1.
Essential Skills in
Health Research
Dr Ghaiath MA Hussein, MBBS, MHSc. (Bioethics)
Doctoral Researcher, University of Birmingham, UK
Email: ghaiathme@gmail.com

2.
This Course: what it is (or not)?
This course is:
• Interactive, skill-based training
• Building on your previous
research knowledge
• Aiming to introduce you to
practical skills through group
work
• A chance to develop your
research skills and outcomes
This course is NOT
• Series of lectures
• Not an introduction to
research methods
• A course where you
listen, take notes and
go home!

3.
Who are we?
• I’m Ghaiath… you?
• Tell me about your current or recent
research activities

4.
Why are we here?
• Learning objectives:
KMC
• What is it?
• Where research
fits?
LR
• Which literature?
• How/where to
find?
• How to cite?
General
skills
• Online forms
• Reference
Management
software

5.
Where are we in R&D?
Source: http://www.worldmapper.org/display.php?selected=165

6.
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

7.
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

8.
Research in Context...the KMC
Generation
Dissemination
SynthesisUtilization
Assessment
Statistics

9.
“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
Better Research is Better Health

10.
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

11.
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.

12.
Criteria for Good Ethics:
WhatMakesResearchEthical?
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

13.
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

14.
Research-to-publication Cycle
Overview on research skills

15.
Research: where to start?
Idea/
observation
Proposal
ConductReporting
Publication

16.
Essential Research Skills
Before conduct (Prepare) During conduct (Do) After conduct
(Disseminate)
Review of literature Research methods (Q&Q) Reference management
Proposal writing Design of data collection
tools
Scientific writing
Grant writing (and hunting) Data analysis (Q&Q) Writing for publication
Research ethics Plagiarism Publication ethics
Cross-cutting skills:
• Critical thinking
• Leadership skills
• Project management
• Presentation (communication) skills
• Resource (Time) management
• Scientific writing

17.
REVIEW OF LITERATURE (LR)
Definition
Why do we need it?
When do we need it?
How to do it?
Disclosure: The following slides are modified from the University of Toronto writing website:
http://www.writing.utoronto.ca/advice/specific-types-of-writing/literature-review

18.
Definition: What LR is?
• A literature review (LR) is an account of what has been
published on a topic by accredited scholars and
researchers.
• LR is an evaluative report of information found in the
literature related to your selected area of study.
• It should describe, summarise, evaluate and clarify this
literature.
• Generally, the purpose of a review is to analyze critically a
segment of a published body of knowledge through
summary, classification, and comparison of prior research
studies, reviews of literature, and theoretical articles.

19.
What LR is NOT?
• It is not just a descriptive list of the material available, or
a set of summaries
• A literature review is more than the search for
information, and goes beyond being a
descriptive annotated bibliography.
• The following is NOT a LR:
Annotated bibliography List in text format
Ibrahim , S. D. (1995). Outcomes of
Intervention X on Pregnant women, Soba
Hospital." BMJ 2/3, 34-38.
This article discusses the effect of the
intervention X on pregnant women
delivering in Soba Teaching Hospital. It
also discusses the implications for
reducing factor Y on these women.
IBRAHIM and BANNAGA (1965)
conducted experiments on pregnant
women in STH, basing on the theoretical
investigation of X interaction
complemented by type Y. It showed that
the numerical results were in reasonable
agreement with laboratory experimental
data."

20.
Why/When do we need LR?
• LR can help in finding, developing, and/or fine-tuning your RQ.
• Determine the nature/method of your research
Find Research questions
• What is not known/established?
• What is not well known?
• What was not well-studied?
• Cross-referencing
Define gaps & references
• Strengths & weaknesses
• Theoretical base
• Comparison of findings
• Critical appraisal
Establish relations

21.
Do and Don’t in LR
• All works included in the review must be read, evaluated
and analysed (cf. annotated bibliography),
• Relationships between the literature must also be identified
and articulated, in relation to your field of research.
• LR must be defined by a guiding concept (e.g., your research
objective, the problem or issue you are discussing, or your
argumentative thesis).
• Works which are irrelevant should be discarded and those
which are peripheral should be looked at critically.

22.
Where to search?
• Library (institutional,
professional,
organizational)
• Archives
• Reports
Offline
• Journals websites
• Publishers’ databases
• Institutional databases
• Institutional libraries
Online

23.
Before going online…
remember!
• The printed resources have almost always been thoroughly ‘peer-
reviewed’, and systematically catalogued and cross-referenced
• On the Internet "anything goes."
• Don't rely exclusively on Internet resources.
• Narrow your research topic before logging on.
• Before you start your search, think about what you're looking for, and
if possible formulate some very specific questions to direct and limit
your search
• Know your subject directories and search engines.
• There are several high quality peer-reviewed subject directories
containing links selected by subject experts
• Keep a detailed record of sites you visit and the sites you use.
• Keeping track is necessary so that you can revisit the useful ones later,
and also put the required references in your paper.

24.
• BioMedCentral:
http://www.biomedcentral.com/
• PubMed Central (PMC):
http://www.ncbi.nlm.nih.gov/pmc/
• Google Scholar: http://scholar.google.com

25.
Online Literature Search
• A good literature search involves the following steps which should
be worked through systematically:
1. Background reading and preparation
2. Working with your title: identify search terms
3. Identify the resources to search
4. Search using search techniques
5. Collate your results
Source: Liverpool Hope University Doing a literature search: a step by step guide. URL:
http://www.hope.ac.uk/media/liverpoolhope/contentassets/documents/library/help/media,1256,en.pdf
Other helpful guides can be found on the following links:
https://becker.wustl.edu/sites/default/files/RespLitSearch.pdf
http://www.birmingham.ac.uk/facilities/hsmc-library/faqs/literature-searching.aspx

26.
LET’S GO ONLINE!
Task:
In your laptops/computers, use the
University of Birmingham literature
search strategy form to conduct an
online search of literature in your
relevant area of research.

27.
Reference
Management
06.01.2015

28.
Outline
• Revise the LR task
• Overview on Responsible Conduct of Research
• What are the Reference Management Software (RMS)?
• Why do we need them?
• How to choose which RMS?
• How to use them in:
• Importing references from the internet to your
PC/Laptop
• Building references databases
• CWYW (Cite While You Write)
• Transfer references among databases and RMS

29.
How was your task?
• What is easy/just ok/hard?
• What was the easiest part?
• What was the hardest part?
• How many words you managed to gather?
• How many references you found/used?

30.
BeforeWeGetOurhands Dirty!

31.
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.

32.
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
http://en.wikipedia.org/wiki/Scientific_misconduct

33.
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 IP includes the unauthorized
use of ideas or unique methods obtained by a privileged
communication, such as a grant or manuscript review.

34.
RMS: What they are?
• It is software for scholars and authors to use for recording and
utilising bibliographic citations (references).
• Once a citation has been recorded, it can be used time and
again in generating bibliographies, such as lists of references
in scholarly books, articles and essays.
• These software packages normally consist of a database in
which full bibliographic references can be entered.
• It can usually be integrated with word processors so that a
reference list in the appropriate format is produced
automatically as an article is written, reducing the risk that a
cited source is not included in the reference list.
Source: http://en.wikipedia.org/wiki/Reference_management_software

35.
RMS: What they do?
Source:(http://www.istl.org/11-summer/refereed2.html)
1. Import citations from bibliographic databases and websites
2. Allow organization of citations within the RM database
3. Allow annotation of citations
4. Allow sharing of the RM database or portions thereof with
colleagues
5. Allow data interchange with other RM products through
standard metadata formats (e.g., RIS, BibTeX)
6. Produce formatted citations in a variety of styles
7. Work with word processing software to facilitate in-text
citation

36.
Examples of RMs
Reference Management Software
(http://en.wikipedia.org/wiki/Reference_management_software)
Open source Retail Web-based
•BibDesk
•Docear
•Ilibrarian
•JabRef
•KBibTeX
•Pybliographer
•Referencer
•Wikindx
•Zotero
• Biblioscape
• Bookends
• Citavi
• Papers
• Qiqqa
• Sente
•BibSonomy
•Qiqqa
•Wikindx
•WizFolio
•Zotero

37.
1. Install your RM of choice
2. Do your online search
3. Build a new database
4. Transfer the reference from the web to your database
5. Use the references you imported in your document

38.
References
• Reference Management Software: a Comparative Analysis of
Four Products, Ron Gilmour, and Laura Cobus-Kuo,
(http://www.istl.org/11-summer/refereed2.html)
• Wikipedia:
http://en.wikipedia.org/wiki/Reference_management_software

39.
What is it?
Different types of scientific writing
Why/When do we need it?
Linguistic and technical tips
13.01.2015

40.
A reminder first ...the KMC
Generation
Dissemination
SynthesisUtilization
Assessment
Statistics

41.
Before writing…
you need to decide… Example
Why are you writing this? Academic requirement, dissemination,
advocacy and promotion
Who is/are your audience? Supervisors, journal editors, colleagues,
conference attendees
What are the requirements of the
audience?
University’s guidelines, manuscript
template, word limits, time limits
Which language you have to use? Lay, simplified technical, pure technical,
Arabic, English, mixed
Which ‘technology’ you will use? Word processers, presentation design,
poster design, photo editors

42.
Today: Two sets of skills
Editorial
Common features of SW
Common mistakes for NNS
Tips to make our SW better
Technical
Organizing your document
Dealing with long documents
Tips to for formatting

43.
Common features of SW
Your scientific writing should be:
• Precise: words mean what they meant to
mean
• Concise: meanings delivered with the least
number of words, & least complication
• Logic: each section builds on the previous
• Systematic: flows in structure
• Appropriate language: correct, readable,
suitable for purpose, and understandable

44.
To achieve them you need…
Divide your piece into (sub)headingsStructure
• IMRAD
• Familiarize with the templates (journal, university, grant, etc..)
Present your work graduallyLogic
• Give enough background
• Clear objectives, and description of methods
• Clear presentation of results
• Conclusions arise ‘logically’ from results
Keep it short!Language
• Read a lot, Write a lot, Submit a lot, and get rejected!
• Keep phrase banks, verb cheat sheets, grammar cheat sheets, etc..
• Share your drafts with colleagues

45.
Common language mistakes in SW
As non-native speakers (NNS) of English, we are more prone to:
• Wordiness: using numerous words in long sentences to get the
message across
• Transfers: what works in my language will work in English
• Assertiveness: use of either too weak or too assertive verbs
• Inappropriate structure: wrong syntax, grammar, spelling, and
punctuation
• Misuse of tables and figures: tables and figures are too few,
too many, or poorly presented
• Inappropriate citation: lack, or excessive, or inadequate use or
acknowledgment of others’ works

46.
Common language mistakes in SW
• Wordiness: using numerous words in long sentences to get the
message across
Example:
“Since its independence, the Sudan has witnessed a number of
political regimes that had different approaches to the
administrative division of the Sudan, including the administrative
division of the Sudan into either regions or states varied from 5
regions in the latest democracy that lasted from 1985, following
the outage of the former president Jaffar Numeiri until 1989
when a military coup took place, to 25 states before the
separation of the southern part of the country to the currently
18 northern Sudanese states.”
• What do you think? Task: write it down in a better way

47.
Examples of other mistakes
Mistake Example of mistake Correction
Transfers/ Mistranslation
what works in Arabic will
work in English
‫عام‬ ‫استغالله‬ ‫على‬ ‫السودان‬ ‫حصل‬
1965.
Sudan got its abuse in 1956.
Assertiveness
use of either too weak or
too assertive verbs
“this study clearly shows
that factor X has caused a
very huge improvement in
the clinical outcome”
“the findings of the study
strongly suggests that
factor X could be a
significant factor to the
improvement in the
clinical outcome”
Inappropriate structure:
wrong syntax, grammar,
spelling, and punctuation
“the outlayers were
excluded from the analysis”
“the outliers were…”
“assessment of factors
affecting prevalence of DM
in pregnant women revising
Soba Hospital, case study of
Khartoum”
Correction?

48.
Tips for better writing
• Keep sentences short. Connect with clauses. (See Sudan example
above)
• Maintain the tenses consistent all over your piece
• Use synonyms and idiosyncrasies for variability
• Define acronyms (and other jargon) when used
• Nominalization: (-tion)it makes your writing looks smarter, but
lacks the ‘who’
• If you are to choose between clarity and wordiness; choose
clarity
• Use positive; avoid passive voices (if possible)

49.
Tables & figures
• What is wrong with this table?
Men Group 1 Men group 2 Rats
Serum Protein A
(Mg/l)
100 158 -
Blood glucose
(mmol/L)
102 160 154
Weight
(average)
138.8989 150.8 1.6588887
Activity level 0 5 8
Data on different responses

50.
What is wrong with this figure?
Diagram of response at different days after treatment
Days after treatment

51.
Let MS Word Works for You
1. Dividing your document: page breaks
2. Use of Styles and Headings
3. Table of contents
4. Review and Track Changes
5. Spelling and grammar check
6. Readability scores

52.
Why do we need to publish?
Where to publish?
Tips to writing for publication
What to do before, during, and after manuscript submission?
Common pitfalls in attempts to publish
20.01.2015
This section is largely based on Springer Author Academy available free online:
http://academy.springer.com/

53.
Why do we need to publish?
• Contribute to knowledge
• Gain academic prestige
• Career Promotion
• Peer-pressure
• Better CV - better job
• Required by the grant/donor
• Writing for money?

54.
Where to publish?
• Peer-reviewed scientific Non peer-reviewed
Peer reviewed Non peer-reviewed
• Scientific (specialized)
journals chosen on:
- Impact factor
- Reputation
- Readability
- Relevance to specialty
- Open access
- Length restriction
- Publication fees
• Newsletters
• Bulletins
• Social media (blogs)
• Professional social
media:
- Academia.edu
- LinkedIn.com
- ?Slideshare.com
- ResearchGate.com

55.
Overview on the publication process:
Manuscript preparation
• Choose your journal
• Read & follow author’s guide
Submission
• Register on online submission
• Letter to the editor
• Text manuscript
• Tables & figures
Peer review & Decision
• The (section) editor reviews
• Only if editor is convinced; sent to
peer review
• Reject, major changes, minor
changes, or accept as such
Publication
• Review the proofs
• Accept the proofs
• Share the publication

56.
Manuscript Preparation
• Before writing
 Read/discuss on the topic you want to publish in
 Identify what you want to publish
 Identify why do you want to publish
 Decide on the key message
 Decide on the best manuscript type
 Agree on tasks (who will do what when?)
 Decide on the journal
 Read the journal’s author’s guide (template,
structure, style, etc..)
 Agree on authorship (defined later)

57.
it is NOT all about the manuscript
The following MUST be submitted with the manuscript:
• Cover letter
• Abstract: Introduction, Rationale/Objectives, Methods,
Results, Discussion, Conclusion,
• Manuscript:
• Tables
• Figures
1. Title 2. Authors’ names, titles, affiliations, contacts
3. Keywords 4. Abstract
5. Introduction 6. Rationale/Objectives
7. Methods & Material 8. Results
9. Discussion 10. Conclusion/Recommendations
11. Limitations 12. References
13. Acknowledgment 14. COI Statement

58.
Manuscript should be:
• Tell an interesting story (why is it important?)
• Novel
• Timely
• Clear, concise, correct, and readable
• Use evidence and argument (counter-argument)
• Use non-text representation
• Use well designed cases, examples, vignettes, etc..
• Use up-to-date references (at least 75% of
references from the last 5 years)
• Follow the journal’s requirements and ethical
guidelines

59.
• IMRaD structure (Introduction, Materials and
Methods, Results, Discussion and Conclusions)
• IMRD is mainly for submission NOT necessarily for
writing
• Writing can start simultaneously from results,
introduction, materials, etc.
• Abstract is usually the last section to write
• Discussion & conclusion should not be written before
results

60.
Cover letter
• It is a letter you send to the editor to ‘sell’ him/her your work
• It explains why the editor would want to publish your manuscript
• Bad example:
• “Dear Editor-in-Chief,
I am sending you our manuscript entitled “Large Scale Analysis of Cell
Cycle Regulators in bladder cancer” by Researcher et al. We would
like to have the manuscript considered for publication in
Pathobiology.
Please let me know of your decision at your earliest convenience.
With my best regards,
Sincerely yours,
A Researcher, PhD”
Source:
http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo

61.
Cover letter … cont.
Commonly used phrases include:
• Please find enclosed our manuscript, “[manuscript title]” by [first
author's name] et al., which we would like to submit for
publication as a [publication type] in [name of the journal].
• To our knowledge, this is the first report showing…
• We believe our findings would appeal to the readership of
[journal name].
• Please address all correspondence to:
• We look forward to hearing from you at your earliest
convenience.
All cover letters should contain these sentences:
• We confirm that this manuscript has not been published
elsewhere and is not under consideration by another journal.
• All authors have approved the manuscript and agree with its
submission to [insert the name of the target journal].
Source:
http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo

62.
Tips for persuasive cover letter
• Address the editor with his/her name and title
• Write the date
• Write the title and the type of the submitted manuscript
• Write a paragraph about your study
• Be brief without a lot of background
• Specify its objective and what makes it unique
• Couple of statements on the methods you used and your main
findings
• Why your findings could be interesting and why they suitable for
publication in this particular journal ?
• Use the required statements (se examples above)
• Sign with the corresponding author’s name and contact
• End by “Yours sincerely”
Source:
http://academy.springer.com/journalauthoracademypart2submittingandpeerreview/node/3668#.VL3ojiuUfXo

63.
Abstract
• A summary of the content of the journal manuscript
• A time-saving shortcut for busy researchers
• A guide to the most important parts of your manuscript’s
written content
• Many readers will only read the Abstract of your manuscript
then decide whether they want to read the rest of the paper.
• Therefore, it has to be able to stand alone.
• Make sure you follow the proper journal manuscript formatting
guidelines (including word count) when preparing your abstract.
Your Abstract should answer these questions about your
manuscript:
• What was done?
• Why did you do it?
• What did you find?
• Why are these findings useful and important?

64.
An Effective Title
An effective title should:
• Grab attention and Attract readers
• Be concise and accurately describe the contents of your manuscript,.
• Convey the main topics of the study
• Highlight the importance of the research and makes people want to read further
Poor Example:
• Does Vaccinating Children and Adolescents with Inactivated Influenza Virus Inhibit
the Spread of Influenza in Unimmunized Residents of Rural Communities? (This title
has too many unnecessary words)
• Influenza Vaccination of Children: A Randomized Trial (This title doesn’t give enough
information about what makes the manuscript interesting)
Effective example:
• Effect of Child Influenza Vaccination on Infection Rates in Rural Communities: A
Randomized Trial
• This is an effective title. It is short, easy to understand, and conveys the important
aspects of the research.
• TIP: Write down a few possible titles, and then select the best to refine further. Ask
your colleagues their opinion. Spending the time needed to do this will result in a
better title.

65.
Introduction, Materials and
Methods, Results
Introduction Materials and Methods Results
Adequate Use subheadings Do not interpret the results
Relevant Use past tense Use subheadings
Up-to-date Detailed enough for
reproducibility
Present in a logical order
Balanced State all statistical tests and
parameters
Use the past tense
Subheading may
be needed
Use figures and tables ; however,
refer to in the present tense. Do
not duplicate data among figures,
tables, and text
Adequately
cited
Include the results of statistical
analyses in the text (usually by
providing p values when
statistically significant)

66.
Discussion & Conclusion
• They answer the question: What do your results mean?
• Discuss your conclusions in order of most to least important.
• Compare your results with those from other studies: Are they
consistent? If not, discuss possible reasons for the difference.
• Mention any inconclusive results and explain them as best you can.
You may suggest additional experiments needed to clarify your
results.
• Briefly describe the limitations of your study to show reviewers and
readers that you have considered your experiment’s weaknesses.
• Discuss what your results may mean for researchers in the same
field as you, researchers in other fields, and the general public. How
could your findings be applied?
• State how your results extend the findings of previous studies.
• If your findings are preliminary, suggest future studies that need to
be carried out.
• At the end of your Discussion and Conclusions sections, state your
main conclusions once again.

67.
Effective Use of References
• Why we use them?
• Establish where ideas came from
• Give evidence for claims
• Connect readers to other research
• Provide a context for your work
• Show that there is interest in this field of research
• Be sure to cite publications whose results disagree with
yours.
• Never cite a publication based on what you have read in a
different publication (such as a review), or based only on the
publication’s abstract.
• Use reference management software

68.
Why manuscripts get rejected?
• Poor structure (including not following journal’s requirements)
• Lacks of necessary details
• Has poor or no new science/knowledge (not novel or genuine)
• Lack of clarity (content, hypotheses, science, or language)
• Poor or inappropriate use of references: not up-to-date,
Plagiarism
• Contains theories, concepts, or conclusions that are not fully
supported by its data, arguments, and information
• Does not provide enough details about materials and methods
• Describes poor experimental design, or faulty or insufficient
statistical analysis
• Lack of ethical requirements

69.
Final talk about ethics
• Informed consent
• Conflict of interests
• Plagiarism and scientific misconduct
• Authorship

70.
What Makes a 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

71.
Criteria of “Good” Science
Research
• Systematic: The research developed, implemented
and reported in a systematic manner.
• Methodolic: 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.

72.
Criteria for Good Ethics:
WhatMakesResearchEthical?
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

73.
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

74.
History of Research Ethics
Pre-World War II
• Research standards left up to the discretion of the
individual researcher
World War II
• Experiments conducted on inmates of Nazi concentration
camps
• 1945-1949 - Trials in Nuremberg, Germany– physicians
convicted of crimes against humanity

75.
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

76.
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)

77.
Nazi Doctors’ Experimentation

78.
InternationalResearchGuidelines
Nuremberg Code (1947)
- As a result of WWII Nazi experiments
- First international code in research ethics
• Voluntary consent absolutely essential
(restricting research with infants, children, developmentally
challenged, etc.)
• Risk/Benefit Analysis essential to ethics review
• Scientific Soundness is important to ethics review

79.
The NurembergCode (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:
• Capacity to consent
• Freedom from coercion
• Comprehension of the risks and benefits involved
• Experiment to be conducted by highest qualified persons
The code on the web: http://ohsr.od.nih.gov/nuremberg.php3

80.
The Declarationof 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”
 Consent should be in writing
 Use caution if participant is in dependent relationship with
researcher
 Limited use of placebo
 Greater access to benefit

81.
WorldMedicalAssociationWMA (1964)
Respect for Persons – people are not a means to an
end; researchers have duty to protect life, health,
privacy and dignity of research participants
Standard of care must be best available, even for
control group
Proxy consent and assent for vulnerable populations

82.
 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 )

83.
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.

84.
CouncilforInternationalOrganizations
ofMedicalScience(CIOMS)Guidelines(1993)
• Informed consent
• Research in developing countries
• Protection of vulnerable populations
• Distribution of the burdens and benefits
• Role of ethics committees

85.
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.

86.
What’s ethically unique about molecular
biology and biotechnology?
ETHICAL ISSUES IN RESEARCH ON
HUMANS

87.
Very rapidly progressing…

88.
Very wide possibilities…
• Identification of the genes responsible for human diseases,
• Identification of the mutations underlying a vast number of phenotypes
• health care (medical), crop production and agriculture, non food
(industrial) uses of crops and other products
• Examples:
• biodegradable plastics, vegetable oil, biofuels), and
environmental uses.
• manufacture of organic products (e.g. milk products)
• Used to recycle, treat waste, cleanup sites contaminated
by industrial activities (bioremediation), and
• to produce biological weapons.

89.
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

90.
Informed Consent

91.
Definition
“Autonomous authorization of a medical intervention…by
individual patients/participants“
(Beauchamp and Faden, 2004)
It's the practical expression of patient's autonomy, and the
respect for him/her personality

92.
Components of FIC:
1. "Disclosure" refers to the provision of relevant
information by the clinician and its comprehension
by the patient.
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.

93.
Disclosure
VoluntarinessCapacity

94.
1. Disclosure
This refers to the process during which
physicians provide information about the
proposed research to the participant.

95.
Eight Required Elements
[45CFR46.116(a)&21CFR50.25]
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

96.
Eight Required Elements Cont.
[45CFR46.116(a)&21CFR50.25]
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
refusal or withdrawal

97.
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

98.
Forms of Consent
Normally, should be provided by participants themselves.
• Deferred consent: is where the subject is entered into a research
study and consent is gained from surrogates after a specified
period of time for continuation of the subject’s inclusion in the
trial.
• Prospective informed consent : represents an attempt to canvass
support in advance from a population considered at risk of
developing a serious illness.
• Surrogate consent (SDM): ideally a substituted judgment made by a
person responsible for health care decision-making for a particular
patient under the relevant legislation

99.
Waiver of Informed Consent
REC must find and document that the following criteria
have been satisfied:
 Poses no more than Minimal risk research
 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

100.
Documentation of Informed
Consent
 Written consent document
 Language understandable to the subject or the subject’s
Legally Authorized Representative (LAR)
 Signed by subject or subject’s LAR
 Copy SHALL be given to subject
 Opportunity to read before signing

101.
Principles for ProvidingInformationto
the Participant:
Make it clear; avoid jargon
Use language appropriate to the patient's level of understanding
in a language of their fluency
Pause and observe patients for their reactions
Invite questions from the patient and check for understanding

102.
Principles for Providing Information
the Participant: Cont.
Invite the patient to share fears, concerns, hopes and
expectations
Watch for patients' emotional response: verbal and non-verbal
Show empathy and compassion
Summarize the imparted information
Provide contact information (and other resources)

103.
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.

104.
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

105.
Voluntariness
• Free of undue influence
• Persuasion: appeals to reason
• Manipulation
• Coercision: explicit or implicit threats
• Force: restraint or sedation

106.
MANIPULATION
• Distortion of facts or omission
• Non-coercive alternation of choices
• Undue financial payment
• Undue influence, government funding only at grade eight for
hpv

107.
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 Sudan.

108.
CONFLICTS OF INTEREST (COI)
Conflicts of interests

109.
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.
Interests are pursued in the setting of social
interactions.

110.
What is COI?
• COI exists when two or more contradictory interests relate to
an activity by an individual or an institution.
• 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

111.
What is COI? Cont.
• “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

112.
Levels of COI
• Researchers
• The REB should assess the likelihood that the
researcher’s judgment may be influenced, or appear
to be influenced, by private or personal interests,
and assess the seriousness of any harm that is likely
to result from such influence or from the mere
appearance of undue influence (TCPS, 200)

113.
Levels of COI
Conflicts of Interest by REB Members
• It is of the highest importance that members of the
REB avoid real or apparent conflicts of interest .
• For example: when their own research projects are
under review by their REB or
• when they have been in direct academic conflict or
collaboration with the researcher whose proposal is
under review.

114.
Levels of COI
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 REB must act independently from the parent
organization.
• Institutions must respect the autonomy of the REB and
ensure that the REB has the appropriate financial and
administrative independence to fulfill its primary duties.

115.
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

116.
What comprises COI? Cont.
• 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

117.
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 an open
and collegial enterprise
4. Exploitation of trainees
5. Transfer of time and interest to Commercial
ventures

118.
• In May 2004, the pharmaceutical giant Pfizer agreed
to pay $430 million to settle a lawsuit by a former
employee turned whistle-blower, who was joined in
the lawsuit by the U.S. federal government and 11
state governments.
• The lawsuit exposes various marketing practices by
the company Warner-Lambert – later bought by
Pfizer.

119.
• Leading academic researchers were paid
to deliver promotional lectures at
educational events and to publish
favorable reports on the off-label use of
its epilepsy drug, Neurontonin.
L. Kowalczyk “Pfizer Drug Strategy Probed: States Question Marketing Tactics for
Neurontin,” Boston Globe, October 18, 2002,

120.
Conflicts Can Occur at all Levels of Research
• In reviews/awarding of grant
• In ethics review of grant
• In recruitment of participants
• In analysis of data
• In presentation of data

121.
The Case of Nancy Oliveiri
• In 1996, Olivieri found that the drug she was
researching (deferiprone, active iron-chelating agent )
at the Hospital for Sick Children in Toronto was showing
unexpected potential risks to some patients in the
trials.
• The drug company sponsoring her research abruptly
terminated the trials and issued warnings of legal
action against Olivieri should she inform her patients at
the Hospital for Sick Children of the risks, or publish her
findings.

122.
The Case of Nancy Oliveiri Cont.
• The manufacturer (Apotex) issued more legal
warnings to deter Dr Olivieri from communicating
this second unexpected risk of L1 to anyone.
• However, she published her findings in the New
England Journal of Medicine and

123.
The Case of Nancy Oliveiri Cont.
• She was subsequently dismissed from her position as
Director of the Hospital for Sick Children Program of
Hemoglobinopathies.
• Apotex was planning to donate USD 100 Million to
the University of Toronto

124.
The Case of Nancy Oliveiri
• After more than seven years of legal battle, an
independent committee of inquiry into the matter
vindicated Olivieri and concluded that neither the
university nor the hospital offered her
appropriate support in her conflict with the
drug company.
• Olivieri was reinstated to her position at the
Hospital for Sick Children and her actions have
also been vindicated by several other independent
reports.

125.
The other side of the story
• Deferiprone is the only effective orally active iron-
chelating agent licensed for the treatment of
patients with thalassaemia major and other
disorders of transfusional iron overload.
• It is the only alternative to deferoxamine—a drug
that has to be given by daily subcutaneous infusions
and fails in many patients worldwide because of the
lack of compliance, high cost, toxicity, or
hypersensitivity.

126.
The other side of the story
• No other clinicians using the drug had found
evidence for long-term liver damage and her
interpretation of the data was immediately
questioned in letters to the New England Journal of
Medicine.
• Four of her patients in whom liver fibrosis had been
suggested also had hepatitis C and all five had iron
overload—both causes of liver fibrosis.

127.
LET’S DEBATE…!
What do you think?
OR ?

128.
Practical Steps to resolve
• 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

129.
ETHICAL REVIEW OF
RESEARCH

130.
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.

131.
Research Requiring Ethics Review
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.

132.
Research exempt from Ethics Review:
Research about living individuals in the public arena
or artists, based exclusively on publicly available
information.
Participant observation of public demonstrations,
political rallies and public meetings.
Quality assurance studies, performance reviews or
normal educational testing.

133.
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