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Presentation at an “IRB Training Program” at
the Ministry of Health Riyadh on 8 June 2015 By Professor Omar Hasan Kasule Sr.
MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional
Review Board at King Fahad Medical City.
ETHICAL ISSUES IN CLINICAL
RESEARCH
·
Ethical obligation to do research
·
Risk vs benefit consideration in
searching for new treatments
·
Informed consent
·
Information given for informed
consent
·
Other considerations: randomization,
patients under the stress of disease may not fully understand the study and
therefore their consent is not free, failure to stop the study when harmful/beneficial
effects appear
Case Scenario -
1
The commander of an
army brigade asked the brigade physician to undertake research on causes of
very high sick leaves. The physician took blood from all soldiers to look for
their immune profiles. When some soldiers protested that they were not asked
for consent he told him he was following military orders.
Case Scenario -
2
A physician was
recruiting patients for a large multi-center study of myocardial infarction. The
informed consent sheet was 10 pages long because there were many procedural
details and adverse effects to disclose.
Most of the subjects were bored reading through or listening to the
details and were ready to sign because they trusted the physicians doing the
study.
Case Scenario -
3
A new drug that had
proved efficacy against leukemia in invitro, animal and phase 2 trials
was submitted for human trials. Its risk profile was not well understood from
earlier studies. It was to be tested against a placebo. There was no known
effective treatment for this disease.
Case Scenario -
4
A multi-center
trial of a new medication was carried out at a local hospital; the hospital was
among the last to join the 5-year trial. Local results showed that the drug was
effective and patients were satisfied. Interim analysis of the data by the
sponsor showed the superiority of the new drug. The sponsor also noticed that
if the results of the local hospital were eliminated, the sample size of the
remaining sites would be adequate. He therefore decided to terminate the study
at the hospital prematurely and cut off the supply of the drug.
Ethical Issues
in Public Health Research
·
Ethical approval
·
Individual vs. Community rights
·
Benefits vs. Risks
·
Informed consent
·
Privacy and confidentiality
·
Conflict of interest
·
Study interpretation and
communication: controversial findings
Case Scenario -
1
A community
randomized study was needed to establish whether adding multivitamin tablets to
food served in public restaurants would help reduce cardiovascular risk. Permission
was obtained from the mayor of the city since it was not possible to get
consent from each individual participant.
Case Scenario -
2
A new vaccine
against flu was found effective overseas. The Ministry of Health wanted to test
its efficacy by a randomized study. Because of a negative media campaign, there
were no volunteers for the study. The Ministry decided to force all hospital
employees above 50 years to enter the study in the next winter season.
Ethico-Legal
Issues in Grant Writing and Publication - 1
·
Issues
§
Introduction to research
malpractice: prevalence and attitudes
§
Introduction to research
malpractice: causes
§
Investigators and authorship
§
Originality
§
Plagiarism: definition
§
Plagiarism: detection and
avoidance
Ethico-Legal
Issues in Grant Writing and Publication - 2
·
Issues
§
Protecting your ideas from
plagiarists
§
Confidentiality and privacy
§
Informed consent
§
Disclosure
§
Financial integrity / COI
§
Regulatory affairs
Case Scenario -
1
A professor of
cardiology conducted a well-designed post marketing survey of a drug that had
been marketed recently in Saudi Arabia but had been marketed for over 10 years
in the US and EU. Preliminary results were against what many researchers had
published and seemed even illogical to him. He told the team of researchers to
keep this information secret until the study was completed. Analysis of the
complete data confirmed the preliminary analysis. The professor decided not to
submit the results for publication for fear of his reputation and also not to
disturb other cardiologists in the country who were satisfied with the drug.
The
Institutional Review Board (IRB): Structure and Functions - 1
·
IRB
§
Definitions: IRB, investigator, investigations
in humans & investigational product,
§
Review and reviewer
§
Roles of IRB: overview, procedures
of assuring objectives, assurance of patient protection
§
Assurance of data accuracy
§
Membership: quorum, meetings of
the IRB
The
Institutional Review Board (IRB): Structure and Functions - 2
·
IRB
§
Types of submissions for review, documents
submitted to IRB
§
Criteria of review for initial
approval: criteria for reviewing a protocol, criteria for reviewing the
qualifications of the investigator, criteria of review for continuing approval,
criteria for auditing, monitoring, and inspections
§
IRB records
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. (SCHS)
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. (SCHS)
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. (SCHS)
Conflict of
Interest in Research
·
COI
§
What is conflict of Interest (COI)?
§
What is a non-financial conflict
of Interest?
§
Examples of COI
§
How does an IRB member deal with
his/her COI?
§
How does an investigator deal with
his/her COI?
§
Some questions used to assess
potential COI
Case Scenario -
1
The IRB of a major
hospital sat to consider a proposal sponsored by a multi-national
pharmaceutical firm and all 5 members declared their interests. The Chairman
has been engaged as a temporary consultant for the firm over the past 5 years
mainly to give lectures on drug development processes to potential researchers.
The son in law of the deputy chairman had shares worth SAR1000 in the firm
acquired during course training course on stock investment. One member was the
brother in law of the principal investigator. The principal investigator a
member for 6 years had not attended the meeting. Only one member had no
interests to declare. The committee proceeded to consider the proposal because
everybody’s interests were now known. (PEER Handbook SCHS 2014)
Case Scenario - 2
The hospital received
a big grant from a pharmaceutical company to do a post marketing survey on a
new analgesic. After trial initiation it was discovered that the physicians in
the hospital rarely prescribed the drug. The principal investigator called a
meeting of all physicians in the outpatient clinic and asked them to start
prescribing the drug so that the hospital would not lose the grant. He
explained that the drug had already been found to be effective and was safe. (PEER
Handbook SCHS 2014)