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Presentation at the Faculty of Medicine held at Princess Noura University, Riyadh on 16 February 2020. By Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board and Ethics Committee, King Fahad Medical City
GIFT AUTHORSHIP:
CASE
SCENARIO - 1
Marwa submitted a research proposal at her university and it was
approved. She carried out the research and wrote the manuscript. Her friend,
Abeer, attending another university read the manuscript and was impressed and
asked to be included as a co-author. Marwa objected that Abeer had not
contributed to the research, Abeer responded that she would reciprocate by
including Marwa as a co-author in a research manuscript she was planning to
write and submit for publication.
PLAGIARISM OF IDEAS:
CASE
SCENARIO - 2
During lunch, students discussed possible research projects. Aisha
listened to several ideas from her friends. When asked by her professor to
submit a research project. She included many ideas from the students but she
did not acknowledge the source.
PLAGIARISM OF TEXT:
CASE
SCENARIO - 3
Maha was writing a proposal to study the relation between salt intake
and hypertension. While doing her literature review she found a paragraph in a
paper on the same topic that stated exactly the research objectives she had in
mind. She decided to include the paragraph as is in her proposal but forgot to
put it in inverted commas and mention its source.
PLAGIARISM OF TEXT BY PARAPHRASING:
CASE
SCENARIO - 4
Nada submitted a proposal to IRB. The plagiarism detection software
discovered that the text was copied (cut and paste) from a published paper. IRB
rejected the proposal. Nada worked on the proposal by paraphrasing it (using
different words or phrases) and resubmitted for approval. Since the words were
hers she did not see any reason for mentioning the source.
DATA FABRICATION:
CASE
SCENARIO - 5
Fatima was undertaking a study on the correlation between weight and
height and had recorded the data directly on an excel sheet. By mistake she
deleted weight data of 4 girls. She could not go back to get data from them
because she did not know who they were; she had not recorded their names for
confidentiality. Not willing to have a paper with missing data, she decided to
insert weights at random and went on to publish the paper.
RESEARCH WITHOUT CONSENT:
CASE
SCENARIO - 6
Shamsa had IRB approval for a study to find the relation between sleep
disturbances and time spent on the mobile phone among students in her class.
Over a period of 1 month she asked each of them on her sleep and phone use as
part of routine conversation and would rush after that to complete the
questionnaire. She never told any of the girls that she was carrying out
research.
HIDING BAD RESULTS:
CASE
SCENARIO - 7
Maryam was repeating a research study that had been carried out overseas
and had shown that drug A was effective against early morning fatigue that
affected students. Her results however showed that the drug made the fatigue
worse and she doubted her work. She decided to hide the results for fear of
being ashamed.
RELATIONS WITH THE PHARMACEUTICAL INDUSTRY:
CASE
SCENARIO - 8
A company producing drugs for the management of hypertension has
offered to pay the part-time salary of a nurse in a doctor's practice. The
nurse's role is to audit patients' records, ensuring that those with
hypertension are regularly examined and receive up-to-date medicine. The doctor
thinks this enhances patient care. The nurse provides anonymous patient data to
the company, but is barred from promoting its products. Information about the
company's drugs is regularly provided by a sales team, which visits the
practice and pays for working lunches with the doctor. A good relationship
exists, and the company provides occasional gifts and invites the doctor's
staff for dinner.
USE OF PLACEBOS IN RESEARCH:
CASE
SCENARIO - 9
A new drug that had proved effective against leukemia in animal, in
vitro, 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.
ALTERATION OF A PROTOCOL WITHOUT IRB APPROVAL:
CASE
SCENARIO - 10
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 subjects found the informed consent information overlong, and they
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.
CONFLICT OF INTEREST FOR IRB MEMBERS:
CASE
SCENARIO - 11
The IRB of a major hospital sat to consider a proposal sponsored by a
multi- national pharmaceutical firm, and 5 of the 6 members declared their
interests. The Chairman had 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
SAR 1,000 in the firm. 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 interest in declaring. The
committee proceeded to consider the proposal because everybody's interests were
now known.
HIDING UNFAVORABLE CLINICAL TRIAL DATA:
CASE
SCENARIO - 12
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 even seemed 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
to avoid disturbing
other cardiologists in the
country who were satisfied with the drug.
SIGNING CONSENT WITHOUT INFORMATION:
CASE
SCENARIO - 13
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.
PREMATURE TERMINATION OF A CLINICAL TRIAL:
CASE
SCENARIO - 14
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.
VACCINE TRIAL WITHOUT VOLUNTARY CONSENT:
CASE
SCENARIO - 15
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.
RESEARCH WITHOUT IRB APPROVAL:
CASE
SCENARIO - 16
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)
SENDING PATIENT DOCUMENTS TO SPONSORS OF RESEARCH:
CASE
SCENARIO - 17
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)
PRESCRIBING FOR THE SAKE OF RESEARCH:
CASE
SCENARIO - 18
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)