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?

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: ghaiathme@gmail.com