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King Saud University - Malaz RCKing Saud University - Malaz RC
3030thth
November 2015November 2015
Research EthicsResearch...
Presentation OutlinePresentation Outline
 ResearchResearch
 EthicsEthics
 Ethical Misconduct and CaseEthical Misconduct...
1- Research1- Research
 ReSearchReSearch
 Re: once more..Re: once more..
 Search: investigation and examinationSearch: ...
Research EthicsResearch Ethics
 It aims to establish practical moral normsIt aims to establish practical moral norms
and ...
Ctnd…Ctnd…
 Areas of focus:Areas of focus:
 HarmHarm
 Informed consentInformed consent
 ConfidentialityConfidentiality...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 66
Introduc on
A review by Knechtle SJ, published in the PhilosTrans R Soc
L...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 77
Ten most important thingsto
know about Research Ethics
• Be Honest
• Be F...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 88
Your Responsibili es
In order to function effectively and make appropriat...
Research ProjectsResearch Projects
 KnowingKnowing ““Rules of ResearchRules of Research”” is goodis good
for everyonefor ...
Q: If both sample and subject areQ: If both sample and subject are
Animal and Human ???Animal and Human ??? 1010
Basic Cli...
Types of ResearchTypes of Research
Benefiting HumanBenefiting Human
 Basic:Basic: (No clinical applications)- Bench work(...
2- Ethics2- Ethics
 Is a way understanding and examiningIs a way understanding and examining
What's RIGHT (What's RIGHT (...
Ctnd…Ctnd…
 Involves application ofInvolves application of fundamental ethicalfundamental ethical
principlesprinciples
 ...
Historical BackgroundHistorical Background
1)1) After misuse of Human in Research in WestAfter misuse of Human in Research...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1515
ImportanceImportance
 PlanningPlanning for Researchfor Research
– Original, continuation, duplicationOriginal, continuati...
RequirementsRequirements
 HUMANHUMAN
– Justification of the research projectJustification of the research project
– Acces...
PrinciplesPrinciples
 The Belmont ReportThe Belmont Report is for the protectionis for the protection
of research partici...
Vulnerable ParticipantsVulnerable Participants
 ChildrenChildren
 Mentally illMentally ill
 Prisoners, poorPrisoners, p...
AutonomyAutonomy
 Each participant should be givenEach participant should be given
RespectRespect, Time and Opportunity, ...
BeneficenceBeneficence
 Do not Harm, prevent it , prevent evilDo not Harm, prevent it , prevent evil
 Promote goodPromot...
Non MaleficenceNon Maleficence
 On BalanceOn Balance
 Generation ofGeneration of more good than harmmore good than harm
...
Risks vs. BenefitsRisks vs. Benefits
 Physical, social andPhysical, social and
emotionalemotional
 StigmaStigma
 Improv...
JusticeJustice
 Select participants who will benefitSelect participants who will benefit
from Researchfrom Research
 Pro...
Key ConcernsKey Concerns
Before-During-AfterBefore-During-After
 Data fabrication & falsification, plagiarismData fabrica...
3- Ethical Misconduct3- Ethical Misconduct
 FabricationFabrication: making up data, results: making up data, results
 To...
CaseCase
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2727
RulingRuling
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2828
Ethical MisconductEthical Misconduct
(what else?)(what else?)
 Plagiarism, Fabrication, falsification, dishonesty ofPlagi...
4- Consenting4- Consenting
 Give permission for something toGive permission for something to
happenhappen
 Informed cons...
Basic ElementsBasic Elements
 Explanation of purpose and durationExplanation of purpose and duration
 Description of ris...
ContentsContents
 Name and contact of researcherName and contact of researcher
 Name and contact of participantName and ...
Ctnd…Ctnd…
 Sources of advices/ helpSources of advices/ help
support/treatmentsupport/treatment
 Freedom of withdrawalFr...
ValidityValidity
 MustMust
–Signed by:Signed by:
a.a. SubjectSubject
b.b. Legal representativeLegal representative
c.c. I...
ProcessProcess
 Identify participant populationIdentify participant population
 Produce information sheet & Consent form...
MinorsMinors
 Consenting:Consenting:
Must be obtained from parentsMust be obtained from parents
Since they are vulnerab...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3737
I have read the Information Sheet and have had the
details of the study...
5- Research Review5- Research Review
CommitteesCommittees
 Institutional Review BoardInstitutional Review Board IRB/ (Eth...
Review from EthicalReview from Ethical
PerspectivesPerspectives
 Full ReviewFull Review: Investigational drugs: Investiga...
Exempted From reviewExempted From review
 Proposal:Proposal:
 Comparison of techniques, surveyComparison of techniques, ...
Ethics CommitteeEthics Committee
Members / IRBMembers / IRB
 ChairpersonChairperson
 3-4 members3-4 members
 One member...
Role of EthicsRole of Ethics
CommitteeCommittee
 Review and approvalReview and approval
 Investigate / resolve conflict ...
Animal Care & UseAnimal Care & Use
CommitteeCommittee
 ACUC Functions & ProceduresACUC Functions & Procedures
– Inspectio...
MembersMembers
 A doctor of veterinary medicineA doctor of veterinary medicine
 At least 3 practicing scientistsAt least...
ProtocolsProtocols
 Rational & purpose of animal use
 Justification of species & number
 Use of less-invasive procedure...
Ctnd …Ctnd …
 Housing & husbandry requirementsHousing & husbandry requirements
 Appropriate sedation, analgesia &Appropr...
6- Ethics Towards6- Ethics Towards
InformationInformation
 ConfidentialityConfidentiality
– Related to researchersRelated...
Can you Think of examplesCan you Think of examples
where confidentiality wouldwhere confidentiality would
be of important ...
 NameName
 Genetic conditionGenetic condition
 DiseasesDiseases
 Treatment of drugs (fertility)Treatment of drugs (fer...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5050
Case Study
Case Study: Data Ownership
Betty. came to Dr. T’s lab as a p...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5151
Case Study – answer
Both have intellectual ownership, but Dr. T. retain...
7- Authorship &7- Authorship &
PublicationPublication
 Names that appear at beginning ofNames that appear at beginning of...
ContributionContribution
 Authorship: limited to individuals whoAuthorship: limited to individuals who
make significant c...
ImportanceImportance
 Authors usually listed in their order ofAuthors usually listed in their order of
importance, with d...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5555
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5656
Even though the reviewer, Mary, did not or will not claim
the author’s ...
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5757
8- Policies must…8- Policies must…
 Establish definitions ofEstablish definitions of ““misconductmisconduct””
 Outline p...
Other Ethical MattersOther Ethical Matters
 Conflict of interestConflict of interest
– Researcher Conflicts: Financial, w...
ConclusionConclusion
 All research projects should beAll research projects should be
conceived, designed and implementedc...
Thank youThank you
١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 6161
Presentation OutlinePresentation Outline
1)1) ResearchResearch
2)2) EthicsEthics
3)3) Ethical MisconductEthical Misconduct...
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  1. 1. 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
  2. 2. 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
  3. 3. 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
  4. 4. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 44
  5. 5. 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 ) ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 55
  6. 6. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 66 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?
  7. 7. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 77 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
  8. 8. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 88 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.
  9. 9. 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
  10. 10. 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 + - - +
  11. 11. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1111
  12. 12. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1212
  13. 13. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1313
  14. 14. 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
  15. 15. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1515
  16. 16. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1616
  17. 17. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1717
  18. 18. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1818
  19. 19. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 1919
  20. 20. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2020
  21. 21. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2121
  22. 22. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2222
  23. 23. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2323
  24. 24. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2424
  25. 25. 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
  26. 26. 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
  27. 27. CaseCase ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2727
  28. 28. RulingRuling ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2828
  29. 29. 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) ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 2929
  30. 30. 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
  31. 31. 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 ? ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3131
  32. 32. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3232
  33. 33. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3333
  34. 34. ValidityValidity  MustMust –Signed by:Signed by: a.a. SubjectSubject b.b. Legal representativeLegal representative c.c. InvestigatorInvestigator –Give copy to subjectGive copy to subject ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3434
  35. 35. 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
  36. 36. MinorsMinors  Consenting:Consenting: Must be obtained from parentsMust be obtained from parents Since they are vulnerable populationSince they are vulnerable population ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3636
  37. 37. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 3737 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
  38. 38. 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
  39. 39. 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
  40. 40. 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) ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4040
  41. 41. Ethics CommitteeEthics Committee Members / IRBMembers / IRB  ChairpersonChairperson  3-4 members3-4 members  One member from general publicOne member from general public ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4141
  42. 42. 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
  43. 43. 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). ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4343
  44. 44. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4444
  45. 45. 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
  46. 46. 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
  47. 47. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4747
  48. 48. Can you Think of examplesCan you Think of examples where confidentiality wouldwhere confidentiality would be of important ?be of important ? ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4848
  49. 49.  NameName  Genetic conditionGenetic condition  DiseasesDiseases  Treatment of drugs (fertility)Treatment of drugs (fertility) ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 4949
  50. 50. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5050 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?
  51. 51. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5151 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
  52. 52. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5252
  53. 53. 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
  54. 54. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5454
  55. 55. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5555
  56. 56. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5656 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?
  57. 57. ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5757
  58. 58. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5858
  59. 59. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 5959
  60. 60. 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 ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 6060
  61. 61. Thank youThank you ١٤٣٧/٠٢/١٩١٤٣٧/٠٢/١٩ Dana BakheetDana Bakheet 6161
  62. 62. 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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