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Presented at a lecture for Clinical Research Coordinators held at King Fahad Medical City, Riyadh on Sunday, June 14, 2020, at 2:00-3:00. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board
7 CRITERIA OF ETHICAL CONDUCT OF CLINICAL TRIALS BY EMANUEL et al.:
} Value:
what is the social or scientific value of the drug or device tested?
} Scientific
validity: will the methods used the result in valid
and reliable results?
} Fair
selection of participants: is there discrimination in the
selection of participant e.g. women, children, minorities?
} Favorable
benefit/risk balance: are risks minimized? Do benefits
outweigh risks?
7 CRITERIA OF
ETHICAL CONDUCT OF CLINICAL TRIALS BY EMANUEL et al., con’t.:
} Independent review: is the approval
process by an independent IRB?
} Informed consent: The most
important ethical issue. Did the participants give free, voluntary, informed
consent that they can withdraw without having to give a reason?
} Respect for
enrolled participants:
rights and welfare of the participants.
INFORMED CONSENT:
BASIC ELEMENTS:
- A statement
that the study involves research.
- An
explanation of the purposes of the research.
- The expected
duration of the subject’s participation.
- A description
of the procedures to be followed.
- Identification
of any procedures that are experimental.
- A description
of any reasonably foreseeable risks or discomforts to the subject.
- A description
of any benefits to the subject or to others that may reasonably be
expected from the research.
INFORMED CONSENT:
BASIC ELEMENTS, con’t.:
- A disclosure
of appropriate alternative procedures or courses of treatment, if any,
that might be advantageous to the subject.
- A statement
describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained.
10.
For
research involving more than minimal risk, an explanation as to whether any
compensation and any medical treatments are available if injury occurs and, if
so, what they consist of, or where further information may be obtained.
INFORMED CONSENT:
ADDITIONAL ELEMENTS:
1. A
statement that the particular treatment or procedure may involve risks to the
subject (or to the embryo or fetus, if the subject is or may become pregnant),
which are currently unforeseeable Anticipated circumstances under which the
subject’s participation may be terminated by the investigator without regard to
the subject’s consent.
2. Any
additional costs to the subject that may result from participation in the
research.
INFORMED CONSENT:
ADDITIONAL ELEMENTS, con’t.:
3. The
consequences of a subject’s decision to withdraw from the research and
procedures for orderly termination of participation by the subject.
4. A
statement that significant new findings developed during the course of the
research, which may relate to the subject’s willingness to continue
participation, will be provided to the subject. The approximate number of
subjects involved in the study.
ETHICAL ISSUES IN
THE PLANNING AND DESIGN STAGE:
} Ethics training: are all the study
personnel trained in research ethics? Do they have a valid certificate of
training in protection of human research subjects?
} Justification for
as clinical trial:
is the disease serious? Are there no other effective and safe treatments? Can
we get the information needed from other types of studies? Will this study add
anything significant to present knowledge?
} Randomization and
fairness:
the experimental group are exposed to risk while the control group may miss a
useful treatment. What about use of the placebo?
ETHICAL ISSUES IN
THE PLANNING AND DESIGN STAGE, con’t.:
} Conflict of
interest:
for the investigator or for the sponsor with harm to the participant?
} Informed consent: 16 elements, 12
basic and 4 additional.
ETHICAL ISSUES IN
THE CONDUCT OF CLINICAL TRIALS:
} Trials in poor
countries and communities: no local benefit, no proper consent, unnecessary
risk.
} Recruitment: payment of
participants beyond compensation of expenses. Biases in recruitment.
Recruitment of vulnerable.
} Safety and Efficacy
Monitoring:
Data and safety monitoring committee and early termination of studies if
dangerous or the answer is obtained.
ETHICAL ISSUES IN
THE CONDUCT OF CLINICAL TRIALS, con’t.:
} Privacy and
Confidentiality:
protection of personally identifying information. Special consideration for
genetic information.
} Data Falsification
or fabrication.
ETHICAL ISSUES IN
THE REPORT-ING OF CLINICAL TRIALS:
} Publication Bias: positive trials
more likely to be published quickly giving a false image of the reality.
} Suppression and
Delay of publishing unfavorable results: sponsor influence.
} Conflicts of
Interest and Publication: ghost authors, gift authors.
REFERENCE:
} Lawrence M.
Friedman; Curt D. Furberg; David L. DeMets; David M. Reboussin; Christopher B.
Granger. Fundamentals of Clinical Trials. Fifth Edition. SPRINGER
Switzerland 2015.
APPENDIX 1: FULL REVIEW INFORMED CONSENT FORM:
APPENDIX 2: GENETIC CONSENT FORM: