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Presentation at a Quantitative Nursing Research Course held at King Fahad Medical City, Riyadh on 10 November 2020; by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman, Institutional Review Board - KFMC
SPECIAL ISSUES IN
NURSING RESEARCH:
} 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)