IRB’s and Ethical
Issue
M E D I C A L I N F O R M AT I C S
BY
GAV IS HNA R
3122213003009
WHAT IS AN IRB?
A committee at an institution applies
research ethics by reviewing the methods
proposed for research done at that institution
to ensure that the projects are ethical.
?
B
WHAT DO THEY DO?
To protect human subjects by reviewing research protocols and related
materials
Ensures the research meets the Ethical standards and Federal requirements
Checks whether it follows the principles of Belmont report- Respect,
Beneficence, Justice
To conduct a risk-benefiting analysis to determine the conduction of the
research
?
Monitor the implementation and follow upon the result of the research
B
AT LEAST 5 MEMBERS
INDEPENDENT IRBs DO
DIFFERENT BACKGROUND
EXIST
1-NOT AFFILIATED TO
1-NOT A SCIENTIST
INSTITUTION
?
B
AT LEAST 5 MEMBERS
INDEPENDENT IRBs DO DIFFERENT BACKGROUND
EXIST
1-NOT AFFILIATED TO
1-NOT A SCIENTIST
INSTITUTION
?
B
AT LEAST 5 MEMBERS
INDEPENDENT IRBs DO
DIFFERENT BACKGROUND
EXIST
1-NOT AFFILIATED TO 1-NOT A SCIENTIST
INSTITUTION
?
B
AT LEAST 5 MEMBERS
INDEPENDENT IRBs DO
DIFFERENT BACKGROUND
EXIST
1-NOT AFFILIATED TO
INSTITUTION 1-NOT A SCIENTIST
?
B
AT LEAST 5 MEMBERS
INDEPENDENT IRBs DO
EXIST DIFFERENT BACKGROUND
1-NOT AFFILIATED TO
INSTITUTION 1-NOT A SCIENTIST
?
B
IRB
verifies
IRB verifies
Potential participants have the necessary
information to make the decisions about
volunteering for the study.
Whether the participants understand
the risks
Informed Consent Process
IRB verifies
Potential participants have the necessary
information to make the decisions about
volunteering for the study.
Whether the participants understand
the risks
Informed Consent Process
IRB verifies
Potential participants have the necessary
information to make the decisions about
volunteering for the study.
Whether the participants understand
the risks
Informed Consent Process
ETHICAL ISSUES
ETHICAL ISSUES
can occur
STUDY DESIGN
AND ETHICS
DATA ANALYSIS AUTHORSHIP
APPROVAL
REDUNDANT
CONFLICTS OF PUBLICATION
INTEREST AND
PLAGIARISM
ETHICAL ISSUES
can occur
STUDY DESIGN
AND ETHICS DATA ANALYSIS AUTHORSHIP
APPROVAL
REDUNDANT
CONFLICTS OF PUBLICATION
INTEREST AND
PLAGIARISM
ETHICAL ISSUES
can occur
STUDY DESIGN
AUTHORSHIP
AND ETHICS DATA ANALYSIS
APPROVAL
REDUNDANT
CONFLICTS OF PUBLICATION
INTEREST AND
PLAGIARISM
ETHICAL ISSUES
can occur
STUDY DESIGN
AND ETHICS DATA ANALYSIS AUTHORSHIP
APPROVAL
REDUNDANT
PUBLICATION
CONFLICTS OF
AND
INTEREST
PLAGIARISM
ETHICAL ISSUES
can occur
STUDY DESIGN
AND ETHICS DATA ANALYSIS AUTHORSHIP
APPROVAL
REDUNDANT
CONFLICTS OF
PUBLICATION
INTEREST
AND
PLAGIARISM
The researchers should pay special attention to
vulnerable subjects to avoid breech of ethical codes
It is essential to obtain approval from the Institutional
Review Board, or Ethics Committee, of the respective
organisations for studies involving people, medical
records, and anonymised human tissues.
STUDY DESIGN
AND ETHICS
APPROVAL Consent should be explained and obtained from the
subjects or guardians, and steps should be taken to
ensure confidentiality of information provided by the
subjects.
Patient information sheet should be given to the
subjects
The discussion section of a paper should mention any
issues of bias, and explain how they have been dealt
with in the design and interpretation of the study
Fabrication and falsification of data constitute to
misconduct
DATA ANALYSIS
all sources and methods used to obtain and analyse
data should be fully disclosed..
The discussion section of a paper should mention any
issues of bias and explain how they have been dealt
with in the design and interpretation of the study.
The author should take responsibility to certify that the
manuscript represents valid work and take public
responsibility for the work
Responsible and ethical authorship requires that the
work be trustworthy, truthful and fair.
AUTHORSHIP
Ghost authorship is a problem, especially seen in
clinical trials or with new technology
Fairness in the public disclosure of the affiliations of
those who participated in the study and its preparation.
An Individual has interests in the outcome of the
research that may lead to personal advantage
Conflicts include personal, commercial, political,
academic or financial interest.
CONFLICTS OF
INTEREST
When publishing, conflicts of interest should be
declared to editors, and readers will judge for
themselves whether the research findings are
trustworthy.
Conflicts of interest can potentially clash with
the purpose of scientific work itself.
Redundant publication occurs when two or more
papers, without full cross reference, share the same
hypothesis, data, discussion points, or conclusions.
plagiarism ranges from unreferenced use of others
published and unpublished ideas, including research
grant applications to submission under “new”
REDUNDANT authorship of a complete paper, sometimes in different
PUBLICATION language.
AND
PLAGIARISM
A large amount of other people’s writing or illustrative
materials is to be used, permission must be sought.
violation of intellectual property rights (plagiarism) is
happening both inadvertently as well as with
knowledge. Cases of fraud and deceit have been
documented in even the most esteemed journals.
UNETHICAL RESEARCHES
EXAMPLES
THE PILTDOWN MAN
The apparently fossilized skull
found at Piltdown Common near
Lewes, Eng., was first proposed
as a new species of prehistoric
man (“Piltdown man”) in 1912.
Only in 1954 was the skull
shown to consist of a human
cranium skilfully joined to the
jaw of an orangutan.
THE TUSKEGEE EXPERIMENT
• The project, which was conducted by
the U.S. Public Health Service (PHS)
from 1932 to 1972, examined the
natural course of untreated syphilis in
African American men.
• Treatment was initially part of the
study, and some patients were
administered arsenic, bismuth, and
mercury. But after the original study
failed to produce any useful data, it
was decided to follow the subjects
until their deaths, and all treatment
was halted. Penicillin was denied to
the infected men after that drug
became available .
REFERENCE
• https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC4453117/
• https://h2020integrity.eu/conflict-of-interest-in-research-what-is-it-and-why-it-
matters/
• https://www.britannica.com/summary/Piltdown-man
• https://www.britannica.com/event/Tuskegee-syphilis-study
