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Presentation at a Basic Quantitative Nursing Research Course held at King Fahad Medical City, Riyadh on 16-17 April 2019. 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 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. The 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 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 - 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 that 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 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 was safe. (PEER Handbook SCHS 2014)