SlideShare a Scribd company logo
1 of 54
Download to read offline
Ghaiath Hussein, MBBS, MHSc. (Bioethics), Doctoral Researcher (UK)
Assistant Professor of Bioethics
Outline
■ Research in context: the Knowledge
Management Cycle (KMC)
■ 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
Synthesis
Utilization
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
Good
Science
•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 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
Lecture 18 research ethics (1)
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
The Nuremberg Code (1947)
The first provision of the code requires that “the voluntary
informed consent of the human subject is absolutely
essential.” The code provides other details implied by
such a requirement:
■ Voluntary consent absolutely essential (restricting
research with infants, children, developmentally
challenged, etc.)
■ Freedom from coercion
■ Comprehension of the risks and benefits involved
■ Experiment to be conducted by highest qualified persons
■ Risk/Benefit Analysis essential to ethics review
■ Scientific Soundness is important to ethics review
The code on the web: http://ohsr.od.nih.gov/nuremberg.php3
The Declaration of Helsinki (DOH)
 The World Medical Association created the Declaration of
Helsinki in 1964 and amended regularly since 1975
The main issues emphasized were:
 “The well-being of the subject should take precedence over
the interests of science and society”
 Respect for Persons – people are not a means to an end;
researchers have duty to protect life, health, privacy and
dignity of research participants
 Consent should be in writing
 Standard of care must be best available, even for control
group
 Greater access to benefit
 Use caution if participant is in dependent relationship with
researcher
 Limited use of placebo
 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.
Lecture 18 research ethics (1)
EXAMPLES OF
ETHICAL ISSUES IN
RESEARCH
Some ethical issues in research
Before
•Benefit/harm
analysis
•Vulnerability
(Risk-
Vulnerability
Matrix)
•Fair selection of
participation
•Conflict of
Interests (COI)
During
•Informed
Consent
•Privacy and
confidentiality
•Risk to
researchers
•Risk to
participants
After
•Sharing results
•Sharing
benefits
•Integrity &
publication
ethics
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
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
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
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)
INFORMED CONSENT
What is IC?
■ A process whereby potential research
participants decide whether they want to
participate in the proposed study after
receiving information about it.
■ 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.
Components of IC:
1. "Disclosure" refers to the provision of relevant
information by the clinician and its
comprehension by the patient. This refers to the
process during which physicians provide information
about the proposed research to the participant
2. "Capacity" refers to the patient's ability to
understand the relevant information and to
appreciate those consequences of his or her
decision that might reasonably be foreseen.
3. "Voluntariness" refers to the patient's right to
come to a decision freely, without force, coercion
or manipulation.
Eight Required Elements
[45 CFR 46.116(a) & 21 CFR 50.25]
1. Statement that study in research and information on
purposes / duration / procedures / experimental
procedures
2. Reasonably foreseeable risks or discomforts
3. Reasonably expected benefits
4. Alternative procedures
5. How confidentiality will be maintained
6. Information on compensation for injuries (unless minimal
risk)
7. Contact persons for information on research, injury,
subject’s rights
8. Voluntary participation, no penalty or loss of benefits for
Six Additional Elements
1. Statement that there may be risks which
are unforeseeable
2. Under what circumstances investigator
could terminate subject’s participation
3. Additional costs to subjects
4. Consequences of subject’s withdrawal
from research
5. Statement that will be told of new findings
6. Approximate number of subjects in study
Waiver of Informed Consent
Conditions to waiver IC:
 Poses no more than Minimal risk
 Waiver or alteration will not adversely
affect the rights and welfare of the
subjects
 Research could not practicably be carried
out without the waiver or alteration
 Does not involve a therapeutic
intervention
 Subjects will be provided with additional
pertinent information
All of the above must apply
Documentation of Informed Consent
 Written consent document
 Language understandable to the subject
or the subject’s Legally Authorized
Representative (LAR), or
 Signed by subject or subject’s LAR
 Copy SHALL be given to subject
 Opportunity to read before signing
Principles for Providing Information to Participant:
Make it clear; avoid jargon
Use language appropriate to the
participant’s level of understanding in a
language of their fluency
Invite questions from the patient and
check for understanding
Summarize the imparted information
Provide contact information (and other
resources)
2. Capacity:
Refers to the presence of a group/set of
functional abilities a person needs to possess
in order to make a specific decisions
(Griso and Applebaum, 1998).
These include:
 To UNDERSTAND the relevant information
 To APPRECIATE the relatively foreseeable
consequences of the various available options
available.
3. Voluntariness:
■ Refers to a participant’s right to make
participation decisions free of any undue
influence.
Influences include:
■ Physical restraint or sedation
■ Coercion involves the use of explicit or
implicit threat to ensure that the
treatment is accepted
■ Manipulation involves the deliberate
distortion or omission of information in
an attempt to induce the subject’s
participation
Practical Challenges to a "Fully Informed
Consent"
■ Diagnostic uncertainty
■ Complexity of medical information
■ Linguistic and cultural differences
■ Overworked health personnel
■ Paternalistic approach in doctor-patient
relationship in developing countries, including
KSA.
CONFLICTS OF INTEREST
(COI)
Conflicts of interests
What is an interest?
•An interest may be defined as a
commitment, goal, or value held
by an individual or an institution.
•Examples include a research
project to be completed, gaining
status through promotion or
recognition, and protecting the
environment.
What is COI?
• Conflicts of interest are “situations in which financial or
other personal considerations may compromise, or
have the appearance of compromising, an
investigator’s judgement in conducting or reporting
research.” AAMC, 1990
• COI exists when two or more contradictory interests
relate to an activity by an individual or an institution.
• “A conflict of interest in research exists when the
individual has interests in the outcome of the research
that may lead to a personal advantage and that might
therefore, in actuality or appearance compromise the
integrity of the research.”
■ NAS, Integrity in Scientific Research
What comprises COI?
• Stock ownership
• Paid employment Board membership
• Patent applications (pending or actual)
• Research grants (from whatever source)
• Travel grants and honoraria for speaking or
participation at meetings
• Gifts Membership of lobbying organizations
• Relationship with the National Research Ethics
Review Committee, or with possible reviewers of
the paper
• Relationship with organizations and funding bodies
Membership of a government advisory board
Levels of COI
1- Researchers
•The REC should assess the likelihood that
the researcher’s judgment may be
influenced, or appear to be influenced, by
private or personal interests (TCPS, 2000)
2- Conflicts of Interest by REC Members
•It is of the highest importance that
members of the REC avoid real or apparent
conflicts of interest .
•E.g.: their research are reviewed by their
REC or when they have been in direct
academic conflict or collaboration with the
researcher whose proposal is under review.
Levels of COI
3- Institutional Conflicts of Interest
• Situations may arise where the parent
organization has a strong interest in seeing a
project approved before all ethical questions are
resolved.
• The REC must act independently from the
parent organization.
• Institutions must respect the autonomy of the
REC and ensure that the REC has the
appropriate financial and administrative
independence to fulfill its primary duties.
Is it always bad?
COIs may result in:
1. Loss of objectivity
2. Reordering of priorities towards
applied research
3. Degradation of the nature of
science as a collegial enterprise
4. Exploitation of trainees
5. Transfer of time and interest to
commercial ventures
Practical Steps to resolve COI
•Disclosure / transparency
•Stringent analysis of COI,
•Review of contracts between
funders and researchers
•Close external monitoring
•Blinding of study, when possible
•Restrict review of colleague’s work
•Peer review of manuscripts
What is Ethical Review?
■ It is a process by which research proposals are
reviewed for their compliance and accordance with
the national/international ethical principles &
guidelines for research involving human subjects.
All research involving living human subjects by collecting
identifiable information or materials including:
 Research with human remains, cadavers, tissues,
biological fluids, embryos and fetuses.
 Interviews, surveys and questionnaires.
 Secondary data analysis of data from living human
subjects.
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.
Office of Research Integrity
(ORI)’s Definition of Plagiarism
■ … plagiarism to include both the theft or misappropriation
of intellectual property (IP) and the substantial
unattributed textual copying of another's work. It does not
include authorship or credit disputes.
■ … the unattributed verbatim or nearly verbatim copying of
sentences and paragraphs which materially mislead the
ordinary reader regarding the contributions of the author.
■ The theft or misappropriation of intellectual property (IP)
includes the unauthorized use of ideas or unique methods
obtained by a privileged communication, such as a grant or
manuscript review.
Forms of misconduct
■ Falsification ‫التزوير‬
■ Obfuscation‫التضليل‬
■ Fabrication‫التلفيق‬
■ Plagiarism ‫سرقة‬
‫فكرية‬
■ Self-plagiarism
■ Ghost writing ‫الكتابة‬
‫الشبحية‬
■ Bare assertions
‫دليل‬ ‫بال‬ ‫التأكيد‬
■ Improper authorship
■ Misappropriation‫اخت‬
‫الس‬
■ Bibliometric inflation
■ Violation of ethical
standards
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?orde
r=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

More Related Content

What's hot

Ethics in research
Ethics in researchEthics in research
Ethics in researchMira K Desai
 
Ethical Issues in Human Subjects Research - Department of Supportive Care
Ethical Issues in Human Subjects Research -  Department of Supportive CareEthical Issues in Human Subjects Research -  Department of Supportive Care
Ethical Issues in Human Subjects Research - Department of Supportive CareGlobal Institute GIPPEC
 
Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014researchcenterm
 
historical_background_research_ethics
historical_background_research_ethicshistorical_background_research_ethics
historical_background_research_ethicsDr Ghaiath Hussein
 
Ethics in research
Ethics in researchEthics in research
Ethics in researchEd Horowicz
 
What is salami slicing
What is salami slicingWhat is salami slicing
What is salami slicingJustin Dabin
 
Research ethics overview for social science researchers
Research  ethics  overview for social science researchers Research  ethics  overview for social science researchers
Research ethics overview for social science researchers Sarah Quinton
 

What's hot (20)

History of human research ethics
History of human research ethicsHistory of human research ethics
History of human research ethics
 
Ethics in research
Ethics in researchEthics in research
Ethics in research
 
Ethical Issues in Human Subjects Research - Department of Supportive Care
Ethical Issues in Human Subjects Research -  Department of Supportive CareEthical Issues in Human Subjects Research -  Department of Supportive Care
Ethical Issues in Human Subjects Research - Department of Supportive Care
 
Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014
 
Ethics in Research
Ethics in ResearchEthics in Research
Ethics in Research
 
Research ethics
Research ethicsResearch ethics
Research ethics
 
Ethical principles in research
Ethical principles in researchEthical principles in research
Ethical principles in research
 
historical_background_research_ethics
historical_background_research_ethicshistorical_background_research_ethics
historical_background_research_ethics
 
Ethics in research
Ethics in researchEthics in research
Ethics in research
 
Research ethics
Research ethicsResearch ethics
Research ethics
 
What is salami slicing
What is salami slicingWhat is salami slicing
What is salami slicing
 
Research ethics
Research ethicsResearch ethics
Research ethics
 
Research ethics overview for social science researchers
Research  ethics  overview for social science researchers Research  ethics  overview for social science researchers
Research ethics overview for social science researchers
 
Research Ethic and Scientific Integrity
Research Ethic and Scientific IntegrityResearch Ethic and Scientific Integrity
Research Ethic and Scientific Integrity
 
Research ethics
Research ethicsResearch ethics
Research ethics
 
Research ethics
Research  ethicsResearch  ethics
Research ethics
 
Research Ethics
Research EthicsResearch Ethics
Research Ethics
 
Ethical issues in research 2
Ethical issues in research 2Ethical issues in research 2
Ethical issues in research 2
 
Ethics in research
Ethics in researchEthics in research
Ethics in research
 
Authorship
AuthorshipAuthorship
Authorship
 

Similar to Lecture 18 research ethics (1)

Ethical considerations in molecular & biotechnology research
Ethical considerations in molecular & biotechnology researchEthical considerations in molecular & biotechnology research
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
 
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...EMPHNET-PHE Course: Module seven ethical issues in public health research& in...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
 
Ethical Concerns Regarding Research on Human Subjects
Ethical Concerns Regarding Research on Human SubjectsEthical Concerns Regarding Research on Human Subjects
Ethical Concerns Regarding Research on Human SubjectsClinosolIndia
 
historical_background_research_ethics
historical_background_research_ethicshistorical_background_research_ethics
historical_background_research_ethicsDr Ghaiath Hussein
 
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.ppt
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.pptEthical Issues in Medical Research_12 Jan 2017_Fortis Mulund.ppt
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.pptRitaLakhani2
 
Lecture 4 history and ethical codes
Lecture 4  history and ethical codesLecture 4  history and ethical codes
Lecture 4 history and ethical codesIshah Khaliq
 
Unit 2,ethical consideration in research
Unit 2,ethical consideration in researchUnit 2,ethical consideration in research
Unit 2,ethical consideration in researchChanda Jabeen
 
Research Ethics ARC Speakers Series v4.0
Research Ethics ARC Speakers Series v4.0Research Ethics ARC Speakers Series v4.0
Research Ethics ARC Speakers Series v4.0James Goho
 
Scientific Research And Ethics by Manu Shreshtha
Scientific Research And Ethics by Manu ShreshthaScientific Research And Ethics by Manu Shreshtha
Scientific Research And Ethics by Manu ShreshthaManu Shreshtha
 
Ethics and nursing research
Ethics and nursing researchEthics and nursing research
Ethics and nursing researchRafath Razia
 
Research Ethics for JPCFM (Jan2011)
Research Ethics for JPCFM (Jan2011)Research Ethics for JPCFM (Jan2011)
Research Ethics for JPCFM (Jan2011)Dr Ghaiath Hussein
 
History ethical guide lines to clinical trial
History ethical guide lines to clinical trialHistory ethical guide lines to clinical trial
History ethical guide lines to clinical trialAnju Thejkumar
 
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdf
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdfKornetsky 1- Investigators' Responsibility PRINTABLE.pdf
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdfHebaLatif1
 
5.ethical consideration in research
5.ethical consideration in research5.ethical consideration in research
5.ethical consideration in researchAESHA ZAFNA
 
Ethical Principles Of The Tuskegee Study
Ethical Principles Of The Tuskegee StudyEthical Principles Of The Tuskegee Study
Ethical Principles Of The Tuskegee StudyMelissa Long
 
ETHICAL ISSUES IN BIOMEDICAL RESEARCH
ETHICAL ISSUES IN BIOMEDICAL RESEARCHETHICAL ISSUES IN BIOMEDICAL RESEARCH
ETHICAL ISSUES IN BIOMEDICAL RESEARCHHealth Forager
 
General Ethics.ppthghhgghhgghfddddghhhgjhh
General Ethics.ppthghhgghhgghfddddghhhgjhhGeneral Ethics.ppthghhgghhgghfddddghhhgjhh
General Ethics.ppthghhgghhgghfddddghhhgjhhKennyjrLMunisi
 

Similar to Lecture 18 research ethics (1) (20)

Ethical considerations in molecular & biotechnology research
Ethical considerations in molecular & biotechnology researchEthical considerations in molecular & biotechnology research
Ethical considerations in molecular & biotechnology research
 
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...EMPHNET-PHE Course: Module seven ethical issues in public health research& in...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...
 
Ethical Concerns Regarding Research on Human Subjects
Ethical Concerns Regarding Research on Human SubjectsEthical Concerns Regarding Research on Human Subjects
Ethical Concerns Regarding Research on Human Subjects
 
historical_background_research_ethics
historical_background_research_ethicshistorical_background_research_ethics
historical_background_research_ethics
 
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.ppt
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.pptEthical Issues in Medical Research_12 Jan 2017_Fortis Mulund.ppt
Ethical Issues in Medical Research_12 Jan 2017_Fortis Mulund.ppt
 
Lecture 4 history and ethical codes
Lecture 4  history and ethical codesLecture 4  history and ethical codes
Lecture 4 history and ethical codes
 
Topic7 research ethics (1)
Topic7 research ethics (1)Topic7 research ethics (1)
Topic7 research ethics (1)
 
Unit 2,ethical consideration in research
Unit 2,ethical consideration in researchUnit 2,ethical consideration in research
Unit 2,ethical consideration in research
 
Research Ethics ARC Speakers Series v4.0
Research Ethics ARC Speakers Series v4.0Research Ethics ARC Speakers Series v4.0
Research Ethics ARC Speakers Series v4.0
 
Scientific Research And Ethics by Manu Shreshtha
Scientific Research And Ethics by Manu ShreshthaScientific Research And Ethics by Manu Shreshtha
Scientific Research And Ethics by Manu Shreshtha
 
Ethics and nursing research
Ethics and nursing researchEthics and nursing research
Ethics and nursing research
 
Ethics in health research
Ethics in health researchEthics in health research
Ethics in health research
 
Research Ethics for JPCFM (Jan2011)
Research Ethics for JPCFM (Jan2011)Research Ethics for JPCFM (Jan2011)
Research Ethics for JPCFM (Jan2011)
 
Ethical issues (2)
Ethical issues (2)Ethical issues (2)
Ethical issues (2)
 
History ethical guide lines to clinical trial
History ethical guide lines to clinical trialHistory ethical guide lines to clinical trial
History ethical guide lines to clinical trial
 
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdf
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdfKornetsky 1- Investigators' Responsibility PRINTABLE.pdf
Kornetsky 1- Investigators' Responsibility PRINTABLE.pdf
 
5.ethical consideration in research
5.ethical consideration in research5.ethical consideration in research
5.ethical consideration in research
 
Ethical Principles Of The Tuskegee Study
Ethical Principles Of The Tuskegee StudyEthical Principles Of The Tuskegee Study
Ethical Principles Of The Tuskegee Study
 
ETHICAL ISSUES IN BIOMEDICAL RESEARCH
ETHICAL ISSUES IN BIOMEDICAL RESEARCHETHICAL ISSUES IN BIOMEDICAL RESEARCH
ETHICAL ISSUES IN BIOMEDICAL RESEARCH
 
General Ethics.ppthghhgghhgghfddddghhhgjhh
General Ethics.ppthghhgghhgghfddddghhhgjhhGeneral Ethics.ppthghhgghhgghfddddghhhgjhh
General Ethics.ppthghhgghhgghfddddghhhgjhh
 

More from Dr Ghaiath Hussein

نظرية التطور عند المسلمين (بروفيسور محمد علي البار
نظرية التطور عند المسلمين (بروفيسور محمد علي البارنظرية التطور عند المسلمين (بروفيسور محمد علي البار
نظرية التطور عند المسلمين (بروفيسور محمد علي البارDr Ghaiath Hussein
 
10 Tips to make your search in Google Scholar more effective.pdf
10 Tips to make your search in Google Scholar more effective.pdf10 Tips to make your search in Google Scholar more effective.pdf
10 Tips to make your search in Google Scholar more effective.pdfDr Ghaiath Hussein
 
Ethical considerations in research during armed conflicts.pptx
Ethical considerations in research during armed conflicts.pptxEthical considerations in research during armed conflicts.pptx
Ethical considerations in research during armed conflicts.pptxDr Ghaiath Hussein
 
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...Dr Ghaiath Hussein
 
Research or not research (JCB 17.11.21).pptx
Research or not research (JCB 17.11.21).pptxResearch or not research (JCB 17.11.21).pptx
Research or not research (JCB 17.11.21).pptxDr Ghaiath Hussein
 
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrain
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrainMedically assisted dying in (MAiD) Ireland - mapping the ethical terrain
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrainDr Ghaiath Hussein
 
الجوانب الأخلاقية في العلاج الجيني
الجوانب الأخلاقية في العلاج الجينيالجوانب الأخلاقية في العلاج الجيني
الجوانب الأخلاقية في العلاج الجينيDr Ghaiath Hussein
 
الضرر في العمل الطبي-البروفيسور جمال جار الله
الضرر في العمل الطبي-البروفيسور جمال جار اللهالضرر في العمل الطبي-البروفيسور جمال جار الله
الضرر في العمل الطبي-البروفيسور جمال جار اللهDr Ghaiath Hussein
 
العلاج الجيني والاخلاق
العلاج الجيني والاخلاقالعلاج الجيني والاخلاق
العلاج الجيني والاخلاقDr Ghaiath Hussein
 
القتل الرحيم و النظرة الإسلامية له
القتل الرحيم و النظرة الإسلامية لهالقتل الرحيم و النظرة الإسلامية له
القتل الرحيم و النظرة الإسلامية لهDr Ghaiath Hussein
 
القواعد الفقهية لتخصص التخدير (2)
القواعد الفقهية لتخصص التخدير (2)القواعد الفقهية لتخصص التخدير (2)
القواعد الفقهية لتخصص التخدير (2)Dr Ghaiath Hussein
 
المقارنة بين الفلسفات الغربية والمقاربة الإسلام
المقارنة بين الفلسفات الغربية والمقاربة الإسلامالمقارنة بين الفلسفات الغربية والمقاربة الإسلام
المقارنة بين الفلسفات الغربية والمقاربة الإسلامDr Ghaiath Hussein
 
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهير
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهيرتحديد الوفاة بالقرائن الدماغية الدكتور محمد زهير
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهيرDr Ghaiath Hussein
 
الاحتضار والموت والمنظور الشرعي له التعامل مع المحتضر والميت طلب عدم الإنعاش...
الاحتضار والموت والمنظور الشرعي له  التعامل مع المحتضر والميت طلب عدم الإنعاش...الاحتضار والموت والمنظور الشرعي له  التعامل مع المحتضر والميت طلب عدم الإنعاش...
الاحتضار والموت والمنظور الشرعي له التعامل مع المحتضر والميت طلب عدم الإنعاش...Dr Ghaiath Hussein
 
إسهامات الفقهاء والأطباء في تطبيق القواعد الفقهية
إسهامات الفقهاء    والأطباء في تطبيق القواعد الفقهيةإسهامات الفقهاء    والأطباء في تطبيق القواعد الفقهية
إسهامات الفقهاء والأطباء في تطبيق القواعد الفقهيةDr Ghaiath Hussein
 
جراحات التجميل ـ محاضرة كلية الطب
جراحات التجميل ـ محاضرة كلية الطبجراحات التجميل ـ محاضرة كلية الطب
جراحات التجميل ـ محاضرة كلية الطبDr Ghaiath Hussein
 
حقوق المريض ـ الحوار الوطني
حقوق المريض ـ الحوار الوطنيحقوق المريض ـ الحوار الوطني
حقوق المريض ـ الحوار الوطنيDr Ghaiath Hussein
 
حقوق المريض في الاسلام
حقوق المريض في الاسلامحقوق المريض في الاسلام
حقوق المريض في الاسلامDr Ghaiath Hussein
 
دراسة حالة وتقديمها
دراسة حالة وتقديمهادراسة حالة وتقديمها
دراسة حالة وتقديمهاDr Ghaiath Hussein
 
سوء الممارسة الطبية 1
سوء الممارسة الطبية 1سوء الممارسة الطبية 1
سوء الممارسة الطبية 1Dr Ghaiath Hussein
 

More from Dr Ghaiath Hussein (20)

نظرية التطور عند المسلمين (بروفيسور محمد علي البار
نظرية التطور عند المسلمين (بروفيسور محمد علي البارنظرية التطور عند المسلمين (بروفيسور محمد علي البار
نظرية التطور عند المسلمين (بروفيسور محمد علي البار
 
10 Tips to make your search in Google Scholar more effective.pdf
10 Tips to make your search in Google Scholar more effective.pdf10 Tips to make your search in Google Scholar more effective.pdf
10 Tips to make your search in Google Scholar more effective.pdf
 
Ethical considerations in research during armed conflicts.pptx
Ethical considerations in research during armed conflicts.pptxEthical considerations in research during armed conflicts.pptx
Ethical considerations in research during armed conflicts.pptx
 
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...
Medically Assisted Dying in (MAiD) Ireland - Mapping the Ethical Terrain (May...
 
Research or not research (JCB 17.11.21).pptx
Research or not research (JCB 17.11.21).pptxResearch or not research (JCB 17.11.21).pptx
Research or not research (JCB 17.11.21).pptx
 
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrain
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrainMedically assisted dying in (MAiD) Ireland - mapping the ethical terrain
Medically assisted dying in (MAiD) Ireland - mapping the ethical terrain
 
الجوانب الأخلاقية في العلاج الجيني
الجوانب الأخلاقية في العلاج الجينيالجوانب الأخلاقية في العلاج الجيني
الجوانب الأخلاقية في العلاج الجيني
 
الضرر في العمل الطبي-البروفيسور جمال جار الله
الضرر في العمل الطبي-البروفيسور جمال جار اللهالضرر في العمل الطبي-البروفيسور جمال جار الله
الضرر في العمل الطبي-البروفيسور جمال جار الله
 
العلاج الجيني والاخلاق
العلاج الجيني والاخلاقالعلاج الجيني والاخلاق
العلاج الجيني والاخلاق
 
القتل الرحيم و النظرة الإسلامية له
القتل الرحيم و النظرة الإسلامية لهالقتل الرحيم و النظرة الإسلامية له
القتل الرحيم و النظرة الإسلامية له
 
القواعد الفقهية لتخصص التخدير (2)
القواعد الفقهية لتخصص التخدير (2)القواعد الفقهية لتخصص التخدير (2)
القواعد الفقهية لتخصص التخدير (2)
 
المقارنة بين الفلسفات الغربية والمقاربة الإسلام
المقارنة بين الفلسفات الغربية والمقاربة الإسلامالمقارنة بين الفلسفات الغربية والمقاربة الإسلام
المقارنة بين الفلسفات الغربية والمقاربة الإسلام
 
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهير
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهيرتحديد الوفاة بالقرائن الدماغية الدكتور محمد زهير
تحديد الوفاة بالقرائن الدماغية الدكتور محمد زهير
 
الاحتضار والموت والمنظور الشرعي له التعامل مع المحتضر والميت طلب عدم الإنعاش...
الاحتضار والموت والمنظور الشرعي له  التعامل مع المحتضر والميت طلب عدم الإنعاش...الاحتضار والموت والمنظور الشرعي له  التعامل مع المحتضر والميت طلب عدم الإنعاش...
الاحتضار والموت والمنظور الشرعي له التعامل مع المحتضر والميت طلب عدم الإنعاش...
 
إسهامات الفقهاء والأطباء في تطبيق القواعد الفقهية
إسهامات الفقهاء    والأطباء في تطبيق القواعد الفقهيةإسهامات الفقهاء    والأطباء في تطبيق القواعد الفقهية
إسهامات الفقهاء والأطباء في تطبيق القواعد الفقهية
 
جراحات التجميل ـ محاضرة كلية الطب
جراحات التجميل ـ محاضرة كلية الطبجراحات التجميل ـ محاضرة كلية الطب
جراحات التجميل ـ محاضرة كلية الطب
 
حقوق المريض ـ الحوار الوطني
حقوق المريض ـ الحوار الوطنيحقوق المريض ـ الحوار الوطني
حقوق المريض ـ الحوار الوطني
 
حقوق المريض في الاسلام
حقوق المريض في الاسلامحقوق المريض في الاسلام
حقوق المريض في الاسلام
 
دراسة حالة وتقديمها
دراسة حالة وتقديمهادراسة حالة وتقديمها
دراسة حالة وتقديمها
 
سوء الممارسة الطبية 1
سوء الممارسة الطبية 1سوء الممارسة الطبية 1
سوء الممارسة الطبية 1
 

Recently uploaded

Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.aarjukhadka22
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfHongBiThi1
 
High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)kishan singh tomar
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfDolisha Warbi
 
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...Shubhanshu Gaurav
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismusChandrasekar Reddy
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologyDeepakDaniel9
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectiondrhanifmohdali
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxNaveenkumar267201
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdfHongBiThi1
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentsaileshpanda05
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.whalesdesign
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu Medical University
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaSujoy Dasgupta
 

Recently uploaded (20)

Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
 
High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
 
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismus
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacology
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissection
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing student
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.
 
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
 
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
 

Lecture 18 research ethics (1)

  • 1. Ghaiath Hussein, MBBS, MHSc. (Bioethics), Doctoral Researcher (UK) Assistant Professor of Bioethics
  • 2. Outline ■ Research in context: the Knowledge Management Cycle (KMC) ■ 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?
  • 3. Where are we in R&D? Source: http://www.worldmapper.org/display.php?selected=165
  • 4. 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
  • 5. 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
  • 6. Research in Context...the KMC Generation Dissemination Synthesis Utilization Assessment Statistics
  • 7. 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
  • 8. Good Science •Problem selection •SMART objectives •Proper methodology •Proper analysis •Fair subject selection •Favorable Risk-Benefit Ratio •Independent Review •Informed Consent
  • 9. 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.
  • 10. 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
  • 11. 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
  • 13. 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)
  • 14. 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
  • 15. The Nuremberg Code (1947) The first provision of the code requires that “the voluntary informed consent of the human subject is absolutely essential.” The code provides other details implied by such a requirement: ■ Voluntary consent absolutely essential (restricting research with infants, children, developmentally challenged, etc.) ■ Freedom from coercion ■ Comprehension of the risks and benefits involved ■ Experiment to be conducted by highest qualified persons ■ Risk/Benefit Analysis essential to ethics review ■ Scientific Soundness is important to ethics review The code on the web: http://ohsr.od.nih.gov/nuremberg.php3
  • 16. The Declaration of Helsinki (DOH)  The World Medical Association created the Declaration of Helsinki in 1964 and amended regularly since 1975 The main issues emphasized were:  “The well-being of the subject should take precedence over the interests of science and society”  Respect for Persons – people are not a means to an end; researchers have duty to protect life, health, privacy and dignity of research participants  Consent should be in writing  Standard of care must be best available, even for control group  Greater access to benefit  Use caution if participant is in dependent relationship with researcher  Limited use of placebo
  • 17.  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 )
  • 18. 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.
  • 19. 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
  • 20. 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.
  • 23. Some ethical issues in research Before •Benefit/harm analysis •Vulnerability (Risk- Vulnerability Matrix) •Fair selection of participation •Conflict of Interests (COI) During •Informed Consent •Privacy and confidentiality •Risk to researchers •Risk to participants After •Sharing results •Sharing benefits •Integrity & publication ethics
  • 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 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
  • 25. 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 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)
  • 26. 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)
  • 27. 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)
  • 29. What is IC? ■ A process whereby potential research participants decide whether they want to participate in the proposed study after receiving information about it. ■ 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.
  • 30. Components of IC: 1. "Disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. This refers to the process during which physicians provide information about the proposed research to the participant 2. "Capacity" refers to the patient's ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen. 3. "Voluntariness" refers to the patient's right to come to a decision freely, without force, coercion or manipulation.
  • 31. Eight Required Elements [45 CFR 46.116(a) & 21 CFR 50.25] 1. Statement that study in research and information on purposes / duration / procedures / experimental procedures 2. Reasonably foreseeable risks or discomforts 3. Reasonably expected benefits 4. Alternative procedures 5. How confidentiality will be maintained 6. Information on compensation for injuries (unless minimal risk) 7. Contact persons for information on research, injury, subject’s rights 8. Voluntary participation, no penalty or loss of benefits for
  • 32. Six Additional Elements 1. Statement that there may be risks which are unforeseeable 2. Under what circumstances investigator could terminate subject’s participation 3. Additional costs to subjects 4. Consequences of subject’s withdrawal from research 5. Statement that will be told of new findings 6. Approximate number of subjects in study
  • 33. Waiver of Informed Consent Conditions to waiver IC:  Poses no more than Minimal risk  Waiver or alteration will not adversely affect the rights and welfare of the subjects  Research could not practicably be carried out without the waiver or alteration  Does not involve a therapeutic intervention  Subjects will be provided with additional pertinent information All of the above must apply
  • 34. Documentation of Informed Consent  Written consent document  Language understandable to the subject or the subject’s Legally Authorized Representative (LAR), or  Signed by subject or subject’s LAR  Copy SHALL be given to subject  Opportunity to read before signing
  • 35. Principles for Providing Information to Participant: Make it clear; avoid jargon Use language appropriate to the participant’s level of understanding in a language of their fluency Invite questions from the patient and check for understanding Summarize the imparted information Provide contact information (and other resources)
  • 36. 2. Capacity: Refers to the presence of a group/set of functional abilities a person needs to possess in order to make a specific decisions (Griso and Applebaum, 1998). These include:  To UNDERSTAND the relevant information  To APPRECIATE the relatively foreseeable consequences of the various available options available.
  • 37. 3. Voluntariness: ■ Refers to a participant’s right to make participation decisions free of any undue influence. Influences include: ■ Physical restraint or sedation ■ Coercion involves the use of explicit or implicit threat to ensure that the treatment is accepted ■ Manipulation involves the deliberate distortion or omission of information in an attempt to induce the subject’s participation
  • 38. Practical Challenges to a "Fully Informed Consent" ■ Diagnostic uncertainty ■ Complexity of medical information ■ Linguistic and cultural differences ■ Overworked health personnel ■ Paternalistic approach in doctor-patient relationship in developing countries, including KSA.
  • 40. What is an interest? •An interest may be defined as a commitment, goal, or value held by an individual or an institution. •Examples include a research project to be completed, gaining status through promotion or recognition, and protecting the environment.
  • 41. What is COI? • Conflicts of interest are “situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator’s judgement in conducting or reporting research.” AAMC, 1990 • COI exists when two or more contradictory interests relate to an activity by an individual or an institution. • “A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance compromise the integrity of the research.” ■ NAS, Integrity in Scientific Research
  • 42. What comprises COI? • Stock ownership • Paid employment Board membership • Patent applications (pending or actual) • Research grants (from whatever source) • Travel grants and honoraria for speaking or participation at meetings • Gifts Membership of lobbying organizations • Relationship with the National Research Ethics Review Committee, or with possible reviewers of the paper • Relationship with organizations and funding bodies Membership of a government advisory board
  • 43. Levels of COI 1- Researchers •The REC should assess the likelihood that the researcher’s judgment may be influenced, or appear to be influenced, by private or personal interests (TCPS, 2000) 2- Conflicts of Interest by REC Members •It is of the highest importance that members of the REC avoid real or apparent conflicts of interest . •E.g.: their research are reviewed by their REC or when they have been in direct academic conflict or collaboration with the researcher whose proposal is under review.
  • 44. Levels of COI 3- Institutional Conflicts of Interest • Situations may arise where the parent organization has a strong interest in seeing a project approved before all ethical questions are resolved. • The REC must act independently from the parent organization. • Institutions must respect the autonomy of the REC and ensure that the REC has the appropriate financial and administrative independence to fulfill its primary duties.
  • 45. Is it always bad? COIs may result in: 1. Loss of objectivity 2. Reordering of priorities towards applied research 3. Degradation of the nature of science as a collegial enterprise 4. Exploitation of trainees 5. Transfer of time and interest to commercial ventures
  • 46. Practical Steps to resolve COI •Disclosure / transparency •Stringent analysis of COI, •Review of contracts between funders and researchers •Close external monitoring •Blinding of study, when possible •Restrict review of colleague’s work •Peer review of manuscripts
  • 47. What is Ethical Review? ■ It is a process by which research proposals are reviewed for their compliance and accordance with the national/international ethical principles & guidelines for research involving human subjects. All research involving living human subjects by collecting identifiable information or materials including:  Research with human remains, cadavers, tissues, biological fluids, embryos and fetuses.  Interviews, surveys and questionnaires.  Secondary data analysis of data from living human subjects.
  • 49. 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.
  • 50. Office of Research Integrity (ORI)’s Definition of Plagiarism ■ … plagiarism to include both the theft or misappropriation of intellectual property (IP) and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. ■ … the unattributed verbatim or nearly verbatim copying of sentences and paragraphs which materially mislead the ordinary reader regarding the contributions of the author. ■ The theft or misappropriation of intellectual property (IP) includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.
  • 51. Forms of misconduct ■ Falsification ‫التزوير‬ ■ Obfuscation‫التضليل‬ ■ Fabrication‫التلفيق‬ ■ Plagiarism ‫سرقة‬ ‫فكرية‬ ■ Self-plagiarism ■ Ghost writing ‫الكتابة‬ ‫الشبحية‬ ■ Bare assertions ‫دليل‬ ‫بال‬ ‫التأكيد‬ ■ Improper authorship ■ Misappropriation‫اخت‬ ‫الس‬ ■ Bibliometric inflation ■ Violation of ethical standards Source: http://en.wikipedia.org/wiki/Scientific_misconduct
  • 52. 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
  • 53. 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?orde r=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.
  • 54. 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