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Presentation at the 5th Forum and Training Course for Local Ethics Committee (IRB) 2019, KACST at Riyadh, Saudi Arabia on 25-26 September 2019. By: Prof. Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard) DrPH (Harvard) Chairman, Institutional Review Board
BASIC TERMINOLOGY:
} Institutional Review Board (IRB) is a body constituted by the institutional highest
authorities but works independently to make ethical reviews and approve
proposed research as well as follow up on the implementation of the research.
} Research is the systematic collection and analysis of empirical
data to describe a phenomenon or to establish causal linkages between and among
phenomena.
} Clinical research is research carried out on patients and healthy
volunteers to test new treatment modalities.
} Informed consent is an agreement of the research subject to participate
in research after full disclosure and explanation of details pertaining to the
research.
} Research
Subject is an individual patient or healthy
volunteer who consents to participate in the research. Research submissions will be
classified as exempted, expedited, or full review.
RISK (A POTENTIAL HARM OR THE
POTENTIAL OF AN ACTION OR EVENT TO CAUSE HARM):
} Minimal risk is no greater than the risk encountered in normal day-to-day activities or during routine physical or psychological examinations.
} Low Risk - Involves a minor increase over a minimal risk- the
intervention or procedure presents experiences that are reasonably commensurate
with those inherent in actual or expected medical, dental, physiological, social, or educational situations.
} Moderate Risk - Risks are reasonable in relation to anticipated
benefits, if any, to subjects and the importance of the knowledge that may
reasonably be expected to result.
} High
Risk - Involves greater than minimal risk with
no prospect of direct benefit to individual subjects, but is likely to yield
generalized knowledge about the subject’s disorder or condition. Studies that
are of high levels of risk may result in permanent physical and/or mental
changes, hospitalization, and/or death.
TYPES OF REVIEW:
} Exempt research is approved without review by the full IRB committee.
It is research using questionnaires or interviews or data abstraction from
charts. It poses no risk to humans.
} Expedited research is approved by the Chair with information to the IRB
later. It involves minimal risk such as drawing blood.
} Full
Review research involves intervention on human
y drugs or devices and must be approved by the full IRB committee.
ADVERSE EVENT:
} Definition: Any untoward or unfavorable medical occurrence in a
human study participant, including any abnormal sign (e.g. abnormal physical
exam or laboratory finding), symptom, or disease, temporally associated with
the participant’s involvement in the research, whether or not considered
related to participation in the research.
} Serious Adverse Events: Any adverse event that: results in death, is life-threatening, or places the participant at immediate risk of death from the
event as it occurred, requires or prolongs hospitalization, causes persistent
or significant disability or incapacity, results in congenital anomalies or
birth defects.
} Unanticipated
Problem: is defined as any incident, experience,
or outcome that meets all of the following criteria: unexpected,
related/possibly related to the research, and places research participants at
greater risk of harm.
AUTHORIZATION:
} Research
involving human subjects must be reviewed and approved by an Institutional
Review Board (IRB) prior to any research intervention with participants.
} The
Institutional Review Board (IRB) of King Fahad Medical City is the body
responsible for ethical approval and regulation of all research proposals and
protocols on humans in the institution that have ethical implications to ensure
that the highest research ethical standards and assure the safety of research
subjects and protect the institution and its staff from ethical violations.
SCOPE OF RESEARCH: IRB COVERS THE FOLLOWING TYPES OF RESEARCH:
} Research
by clinical observation
} Controlled
clinical comparative research
} Laboratory
research
} Epidemiological
research
} Genetic
research
} Qualitative
research
} Genetic
research
CORE FUNCTIONS OF IRB:
} Assessing
and approving research on patients, volunteers, and human tissues.
} Assessing
any research involving access to medical records with the potential to breach
confidentiality.
} Monitoring
the conduct of research to detect any ethical violations.
} Assuring the protection of research subjects’ physical and mental well-being as stipulated
in the Helsinki Declaration.
} Protection
of the researchers and the institution in which they work by advising them
about ethical conduct so that they do not commit mistakes that will lead to
criminal prosecution.
MEMBERSHIP OF THE IRB:
} Membership
is designed in such a way that all professional and technical competencies
needed for the proper evaluation of a research proposal are included.
} Members
represent the major medical and surgical specializations practiced in KFMC
including physicians, nursing staff, general practitioners, pharmacists,
statisticians, ethicists, and lay persons from the community who have no
connection with medical work.
} The
period of service on the committee is renewable and is usually three years.
DIVERSITY AND INDEPENDENCE OF IRB:
} Selection
of members ensures representation of the population subgroups by gender, age
groups, ethnicity, and socio-economic background.
} Members
are selected on their own personal merit as people with knowledge, skills, and
sound judgment and not as members or advocates of any profession or
organization.
IRB OPERATIONAL POLICY GUIDELINES:
} Balance
between research and care delivery research such that research that is a
departure from the commonly accepted treatment does not affect the patient’s
treatment adversely.
} Equity
and justice in research to ensure that recruitment into studies should reflect
the community’s ethnic, gender, and age distribution since the results of an
unbalanced study may not be applicable to all groups.
} The
source of funding for research should not in an indirect and discreet way
influence the conduct of research and the report of its findings thus leading
to a lack of objectivity.
} Research
malpractice is prevented and if it occurs is detected early. Examples of
malpractice include cooking or doctoring data, selective reporting of data,
suppression of negative information, and ‘stealing’ others’ work.
} Expedited
review procedures can also be used to review minor changes in previously
approved research during the period (of one year or less) for which approval is
authorized.
IRB PROCEDURES:
} The
Principal Investigator dialogues with applicable departments that will be
involved in the proposed study prior to the submission of a research proposal
to the KFMC IRB.
} The
Principal Investigator submits the KFMC IRB research application package in
standard format for IRB review including the following information.
} IRB
committee Requests a quorum of at least half of the members for holding a
meeting. Members who cannot attend can send written comments and can vote.
} Proposals,
protocols, and reports to be tabled are sent to the members in advance so that
they have a chance to study them.
} IRB
meets in private to preserve confidentiality.
} IRB
Committee Member excuses himself/herself if a project is for review that they
are associated with.
IRB USES THE FOLLOWING CRITERIA FOR
ASSESSING RESEARCH:
} Full
disclosure to research subjects of the objectives of the study and of their
rights to participate, abstain, or withdraw from the study.
} Research
objectives that are clearly stated and are attainable
} Research
design and statistical methods judged adequate to produce clinically and
scientifically useful results.
} Comparison
of the scientific merit and benefit of the research against risks and costs to
patients.
} Investigators
are qualified and competent to undertake the research successfully.
} Research
facilities are adequate.
} Details
on how confidentiality and security of the data will be assured.
} Designated
IRB members review the application and present their report to the IRB
Committee (Appendix G Template for Reviewer’s Report).
FOLLOW-UP OF RESEARCH
IMPLEMENTATION:
} IRB
monitors the progress of the research and receives reports of all adverse reactions
whether related to the drug tested or not.
} IRB
makes on-site inspections to ensure the approved protocol is adhered to and to
inspect research documents and records as per IRB audit and monitoring
procedures.
} IRB
holds regular monitoring meetings to review the progress of recruitment of
research subjects, changes to the protocol, adverse reactions, the process of
informed consent, refusals and withdrawals, and case record forms.
ROLES OF THE PRINCIPAL INVESTIGATOR
(PI):
} Submits
the required documents through the Research Center to the Saudi Food and Drug
Administration if applicable to research CPP 1435-20).
} Submits
the study documents along with an IRB approval letter to the Ministry of Health
for approval to send tissue abroad for research (CPP 1432-86).
} Submits
annual continuation requests to the Chair IRB.
} Submits
an Adverse Events Report as per policy to the IRB Chair.
} Submits
a study status report (Appendix I) to the Chair IRB.
ROLES OF THE PRINCIPAL INVESTIGATOR
(PI) (CON’T.):
} Submits
a Progress Report Protocols Approved by Expedited Review to the Chair IRB.
} Submits
a Final Report for IRB Study Completion or Study Termination to the Chair IRB.
} Declares
conflict of interest.
} Keep
full records of all its actions.
} Ensures
secure location for records (locked door, password-protected computer).
} Submits
an annual report listing all proposals considered in the past year, the number
approved, and any matters that deserve attention from higher authorities.
NUREMBERG DECLARATION 1946:
THE BELMONT REPORT 1972:
DECLARATION OF HELSINKI 1964 AND
2013:
ICH HARMONIZED GUIDELINE GENERAL
CONSIDERATION FOR CLINICAL STUDIES E8(R1):
SFDA CLINICAL TRIALS REQUIREMENTS
GUIDELINES:
IMPLEMENTING REGULATIONS OF THE LAW
OF ETHICS OF RESEARCH ON LIVING CREATURES:
CIOMS - INTERNATIONAL ETHICAL
GUIDELINES FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS:
