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ReseaRch ethics and PLaGiaRisMReseaRch ethics and PLaGiaRisM
Prof. K. H. Mujtaba QuadriProf. K. H. Mujtaba Quadri
Chairman, Department of Medicine and Hospital Ethics CommitteeChairman, Department of Medicine and Hospital Ethics Committee
Professor of Medicine/NephrologyProfessor of Medicine/Nephrology
King Saud Bin Abdulaziz University of Health Sciences,King Saud Bin Abdulaziz University of Health Sciences,
National Guard Health Affairs, KAMC, JeddahNational Guard Health Affairs, KAMC, Jeddah
Diplomate American Boards of Internal Medicine (1990-2020 ) and Nephrology (1992-2022)Diplomate American Boards of Internal Medicine (1990-2020 ) and Nephrology (1992-2022)
Certification in Principles and Practice of Clinical Research (Harvard)Certification in Principles and Practice of Clinical Research (Harvard)
ObjectivesObjectives
 To establish awareness about Research ethics andTo establish awareness about Research ethics and
answer “why research ethics”?answer “why research ethics”?
 To examine some principles of Islamic ResearchTo examine some principles of Islamic Research
EthicsEthics
 To encourage reflection on illustrative casesTo encourage reflection on illustrative cases
 To introduce the concepts of plagiarism and otherTo introduce the concepts of plagiarism and other
forms of ‘scientific misconduct’forms of ‘scientific misconduct’
Case: 1Case: 1
 ProfessorProfessor ‘Greedy‘Greedy’ is about to land his “biggest grant” yet. The’ is about to land his “biggest grant” yet. The
industry ‘sponsorindustry ‘sponsor’ would like him to be a’ would like him to be a Principle InvestigatorPrinciple Investigator
and first author for a study on a new ace-inhibitor. He has aand first author for a study on a new ace-inhibitor. He has a
brilliant PhD, Doctorbrilliant PhD, Doctor ‘Sincere‘Sincere’, who has joined the project’, who has joined the project
which translates his basic science work into clinicalwhich translates his basic science work into clinical
application. The idea of Dr. Sincere’s preliminary work wasapplication. The idea of Dr. Sincere’s preliminary work was
picked up by Professor Greedy and discussed with thepicked up by Professor Greedy and discussed with the
industry, who are keen to cash in on Professor Greedy’sindustry, who are keen to cash in on Professor Greedy’s
name. Halfway into the project, the two have an intensename. Halfway into the project, the two have an intense
argument onargument on first authorshipfirst authorship and Prof Greedy indicates thatand Prof Greedy indicates that
he has alternate PhD candidates that “he is currentlyhe has alternate PhD candidates that “he is currently
interviewing” to complete the study . Dr. Sincere reflects oninterviewing” to complete the study . Dr. Sincere reflects on
what to do next?…what to do next?…
 DoctorDoctor ‘Ambitious’‘Ambitious’ is completing the 2is completing the 2ndnd
and crucial periodand crucial period
of his phase 3 clinical trial, comparing in anof his phase 3 clinical trial, comparing in an RCTRCT , a novel, a novel
anti-coagulant NAC with oral warfarin. He has beenanti-coagulant NAC with oral warfarin. He has been
provided the results of anprovided the results of an interim analysisinterim analysis that the datathat the data
safety monitoring board requires. On eyeballing thesafety monitoring board requires. On eyeballing the
figures, he notices that omission of just one patient forfigures, he notices that omission of just one patient for
an “additional” previouslyan “additional” previously unspecifiedunspecified exclusionexclusion criterion,criterion,
may make his data highly significant in favour of NAC .may make his data highly significant in favour of NAC .
He daydreams of how people will read his paper in theHe daydreams of how people will read his paper in the
Lancet !…Lancet !…
Case: 2Case: 2
 DoctorDoctor ‘Conscience‘Conscience’ has been approached with a 800,000’ has been approached with a 800,000
Riyal grant by an International funding agency to conductRiyal grant by an International funding agency to conduct
an RCT in Jeddah, comparing an established sedative-an RCT in Jeddah, comparing an established sedative-
hypnotic (“hypnotic (“sweetdreamsweetdream”) with a new drug (“”) with a new drug (“nightmarenightmare”)”)
watching for the effects of sleep-deprivation of greater thanwatching for the effects of sleep-deprivation of greater than
48hrs on cognitive skills of patients with chronic insomnia.48hrs on cognitive skills of patients with chronic insomnia.
‘Nightmare’ was tolerated successfully in phase 1 trials for‘Nightmare’ was tolerated successfully in phase 1 trials for
safety but insafety but in phase11phase11 trials for efficacy and safety it wastrials for efficacy and safety it was
marginally superior to placebomarginally superior to placebo in its sedative hypnoticin its sedative hypnotic
effects when tested in European population.effects when tested in European population.
 The study is part of aThe study is part of a proposed Phase 111 multicenter trialproposed Phase 111 multicenter trial
being done in the Middle East to see its effects in thebeing done in the Middle East to see its effects in the
Middle EasternMiddle Eastern population: Doctor ‘Conscience’ now losespopulation: Doctor ‘Conscience’ now loses
sleep!sleep!
Case: 3Case: 3
 Thiazolidinedione Intervention with Vitamin D EvaluationThiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial(TIDE) trial
compared thecompared the cardiovascular outcomescardiovascular outcomes of long-term treatment withof long-term treatment with
rosiglitazone with those of pioglitazone (Actos, Takeda) in patients with typerosiglitazone with those of pioglitazone (Actos, Takeda) in patients with type
2 diabetes as a Phase 1V RCT .2 diabetes as a Phase 1V RCT .
 TheThe FDA haltedFDA halted the trial and at their request an Institute of Medicinethe trial and at their request an Institute of Medicine
(IOM) committee was convened to independantly examine the ethics and(IOM) committee was convened to independantly examine the ethics and
science of FDA required post-marketing researchscience of FDA required post-marketing research
AnyAny volunteersvolunteers as to what were the ethical concerns?as to what were the ethical concerns?
Ethical Considerations in Studying Drug SafetyEthical Considerations in Studying Drug Safety——
The Institute of Medicine ReportThe Institute of Medicine Report
Michelle M. Mello, J.D., Ph.D., Steven N. Goodman, M.D., M.H.S., Ph.DMichelle M. Mello, J.D., Ph.D., Steven N. Goodman, M.D., M.H.S., Ph.D.,.,
and Ruth R. Faden, Ph.D., M.P.H.NEJM SEP 6, 2012and Ruth R. Faden, Ph.D., M.P.H.NEJM SEP 6, 2012
Case: 4Case: 4
Table 1.Table 1. Major Deficiencies in the Informed-Consent Form forMajor Deficiencies in the Informed-Consent Form for
the TIDE Trialthe TIDE Trial
 InadequateInadequate explanationexplanation of the purpose of researchof the purpose of research
 Did not clearly explain that the purpose of the study was to definitively establish thatDid not clearly explain that the purpose of the study was to definitively establish that
rosiglitazone involved a significantly higher risk ofrosiglitazone involved a significantly higher risk of serious harmsserious harms than pioglitazone.than pioglitazone.
 Title included minor intervention (vitamin D) whose effects were not a subject of FDA concernTitle included minor intervention (vitamin D) whose effects were not a subject of FDA concern
 Inadequate explanation of theInadequate explanation of the risks of research participation.risks of research participation.
 Did not convey that the FDA was concerned primarily about theDid not convey that the FDA was concerned primarily about the safetysafety of rosiglitazone and wasof rosiglitazone and was
requiring the sponsor to conduct the TIDE trial to investigate safety signals.requiring the sponsor to conduct the TIDE trial to investigate safety signals.
 SubmergedSubmerged cardiovascular risks associated with rosiglitazone in a list of outcomes related tocardiovascular risks associated with rosiglitazone in a list of outcomes related to
potential effects of vitamin D on cancer and bone fractures.potential effects of vitamin D on cancer and bone fractures.
Table 1.Table 1. Major Deficiencies in the Informed-Major Deficiencies in the Informed-
Consent Form for the TIDE TrialConsent Form for the TIDE Trial
 Characterized previous studies as having providedCharacterized previous studies as having provided conflicting findingsconflicting findings
concerning the cardiovascular safety of rosiglitazone, when the weight of theconcerning the cardiovascular safety of rosiglitazone, when the weight of the
evidence was against rosiglitazone.evidence was against rosiglitazone.
 Inadequate explanation of alternativesInadequate explanation of alternatives to research participation.to research participation.
 DidDid not disclosenot disclose that the current clinical standard of care had moved awaythat the current clinical standard of care had moved away
from the use of rosiglitazone.from the use of rosiglitazone.
 Did not mention that the American Diabetes Association had recommendedDid not mention that the American Diabetes Association had recommended
rosiglitazone not be used.rosiglitazone not be used.
““What is the fuss aboutWhat is the fuss about
ethics and regulatoryethics and regulatory
requirements in research?”requirements in research?”
Adapted from: Steve Freedman, PPCRAdapted from: Steve Freedman, PPCR
course, Harvard Med School 2011course, Harvard Med School 2011
Research Ethics: Why?Research Ethics: Why?
TragedyTragedy
 In 1937, the manufacturer of sulfanilamide tablets, aIn 1937, the manufacturer of sulfanilamide tablets, a
popular cold remedy, produced a more ‘palatable’popular cold remedy, produced a more ‘palatable’
liquid version, with a ‘sweet raspberry’ taste.liquid version, with a ‘sweet raspberry’ taste.
 AMA received numerous reports of patients with:AMA received numerous reports of patients with:
abdominal pain, nausea / vomiting, renal failure andabdominal pain, nausea / vomiting, renal failure and
death.death.
 105 people in 15 states died, including 34 children105 people in 15 states died, including 34 children
 The compound used to dissolve the tablets intoThe compound used to dissolve the tablets into
solution was diethylene glycol!solution was diethylene glycol!
 The manufacturer had done nothing legally wrong!The manufacturer had done nothing legally wrong!
Adverse EffectsAdverse Effects
1959: West German physicians began to1959: West German physicians began to
prescribe thalidomide to relieve morningprescribe thalidomide to relieve morning
sickness and insomniasickness and insomnia
40 U.S. physicians were authorized to use40 U.S. physicians were authorized to use
thalidomide in clinical trials.thalidomide in clinical trials.
After the link was made between thalidomideAfter the link was made between thalidomide
and fetal malformations, the approval wasand fetal malformations, the approval was
withdrawn.withdrawn.
Adverse EffectsAdverse Effects
 FDA discovered that 2.5 million tablets ofFDA discovered that 2.5 million tablets of
thalidomide were distributed to 1,270 U.S.thalidomide were distributed to 1,270 U.S.
physicians as samplesphysicians as samples
 200,000 American patients received200,000 American patients received
thalidomidethalidomide
 Mid-1960s: 10,000 birth defects worldwideMid-1960s: 10,000 birth defects worldwide
Regulations:Regulations:
Kefauver-Harris Drug act 1962Kefauver-Harris Drug act 1962
 Safety requirements tightened.Safety requirements tightened.
 Drugs to be proven effective as well as safe prior toDrugs to be proven effective as well as safe prior to
marketing.marketing.
 Drug companies to register with the FDA, and gaveDrug companies to register with the FDA, and gave
FDA explicit authority to require compliance with goodFDA explicit authority to require compliance with good
manufacturing practices.manufacturing practices.
 Drug1966: the FDA released the Guidelines forDrug1966: the FDA released the Guidelines for
Reproduction Studies specifying that a new drug mustReproduction Studies specifying that a new drug must
have reproduction studies in at least two species ofhave reproduction studies in at least two species of
animals, using two dosage levels of the drug.animals, using two dosage levels of the drug.
Pre World War 11: EthicsPre World War 11: Ethics
 No regulations concerning the practice of clinicalNo regulations concerning the practice of clinical
research.research.
 Investigators guided by “conscience” and the “ethicsInvestigators guided by “conscience” and the “ethics
of immediate peers and Mentors”of immediate peers and Mentors”
 1932: the Tuskegee Study was funded by the Public1932: the Tuskegee Study was funded by the Public
Health Service which had black men with latentHealth Service which had black men with latent
syphilis remain untreated ,with 28 deaths fromsyphilis remain untreated ,with 28 deaths from
syphilis, 100 from related complications, 40 wivessyphilis, 100 from related complications, 40 wives
effected, 19 children born with congenital syphilis!effected, 19 children born with congenital syphilis!
Criminal StudiesCriminal Studies
 Nazi physicians conducted cruel and lethalNazi physicians conducted cruel and lethal
experimentation on concentration camp inmates andexperimentation on concentration camp inmates and
prisoners of war during WWIIprisoners of war during WWII
 December 9, 1946, the military trial (Nazi DoctorsDecember 9, 1946, the military trial (Nazi Doctors
Trial) began in Nuremberg, Germany; guilty verdictsTrial) began in Nuremberg, Germany; guilty verdicts
were returned for 15 of 23 defendants; sevenwere returned for 15 of 23 defendants; seven
received death sentences.received death sentences.
 Final judgment: human experimentation wasFinal judgment: human experimentation was
necessary for the advancement of medicalnecessary for the advancement of medical
knowledge, but ONLY if done consistent with theknowledge, but ONLY if done consistent with the
principles of what has come to be known as theprinciples of what has come to be known as the
Nuremberg CodeNuremberg Code
Code of Ethics:Code of Ethics:
The Nuremberg CodeThe Nuremberg Code
 Nuremberg Code describes 10 basic principles of ethical conduct ofNuremberg Code describes 10 basic principles of ethical conduct of
human experimentationhuman experimentation
 Pivotal principles:Pivotal principles:
–– Voluntary consent of the subject must be obtainedVoluntary consent of the subject must be obtained
–– Prior animal experimentation to determine risk must bePrior animal experimentation to determine risk must be
performedperformed
 Investigators must be qualified medical personnelInvestigators must be qualified medical personnel
 Adopted by the United Nations in 1948Adopted by the United Nations in 1948
 Recognized as international ‘common law’ guiding medical researchRecognized as international ‘common law’ guiding medical research
Any impact of Nuremberg Code?Any impact of Nuremberg Code?
 The Tuskegee Syphilis Study proceeded through theThe Tuskegee Syphilis Study proceeded through the
1950s and 1960s despite data suggesting arsenic and1950s and 1960s despite data suggesting arsenic and
bismuth were effective and even when penicillin becamebismuth were effective and even when penicillin became
established as standard therapy.established as standard therapy.
 Enrolled subjects were told they were receiving therapy forEnrolled subjects were told they were receiving therapy for
their disease, when in fact they never received any study-their disease, when in fact they never received any study-
related treatment!related treatment!
 In 1963, institutionalized mentally retarded children wereIn 1963, institutionalized mentally retarded children were
intentionally exposed to Hepatitis A virus and their clinicalintentionally exposed to Hepatitis A virus and their clinical
course followed!course followed!
Helsinki Declaration: 1964Helsinki Declaration: 1964
 Responding to the thalidomide disaster, the 18Responding to the thalidomide disaster, the 18thth
WorldWorld
Medical Assembly, held in Helsinki, adopted a resolutionMedical Assembly, held in Helsinki, adopted a resolution
on human experimentation.on human experimentation.
 Outlines basic principles of human experimentationOutlines basic principles of human experimentation
 Requires informed consent of study subjectsRequires informed consent of study subjects
 Describes ethical approval and review of researchDescribes ethical approval and review of research
National Research Act: 1974National Research Act: 1974
 1972: US Congress passed the National Research Act.1972: US Congress passed the National Research Act.
 Required the review of all clinical research by an IRB.Required the review of all clinical research by an IRB.
 Set up commission to define ethical standards for clinicalSet up commission to define ethical standards for clinical
research in the U.S.research in the U.S.
 The recommendations, known as the Belmont Report,The recommendations, known as the Belmont Report,
published in the Federal Register in April, 1979, whichpublished in the Federal Register in April, 1979, which
led to new regulations issued by the FDA and the DHHSled to new regulations issued by the FDA and the DHHS
in 1981.in 1981.
Belmont report and Principles ofBelmont report and Principles of
Research :Research : AutonomyAutonomy
 Autonomy; The ability to make thought outAutonomy; The ability to make thought out
decisions for oneself without any coercion,decisions for oneself without any coercion,
with full mental capacitywith full mental capacity
BeneficenceBeneficence
 Refers to the concept of always doing good, orRefers to the concept of always doing good, or
to do no harm.to do no harm.
 To accomplish beneficence, risks must beTo accomplish beneficence, risks must be
balanced against benefits.balanced against benefits.
JusticeJustice
 Groups defined by socioeconomic status, intelligence,Groups defined by socioeconomic status, intelligence,
race, etc should not be singled out for participation in arace, etc should not be singled out for participation in a
trial.trial.
 Prevents subgroups of patients, especially vulnerablePrevents subgroups of patients, especially vulnerable
populations, from being unfairly targeted and bearingpopulations, from being unfairly targeted and bearing
the burden of research that will benefit others.the burden of research that will benefit others.
 Demands an equal and fair selection of subjectsDemands an equal and fair selection of subjects
Modern significant reported eventsModern significant reported events::
 Death of an 18-year-old research subject in a geneDeath of an 18-year-old research subject in a gene
replacement study at U Penn in 1999 (Jesse Gelsinger)replacement study at U Penn in 1999 (Jesse Gelsinger)
 Raised concerns about financial relationships andRaised concerns about financial relationships and
interests on the part of biomedical researchers thatinterests on the part of biomedical researchers that
could compromise the safety of research subjects.could compromise the safety of research subjects.
 Kennedy-Krieger Institute case: Raised concerns aboutKennedy-Krieger Institute case: Raised concerns about
the distinction between doctor-patient relationship andthe distinction between doctor-patient relationship and
investigator-subject relationshipinvestigator-subject relationship
 Federal shutdowns of academic clinical researchFederal shutdowns of academic clinical research
programs for a variety of reasons (Duke, Johnsprograms for a variety of reasons (Duke, Johns
Hopkins).Hopkins).
Steps of Drug Development: FDASteps of Drug Development: FDA
Phase IPhase I
 Normal VolunteersNormal Volunteers
 SafetySafety
 Dose-KineticsDose-Kinetics
 ActionAction
Phase IIPhase II
 PatientsPatients
 Evidence of ActivityEvidence of Activity
 DoseDose
Phase IIIPhase III
 Pivotal StudiesPivotal Studies
Phase IVPhase IV
 Post NDAPost NDA
 Expanded IndicationsExpanded Indications
 Safety StudiesSafety Studies
What is the process forWhat is the process for drug developmentdrug development??
Clinical Drug trialsClinical Drug trials
Phase IPhase I 12 - 18 months, 200 volunteers12 - 18 months, 200 volunteers
Phase IIPhase II 1.5 – 2.5 years, 300 - 5001.5 – 2.5 years, 300 - 500
patientspatients
 Phase IIIPhase III and beyond 3 – 4 years, 2000and beyond 3 – 4 years, 2000
–– 3000 patients3000 patients
Saudi Council For Health SpecialtiesSaudi Council For Health Specialties..
Guidelines 2003: Human researchGuidelines 2003: Human research
 Objectives and Methods in conformity with ShariahObjectives and Methods in conformity with Shariah
 Should significantly contribute to enriching medicalShould significantly contribute to enriching medical
knowledgeknowledge
 In conformity with scientific and morally-approvedIn conformity with scientific and morally-approved
principles e.g Helsinki Principleprinciples e.g Helsinki Principle
 Desired benefits should outweigh potential harmsDesired benefits should outweigh potential harms
 The researcher must be qualified.The researcher must be qualified.
SCHS GuidelinesSCHS Guidelines
 Must respect patient rights and treat them humanelyMust respect patient rights and treat them humanely
 Research on humans should be with full informedResearch on humans should be with full informed
consentconsent
 Physician must explain all the details and potentialPhysician must explain all the details and potential
harmsharms
 The consenting subject must be adult and mentallyThe consenting subject must be adult and mentally
sound (for minors, guardian’s consent necessary)sound (for minors, guardian’s consent necessary)
SCHS GuidelinesSCHS Guidelines
 Written consentWritten consent
 Consent should not involve any pressure, coercion orConsent should not involve any pressure, coercion or
exploitationexploitation
 The researcher must comply with laws of the land (forThe researcher must comply with laws of the land (for
National Guard, KAIMRC- ICH-GCP)National Guard, KAIMRC- ICH-GCP)
 Researcher must obtain permission from InstitutionalResearcher must obtain permission from Institutional
Review Board and Ethics Committee and the relevantReview Board and Ethics Committee and the relevant
departmentdepartment
ConductingConducting Research On AnimalsResearch On Animals
 Prophet Muhammad (SAW) enjoined kindness andProphet Muhammad (SAW) enjoined kindness and
mercy towards animals, so the sacrificial animal must bemercy towards animals, so the sacrificial animal must be
subject to principles of slaughter in Islam.subject to principles of slaughter in Islam.
 Animal must not be tortured.Animal must not be tortured.
 The aim of the experiment should not be frivolous.The aim of the experiment should not be frivolous.
 Permission must be obtained from the relevant sector forPermission must be obtained from the relevant sector for
sacrificing animals.sacrificing animals.
SCHS: Controls For AcceptingSCHS: Controls For Accepting GrantsGrants
 Researcher may accept grants subject to abiding by theResearcher may accept grants subject to abiding by the
guiding principles of Shariah and scientific integrity.guiding principles of Shariah and scientific integrity.
 Research must be conducted in a proper, scientificResearch must be conducted in a proper, scientific
method.method.
 Grant body awarding financial support should notGrant body awarding financial support should not
interfere in the research findings or the conduct of theinterfere in the research findings or the conduct of the
researchresearch
SCHS: Research InvolvingSCHS: Research Involving UnprecedentedUnprecedented
InterventionalInterventional OperationsOperations
 Must be confident of his/her and the work team’sMust be confident of his/her and the work team’s
abilities in performing the operation complying withabilities in performing the operation complying with
technical considerations.technical considerations.
 Such interventions should have been performed onSuch interventions should have been performed on
experimental animals first, except in very specialexperimental animals first, except in very special
cases conducted by experts after approval ofcases conducted by experts after approval of
Medical Research Ethics Committee.Medical Research Ethics Committee.
 These procedures must be performed in recognizedThese procedures must be performed in recognized
hospitals with appropriate specializationhospitals with appropriate specialization
Ethical & Scientific Implications ofEthical & Scientific Implications of
GlobalizationGlobalization of Clinical Researchof Clinical Research
 Globalization of clinical research fairly recentGlobalization of clinical research fairly recent
phenomenon. Possible reasons include cost-saving byphenomenon. Possible reasons include cost-saving by
conducting trials in developing countries for Phase 2 andconducting trials in developing countries for Phase 2 and
Phase 3, e.g. South Asia and South American countries.Phase 3, e.g. South Asia and South American countries.
 Advantages : shortening time to approval of the drug.Advantages : shortening time to approval of the drug.
 A major concern is ethical oversight due to disparities inA major concern is ethical oversight due to disparities in
education, economic and social standing, and healthcareeducation, economic and social standing, and healthcare
systems.systems.
 Another concern is the transparency of research inAnother concern is the transparency of research in
developing countries. NEJM 360; 8 Feb 2009 (Glickmandeveloping countries. NEJM 360; 8 Feb 2009 (Glickman
et al)et al)
International Conference for Harmonization ofInternational Conference for Harmonization of
Research: Good Clinical PracticesResearch: Good Clinical Practices
The ICH-GCP guidelines are currentlyThe ICH-GCP guidelines are currently
accepted as global standards governingaccepted as global standards governing
clinical research:clinical research:
-Technical standards-Technical standards
-Ethical oversight-Ethical oversight
-Appropriate monitoring of trials-Appropriate monitoring of trials
Ethical Issues Of Clinical Trials InEthical Issues Of Clinical Trials In
ChildrenChildren: A European Perspective: A European Perspective
 Children should not be harmed by their participation in clinicalChildren should not be harmed by their participation in clinical
trials.trials.
 Children are not young adults and trials of adults cannot beChildren are not young adults and trials of adults cannot be
extrapolated to children.extrapolated to children.
 Consent and assent is a dynamic and continuous processConsent and assent is a dynamic and continuous process
when a child is involved in a trial, involving on-goingwhen a child is involved in a trial, involving on-going
dialogue between children, their parents and thedialogue between children, their parents and the
investigators.investigators.
 Study design should allow for smallest number of patients toStudy design should allow for smallest number of patients to
be recruited to give statistically and clinically significantbe recruited to give statistically and clinically significant
result.result.
 Study design needs to limit invasiveness.Study design needs to limit invasiveness.
 Risks and benefits should be carefully weighed.Risks and benefits should be carefully weighed.
 Safety monitoring should be conducted at appropriateSafety monitoring should be conducted at appropriate
intervals.intervals. H Salmons Arch.Dis.Child 2009; 94 Pg 474-477H Salmons Arch.Dis.Child 2009; 94 Pg 474-477
Ethics ofEthics of Informed ConsentInformed Consent :Key Elements ::Key Elements :
 Purpose of the research projectPurpose of the research project
 ProceduresProcedures
 Risks and DiscomfortRisks and Discomfort
 BenefitsBenefits
 Alternatives to participationAlternatives to participation
 ConfidentialityConfidentiality
 Request for more informationRequest for more information
 Right for Refusal or withdrawalRight for Refusal or withdrawal
 Injury StatementInjury Statement
 Consent StatementConsent Statement
 SignaturesSignatures
Foundations of Clinical Research :Portney Watkins: 2009 P 47-59Foundations of Clinical Research :Portney Watkins: 2009 P 47-59
ICMJE: ResearchICMJE: Research AuthorshipAuthorship EthicsEthics::
 Comply with international committee of medicalComply with international committee of medical
journal editors – Significant contribution in researchjournal editors – Significant contribution in research
idea, methodology ,collection of data, analysis of dataidea, methodology ,collection of data, analysis of data
++
 Write distinct portion of article +Write distinct portion of article +
 Review/rewrite the final draft of the articleReview/rewrite the final draft of the article
Research MisconductResearch Misconduct
•FalsificationFalsification: The manipulation of research: The manipulation of research
materials, equipment,processes, or changing ormaterials, equipment,processes, or changing or
omitting data or results thus affecting accuracyomitting data or results thus affecting accuracy
of reportingof reporting..
Fabrication:Fabrication: Making up results and recording orMaking up results and recording or
reporting themreporting them..
Plagiarism:Plagiarism: the appropriation of other person’sthe appropriation of other person’s
ideas, processes, results, or words withoutideas, processes, results, or words without
giving appropraite credit and includesgiving appropraite credit and includes
citation plagiarismcitation plagiarism
US National Science FoundationUS National Science Foundation
Research MisconductResearch Misconduct
Plagiarism-fabrication :Plagiarism-fabrication : taking an unrelated figuretaking an unrelated figure
from an unrelated publication andfrom an unrelated publication and
reproducing it exactly in a new publicationreproducing it exactly in a new publication
Self-plagiarism:Self-plagiarism: multiple publication of samemultiple publication of same
content with different titles and /or in differentcontent with different titles and /or in different
journalsjournals
US National Science FoundationUS National Science Foundation
Research MisconductResearch Misconduct
Ghost-writing:Ghost-writing: Where someone other than theWhere someone other than the
named author makes a major contributionnamed author makes a major contribution
Guest/Gift authorship:Guest/Gift authorship: Where there is statedWhere there is stated
authorship in the absence of involvementauthorship in the absence of involvement
US National Science FoundationUS National Science Foundation
Research MisconductResearch Misconduct
Coercion authorshipCoercion authorship: the practice of being: the practice of being
pressured to give authorship to individualspressured to give authorship to individuals
because of their positionsbecause of their positions
Mutual support/admiration authorship:Mutual support/admiration authorship: TheThe
practice of authors placing each other’spractice of authors placing each other’s
names on papers even though they madenames on papers even though they made
little or no direct contributionslittle or no direct contributions
Unapproved authorshipUnapproved authorship: listing someone as: listing someone as
author who has not agreed to be an author orauthor who has not agreed to be an author or
not consulted about authorshipnot consulted about authorship
US National Science FoundationUS National Science Foundation
Case: 1Case: 1
 Professor ‘Greedy’ is about to land his “biggest grant” yet. TheProfessor ‘Greedy’ is about to land his “biggest grant” yet. The
industry ‘sponsor’ would like him to be a Principle Investigatorindustry ‘sponsor’ would like him to be a Principle Investigator
and first author for a study on a new ace-inhibitor. He has aand first author for a study on a new ace-inhibitor. He has a
brilliant PhD, Doctor ‘Sincere’, who has joined the projectbrilliant PhD, Doctor ‘Sincere’, who has joined the project
which translates his basic science work into clinicalwhich translates his basic science work into clinical
application. The idea of Dr. Sincere’s preliminary work wasapplication. The idea of Dr. Sincere’s preliminary work was
picked up by Professor Greedy and discussed with thepicked up by Professor Greedy and discussed with the
industry, who are keen to cash in on Professor Greedy’sindustry, who are keen to cash in on Professor Greedy’s
name. Halfway into the project, the two have an intensename. Halfway into the project, the two have an intense
argument on first authorship and Prof Greedy indicates thatargument on first authorship and Prof Greedy indicates that
he has alternate PhD candidates that “he is currentlyhe has alternate PhD candidates that “he is currently
interviewing” to complete the study . Dr. Sincere reflects oninterviewing” to complete the study . Dr. Sincere reflects on
what to do next?…what to do next?…
Case: 2Case: 2
 Doctor ‘Ambitious’ is completing the 2Doctor ‘Ambitious’ is completing the 2ndnd
and crucial periodand crucial period
of his phase 3 clinical trial, comparing in an RCT , a novelof his phase 3 clinical trial, comparing in an RCT , a novel
anti-coagulant ( NAC) with oral warfarin. He has beenanti-coagulant ( NAC) with oral warfarin. He has been
provided the results of an interim analysis that the dataprovided the results of an interim analysis that the data
safety monitoring board requires. On eyeballing thesafety monitoring board requires. On eyeballing the
figures, he notices that omission of just one patient forfigures, he notices that omission of just one patient for
an “additional” previously unspecified exclusion criterion,an “additional” previously unspecified exclusion criterion,
may make his data highly significant in favour of NAC . Hemay make his data highly significant in favour of NAC . He
daydreams of how people will read his paper in thedaydreams of how people will read his paper in the
Lancet !…Lancet !…
Case: 2Case: 2
 Doctor ‘Conscience’ has been approached with a 800,000Doctor ‘Conscience’ has been approached with a 800,000
Riyal grant by an International funding agency to conductRiyal grant by an International funding agency to conduct
an RCT in Jeddah, comparing an established sedative-an RCT in Jeddah, comparing an established sedative-
hypnotic (“sweetdream”) with a new drug (“nightmare”)hypnotic (“sweetdream”) with a new drug (“nightmare”)
watching for the effects of sleep-deprivation of greater thanwatching for the effects of sleep-deprivation of greater than
48hrs on cognitive skills of patients with chronic insomnia.48hrs on cognitive skills of patients with chronic insomnia.
‘Nightmare’ was tolerated successfully in phase 1 trials for‘Nightmare’ was tolerated successfully in phase 1 trials for
safety but in phase11 trials for efficacy and safety it wassafety but in phase11 trials for efficacy and safety it was
marginally superior to placebo in its sedative hypnoticmarginally superior to placebo in its sedative hypnotic
effects when tested in European population.effects when tested in European population.
 The study is part of a proposed Phase 111 multicenter trialThe study is part of a proposed Phase 111 multicenter trial
being done in the Middle East to see its effects in thebeing done in the Middle East to see its effects in the
Middle Eastern population: Doctor ‘Conscience’ now losesMiddle Eastern population: Doctor ‘Conscience’ now loses
sleep!sleep!
Case: 3Case: 3
Some ‘Q-Tips’ to avoid scientificSome ‘Q-Tips’ to avoid scientific
misconductmisconduct
Search into
your soul
before
research
Do No harm Think of
advancing
science
primarily and
yourself
secondarily
Do not
disclose
preliminary
data to press
or media
Avoid
fabrication of
data and
falsification
of results
Avoid
voluntary and
involuntary
plagiarism
Avoid
selective
omission of
data
Avoid hiding
adverse
reactions
Avoid ghost
and gift
authorship
Exercise
humility in
research and
learn to reflect
and
reevaluate
Email your Reflections!Email your Reflections!
quadrimu@ngha.med.saquadrimu@ngha.med.sa
Acknowledgement: Ms M Khalil Res Asst.Acknowledgement: Ms M Khalil Res Asst.
THANK YOU!THANK YOU!
and enjoy the fruits of ethical research!and enjoy the fruits of ethical research!

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Research ethics

  • 1. ReseaRch ethics and PLaGiaRisMReseaRch ethics and PLaGiaRisM Prof. K. H. Mujtaba QuadriProf. K. H. Mujtaba Quadri Chairman, Department of Medicine and Hospital Ethics CommitteeChairman, Department of Medicine and Hospital Ethics Committee Professor of Medicine/NephrologyProfessor of Medicine/Nephrology King Saud Bin Abdulaziz University of Health Sciences,King Saud Bin Abdulaziz University of Health Sciences, National Guard Health Affairs, KAMC, JeddahNational Guard Health Affairs, KAMC, Jeddah Diplomate American Boards of Internal Medicine (1990-2020 ) and Nephrology (1992-2022)Diplomate American Boards of Internal Medicine (1990-2020 ) and Nephrology (1992-2022) Certification in Principles and Practice of Clinical Research (Harvard)Certification in Principles and Practice of Clinical Research (Harvard)
  • 2. ObjectivesObjectives  To establish awareness about Research ethics andTo establish awareness about Research ethics and answer “why research ethics”?answer “why research ethics”?  To examine some principles of Islamic ResearchTo examine some principles of Islamic Research EthicsEthics  To encourage reflection on illustrative casesTo encourage reflection on illustrative cases  To introduce the concepts of plagiarism and otherTo introduce the concepts of plagiarism and other forms of ‘scientific misconduct’forms of ‘scientific misconduct’
  • 3. Case: 1Case: 1  ProfessorProfessor ‘Greedy‘Greedy’ is about to land his “biggest grant” yet. The’ is about to land his “biggest grant” yet. The industry ‘sponsorindustry ‘sponsor’ would like him to be a’ would like him to be a Principle InvestigatorPrinciple Investigator and first author for a study on a new ace-inhibitor. He has aand first author for a study on a new ace-inhibitor. He has a brilliant PhD, Doctorbrilliant PhD, Doctor ‘Sincere‘Sincere’, who has joined the project’, who has joined the project which translates his basic science work into clinicalwhich translates his basic science work into clinical application. The idea of Dr. Sincere’s preliminary work wasapplication. The idea of Dr. Sincere’s preliminary work was picked up by Professor Greedy and discussed with thepicked up by Professor Greedy and discussed with the industry, who are keen to cash in on Professor Greedy’sindustry, who are keen to cash in on Professor Greedy’s name. Halfway into the project, the two have an intensename. Halfway into the project, the two have an intense argument onargument on first authorshipfirst authorship and Prof Greedy indicates thatand Prof Greedy indicates that he has alternate PhD candidates that “he is currentlyhe has alternate PhD candidates that “he is currently interviewing” to complete the study . Dr. Sincere reflects oninterviewing” to complete the study . Dr. Sincere reflects on what to do next?…what to do next?…
  • 4.  DoctorDoctor ‘Ambitious’‘Ambitious’ is completing the 2is completing the 2ndnd and crucial periodand crucial period of his phase 3 clinical trial, comparing in anof his phase 3 clinical trial, comparing in an RCTRCT , a novel, a novel anti-coagulant NAC with oral warfarin. He has beenanti-coagulant NAC with oral warfarin. He has been provided the results of anprovided the results of an interim analysisinterim analysis that the datathat the data safety monitoring board requires. On eyeballing thesafety monitoring board requires. On eyeballing the figures, he notices that omission of just one patient forfigures, he notices that omission of just one patient for an “additional” previouslyan “additional” previously unspecifiedunspecified exclusionexclusion criterion,criterion, may make his data highly significant in favour of NAC .may make his data highly significant in favour of NAC . He daydreams of how people will read his paper in theHe daydreams of how people will read his paper in the Lancet !…Lancet !… Case: 2Case: 2
  • 5.  DoctorDoctor ‘Conscience‘Conscience’ has been approached with a 800,000’ has been approached with a 800,000 Riyal grant by an International funding agency to conductRiyal grant by an International funding agency to conduct an RCT in Jeddah, comparing an established sedative-an RCT in Jeddah, comparing an established sedative- hypnotic (“hypnotic (“sweetdreamsweetdream”) with a new drug (“”) with a new drug (“nightmarenightmare”)”) watching for the effects of sleep-deprivation of greater thanwatching for the effects of sleep-deprivation of greater than 48hrs on cognitive skills of patients with chronic insomnia.48hrs on cognitive skills of patients with chronic insomnia. ‘Nightmare’ was tolerated successfully in phase 1 trials for‘Nightmare’ was tolerated successfully in phase 1 trials for safety but insafety but in phase11phase11 trials for efficacy and safety it wastrials for efficacy and safety it was marginally superior to placebomarginally superior to placebo in its sedative hypnoticin its sedative hypnotic effects when tested in European population.effects when tested in European population.  The study is part of aThe study is part of a proposed Phase 111 multicenter trialproposed Phase 111 multicenter trial being done in the Middle East to see its effects in thebeing done in the Middle East to see its effects in the Middle EasternMiddle Eastern population: Doctor ‘Conscience’ now losespopulation: Doctor ‘Conscience’ now loses sleep!sleep! Case: 3Case: 3
  • 6.  Thiazolidinedione Intervention with Vitamin D EvaluationThiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial(TIDE) trial compared thecompared the cardiovascular outcomescardiovascular outcomes of long-term treatment withof long-term treatment with rosiglitazone with those of pioglitazone (Actos, Takeda) in patients with typerosiglitazone with those of pioglitazone (Actos, Takeda) in patients with type 2 diabetes as a Phase 1V RCT .2 diabetes as a Phase 1V RCT .  TheThe FDA haltedFDA halted the trial and at their request an Institute of Medicinethe trial and at their request an Institute of Medicine (IOM) committee was convened to independantly examine the ethics and(IOM) committee was convened to independantly examine the ethics and science of FDA required post-marketing researchscience of FDA required post-marketing research AnyAny volunteersvolunteers as to what were the ethical concerns?as to what were the ethical concerns? Ethical Considerations in Studying Drug SafetyEthical Considerations in Studying Drug Safety—— The Institute of Medicine ReportThe Institute of Medicine Report Michelle M. Mello, J.D., Ph.D., Steven N. Goodman, M.D., M.H.S., Ph.DMichelle M. Mello, J.D., Ph.D., Steven N. Goodman, M.D., M.H.S., Ph.D.,., and Ruth R. Faden, Ph.D., M.P.H.NEJM SEP 6, 2012and Ruth R. Faden, Ph.D., M.P.H.NEJM SEP 6, 2012 Case: 4Case: 4
  • 7. Table 1.Table 1. Major Deficiencies in the Informed-Consent Form forMajor Deficiencies in the Informed-Consent Form for the TIDE Trialthe TIDE Trial  InadequateInadequate explanationexplanation of the purpose of researchof the purpose of research  Did not clearly explain that the purpose of the study was to definitively establish thatDid not clearly explain that the purpose of the study was to definitively establish that rosiglitazone involved a significantly higher risk ofrosiglitazone involved a significantly higher risk of serious harmsserious harms than pioglitazone.than pioglitazone.  Title included minor intervention (vitamin D) whose effects were not a subject of FDA concernTitle included minor intervention (vitamin D) whose effects were not a subject of FDA concern  Inadequate explanation of theInadequate explanation of the risks of research participation.risks of research participation.  Did not convey that the FDA was concerned primarily about theDid not convey that the FDA was concerned primarily about the safetysafety of rosiglitazone and wasof rosiglitazone and was requiring the sponsor to conduct the TIDE trial to investigate safety signals.requiring the sponsor to conduct the TIDE trial to investigate safety signals.  SubmergedSubmerged cardiovascular risks associated with rosiglitazone in a list of outcomes related tocardiovascular risks associated with rosiglitazone in a list of outcomes related to potential effects of vitamin D on cancer and bone fractures.potential effects of vitamin D on cancer and bone fractures.
  • 8. Table 1.Table 1. Major Deficiencies in the Informed-Major Deficiencies in the Informed- Consent Form for the TIDE TrialConsent Form for the TIDE Trial  Characterized previous studies as having providedCharacterized previous studies as having provided conflicting findingsconflicting findings concerning the cardiovascular safety of rosiglitazone, when the weight of theconcerning the cardiovascular safety of rosiglitazone, when the weight of the evidence was against rosiglitazone.evidence was against rosiglitazone.  Inadequate explanation of alternativesInadequate explanation of alternatives to research participation.to research participation.  DidDid not disclosenot disclose that the current clinical standard of care had moved awaythat the current clinical standard of care had moved away from the use of rosiglitazone.from the use of rosiglitazone.  Did not mention that the American Diabetes Association had recommendedDid not mention that the American Diabetes Association had recommended rosiglitazone not be used.rosiglitazone not be used.
  • 9. ““What is the fuss aboutWhat is the fuss about ethics and regulatoryethics and regulatory requirements in research?”requirements in research?” Adapted from: Steve Freedman, PPCRAdapted from: Steve Freedman, PPCR course, Harvard Med School 2011course, Harvard Med School 2011 Research Ethics: Why?Research Ethics: Why?
  • 10. TragedyTragedy  In 1937, the manufacturer of sulfanilamide tablets, aIn 1937, the manufacturer of sulfanilamide tablets, a popular cold remedy, produced a more ‘palatable’popular cold remedy, produced a more ‘palatable’ liquid version, with a ‘sweet raspberry’ taste.liquid version, with a ‘sweet raspberry’ taste.  AMA received numerous reports of patients with:AMA received numerous reports of patients with: abdominal pain, nausea / vomiting, renal failure andabdominal pain, nausea / vomiting, renal failure and death.death.  105 people in 15 states died, including 34 children105 people in 15 states died, including 34 children  The compound used to dissolve the tablets intoThe compound used to dissolve the tablets into solution was diethylene glycol!solution was diethylene glycol!  The manufacturer had done nothing legally wrong!The manufacturer had done nothing legally wrong!
  • 11. Adverse EffectsAdverse Effects 1959: West German physicians began to1959: West German physicians began to prescribe thalidomide to relieve morningprescribe thalidomide to relieve morning sickness and insomniasickness and insomnia 40 U.S. physicians were authorized to use40 U.S. physicians were authorized to use thalidomide in clinical trials.thalidomide in clinical trials. After the link was made between thalidomideAfter the link was made between thalidomide and fetal malformations, the approval wasand fetal malformations, the approval was withdrawn.withdrawn.
  • 12. Adverse EffectsAdverse Effects  FDA discovered that 2.5 million tablets ofFDA discovered that 2.5 million tablets of thalidomide were distributed to 1,270 U.S.thalidomide were distributed to 1,270 U.S. physicians as samplesphysicians as samples  200,000 American patients received200,000 American patients received thalidomidethalidomide  Mid-1960s: 10,000 birth defects worldwideMid-1960s: 10,000 birth defects worldwide
  • 13. Regulations:Regulations: Kefauver-Harris Drug act 1962Kefauver-Harris Drug act 1962  Safety requirements tightened.Safety requirements tightened.  Drugs to be proven effective as well as safe prior toDrugs to be proven effective as well as safe prior to marketing.marketing.  Drug companies to register with the FDA, and gaveDrug companies to register with the FDA, and gave FDA explicit authority to require compliance with goodFDA explicit authority to require compliance with good manufacturing practices.manufacturing practices.  Drug1966: the FDA released the Guidelines forDrug1966: the FDA released the Guidelines for Reproduction Studies specifying that a new drug mustReproduction Studies specifying that a new drug must have reproduction studies in at least two species ofhave reproduction studies in at least two species of animals, using two dosage levels of the drug.animals, using two dosage levels of the drug.
  • 14. Pre World War 11: EthicsPre World War 11: Ethics  No regulations concerning the practice of clinicalNo regulations concerning the practice of clinical research.research.  Investigators guided by “conscience” and the “ethicsInvestigators guided by “conscience” and the “ethics of immediate peers and Mentors”of immediate peers and Mentors”  1932: the Tuskegee Study was funded by the Public1932: the Tuskegee Study was funded by the Public Health Service which had black men with latentHealth Service which had black men with latent syphilis remain untreated ,with 28 deaths fromsyphilis remain untreated ,with 28 deaths from syphilis, 100 from related complications, 40 wivessyphilis, 100 from related complications, 40 wives effected, 19 children born with congenital syphilis!effected, 19 children born with congenital syphilis!
  • 15. Criminal StudiesCriminal Studies  Nazi physicians conducted cruel and lethalNazi physicians conducted cruel and lethal experimentation on concentration camp inmates andexperimentation on concentration camp inmates and prisoners of war during WWIIprisoners of war during WWII  December 9, 1946, the military trial (Nazi DoctorsDecember 9, 1946, the military trial (Nazi Doctors Trial) began in Nuremberg, Germany; guilty verdictsTrial) began in Nuremberg, Germany; guilty verdicts were returned for 15 of 23 defendants; sevenwere returned for 15 of 23 defendants; seven received death sentences.received death sentences.  Final judgment: human experimentation wasFinal judgment: human experimentation was necessary for the advancement of medicalnecessary for the advancement of medical knowledge, but ONLY if done consistent with theknowledge, but ONLY if done consistent with the principles of what has come to be known as theprinciples of what has come to be known as the Nuremberg CodeNuremberg Code
  • 16. Code of Ethics:Code of Ethics: The Nuremberg CodeThe Nuremberg Code  Nuremberg Code describes 10 basic principles of ethical conduct ofNuremberg Code describes 10 basic principles of ethical conduct of human experimentationhuman experimentation  Pivotal principles:Pivotal principles: –– Voluntary consent of the subject must be obtainedVoluntary consent of the subject must be obtained –– Prior animal experimentation to determine risk must bePrior animal experimentation to determine risk must be performedperformed  Investigators must be qualified medical personnelInvestigators must be qualified medical personnel  Adopted by the United Nations in 1948Adopted by the United Nations in 1948  Recognized as international ‘common law’ guiding medical researchRecognized as international ‘common law’ guiding medical research
  • 17. Any impact of Nuremberg Code?Any impact of Nuremberg Code?  The Tuskegee Syphilis Study proceeded through theThe Tuskegee Syphilis Study proceeded through the 1950s and 1960s despite data suggesting arsenic and1950s and 1960s despite data suggesting arsenic and bismuth were effective and even when penicillin becamebismuth were effective and even when penicillin became established as standard therapy.established as standard therapy.  Enrolled subjects were told they were receiving therapy forEnrolled subjects were told they were receiving therapy for their disease, when in fact they never received any study-their disease, when in fact they never received any study- related treatment!related treatment!  In 1963, institutionalized mentally retarded children wereIn 1963, institutionalized mentally retarded children were intentionally exposed to Hepatitis A virus and their clinicalintentionally exposed to Hepatitis A virus and their clinical course followed!course followed!
  • 18. Helsinki Declaration: 1964Helsinki Declaration: 1964  Responding to the thalidomide disaster, the 18Responding to the thalidomide disaster, the 18thth WorldWorld Medical Assembly, held in Helsinki, adopted a resolutionMedical Assembly, held in Helsinki, adopted a resolution on human experimentation.on human experimentation.  Outlines basic principles of human experimentationOutlines basic principles of human experimentation  Requires informed consent of study subjectsRequires informed consent of study subjects  Describes ethical approval and review of researchDescribes ethical approval and review of research
  • 19. National Research Act: 1974National Research Act: 1974  1972: US Congress passed the National Research Act.1972: US Congress passed the National Research Act.  Required the review of all clinical research by an IRB.Required the review of all clinical research by an IRB.  Set up commission to define ethical standards for clinicalSet up commission to define ethical standards for clinical research in the U.S.research in the U.S.  The recommendations, known as the Belmont Report,The recommendations, known as the Belmont Report, published in the Federal Register in April, 1979, whichpublished in the Federal Register in April, 1979, which led to new regulations issued by the FDA and the DHHSled to new regulations issued by the FDA and the DHHS in 1981.in 1981.
  • 20. Belmont report and Principles ofBelmont report and Principles of Research :Research : AutonomyAutonomy  Autonomy; The ability to make thought outAutonomy; The ability to make thought out decisions for oneself without any coercion,decisions for oneself without any coercion, with full mental capacitywith full mental capacity
  • 21. BeneficenceBeneficence  Refers to the concept of always doing good, orRefers to the concept of always doing good, or to do no harm.to do no harm.  To accomplish beneficence, risks must beTo accomplish beneficence, risks must be balanced against benefits.balanced against benefits.
  • 22. JusticeJustice  Groups defined by socioeconomic status, intelligence,Groups defined by socioeconomic status, intelligence, race, etc should not be singled out for participation in arace, etc should not be singled out for participation in a trial.trial.  Prevents subgroups of patients, especially vulnerablePrevents subgroups of patients, especially vulnerable populations, from being unfairly targeted and bearingpopulations, from being unfairly targeted and bearing the burden of research that will benefit others.the burden of research that will benefit others.  Demands an equal and fair selection of subjectsDemands an equal and fair selection of subjects
  • 23. Modern significant reported eventsModern significant reported events::  Death of an 18-year-old research subject in a geneDeath of an 18-year-old research subject in a gene replacement study at U Penn in 1999 (Jesse Gelsinger)replacement study at U Penn in 1999 (Jesse Gelsinger)  Raised concerns about financial relationships andRaised concerns about financial relationships and interests on the part of biomedical researchers thatinterests on the part of biomedical researchers that could compromise the safety of research subjects.could compromise the safety of research subjects.  Kennedy-Krieger Institute case: Raised concerns aboutKennedy-Krieger Institute case: Raised concerns about the distinction between doctor-patient relationship andthe distinction between doctor-patient relationship and investigator-subject relationshipinvestigator-subject relationship  Federal shutdowns of academic clinical researchFederal shutdowns of academic clinical research programs for a variety of reasons (Duke, Johnsprograms for a variety of reasons (Duke, Johns Hopkins).Hopkins).
  • 24. Steps of Drug Development: FDASteps of Drug Development: FDA Phase IPhase I  Normal VolunteersNormal Volunteers  SafetySafety  Dose-KineticsDose-Kinetics  ActionAction Phase IIPhase II  PatientsPatients  Evidence of ActivityEvidence of Activity  DoseDose Phase IIIPhase III  Pivotal StudiesPivotal Studies Phase IVPhase IV  Post NDAPost NDA  Expanded IndicationsExpanded Indications  Safety StudiesSafety Studies What is the process forWhat is the process for drug developmentdrug development??
  • 25. Clinical Drug trialsClinical Drug trials Phase IPhase I 12 - 18 months, 200 volunteers12 - 18 months, 200 volunteers Phase IIPhase II 1.5 – 2.5 years, 300 - 5001.5 – 2.5 years, 300 - 500 patientspatients  Phase IIIPhase III and beyond 3 – 4 years, 2000and beyond 3 – 4 years, 2000 –– 3000 patients3000 patients
  • 26. Saudi Council For Health SpecialtiesSaudi Council For Health Specialties.. Guidelines 2003: Human researchGuidelines 2003: Human research  Objectives and Methods in conformity with ShariahObjectives and Methods in conformity with Shariah  Should significantly contribute to enriching medicalShould significantly contribute to enriching medical knowledgeknowledge  In conformity with scientific and morally-approvedIn conformity with scientific and morally-approved principles e.g Helsinki Principleprinciples e.g Helsinki Principle  Desired benefits should outweigh potential harmsDesired benefits should outweigh potential harms  The researcher must be qualified.The researcher must be qualified.
  • 27. SCHS GuidelinesSCHS Guidelines  Must respect patient rights and treat them humanelyMust respect patient rights and treat them humanely  Research on humans should be with full informedResearch on humans should be with full informed consentconsent  Physician must explain all the details and potentialPhysician must explain all the details and potential harmsharms  The consenting subject must be adult and mentallyThe consenting subject must be adult and mentally sound (for minors, guardian’s consent necessary)sound (for minors, guardian’s consent necessary)
  • 28. SCHS GuidelinesSCHS Guidelines  Written consentWritten consent  Consent should not involve any pressure, coercion orConsent should not involve any pressure, coercion or exploitationexploitation  The researcher must comply with laws of the land (forThe researcher must comply with laws of the land (for National Guard, KAIMRC- ICH-GCP)National Guard, KAIMRC- ICH-GCP)  Researcher must obtain permission from InstitutionalResearcher must obtain permission from Institutional Review Board and Ethics Committee and the relevantReview Board and Ethics Committee and the relevant departmentdepartment
  • 29. ConductingConducting Research On AnimalsResearch On Animals  Prophet Muhammad (SAW) enjoined kindness andProphet Muhammad (SAW) enjoined kindness and mercy towards animals, so the sacrificial animal must bemercy towards animals, so the sacrificial animal must be subject to principles of slaughter in Islam.subject to principles of slaughter in Islam.  Animal must not be tortured.Animal must not be tortured.  The aim of the experiment should not be frivolous.The aim of the experiment should not be frivolous.  Permission must be obtained from the relevant sector forPermission must be obtained from the relevant sector for sacrificing animals.sacrificing animals.
  • 30. SCHS: Controls For AcceptingSCHS: Controls For Accepting GrantsGrants  Researcher may accept grants subject to abiding by theResearcher may accept grants subject to abiding by the guiding principles of Shariah and scientific integrity.guiding principles of Shariah and scientific integrity.  Research must be conducted in a proper, scientificResearch must be conducted in a proper, scientific method.method.  Grant body awarding financial support should notGrant body awarding financial support should not interfere in the research findings or the conduct of theinterfere in the research findings or the conduct of the researchresearch
  • 31. SCHS: Research InvolvingSCHS: Research Involving UnprecedentedUnprecedented InterventionalInterventional OperationsOperations  Must be confident of his/her and the work team’sMust be confident of his/her and the work team’s abilities in performing the operation complying withabilities in performing the operation complying with technical considerations.technical considerations.  Such interventions should have been performed onSuch interventions should have been performed on experimental animals first, except in very specialexperimental animals first, except in very special cases conducted by experts after approval ofcases conducted by experts after approval of Medical Research Ethics Committee.Medical Research Ethics Committee.  These procedures must be performed in recognizedThese procedures must be performed in recognized hospitals with appropriate specializationhospitals with appropriate specialization
  • 32. Ethical & Scientific Implications ofEthical & Scientific Implications of GlobalizationGlobalization of Clinical Researchof Clinical Research  Globalization of clinical research fairly recentGlobalization of clinical research fairly recent phenomenon. Possible reasons include cost-saving byphenomenon. Possible reasons include cost-saving by conducting trials in developing countries for Phase 2 andconducting trials in developing countries for Phase 2 and Phase 3, e.g. South Asia and South American countries.Phase 3, e.g. South Asia and South American countries.  Advantages : shortening time to approval of the drug.Advantages : shortening time to approval of the drug.  A major concern is ethical oversight due to disparities inA major concern is ethical oversight due to disparities in education, economic and social standing, and healthcareeducation, economic and social standing, and healthcare systems.systems.  Another concern is the transparency of research inAnother concern is the transparency of research in developing countries. NEJM 360; 8 Feb 2009 (Glickmandeveloping countries. NEJM 360; 8 Feb 2009 (Glickman et al)et al)
  • 33. International Conference for Harmonization ofInternational Conference for Harmonization of Research: Good Clinical PracticesResearch: Good Clinical Practices The ICH-GCP guidelines are currentlyThe ICH-GCP guidelines are currently accepted as global standards governingaccepted as global standards governing clinical research:clinical research: -Technical standards-Technical standards -Ethical oversight-Ethical oversight -Appropriate monitoring of trials-Appropriate monitoring of trials
  • 34. Ethical Issues Of Clinical Trials InEthical Issues Of Clinical Trials In ChildrenChildren: A European Perspective: A European Perspective  Children should not be harmed by their participation in clinicalChildren should not be harmed by their participation in clinical trials.trials.  Children are not young adults and trials of adults cannot beChildren are not young adults and trials of adults cannot be extrapolated to children.extrapolated to children.  Consent and assent is a dynamic and continuous processConsent and assent is a dynamic and continuous process when a child is involved in a trial, involving on-goingwhen a child is involved in a trial, involving on-going dialogue between children, their parents and thedialogue between children, their parents and the investigators.investigators.  Study design should allow for smallest number of patients toStudy design should allow for smallest number of patients to be recruited to give statistically and clinically significantbe recruited to give statistically and clinically significant result.result.  Study design needs to limit invasiveness.Study design needs to limit invasiveness.  Risks and benefits should be carefully weighed.Risks and benefits should be carefully weighed.  Safety monitoring should be conducted at appropriateSafety monitoring should be conducted at appropriate intervals.intervals. H Salmons Arch.Dis.Child 2009; 94 Pg 474-477H Salmons Arch.Dis.Child 2009; 94 Pg 474-477
  • 35. Ethics ofEthics of Informed ConsentInformed Consent :Key Elements ::Key Elements :  Purpose of the research projectPurpose of the research project  ProceduresProcedures  Risks and DiscomfortRisks and Discomfort  BenefitsBenefits  Alternatives to participationAlternatives to participation  ConfidentialityConfidentiality  Request for more informationRequest for more information  Right for Refusal or withdrawalRight for Refusal or withdrawal  Injury StatementInjury Statement  Consent StatementConsent Statement  SignaturesSignatures Foundations of Clinical Research :Portney Watkins: 2009 P 47-59Foundations of Clinical Research :Portney Watkins: 2009 P 47-59
  • 36. ICMJE: ResearchICMJE: Research AuthorshipAuthorship EthicsEthics::  Comply with international committee of medicalComply with international committee of medical journal editors – Significant contribution in researchjournal editors – Significant contribution in research idea, methodology ,collection of data, analysis of dataidea, methodology ,collection of data, analysis of data ++  Write distinct portion of article +Write distinct portion of article +  Review/rewrite the final draft of the articleReview/rewrite the final draft of the article
  • 37. Research MisconductResearch Misconduct •FalsificationFalsification: The manipulation of research: The manipulation of research materials, equipment,processes, or changing ormaterials, equipment,processes, or changing or omitting data or results thus affecting accuracyomitting data or results thus affecting accuracy of reportingof reporting.. Fabrication:Fabrication: Making up results and recording orMaking up results and recording or reporting themreporting them.. Plagiarism:Plagiarism: the appropriation of other person’sthe appropriation of other person’s ideas, processes, results, or words withoutideas, processes, results, or words without giving appropraite credit and includesgiving appropraite credit and includes citation plagiarismcitation plagiarism US National Science FoundationUS National Science Foundation
  • 38. Research MisconductResearch Misconduct Plagiarism-fabrication :Plagiarism-fabrication : taking an unrelated figuretaking an unrelated figure from an unrelated publication andfrom an unrelated publication and reproducing it exactly in a new publicationreproducing it exactly in a new publication Self-plagiarism:Self-plagiarism: multiple publication of samemultiple publication of same content with different titles and /or in differentcontent with different titles and /or in different journalsjournals US National Science FoundationUS National Science Foundation
  • 39. Research MisconductResearch Misconduct Ghost-writing:Ghost-writing: Where someone other than theWhere someone other than the named author makes a major contributionnamed author makes a major contribution Guest/Gift authorship:Guest/Gift authorship: Where there is statedWhere there is stated authorship in the absence of involvementauthorship in the absence of involvement US National Science FoundationUS National Science Foundation
  • 40. Research MisconductResearch Misconduct Coercion authorshipCoercion authorship: the practice of being: the practice of being pressured to give authorship to individualspressured to give authorship to individuals because of their positionsbecause of their positions Mutual support/admiration authorship:Mutual support/admiration authorship: TheThe practice of authors placing each other’spractice of authors placing each other’s names on papers even though they madenames on papers even though they made little or no direct contributionslittle or no direct contributions Unapproved authorshipUnapproved authorship: listing someone as: listing someone as author who has not agreed to be an author orauthor who has not agreed to be an author or not consulted about authorshipnot consulted about authorship US National Science FoundationUS National Science Foundation
  • 41. Case: 1Case: 1  Professor ‘Greedy’ is about to land his “biggest grant” yet. TheProfessor ‘Greedy’ is about to land his “biggest grant” yet. The industry ‘sponsor’ would like him to be a Principle Investigatorindustry ‘sponsor’ would like him to be a Principle Investigator and first author for a study on a new ace-inhibitor. He has aand first author for a study on a new ace-inhibitor. He has a brilliant PhD, Doctor ‘Sincere’, who has joined the projectbrilliant PhD, Doctor ‘Sincere’, who has joined the project which translates his basic science work into clinicalwhich translates his basic science work into clinical application. The idea of Dr. Sincere’s preliminary work wasapplication. The idea of Dr. Sincere’s preliminary work was picked up by Professor Greedy and discussed with thepicked up by Professor Greedy and discussed with the industry, who are keen to cash in on Professor Greedy’sindustry, who are keen to cash in on Professor Greedy’s name. Halfway into the project, the two have an intensename. Halfway into the project, the two have an intense argument on first authorship and Prof Greedy indicates thatargument on first authorship and Prof Greedy indicates that he has alternate PhD candidates that “he is currentlyhe has alternate PhD candidates that “he is currently interviewing” to complete the study . Dr. Sincere reflects oninterviewing” to complete the study . Dr. Sincere reflects on what to do next?…what to do next?…
  • 42. Case: 2Case: 2  Doctor ‘Ambitious’ is completing the 2Doctor ‘Ambitious’ is completing the 2ndnd and crucial periodand crucial period of his phase 3 clinical trial, comparing in an RCT , a novelof his phase 3 clinical trial, comparing in an RCT , a novel anti-coagulant ( NAC) with oral warfarin. He has beenanti-coagulant ( NAC) with oral warfarin. He has been provided the results of an interim analysis that the dataprovided the results of an interim analysis that the data safety monitoring board requires. On eyeballing thesafety monitoring board requires. On eyeballing the figures, he notices that omission of just one patient forfigures, he notices that omission of just one patient for an “additional” previously unspecified exclusion criterion,an “additional” previously unspecified exclusion criterion, may make his data highly significant in favour of NAC . Hemay make his data highly significant in favour of NAC . He daydreams of how people will read his paper in thedaydreams of how people will read his paper in the Lancet !…Lancet !… Case: 2Case: 2
  • 43.  Doctor ‘Conscience’ has been approached with a 800,000Doctor ‘Conscience’ has been approached with a 800,000 Riyal grant by an International funding agency to conductRiyal grant by an International funding agency to conduct an RCT in Jeddah, comparing an established sedative-an RCT in Jeddah, comparing an established sedative- hypnotic (“sweetdream”) with a new drug (“nightmare”)hypnotic (“sweetdream”) with a new drug (“nightmare”) watching for the effects of sleep-deprivation of greater thanwatching for the effects of sleep-deprivation of greater than 48hrs on cognitive skills of patients with chronic insomnia.48hrs on cognitive skills of patients with chronic insomnia. ‘Nightmare’ was tolerated successfully in phase 1 trials for‘Nightmare’ was tolerated successfully in phase 1 trials for safety but in phase11 trials for efficacy and safety it wassafety but in phase11 trials for efficacy and safety it was marginally superior to placebo in its sedative hypnoticmarginally superior to placebo in its sedative hypnotic effects when tested in European population.effects when tested in European population.  The study is part of a proposed Phase 111 multicenter trialThe study is part of a proposed Phase 111 multicenter trial being done in the Middle East to see its effects in thebeing done in the Middle East to see its effects in the Middle Eastern population: Doctor ‘Conscience’ now losesMiddle Eastern population: Doctor ‘Conscience’ now loses sleep!sleep! Case: 3Case: 3
  • 44. Some ‘Q-Tips’ to avoid scientificSome ‘Q-Tips’ to avoid scientific misconductmisconduct Search into your soul before research Do No harm Think of advancing science primarily and yourself secondarily Do not disclose preliminary data to press or media Avoid fabrication of data and falsification of results Avoid voluntary and involuntary plagiarism Avoid selective omission of data Avoid hiding adverse reactions Avoid ghost and gift authorship Exercise humility in research and learn to reflect and reevaluate
  • 45. Email your Reflections!Email your Reflections! quadrimu@ngha.med.saquadrimu@ngha.med.sa Acknowledgement: Ms M Khalil Res Asst.Acknowledgement: Ms M Khalil Res Asst. THANK YOU!THANK YOU! and enjoy the fruits of ethical research!and enjoy the fruits of ethical research!