
quoted reference should be made to
the original author (Piracy vs plagiarism)
 Acknowledgement should include the
names of person who helped
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Breach of ethics in research
would amount to scientific
misconduct
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Scientific misconduct
 Fraud : invention/fabrication of data
 Plagiarism : copying data, ideas, text
without acknowledgement of source
 Piracy : infringement of a copyright
 Submitting/Publishing the same paper to
different journals
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Scientific misconduct …
 Not informing a collaborator of your
intent to file a patent in order to make
sure that you are the sole inventor
 Including a colleague as an author on a
paper in return for a favor even though
the colleague did not make a serious
contribution to the paper
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Trimming outliers from a data set without
discussing your reasons in paper
 Using an inappropriate statistical
technique in order to enhance the
significance of your research
 Bypassing the peer review process and
announcing your results through a press
conference without giving peers
adequate information to review your work
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Conducting a review of the literature that
fails to acknowledge contributions of
others
 Stretching the truth on a grant application
in order to convince reviewers that your
project will make a significant contribution
to the field
 Giving the same research project to two
graduate students in order to see who can
do it the fastest Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Overworking, neglecting, or exploiting
research students
 Making derogatory comments and
personal attacks in your review of
author's submission
 Making significant deviations from the
research protocol approved by the
Review Board without informing the
committee
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Not reporting an adverse event in a
human research experiment
 Wasting animals in research
 Exposing students and staff to biological
risks
 Rejecting a manuscript for publication
without even reading it
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 Sabotaging someone's work
 Rigging an experiment so you know how
it will turn out
 Deliberately overestimating the clinical
significance of a new drug in order to
obtain economic benefits
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Ethical review committee
(Institutional Review Boards)
Convened to
 maintain ethical standards of practice in
research
 ensure protection of subjects/research
workers from harm or exploitation
 to provide reassurance to the public
 protect researchers from unjustified
criticism
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
Procedure for ethical clearance
 Fill ethical clearance form and attach
proposal, questionnaires, informed
consent forms, information leaflets etc.,
and submit
 When ethical clearance is granted, data
collection can commence according to
the approved methodology
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
 A group of undergraduate students
planned a research on family planning
practices of Sri Lankan females. As they
were close to the deadline for presenting
their results, they started collecting
information form participants before
formal approval by the ethics review
committee
Ethics in Research by Adebisi Yusuf (NiMSA
SCORE - TORASIF webinar)
THANK YOU
Ethics in Research by Adebisi
Yusuf (NiMSA SCORE - TORASIF
webinar)

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Research Ethics by Adebisi Yusuf.ppt

  • 1. ETHICS IN RESEARCH Yusuff Adebayo Adebisi Director for Research and Thought Leadership, Global Health Focus 25 September 2021 Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 2. OBJECTIVES  Discuss what is meant by and why there should be ethical standards in Bio- Medical research  Identify ethical issues in Bio-Medical research which would amount to scientific misconduct  Explain the role of an ethics review committee  Construct a set of guidelines for members of ethics review committees Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 3. Research Ethics….. Involves the application of fundamental ethical principles to planning, conducting & publishing of research Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 4. Guiding principles  Autonomy and respect  Beneficence  Non-maleficence  Justice ( free from exploitation)  Scientific validity  Honesty Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 5. Activity Identify ethical issues in the following scenarios Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 6. Group 1 Two graduate students have made some measurements on a new material. The data points are as shown. To prove their hypothesis the results should lie on the curve shown. The two students considered omitting the two data points which were off the theoretical curve. Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 7.  Unethical as it would amount to falsification of data  Should include outliers and give probable reasons or find out statistically acceptable ways of trimming outliers Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 8. Group 2 A group of medical students conducted a research on the awareness of diabetic diet in medical clinic participants. Their research was recognized as the best undergraduate research and later they submitted the same research paper to two different journals to see which journal publishes it first. Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 9.  Unethical as it would result in "inadvertent double-counting or inappropriate weighting of the results of a single study, which distorts the available evidence  it would give a false idea of the number of publications in a given area  Wasting of resources on the review and publication process  Should submit to one journal and wait for response prior to submitting to another Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 10. Group 3 Students are required to prepare a research proposal during their undergraduate program. Nimal developed the idea for his project and discussed with a friend. Several months later, he found that his idea had been submitted as a research proposal by his friend without his knowledge. Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 11.  Unethical as failure to give credit to the person whose idea it is (intellectual property) amounts to plagiarism  Should discuss and include as co- author Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 12. Group 4 Four friends decide to work together on a research project during the vacation. One of them went abroad during the vacation and did not contribute to the research. The friends include all 4 names in a presentation made at a scientific congress. Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 13.  Unethical as only those who contributed intellectually should be cited as authors  Those who contribute in other ways may be acknowledged Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 14. Group 5 A group of undergraduate students planned a research project on the detection of fetal abnormalities in the second trimester, by ultrasound scanning. They collected data from the scan room without informing the mothers Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 15.  Unethical as informed consent was not taken  Should have informed mothers of their intent even though there is no particular advantage/disadvantage to the mother in doing so Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 16. Group 6 A group of undergraduate students collected data from a group of bank officers, with their consent, regarding their working hours and salary with regards to the prevalence of high blood pressure. Subsequently the researchers gave the same data to another group who were in need of same data variables. Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 17.  Unethical as violating principles of consent and confidentiality  Data can be used for a secondary purpose which was not first considered as long as - informed consent for sharing has been given - identities anonymised - due consideration to access restrictions  Develop ethical guidelines for data sharing? Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 18. Why should there be research ethics?  To protect participants /patients /society /resources /researcher?  To ensure accuracy of scientific knowledge  To protect intellectual and property rights Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 19. To protect participants/patients/society/resources  Protect from harm  Show respect -privacy /confidentiality  -Informed consent  Refrain from Coercion and undue inducement When do incentives amount to coersion/undue inducement? http://www.ncbi.nlm.nih.gov/pmc/articles/P MC2600442 Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 20.  Refrain from exploitation of vulnerable participants Who are the vulnerable groups?  Refrain from indiscriminate use of resources  Ensure Favorable Risk-Benefit Ratio: risk should be minimized & potential benefit to society must outweigh risks Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 21.  Must be of social value: improvement of health/knowledge for the benefit of society/science high social value: use of stem cells to improve quality of life for Huntington's disease patients less social value: drug studies conducted to obtain data that allows a new drug to compete in the healthcare marketplace even though existing effective and often cheaper therapeutics are already available Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 22. To ensure accuracy of scientific knowledge  Should be methodically rigorous - Scientific validity  Fair subject selection: with inclusion / exclusion criteria & a valid number of subjects in order to project results to the population  State research method clearly so that another person can conduct advanced study in future by using publication Is it ethical to copy the methodology from a published paper? Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 23.  Do not gloss research method  Should not falsify/modify/omit data  Use actual data for analysis/cannot include someone else's data  Report errors  Be aware of conflict of interest  Should not withhold and/or ‘vaguing up’ information  Keep data and material for 5 years  Data and material should be available to others Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 24.  Do not present/publish paper from incomplete research or from anticipated outcomes  Should not duplicate publications and submissions  Avoid piecemeal publication  Should be reviewed Independently by unaffiliated individuals Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 25. To protect intellectual and property rights  Citation and authorship inclusion-Writing and significant scientific contribution order- order of contribution -actual researchers -approval must be sought to include a name Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 26.  Whenever somebody else’s work is quoted reference should be made to the original author (Piracy vs plagiarism)  Acknowledgement should include the names of person who helped Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 27. Breach of ethics in research would amount to scientific misconduct Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 28. Scientific misconduct  Fraud : invention/fabrication of data  Plagiarism : copying data, ideas, text without acknowledgement of source  Piracy : infringement of a copyright  Submitting/Publishing the same paper to different journals Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 29. Scientific misconduct …  Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor  Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 30.  Trimming outliers from a data set without discussing your reasons in paper  Using an inappropriate statistical technique in order to enhance the significance of your research  Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 31.  Conducting a review of the literature that fails to acknowledge contributions of others  Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field  Giving the same research project to two graduate students in order to see who can do it the fastest Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 32.  Overworking, neglecting, or exploiting research students  Making derogatory comments and personal attacks in your review of author's submission  Making significant deviations from the research protocol approved by the Review Board without informing the committee Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 33.  Not reporting an adverse event in a human research experiment  Wasting animals in research  Exposing students and staff to biological risks  Rejecting a manuscript for publication without even reading it Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 34.  Sabotaging someone's work  Rigging an experiment so you know how it will turn out  Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 35. Ethical review committee (Institutional Review Boards) Convened to  maintain ethical standards of practice in research  ensure protection of subjects/research workers from harm or exploitation  to provide reassurance to the public  protect researchers from unjustified criticism Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 36. Procedure for ethical clearance  Fill ethical clearance form and attach proposal, questionnaires, informed consent forms, information leaflets etc., and submit  When ethical clearance is granted, data collection can commence according to the approved methodology Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 37.  A group of undergraduate students planned a research on family planning practices of Sri Lankan females. As they were close to the deadline for presenting their results, they started collecting information form participants before formal approval by the ethics review committee Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)
  • 38. THANK YOU Ethics in Research by Adebisi Yusuf (NiMSA SCORE - TORASIF webinar)