9. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
Subjects
Rights, Safety, and Wellbeing
Study
Credible with No conflict of interest
10. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
Milestones in the Development of Regulations of
Research Ethics starting the In the 20th century
Nuremberg
Code 1947
Declaration
of Helsinki
1964
ICH-GCP
(1996)
11. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
ICH-GCP
International Council on Harmonization-
Good Clinical Practice
A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that
provides assurance that the data and reported results are credible
and accurate, and that the rights, integrity, and confidentiality of
trial subjects are protected.
ICH Harmonised Tripartite Guideline Guideline For Good Clinical Practice E6(R1) 1996
12. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
Clinical Research Vs Clinical Trials
Clinical research is the study of health and illness in people…….it
involves human participants…
Example: “Perception of Women on the Effectiveness of Self Breast Examination”
Clinical Trial is a type of clinical research. It is an experiment designed to
answer specific questions about possible new treatments..
Example: “The Effectiveness of Behavioral Therapy on the Anxiety Level of Women
with Breast Cancer”
University of Virginia-School of Medicine, accessed Nov. 2018
13. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
Why does Research Ethics Committee-MOHAP
requires GCP certification for research team?
Because MOHAP cares for people’s safety and is
keen to ensure that gathered data is credible and
reliable
15. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
GCP: Basic Principles
How can I become
GCP certified?
It is very simple;
Register through
https://gcp.nidatrain
ing.org/
16. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Research Proposal Writing Process
Do
Define Obligations
No
Nail the Spirit
Harm
Harness it Altogether
17. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Research Proposal Writing Process
Do Define Obligations
The Pre-Writing Brainstorming Exercise
Team members should ensure:
• study will not violate human rights
• data will be kept safe and not manipulated
20. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Research Proposal Writing Process
No: Nail the Spirit of Ethics
The Writing Exercise
Proposal
(Form by
REC)
CV GCP
Certification
Study
Tool
Financial
Agreement
Informed
Consent
Form
(ICF)
21. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Research Proposal Writing Process
Harm :Harness it Altogether
The Proof Reading Exercise
Rule of 4 C’s
Completeness Clearness
Consistency Cohesiveness
22. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Practical Examples
CASE
STUDY
1
Query
Dr. Haleima is interested in
conducting a study on the
effect of therapeutic play on
diabetic children at the
pediatric unit.
What should Dr. Haleima do
to preserve the rights of her
study subjects?
23. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Practical Examples
CASE
STUDY
2
Query
“Dr. Khalifa and Dr. Saood have been
working on a research project studying
the prevalence of pneumonia in nursing
home residents. Dr. Khalifa learns that
while Dr. Saood is interviewing research
participants, if he does not elicit an
answer, he invents one and passes it off as
truthful data collection. Dr. Khalifa
questions Dr. Saood and he denies the
allegation. What should Dr. Khalifa do?”
24. Nariman Ghader/Research Symposium /UAQ / Nov. 11, 2018
Contemporary Cases of Research Misconduct
Haruko Obokata
Riken Center for Developmental Biology, Japan
