1. WRITING RESEARCH
STUDY APPLICATION
S T E P B Y S T E P TO F U L F I L L I N G E T H I C S
R E Q U I R E M E N T S
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2. STEP1
PRE-WRITING
E N S U R I N G YO U P O S S E S S N E E D E D
Q U A L I F I C AT I O N S A N D D I S P O S I T I O N S
TO E M B A R K O N A R E S E A R C H S T U DY
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3. PRE-WRITING
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Ensuring you possess needed qualifications and dispositions
Step 1.1
Qualifications
Degrees
Experience
Training
Step 1.2
Dispositions
Team
Perseverance
Communication skills
4. CV
FOUNDATIONAL
COMPONENTS
• Academic qualifications up to
research work requirements and /
or,
• Professional experience up to
research work requirements
• Academic qualifications in the
specific field of study and / or,
• Professional experience in the
specific field of study
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QUALIFICATIONS
CV
6. WHO SHOULD
BE IN YOUR
TEAM!!
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DISPOSITIONS
TEAM
PI, Co-PI,Authors
Multiple disciplines
Senior and junior
Accessible
Publishing experience
Commitment
Rich CV
Professional
reputation
7. HURDLES THAT
MIGHT DIMINISH
MOTIVATION
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DISPOSITIONS
PERSEVERANCE
Long processes to get
approvals
Inadequate resources
Pre-occupations
Passive team
Unresponded
correspondences
Scarcity of study
subjects
Uncertainties about
study results
Indifferent bosses
9. STEP2
WRITING
E N S U R I N G YO U R R E S E A R C H S T U DY
A P P L I C AT I O N I S L I K E LY TO B E
A P P R OV E D B Y R E S E A R C H E T H I C S
C O M M I T T E E
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12. STUDY
PACKAGE
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RESEARCH STUDY PACKAGE
SUB-FOLDERS
All REC documents
Research registry
Assignments
References
Data sources
All correspondences
(paper and electronic)
Study
Package
Step 2.2
13. PROTOCOL
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RESEARCH STUDY PACKAGE
REC DOCUMENTS
A research protocol is
a document that
describes the background,
rationale, objectives,
design, methodology,
statistical considerations
, and organization of a
clinical research project
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RESEARCH STUDY PACKAGE
INFORMED CONSENT FORM (ICF)
INFORMED
CONSENT
FORM
Permission granted by
a participant to a
researcher in full
knowledge of the
possible consequences
for data collection,
relevant procedures,
possible risks, and
benefits
15. PARTICIPANT
INFO. SHEET
(PIS)
gives
potential participants
the necessary
understanding for the
motivation and
procedures of the study
and sources of
information to answer
any further questions to
allow them to give
informed consent
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2019
15
RESEARCH STUDY PACKAGE
PARTICIPANT INFO SHEET(PIS)
16. TOOL
Anything that becomes a
means of collecting
information for a
study is called
a research tool or
a research instrument.
For example,
observation forms,
interview schedules,
questionnaires, and
interview guides are all
classified as research
tools.
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2019
16
RESEARCH STUDY PACKAGE
THE RESEARCH INSTRUMENT
17. RESEARCH
REGISTRY
a one-stop shop for
registering all types of
research studies, from
‘first in man’ case
reports to
observational /
interventional studies
to systematic reviews
and meta-analyses
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17
RESEARCH STUDY PACKAGE
THE RESEARCH REGISTRY
18. TAKEAWAYS
E N S U R I N G YO U R R E S E A R C H S T U DY
A P P L I C AT I O N I S L I K E LY TO B E
A P P R OV E D B Y R E S E A R C H E T H I C S
C O M M I T T E E
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20. REFERENCES
R E F E R E N C E S
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21. REFERENCES
• University of Southern California (2013), Comprehensive Study
Documents List, https://oprs.usc.edu/files/2017/05/Comprehensive-
Study-Document-List.pdf
• University of Cambridge, Consent forms and participant information
sheets, accessed on March 2019, https://www.research-
integrity.admin.cam.ac.uk/research-ethics/ethics-application-
guidance/consent-forms-and-participant-information-sheets
• WHO, Recommended Format for a Research protocol, accessed on
March 2019, https://www.who.int/rpc/research_ethics/format_rp/en/
• McGraw, H., et al (2010), Principles of Good Clinical Practice,
ISBN 978 0 85369 790 9
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