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Presentation
at a training program ‘Applying the Principles of Ethics to Clinical
Practice:’ held at Aramco Dhahran April 6, 2015 by Professor Omar Hasan
Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics
Committee King Fahad Medical City.
Definition: IRB
·
An independent
body reporting directly to the CEO through a report once or twice a year
·
Members from
diverse disciplines including non-health professionals
·
Main function
is protection of the rights and welfare
of research subjects and assures the public that this role is carried out well
·
Works mainly to
review and approve research protocols, investigator qualifications, and methods
of informed consent
·
Follow up /
monitor on-going research for adverse effects, protocol adherence
Definition: investigator:
·
A qualified person
who is responsible for the conduct of research.
·
Sub-investigators
assist the investigator in all aspects of the study.
·
The investigator
or sub-investigator may be or may not be a staff member at KFMC.
·
The investigator /
sub-investigator may be a student, a health professional, or any other
profession if the project has a health-related component.
Definition: investigations
in humans & investigational product:
·
Investigation is
research undertaken for purposes of studying the absorption, distribution,
metabolism, efficacy, and safety of an investigational product.
·
Investigational
product is a pharmaceutical form of an active ingredient or placebo being
tested in a clinical study.
Definition: review and
reviewer
·
Review is a
rigorous and systematic process of assessing a research project regarding its
scientific merit, validity and reliability of the research methodology, qualification
of the investigators, research subject rights and safety, and other ethical
considerations
·
A Reviewer is a
person with specialist knowledge in a field of medicine, healthcare, and
research methodology asked to review a research project and recommend to IRB
its approval, modification, or rejection.
Roles of IRB 1: overview
·
The primary
role of the IRB is protecting the rights, safety, and welfare of the
subject/patient.
·
The secondary
role is assuring that data from a study will be accurate, reliable, and
accurate.
Roles of IRB 2: Procedures of assuring objectives
·
Review and
approval of the protocol
·
Assessing the
qualifications of the investigator
·
Assuring that
methods and materials for informed consent are appropriate
·
Reviewing
financial aspects to ensure no conflicts of interest
·
Monitoring the
conduct of the study
·
IRB shall
operate according to written SOPs.
Roles of IRB 3: assurance of patient protection
·
Independent
review and monitoring of the protocol to ensure a favorable risk-benefit ratio
·
Putting patient
interests before public interest
·
Assuring
informed consent
·
Conducting the
study according to the protocol
·
Making sure
that the study is carried out by qualified personnel.
Roles of IRB 4: Assurance of data
accuracy
·
Monitoring
reports
·
Auditing
reports
·
Inspection
reports
Membership of IRB
·
IRB shall consist
of at least 5 members representing various disciplines of science, medicine,
and ethics.
·
KFMC IRB has 18
members including the chairman and a non-medical community representative
·
At least one
member must be a non-scientist and one must be a lay community representative.
·
Alternate members
shall attend and vote if principal members notified the chairman of their
absence.
·
Members shall be
independent of the sponsor and the investigator to avoid potential conflict of
interests.
·
Members are
appointed on the basis of their expertise and not as representatives of their
departments or units
Quorum
·
The quorum shall
be half of the members and decisions shall be carried by a simple majority.
·
Members shall sign
an attendance roster indicating time of arrival and if time of departure if
they do not sit throughout the meeting.
·
If members do not
attend the whole session a notation must be made in the minutes on what
protocol discussions they missed.
Meetings of the IRB
·
IRB shall meet
once every 4-6 weeks unless an emergency meeting is necessary.
·
The meeting dates
and venues are advertised 6 months in advance.
·
Members receive
the agenda and documents relating to the meeting 10 days in advance.
·
The chairman
designates 1-2 members to make a detailed analysis of each submission and
report to the meeting.
·
The agenda
includes the following sections: follow up of previously approved studies,
safety reports, amendments, and new studies for approval (exempt, expedited,
and full review).
Types of submissions for
review
·
Exempt, expedited,
and full review submissions for projects to be carried out at KFMC that have a
KFMC staff member as an investigator or a co-investigator.
·
Exempt, expedited,
and full review submissions of projects to be carried out at KFMC by external
investigators.
·
At its discretion
the IRB shall review (a) exempt projects carried out in other institutions if
they have a KFMC staff as an investigator or a co-investigator. (b) Projects
carried out at other institutions without a KFMC staff member as investigator
or co-investigator. At its discretion IRB may charge for this service.
Documents submitted to IRB:
·
Exempt studies: IRB
application form, protocol/research proposal, informed consent material if
applicable, data collection instruments if applicable, current curriculum vita
(e) of the researcher(s).
·
Clinical research
either expedited or full review:
protocol and its amendments, written information provided to the research subjects
and the informed consent form (ICF), the case report form (CRF), the
investigator brochure (IB), study recruitment procedures not in the protocol
including recruitment advertisements, insurance / payments for study subjects,
financial agreements between the sponsor and the investigator, any other
applicable agreements, and the current curriculum vita (e) of investigators,
safety reports from this site and other sites.
Criteria of review for
initial approval:
·
Risks are minimal
and are reasonable in relation to the anticipated benefits.
·
Consent is
informed and is properly documented
·
Provisions are
adequate to ensure privacy and confidentiality
·
The research plan
contains adequate provisions for monitoring the data to ensure safety
·
Subject selection
is equitable
·
There are adequate
safeguards to protect vulnerable subjects (children, pregnant women, mental
patients etc.).
Criteria for reviewing a
protocol:
·
Simple and logical
eligibility and exclusion
·
Objective and easy
to assess outcome measures
·
Proper subject
selection and randomization
·
Simple
intervention not likely to be mistaken
·
Adequate sample
size and power to detect a difference
·
Low risk of
missing important data by too short a follow up
·
Overall
reliability of the trial results.
Criteria for reviewing the
qualifications of the investigator
·
Education
·
Training
·
Experience
·
Familiar with the
investigational product
·
Knowledge of GCP
guidelines
·
Has time to devote
to the study
·
Has sufficient
qualified staff.
Criteria of review for
continuing approval
·
Reports of adverse
effects
·
Protocol
amendments / violations / deviations
·
Patient
recruitment
·
Any special
problems
Criteria for auditing,
monitoring, and inspections:
·
Compliance with
the protocol
·
Submission of
necessary reports
·
Safety reporting
·
Termination or
suspension
·
Final report /
close out
IRB records
·
All documents
submitted by the PI, IRB correspondence, and IRB minutes are part of IRB
official records
·
IRB official
records must be kept for a minimum of 3 years after the end of the study.
Case Scenario 1
A very experienced professor of surgery wanted to undertake
research comparing two surgical approaches that he has been using alternately
over the past 15 years. He reviewed the Nuremberg and Helsinki declarations as
well as the ICH-GCP guidelines and the Saudi regulations on research. He made
sure he fulfilled all stipulations of these documents in his research and saw
no reason to seek the approval of the local IRB that in his view consisted of
young inexperienced members most of whom had been his students. (PEER Handbook SCHS
2014)
Case Scenario 2
A physician was given a fat grant to study a new drug. The sponsor
provided a well written and detailed protocol. Implementation of the protocol
was difficult in the local circumstances: the informed consent information was
too much and the subjects could not adhere to the visit dates fixed in the
protocol. The physician made alterations in the protocol that he thought were
simple and did not affect study validity or patient safety and saw no reason to
inform IRB/REC. The sponsor sent monitors who discovered the discrepancy. The
physician ignored their observations and continued the study without
documenting the changes he had made. . (PEER Handbook SCHS 2014)
Case Scenario 3
A physician in a local hospital agreed to be an investigator of a
multi-center international trial sponsored by the pharmaceutical company. He
regularly completed and sent CRFs to the sponsor overseas. On one occasion the sponsor
questioned the data submitted and insisted that the original patient’s chart be
shipped to him for inspection and verification. . (PEER Handbook SCHS 2014)