Research Ethics
Saleem Saaed Qader
MBChB, MD, MSc, MPH, PhD, SBGS
Consultant General Surgeon and Lecturer
Director General
Medical Research Centre, Hawler Medical University, Erbil
Department of Surgery, Medical College, Hawler Medical University
Department of Surgery, Rizgary Teaching Hospital, Erbil
TMC
Oct 2014
Ethics
Body of principles governing right and wrong
OR
Reference to morals or the rules or standards
governing the conduct of a person or the
members of a profession
Protection of the Human Subject in Medical
Research
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Cultural Mores
Laws respecting Human Rights
Professional Codes of Conduct
Individual Conscience
Research Ethics Committee “REC”
Why is research ethics necessary?
To ensure responsible conduct in research
To protect research participants
To protect researchers
When is human research ethics review
required?
Required for all research involving human and animals
Research involving human participants includes:
Collection of information through from a living person
Secondary use of data previously collected from human
Use of identifiable private information of an individual
Research involving human remains, cadavers, human
organs, tissues and biological fluids, embryos or fetuses
When is human research ethics review
not required?
Some exemptions…
Research about a living individual involved in
the public arena (publicly available information)
Research conducted using secondary analysis of
datasets or coded samples - identity of
participants unknown
Research Ethics Committees (REC)
The main objectives are to review the proposals to:
 Maintain ethical standards in research
 Protect research subject/worker from any
harm/exploitation
 Preserve the subjects rights, safety and dignity
Provide reassurance to the public that this is being done
 Protect research workers from unjustified criticism
Ethical Issues
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Multiple submissions
Redundant publications
Plagiarism
Data fabrication and falsification
Improper use of human subjects and animals in research
Improper author contribution
1. Multiple submissions
 Multiple submissions save your time but waste
editors
 The editorial process of your manuscripts will be
completely stopped if the duplicated submission
are discovered
 Competing journals exchange information on
suspicious papers (even between competitors)
 You should not send your manuscripts to a
second journal UNTIL you receive the final
decision of the first journal
2. Redundant publication
An author should not submit a previously published paper to
another journal, except in these conditions:
1. Published studies do not need to be repeated unless
further conformation is required
2. Previous publication of an abstract during the
proceedings of conferences does not preclude
subsequent submission for publication, but full disclosure
should be made at the time of submission
3. Re-publication of a paper in another language is
acceptance, provided that there is full and prominent
disclosure of its original source at the time of submission
3. Plagiarism
“Plagiarism is the appropriation of another
person’s ideas, processes results, or words
without giving appropriate credit, including
those obtained through confidential review of
others’ research proposals and
manuscripts ”(the Federal Office of Science
and Technology Policy,1999)
4. Data fabrication and falsification
 Fabrication is making up data or results,
and recording or reporting them
 Falsification is manipulating research
materials, equipment, processes, or
changing/omitting data or results
5. Improper use of human subjects & animals
 Experiments on human subjects or animals
should follow related ethical standards, e.g.
Helsinki Declaration of 1975, as revised in 2000
 If doubt exists in accordance of the research with
Helsinki Declaration, authors must explain the
rationale for their approach and demonstrate the
approval from the institutional review body
6. Improper author contribution
Authorship credit should be based on
1. substantial contributions to conception and
design, or acquisition of data, or analysis and
interpretation of data
2. drafting the article or revising it critically
3. final approval of the version to be published.
Authors should meet conditions 1, 2, and 3
Those who have participated in certain substantive
aspects of the research project should be
acknowledged or listed as contributors
Nuremberg Code (1947)
 Voluntary & Informed Consent
 Experimentation on humans had to be necessary
and yield benefit that overweighed the risk
 Right to withdraw without penalty
 Subject must be protected against possible
injury, disability, or death
 Research only conducted by scientifically
qualified personnel
1979 Belmont Report
Three ethical principles related to research on
human subjects:
Respect for Persons
 Individuals should be treated as autonomous
agents
 Individuals with diminished autonomy need
protections
Beneficence
 Do not harm
 Maximum benefits/ minimize potential harms
Justice
Fair distribution of burdens/benefits of research
Declaration of Helsinki 1964
 Potential benefits must outweigh hazards
 The need for informed consent
 A distinction between scientific and clinical
research
Seven Ethical Pillars of Clinical Research
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Autonomy
Beneficence
Non malfeasance
Fidelity
Truthfulness
Confidentiality
Justice
Autonomy
Consent
Para 20 The subjects must be volunteers and
informed participants in the research project
Para 22 After ensuring that the subject has
understood the information, the physician should
then obtain the subject's freely-given informed
consent, preferably in writing
Beneficence
In medical research on human subjects,
considerations related to the well-being of the
human subject should take precedence over the
interests of science and society
Para 5
Medical research involving human subjects
should only be conducted if the importance of the
objective outweighs the inherent risks and
burdens to the subject
Para 18
Non Malfeasance
Para 16
Every medical research project involving
human subjects should be preceded by
careful assessment of predictable risks and
burdens in comparison with foreseeable
benefits to the subject or to others
Fidelity– duty of care
Para 11
Medical research involving human subjects must
conform to generally accepted scientific
principles, be based on a thorough knowledge of
the scientific literature
Para 15
Medical research involving human subjects
should be conducted only by scientifically
qualified persons and under the supervision of
a clinically competent medical person
Truthfulness - Honesty
Para 27
Both authors and publishers have ethical
obligations. In publication of the results of
research, the investigators are obliged to
preserve the accuracy of the results.
Negative as well as positive results should
be published or otherwise publicly available
Confidentiality
Para 21
Every precaution should be taken to respect the
privacy of the subject, the confidentiality of the
patient's information and to minimize the impact
of the study on the subject's physical and mental
integrity and on the personality of the subject
Justice
Para 30
Every patient entered into the study should be
assured of access to the best proven
prophylactic, diagnostic and therapeutic methods
identified by the study
Para 8
Medical research is subject to ethical standards
that promote respect for all human beings and
protect their health and rights
Para 10
‘It is the duty of the physician in medical research
to protect the life, health, privacy and dignity of
the human subject’
Threats to the Principle of Respect
Coercion
Undue Inducements
Exploitation
Coercion
Requires the presence of a threat
Perceived coercion in research can occur with
Prisoners
Students and staff
Payment for research is not coercive:
Payment is an offer not a threat
Inducement
Offers that make people to do things they would
not otherwise do:
Acceptable Inducements:
Free car wash with fill-up
Usually monetary
Medical/diagnostic services
Results from MRI scan
Knowledge of genetic testing
Undue Inducements
Excessively attractive offers that lead people to do
something to which they normally would object based
on risk or other fundamental value (Dickert, 2004)
Monetary inducement that alters individual’s decisionmaking process such that they underestimate risks
Payments invalidates the consent process
Undue inducements may make subjects to lie/ conceal
information that, if known, would disqualify them
from participation
Exploitation
An exploitative transaction is one in which person A takes
unfair advantage of person B (Wertheimer, 1999)
There is always an ethical concern when recruiting
from vulnerable populations:
 Poor; homeless
 Mentally ill
 Terminally ill
 Prisoners
 Students
 Staff