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RESEARCH ETHICS &
SCIENTIFIC MISCONDUCT(FMOH, MARCH 04, 2015)
Ghaiath Hussein, MBBS, MHSc. (Bioethics),
Doctoral Researcher (UK)
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?
Expenditure on R&D as % of GDP (2013):[1]
• Arab world: 0.5%
• China (2%),
• EU (2.3%),
• USA (2.8%),
• Israel (4%)
Number of researchers (per 1,000,000 population) [2]
• Morocco : 864
• Argentina: 1,236
• Malaysia: 1,643
• Slovenia: 4,255
• 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
Dissemination
SynthesisUtilization
Assessment
Statistics
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
Science
Good
Ethics
•Problem selection
•SMART objectives
•Proper methodology
•Proper analysis
•Fair subject selection
•Favorable Risk-Benefit Ratio
•Independent Review
•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 thatserves the needs of such participants and ofsociety as a whole.
It works when and only when it is applied before theresearch is conducted
History of Research EthicsPre-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’ ExperimentationExperiments conducted on inmates of Nazi concentration camps1945-1949:Trials in Nuremberg, Germany– physicians convicted of crimes against humanity
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
TUSKEGEE SYPHILIS STUDY,ALABAMA ( 1932 – 1972 )
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
principle/issue
Definition1 Examples of
guidelines
Respect for
people’s
autonomy
The duty to respect people’s ability to make decisions on issues
related to their health and their body, if they are competent to
make such decisions; and the duty to protect individuals with
impaired or diminished autonomy
CIOMS, General
principles
TCPS, article 1.1
Belmont Report
Informed
consent
A process whereby potential research participants decide
whether they want to participate in the proposed study after
receiving information about it. The requirements for consent
considered to be valid vary by guideline and regulation. In
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.
CIOMS
(guidelines 4–6),
DOH (articles
25–32), TCPS
(Chapter 3)
Ethical
principle/issue
Definition1 Examples of
guidelines
Beneficence The moral duty to pursue actions that promote the
well-being of others and the ethical obligation to
maximize benefit and to minimize harm
CIOMS, Belmont
Report,
Non-
maleficence
The moral duty not to cause harm to others
through interventions
CIOMS,
DOH (articles 16–18)
Justice Primarily distributive justice, which requires
equitable distribution of benefits and burdens, i.e.
distribution such that no segment of the
population is unduly burdened by the harms of
research or denied the benefits of the knowledge
generated from it
CIOMS (guidelines 10
and 12)
DOH (articles 16–18)
TCPS (article 1.1 and
Chapter 4)
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
principle/issue
Definition1 Examples of
guidelines
Vulnerability A status in which some people may struggle to protect
their interests or be at greater risk of being exploited.
This situation is usually linked to specific physical,
financial, educational or social circumstances.
Groups considered as vulnerable vary by guideline, but
children, mentally retarded and handicapped people,
prisoners, refugees, terminally ill patients and women
are often cited as the prime vulnerable groups.
CIOMS ( guidelines 13–
16), DOH (articles 19 &
20)
Common rule, subparts
B, C and D
TCPS (Chapter 9)
Privacy The right or expectation not to be interfered with or to
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.
TCPS (Chapter 5), DOH
(article 24)
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
principle/issue
Definition1 Examples of
guidelines
Confidentiality The principle that ensures that identifiable
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.
CIOMS (Guideline 18),
TCPS (Chapter 5)
Research ethics
review
A process by which a group of experts in
research, ethics and other disciplines decides
whether a research protocol fulfils the ethical
standards of research before being undertaken
CIOMS, Guidelines 2
and 20; Common Rule,
subpart A, (articles
46.107, 46.108 and
46.109); DOH (article
23); TCPS (Chapter 6)
Core ethical principles/issues in research(Source: WHO Training manual: Ethics in research, surveillance and patient care in epidemics, emergencies and disasters, WHO (2014))
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
• Obfuscation
• Fabrication
• Plagiarism
• Self-plagiarism
• Ghost writing
• Bare assertions
• Improper authorship
• Misappropriation
• Bibliometric inflation
• Violation of ethical
standards regarding
human and animal
experiments
Source: http://en.wikipedia.org/wiki/Scientific_misconduct
How to maintain research ethics
and avoid scientific misconduct?Before conduct
of research
• Develop clear research plan (who will do what when and how)
• Submit protocol to ethical review
• Prepare (communicate) well with your research community
• Agree on authorship
During conduct of research
• Follow the approved protocol
• Gain consent
• Involve the community
• Protect yourself, your team, & your participants
• Regularly check your data
After research
• Share your study report(s) with
• Return ‘something’ back to the researched community
• Publish following publication ethics
• Use Reference Management Software
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: [email protected]