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Presentation at a workshop for family
medicine residents on October 10, 2015 by Professor Omar Hasan Kasule Sr. MB
ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King
Fahad Medical City.
GROUP A
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 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 3:
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)
GROUP B
Case Scenario 1:
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 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.
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)
GROUP C
Case Scenario 1:
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 2:
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.
Case Scenario 3:
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)
GROUP D
Case Scenario 1:
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.
Case
Scenario 2:
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 3:
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)