Home 
Contact 
Profile 
Videos 
Presentation at a Quantitative Nursing Research Course held at King Fahad Medical City, Riyadh on 11-12 February 2020. By Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman, Institutional Review Board - KFMC
SPECIAL ISSUES IN NURSING RESEARCH:
} Malpractice is
failure to fulfill the duties of the trust put on the physician.
} The nurse as a
research subject.
} Quality
Improvement vs research: consent and IRB approval.
} The nurse
investigator and voluntary patient consent.
} Issues of validity
in qualitative research: sampling and data collection.
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.
} Privacy and
confidentiality.
CASE SCENARIO - 1:
} The commander of
an army brigade asked the brigade physician to undertake research on the 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 them 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. They 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 the flu was found effective overseas. The Ministry of Health wanted to test
its efficacy through 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:
§ Protecting your ideas from plagiarists.
§ Confidentiality and privacy & Disclosure.
§ Informed consent.
§ Financial integrity / COI.
§ Regulatory affairs: IRB.
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 which 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 a 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 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 safe. (PEER Handbook SCHS 2014)