دانه

King Saud University - Malaz RCKing Saud University - Malaz RC
3030thth
November 2015November 2015
Research EthicsResearch Ethics
Dana Bakheet, PhDDana Bakheet, PhD
Scientist @ KFSH&RCScientist @ KFSH&RC
Vice Dean @ Alfaisal UniversityVice Dean @ Alfaisal University
dbakheet@Kfshrc.edu.sadbakheet@Kfshrc.edu.sa
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 11

Presentation OutlinePresentation Outline
 ResearchResearch
 EthicsEthics
 Ethical Misconduct and CaseEthical Misconduct and Case
 ConsentingConsenting
 Research Review CommitteesResearch Review Committees
 IRB/ Ethics and ACUCIRB/ Ethics and ACUC
 Ethics Towards Information and CaseEthics Towards Information and Case
 Authorship & Publication and CaseAuthorship & Publication and Case
 Wrap UpWrap Up 22

1- Research1- Research
 ReSearchReSearch
 Re: once more..Re: once more..
 Search: investigation and examinationSearch: investigation and examination
to find unknownsto find unknowns
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ 33
- Systematic investigation into
Study of materials & sources
In order
- to establish facts
and
-Reach new conclusions

Research EthicsResearch Ethics
 It aims to establish practical moral normsIt aims to establish practical moral norms
and standards for the conduct ofand standards for the conduct of
researchresearch”” ((AcceptableAcceptable andand UnacceptableUnacceptable))
 Four basic guidelines:Four basic guidelines:
– Honesty in conveying informationHonesty in conveying information
– Accuracy in reporting findingsAccuracy in reporting findings
– Efficiency by using resources wiselyEfficiency by using resources wisely
– Objectivity by letting facts speakObjectivity by letting facts speak

Ctnd…Ctnd…
 Areas of focus:Areas of focus:
 HarmHarm
 Informed consentInformed consent
 ConfidentialityConfidentiality
 Reporting results and plagiarismReporting results and plagiarism
 Deception (mislead , hide )Deception (mislead , hide )

Introduc on
A review by Knechtle SJ, published in the PhilosTrans R Soc
Lond B Biol Sci, 2001, May 29;356(1409):681-9, entitled
‘Treatment with immunotoxin,’ cites 4 publications from the
Thomas Laboratory.
Not only were these papers cited, but the reviewer seemed
impressed by the Thomas work.
All 4 papers were later retracted because of false claims.
What does this do to the credibility of other papers from this
research lab?
What does this do to the credibility of Knechtle & his paper?
What does this do to the field of immunotoxicology?

Ten most important thingsto
know about Research Ethics
• Be Honest
• Be Fair
• Do no harm
• Know and Follow the Rules
• Bad rules should be changed, not broken
• Be a good ci zen
• When in doubt, ask ques ons
• Listen to the s ll small voice of your conscience, especially
when it’s being overwhelmed by the cacophony of stress
• If you suspect unethical behavior, proceed cau ously

Your Responsibili es
In order to function effectively and make appropriate ethical
decisions, faculty and administrative staff need to develop
the skills to:
1. identify when situations present ethical conflicts,
2. reason among possible courses of action, and
3. effectively implement their best solution to the problem.
We all function in an environment governed by regulations
and policies, which we must abide by within a core of
ethical principles.

Research ProjectsResearch Projects
 KnowingKnowing ““Rules of ResearchRules of Research”” is goodis good
for everyonefor everyone
 Ethical & Scientific review Path ofEthical & Scientific review Path of
proposal once submittedproposal once submitted
 Office of Research Affairs (ORA)Office of Research Affairs (ORA)
– Basic & or Clinical & or Animal & or EthicsBasic & or Clinical & or Animal & or Ethics
– Any proposal can go to any combination ofAny proposal can go to any combination of
above depending Research subject &above depending Research subject &
sample typessample types١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ 99

Q: If both sample and subject areQ: If both sample and subject are
Animal and Human ???Animal and Human ??? 1010
Basic Clinical Ethics ACUC
Subject
Type
Human
(even Chart)
+ + + -
Animal + - - +
Chemical
Physical
+ - - -
Sample
Types
Human
(even chart)
+ + + -
Animal + - - +

Types of ResearchTypes of Research
Benefiting HumanBenefiting Human
 Basic:Basic: (No clinical applications)- Bench work(No clinical applications)- Bench work
LaysLays foundation for advancements infoundation for advancements in
knowledgeknowledge
 Clinical:Clinical: (including clinical trials) determines(including clinical trials) determines
safety and effectivenesssafety and effectiveness of medication,of medication,
diagnostic products and treatment regimensdiagnostic products and treatment regimens
 Animal:Animal: Understanding of diseasesUnderstanding of diseases &&
development of effective medical treatmentsdevelopment of effective medical treatments

2- Ethics2- Ethics
 Is a way understanding and examiningIs a way understanding and examining
What's RIGHT (What's RIGHT (GoodGood))
ANDAND
What's WRONG (What's WRONG (EvilEvil))
Dealing with Human MoralityDealing with Human Morality

Ctnd…Ctnd…
 Involves application ofInvolves application of fundamental ethicalfundamental ethical
principlesprinciples
 These include design and implementation ofThese include design and implementation of
medical and biological research involving:medical and biological research involving:
– Human experimentationHuman experimentation
– Animal experimentationAnimal experimentation
– Various aspects of academic misconduct,Various aspects of academic misconduct,
including scientific fraud, fabrication,including scientific fraud, fabrication,
plagiarismplagiarism

Historical BackgroundHistorical Background
1)1) After misuse of Human in Research in WestAfter misuse of Human in Research in West
- 1947 lead Nuremberg Code (- 1947 lead Nuremberg Code (First modern code1948First modern code1948))
- 1979 lead- 1979 lead Belmont ReportBelmont Report ((Tuskegee Syphilis Study)Tuskegee Syphilis Study)
1)1) International guidelinesInternational guidelines
- 1990 WHO International Guidelines on ethics- 1990 WHO International Guidelines on ethics
- 1993 WHO International ethics guidelines for- 1993 WHO International ethics guidelines for
biomedical research involving human subjectsbiomedical research involving human subjects
1)1) Local ethical guidelines (KACST, KFSHRC,Local ethical guidelines (KACST, KFSHRC,
KSU)KSU)
 Q: Multi center study ? Multi national study?
1414

ImportanceImportance
 PlanningPlanning for Researchfor Research
– Original, continuation, duplicationOriginal, continuation, duplication
 ConductingConducting projectproject
– Fabrication, falsification of dataFabrication, falsification of data
– Proper consenting of patientProper consenting of patient
 PublishingPublishing its resultsits results
– Authorship, fabrication of outcomeAuthorship, fabrication of outcome

RequirementsRequirements
 HUMANHUMAN
– Justification of the research projectJustification of the research project
– Access to participantsAccess to participants
– Protecting privacyProtecting privacy
– Informed Consent (form, process)Informed Consent (form, process)
– Clarify potential harmClarify potential harm
 Q: any sharing experience in process /Q: any sharing experience in process /
difficultydifficulty

PrinciplesPrinciples
 The Belmont ReportThe Belmont Report is for the protectionis for the protection
of research participantsof research participants
 http://www.hhs.gov/ohrp/humansubjects/guidanchttp://www.hhs.gov/ohrp/humansubjects/guidanc
 Pillars:Pillars:
– AutonomyAutonomy
– Beneficence & Non-MaleficenceBeneficence & Non-Maleficence
 Risks Vs. BenefitsRisks Vs. Benefits
– JusticeJustice

Vulnerable ParticipantsVulnerable Participants
 ChildrenChildren
 Mentally illMentally ill
 Prisoners, poorPrisoners, poor
 ElderlyElderly
 Others as in military, peer pressure,Others as in military, peer pressure,
pregnant & lactating womenpregnant & lactating women
– Extra care is needed to protect themExtra care is needed to protect them

AutonomyAutonomy
 Each participant should be givenEach participant should be given
RespectRespect, Time and Opportunity, Time and Opportunity
necessary to make their own decisionsnecessary to make their own decisions
 Must be givenMust be given sufficient informationsufficient information
that they will need to decide to enter athat they will need to decide to enter a
study or refusestudy or refuse
 No PRESSURENo PRESSURE

BeneficenceBeneficence
 Do not Harm, prevent it , prevent evilDo not Harm, prevent it , prevent evil
 Promote goodPromote good
 So the most important responsibility ofSo the most important responsibility of
the researcherthe researcher
– Protect physical, mental, social well beingProtect physical, mental, social well being
of each participantof each participant
– MaximizeMaximize benefitsbenefits
– MinimizeMinimize risksrisks

Non MaleficenceNon Maleficence
 On BalanceOn Balance
 Generation ofGeneration of more good than harmmore good than harm
 Risks of research should beRisks of research should be
reasonable in light of expectedreasonable in light of expected
benefits to individual and societybenefits to individual and society

Risks vs. BenefitsRisks vs. Benefits
 Physical, social andPhysical, social and
emotionalemotional
 StigmaStigma
 Improved access toImproved access to
health carehealth care
 Better prevention,Better prevention,
diagnosis anddiagnosis and
treatmenttreatment
 Social contributionSocial contribution

JusticeJustice
 Select participants who will benefitSelect participants who will benefit
from Researchfrom Research
 Provide protection for vulnerableProvide protection for vulnerable
groupsgroups
 Share Risks & BenefitsShare Risks & Benefits

Key ConcernsKey Concerns
Before-During-AfterBefore-During-After
 Data fabrication & falsification, plagiarismData fabrication & falsification, plagiarism
 ConsentConsent
– Voluntary & Provide fully detailsVoluntary & Provide fully details
 Not be used for unrelated purposesNot be used for unrelated purposes
– Unless with prior agreementUnless with prior agreement
 Confidentiality and AnonymityConfidentiality and Anonymity
 Q: what is the difference between last 2Q: what is the difference between last 2
itemsitems Dana BakheetDana Bakheet 2525

3- Ethical Misconduct3- Ethical Misconduct
 FabricationFabrication: making up data, results: making up data, results
 To record / report themTo record / report them
 FalsificationFalsification: manipulating research materials,: manipulating research materials,
equipment, processes, changing, omitting dataequipment, processes, changing, omitting data
 Research not accurately representedResearch not accurately represented
 PlagiarismPlagiarism is appropriation of another personis appropriation of another person’’ss
ideas, processes, results without givingideas, processes, results without giving
appropriate creditappropriate credit
 Research misconduct does not includeResearch misconduct does not include
differences of opiniondifferences of opinion 2626

CaseCase

RulingRuling

Ethical MisconductEthical Misconduct
(what else?)(what else?)
 Plagiarism, Fabrication, falsification, dishonesty ofPlagiarism, Fabrication, falsification, dishonesty of
researchresearch
 Publishing the same paper in two differentPublishing the same paper in two different
journals without telling the editorsjournals without telling the editors
 Publication authorship (not giving credit toPublication authorship (not giving credit to
all authors for their roles in research)all authors for their roles in research)

4- Consenting4- Consenting
 Give permission for something toGive permission for something to
happenhappen
 Informed consentInformed consent is process foris process for
getting permission before conductinggetting permission before conducting
healthcare intervention on personhealthcare intervention on person
 Health care provider may ask patient toHealth care provider may ask patient to
consent to receive therapy beforeconsent to receive therapy before
providing it OR clinical researcher mayproviding it OR clinical researcher may
ask research participant before enrollingask research participant before enrolling

Basic ElementsBasic Elements
 Explanation of purpose and durationExplanation of purpose and duration
 Description of risks and benefitsDescription of risks and benefits
 Explanation of confidentialityExplanation of confidentiality
 SignaturesSignatures
 Q: what does the word Basic refers to ?Q: what does the word Basic refers to ?

ContentsContents
 Name and contact of researcherName and contact of researcher
 Name and contact of participantName and contact of participant
 Aims & objectives of research projectAims & objectives of research project
 Role of participantRole of participant
 Treatment of material/informationTreatment of material/information
collectedcollected
 Potential risksPotential risks

Ctnd…Ctnd…
 Sources of advices/ helpSources of advices/ help
support/treatmentsupport/treatment
 Freedom of withdrawalFreedom of withdrawal
 Option of receiving of summary findingsOption of receiving of summary findings
 Confirmation project has ethical approvalConfirmation project has ethical approval
 Signature of and date of researcher andSignature of and date of researcher and
participantparticipant

ValidityValidity
 MustMust
–Signed by:Signed by:
a.a. SubjectSubject
b.b. Legal representativeLegal representative
c.c. InvestigatorInvestigator
–Give copy to subjectGive copy to subject

ProcessProcess
 Identify participant populationIdentify participant population
 Produce information sheet & Consent formProduce information sheet & Consent form
 Submit & Obtain permission of EthicsSubmit & Obtain permission of Ethics
CommitteeCommittee
 Distribute Inf. sheet &perform consentingDistribute Inf. sheet &perform consenting
– Discuss content, research, its implicationsDiscuss content, research, its implications
– Allow time for withdrawal and decisionAllow time for withdrawal and decision
– Obtain signature -Obtain signature - Not the main aimNot the main aim
 START RESEARCHSTART RESEARCH
3535

MinorsMinors
 Consenting:Consenting:
Must be obtained from parentsMust be obtained from parents
Since they are vulnerable populationSince they are vulnerable population

I have read the Information Sheet and have had the
details of the study explained to me. My questions
have been answered to my satisfaction, and I may ask
further questions at any time.
I understand I have the right to withdraw from the
study at any time and decline to answer any particular
questions.
I agree to provide information to the researcher(s) on
the understanding that my name will not be used
without my permission.
I agree/do not agree to the interview being recorded
electronically.
I understand that I have the right to ask for the tape to
be turned off at any time during the interview
I agree to participate in this study under the conditions
set out in the information sheet
Signature – Name - Date

5- Research Review5- Research Review
CommitteesCommittees
 Institutional Review BoardInstitutional Review Board IRB/ (Ethics)IRB/ (Ethics)
 Animal Care and Use CommitteeAnimal Care and Use Committee ACUCACUC
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ 3838

Review from EthicalReview from Ethical
PerspectivesPerspectives
 Full ReviewFull Review: Investigational drugs: Investigational drugs
(clinical trials), devices, invasive(clinical trials), devices, invasive
techniques etc… even for Basictechniques etc… even for Basic
ResearchResearch
 ExpeditedExpedited: Non invasive collection: Non invasive collection
(sweat), hair, teeth and Adult blood (not(sweat), hair, teeth and Adult blood (not
more than 2 times / week), ECG,more than 2 times / week), ECG,
weighingweighing Dana BakheetDana Bakheet 3939

Exempted From reviewExempted From review
 Proposal:Proposal:
 Comparison of techniques, surveyComparison of techniques, survey
without identifiers, Public datawithout identifiers, Public data
 Consent form:Consent form:
 May be waived by IRB for someMay be waived by IRB for some
research types (as studying patientsresearch types (as studying patients
discarded materials)discarded materials)

Ethics CommitteeEthics Committee
Members / IRBMembers / IRB
 ChairpersonChairperson
 3-4 members3-4 members
 One member from general publicOne member from general public

Role of EthicsRole of Ethics
CommitteeCommittee
 Review and approvalReview and approval
 Investigate / resolve conflict in ownershipInvestigate / resolve conflict in ownership
(patent/ software)(patent/ software)
 Protect Rights of participants by assuring:Protect Rights of participants by assuring:
1.1. Risks to be minimizedRisks to be minimized
2.2. Reasonable balance b/w Risks & BenefitsReasonable balance b/w Risks & Benefits
3.3. Selection of participants is fairSelection of participants is fair
4.4. Approve CONSENT FORM and document itApprove CONSENT FORM and document it
5.5. Assure Privacy & ConfidentialityAssure Privacy & Confidentiality 4242

Animal Care & UseAnimal Care & Use
CommitteeCommittee
 ACUC Functions & ProceduresACUC Functions & Procedures
– Inspection of facilitiesInspection of facilities
– Evaluation & reporting (once/ 6 monthsEvaluation & reporting (once/ 6 months
minimum)minimum)
– Review of proposed uses of animals inReview of proposed uses of animals in
research, testing, or education (ie.,research, testing, or education (ie.,
protocols).protocols).

MembersMembers
 A doctor of veterinary medicineA doctor of veterinary medicine
 At least 3 practicing scientistsAt least 3 practicing scientists
 At least 1 technician from Animal FacilityAt least 1 technician from Animal Facility
 At least 1 member from ManagementAt least 1 member from Management
 At least 3 members from HospitalAt least 3 members from Hospital’’ss
PhysiciansPhysicians
 An unaffiliated member from CommunityAn unaffiliated member from Community

ProtocolsProtocols
 Rational & purpose of animal use
 Justification of species & number
 Use of less-invasive procedures
 Appropriateness of
– Species
– Organ preparation, Cell or tissue culture
– Computer simulation
– Q: what is the best preference ?١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4545

Ctnd …Ctnd …
 Housing & husbandry requirementsHousing & husbandry requirements
 Appropriate sedation, analgesia &Appropriate sedation, analgesia &
anesthesiaanesthesia
 Euthanasia if painful or stressfulEuthanasia if painful or stressful
outcomes are anticipatedoutcomes are anticipated
 Disposition of animalDisposition of animal
 Method of euthanasia or Safety ofMethod of euthanasia or Safety of
working environment for personnelworking environment for personnel١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4646

6- Ethics Towards6- Ethics Towards
InformationInformation
 ConfidentialityConfidentiality
– Related to researchersRelated to researchers’’ conductconduct
 Data protectionData protection
– Related to work sheets and materialsRelated to work sheets and materials
 Who accesses the data ?Who accesses the data ?
– Physician, PI and project coordinatorPhysician, PI and project coordinator
 Who owns information: InstitutionWho owns information: Institution

Can you Think of examplesCan you Think of examples
where confidentiality wouldwhere confidentiality would
be of important ?be of important ?

 NameName
 Genetic conditionGenetic condition
 DiseasesDiseases
 Treatment of drugs (fertility)Treatment of drugs (fertility)

Case Study
Case Study: Data Ownership
Betty. came to Dr. T’s lab as a post-doc after completing
her Ph.D. at a leading university. Dr. T accepted her
because of her ability in isolating and manipulating
proteins in complex structures. Dr. T. has some grant
support that will cover much of Betty’s stipend for three
years. Under Dr. T’s intellectual leadership they
complete some basic research that promises intellectual
property development. They file a patent application.
Question: Who has the intellectual ownership?

Case Study – answer
Both have intellectual ownership, but Dr. T. retains
primary project management and supervisory role.
The university has legal ownership based on access
to and retention of research data.
Ruling

7- Authorship &7- Authorship &
PublicationPublication
 Names that appear at beginning ofNames that appear at beginning of
paper serve one important purposepaper serve one important purpose
– Let others know who conducted researchLet others know who conducted research
and should get credit for itand should get credit for it
– Authors listed on papers should accuratelyAuthors listed on papers should accurately
represent person/s responsible for workrepresent person/s responsible for work
 ContributionContribution
 ImportanceImportance
 Corresponding/primary authorCorresponding/primary author

ContributionContribution
 Authorship: limited to individuals whoAuthorship: limited to individuals who
make significant contributions thismake significant contributions this
includes:includes:
– Instrumental in obtaining funding for projectInstrumental in obtaining funding for project
– Involved in conception & design of researchInvolved in conception & design of research
– Data collection, analysis and interpretationData collection, analysis and interpretation
– Participated in drafting publication andParticipated in drafting publication and
approved final version of publicationapproved final version of publication
5353

ImportanceImportance
 Authors usually listed in their order ofAuthors usually listed in their order of
importance, with designation first orimportance, with designation first or
last author carrying special weightlast author carrying special weight
 Some journals have specific rules forSome journals have specific rules for
listing authorslisting authors
 Others do notOthers do not
– again placing most of responsibility foragain placing most of responsibility for
this decision on authors themselvesthis decision on authors themselves

Even though the reviewer, Mary, did not or will not claim
the author’s technique as her own, by writing it in a paper
or presenting it at a conference, she nevertheless
appropriated to herself someone else’s intellectual
property and used it to her own advantage without the
permission of the true owner.
Mary abused one of the important tenets of the review
process, namely that reviewers will keep the contents of
the manuscripts confidential and will not use that
information to give them an unfair advantage.
Ruling
Question 2: What should Mary have done?

8- Policies must…8- Policies must…
 Establish definitions ofEstablish definitions of ““misconductmisconduct””
 Outline procedures for reporting andOutline procedures for reporting and
investigation misconductinvestigation misconduct
 Provide protection for whistle-blowersProvide protection for whistle-blowers
 Without these, studies can get out ofWithout these, studies can get out of
handhand

Other Ethical MattersOther Ethical Matters
 Conflict of interestConflict of interest
– Researcher Conflicts: Financial, workResearcher Conflicts: Financial, work
commitments, personal & intellectual matterscommitments, personal & intellectual matters
 Data managementData management
 Mentor-Trainee relationship (agreement)Mentor-Trainee relationship (agreement)
– Mentoring EthicsMentoring Ethics
 Peer ReviewPeer Review

ConclusionConclusion
 All research projects should beAll research projects should be
conceived, designed and implementedconceived, designed and implemented
according toaccording to highest standardshighest standards
 Experiments should be conducted inExperiments should be conducted in
accordance withaccordance with health & safetyhealth & safety
regulationsregulations
 No harm in researchNo harm in research
– Codes and policies are in placeCodes and policies are in place

Thank youThank you

Presentation OutlinePresentation Outline
1)1) ResearchResearch
2)2) EthicsEthics
3)3) Ethical MisconductEthical Misconduct
4)4) ConsentingConsenting
5)5) Research Review CommitteesResearch Review Committees
 IRB/ Ethics and ACUCIRB/ Ethics and ACUC
1)1) Ethics Towards Information and CaseEthics Towards Information and Case
2)2) Authorship & Publication and CaseAuthorship & Publication and Case
3)3) Wrap UpWrap Up 6262

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