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Presentation at a KFMC Nursing Diploma Program Epidemiology: Ethics in Research Held at King Fahad Medical City, Riyadh on 11 January 2022. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics
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 is 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 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. 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 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
} Protecting
your ideas from plagiarists.
} Confidentiality
and privacy & Disclosure.
} Informed
consent.
} Financial
integrity / COI.
} Regulatory
affairs: IRB.
CASE
SCENARIO
} 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
} 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)