RESEARCH ETHICS &

SCIENTIFIC MISCONDUCT
(FMOH, MARCH 04, 2015)

Ghaiath Hussein, MBBS, MHSc. (Bioethics),

Doctoral Researcher (UK)
ghaiathme@gmail.com
Outline
• Overview on the Knowledge Management Cycle
and how research fits in it
• Brief historical background on research ethics
• What makes research ethical?
• Definition and examples of scientific misconduct
• How to make your research ethical and avoid
scientific misconduct?
Where are we in R&D?

Source: http://www.worldmapper.org/display.php?selected=165
Where are we in R&D?
Number of researchers (per
Expenditure on R&D as % of 1,000,000 population) [2]
GDP (2013):[1]
• Arab world: 0.5% • Morocco : 864
• China (2%), • Argentina: 1,236
• EU (2.3%), • Malaysia: 1,643
• USA (2.8%), • Slovenia: 4,255
• Israel (4%) • Israel: 6,494

Published scientific papers (1996 -2013):[3]

Egypt (42nd): 104,784 Brazil: 529,841

Israel: 247,561 India: 868,719

Turkey: 348,836 USA: 7,846,972

 What is Research?
 “Research” is defined as an undertaking intended to
extend knowledge through a disciplined inquiry or
systematic investigation.

 Systematic methodological scientific approach for

basic facts around a certain problem in order to find
solutions based on these facts.

Research on Humans:
The systematic undertaking of activities that involve the
collection of human personal data, measurements,
and/or biological samples for purposes that are not
related to clinical management of a health condition
Research in Context...the KMC

Generation
Statistics

Assessment
Dissemination

Utilization
Synthesis
Better Research is Better Health

“Good” research: Good Science & Good

Ethics

“Good” Evidence: near-top to hierarchy

of Evidence

Evidence-Based Healthcare:
Better practice that is based on best evidence

Better health status

What Makes Good Research?

Good •Problem selection

•SMART objectives
•Proper methodology
Science •Proper analysis

Good •Fair subject selection

•Favorable Risk-Benefit Ratio
•Independent Review
Ethics •Informed Consent
Criteria of “Good” Science Research
• Systematic: The research developed,
implemented and reported in a systematic
manner.

• Methodological: Adopt & use skillfully the

research methods, materials, approaches in order
to ensure reliability of the results & findings.

• Scientific: The research should be scientifically

sound through utilizing scientific approaches,
tools and techniques.
Criteria for Good Ethics:
What Makes Research Ethical?

1. Social or Scientific Value

2. Scientific Validity
3. Fair Subject Selection
4. Favorable Risk-Benefit Ratio
5. Independent Review
6. Informed Consent
7. Respect for the potential and enrolled
subjects
What’s Research Ethics?
 It is the field of ethics that systematically analyze the ethical
(and legal?) questions raised by research involving human
subjects.

 Its main focus is to ensure that the study participants are

protected and, ultimately,

 that clinical research is conducted in a way that

serves the needs of such participants and of
society as a whole.

It works when and only when it is applied before the

research is conducted
 History of Research Ethics
Pre-World War II: Research standards left up to the discretion
of the individual researcher

18th and 19th Centuries

• James Lind “scurvy study in sailors - Salisbury
• Edward Jenner cowpox vaccine test
• 1897 Giuseppe Sanarelli yellow fever test

1900 Walter Reed established several [first ever]

“safeguards”
• Self-experimentation
• Only adults would be enrolled in research
• Written informed consent
• Reimbursement (inducement)
 World War II: Nazi Doctors’ Experimentation
Experiments conducted on inmates of Nazi concentration camps
1945-1949:Trials in Nuremberg, Germany– physicians convicted of crimes against
humanity
TUSKEGEE SYPHILIS STUDY,
ALABAMA ( 1932 – 1972 )

 More than 400 African-

American men with latent
syphilis were followed for the
natural course of the disease
rather than receiving treatment.

 Continued after penicillin

available

 40 wives infected, 19 children

born with congenital syphilis
The Belmont Report (1979)
1972: the public became aware of the Tuskegee study

1974: the National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research was
established.

1978: the commission submitted its report titled, The

Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research.

Those principles respect for persons, beneficence and

justice are accepted as the 3 fundamental principles for the
ethical conduct of research involving human participants.
 Year Benchmark
2013 WMA updates DOH (Brazil)

2010 TCPS updated

2008 WMA updates DOH (Seoul)

2004 WMA updates DOH (Tokyo)

2002 WMA updates DOH (Washington) CIOMS Guidelines updated
2000 WMA updates DOH (Edinburgh)
1998 Tri-Council Policy Statement (TCPS)published in Canada
1996 WMA updates DOH (South Africa)

1993 CIOMS guidelines for biomedical research involving human subjects

1991 US CFR title 45, Part 46 issued CIOMS Guidelines for Epidemiological studies
1989 WMA updates DOH (Hong Kong)

1983 WMA updates DOH (Venice)

1981 US Common rule updated

1979 The Belmont Report

1975 WMA updates DOH (Tokyo)

1966 Dr. Beecher’s Article “Ethics and Clinical Research”

1964 World Medical Association (WMA) published the Declaration of Helsinki (DOH)
1947 The Nuremberg Code

1900 Walter Reed’s ‘consent’ for yellow fever experiments

Pre-1900 Edward Jenner smallpox vaccines
Is it over?... Torvan trial in Kano,
Nigeria
 Kano Trovan clinical trials in 1996, on pediatric age
group, during the worst ever meningococcal
meningitis.

 Lack of proper Governmental authorization and

informed consent during the studies publicized in
2000, by Washington Post.

 Court trial and release of investigation panel reports

stalled in Nigeria.

 Suit for 5.8 billion USD moved to the USA and report
leaked there too.

 Settlement out of court being discussed.

Examples of the ethical issues in
research
• Benefit/harm analysis
• Vulnerability (Risk-Vulnerability Matrix)
• Informed Consent
• Fairness and equity in research
participation
• Privacy and confidentiality
• Conflict of Interests (COI)
• Integrity & publication ethics
 Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient carein epidemics, emergencies and disasters, WHO (2014))

Ethical Definition1 Examples of

guidelines
principle/issue
Respect for The duty to respect people’s ability to make decisions on issues CIOMS, General
principles
people’s related to their health and their body, if they are competent to
TCPS, article 1.1
autonomy make such decisions; and the duty to protect individuals with Belmont Report
impaired or diminished autonomy
Informed A process whereby potential research participants decide CIOMS
(guidelines 4–6),
consent whether they want to participate in the proposed study after
DOH (articles
receiving information about it. The requirements for consent 25–32), TCPS
considered to be valid vary by guideline and regulation. In (Chapter 3)
general, they agree that decisions must be made free from
coercion, by a competent person who can understand the
information given and appreciate the associated risks. The
information given to the participant should be in a language and
format suitable to the participant’s ability to comprehend it.
 Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters, WHO (2014))

Ethical Definition1 Examples of

principle/issue guidelines

Beneficence The moral duty to pursue actions that promote the CIOMS, Belmont
Report,
well-being of others and the ethical obligation to
maximize benefit and to minimize harm

Non- The moral duty not to cause harm to others CIOMS,

DOH (articles 16–18)
maleficence through interventions

Justice Primarily distributive justice, which requires CIOMS (guidelines 10

and 12)
equitable distribution of benefits and burdens, i.e.
DOH (articles 16–18)
distribution such that no segment of the
TCPS (article 1.1 and
population is unduly burdened by the harms of Chapter 4)
research or denied the benefits of the knowledge
generated from it
Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters, WHO (2014))

Ethical Definition1 Examples of

principle/issue guidelines
Vulnerability A status in which some people may struggle to protect CIOMS ( guidelines 13–
their interests or be at greater risk of being exploited. 16), DOH (articles 19 &
This situation is usually linked to specific physical, 20)
Common rule, subparts
financial, educational or social circumstances. B, C and D
Groups considered as vulnerable vary by guideline, but TCPS (Chapter 9)
children, mentally retarded and handicapped people,
prisoners, refugees, terminally ill patients and women
are often cited as the prime vulnerable groups.

Privacy The right or expectation not to be interfered with or to TCPS (Chapter 5), DOH
(article 24)
be free from surveillance or, more generally, a moral
right to be left alone. In practical terms, privacy is for
instance concerned with the setting in which a person’s
health-related information is acquired.
 Core ethical principles/issues in research
(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters, WHO (2014))

Ethical Definition1 Examples of

principle/issue guidelines
Confidentiality The principle that ensures that identifiable CIOMS (Guideline 18),
TCPS (Chapter 5)
information is kept out of reach of others.
All identifiable information about individuals,
whether recorded (written, computerized,
visual, audio) or simply held in the memory of
health professionals, is subject to the duty of
confidentiality.

Research ethics A process by which a group of experts in CIOMS, Guidelines 2

and 20; Common Rule,
review research, ethics and other disciplines decides subpart A, (articles
whether a research protocol fulfils the ethical 46.107, 46.108 and
46.109); DOH (article
standards of research before being undertaken 23); TCPS (Chapter 6)
RESEARCH MISCONDUCT
(FFP)
 Research Misconduct (FFP)
Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or
in reporting research results.
• Fabrication is making up data or results and recording or
reporting them.
• Falsification is manipulating research materials, equipment,
or processes, or changing or omitting data or results.
• Plagiarism is the appropriation of another person’s ideas,
processes, results, or words without giving appropriate credit.
• Research misconduct does not include honest error or
differences of opinion.
• Research misconduct includes the destruction of, absence of,
or accused person's failure to provide research records
accurately documenting the questioned research.
 Forms of misconduct
• Falsification • Improper authorship
• Obfuscation • Misappropriation
• Fabrication • Bibliometric inflation
• Plagiarism • Violation of ethical
• Self-plagiarism standards regarding
• Ghost writing
human and animal
experiments
• Bare assertions

Source: http://en.wikipedia.org/wiki/Scientific_misconduct
 How to maintain research ethics
and avoid scientific misconduct?
Before conduct During conduct
After research
of research of research
• Develop clear • Follow the • Share your study
research plan approved report(s) with
(who will do what protocol • Return
when and how) • Gain consent ‘something’ back
• Submit protocol • Involve the to the researched
to ethical review community community
• Prepare • Protect yourself, • Publish following
(communicate) your team, & publication ethics
well with your your participants • Use Reference
research • Regularly check Management
community your data Software
• Agree on
authorship
References
1. World Bank’s interactive website:
http://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS
2. World Bank website:
http://data.worldbank.org/indicator/SP.POP.SCIE.RD.P6?ord
er=wbapi_data_value_2011+wbapi_data_value&sort=desc
3. SCImago. (2007). SJR — SCImago Journal & Country
Rank. Retrieved December 09, 2014, from
http://www.scimagojr.com
4. Training manual: Ethics in research, surveillance and
patient care in epidemics, emergencies and disasters.
Geneva, Switzerland: World Health Organization; 2014.
 This presentation and more material can be found online:
http://www.slideshare.net/ghaiath
https://www.youtube.com/ghaiathme

• You may also contact me on my email: ghaiathme@gmail.com