workshop scientific integrity and ethical issues in publishing

WorkshopWorkshop

Scientific Integrity and Scientific Integrity and Ethical Issues in PublishingEthical Issues in Publishing

Publication EthicsPublication Ethics

The deliberate and systematic consideration The deliberate and systematic consideration or moral problems arising in connection or moral problems arising in connection with the publication of scientific research.with the publication of scientific research.

Procedures to prevent or resolve Procedures to prevent or resolve moral dilemmasmoral dilemmas

•• Ethical reviewEthical review•• RiskRisk--benefit analysisbenefit analysis•• Informed consentInformed consent•• Peer reviewPeer review•• Uniform requirements for attributing Uniform requirements for attributing

authorship creditsauthorship credits•• Professional ethics: Professional ethics: Ethical GuidelinesEthical Guidelines

Journal Ethical PoliciesJournal Ethical PoliciesAuthor DeclarationsAuthor Declarations

Authorship StatementAuthorship Statement –– Declaration of substantive Declaration of substantive contribution signed by all authorscontribution signed by all authorsConflict of Interest StatementConflict of Interest Statement –– Declaration of real and Declaration of real and apparent Conflicts of Interest, in language apparent Conflicts of Interest, in language comprehensible to average reader, signed by all authorscomprehensible to average reader, signed by all authorsRedundant Publication StatementRedundant Publication Statement –– Declaration that the Declaration that the work has not been published previously in whole or in work has not been published previously in whole or in partpartHuman/animal subjects StatementHuman/animal subjects Statement –– Declaration that the Declaration that the study was reviewed by an Ethical Review Committeestudy was reviewed by an Ethical Review CommitteeDuplicate submissionsDuplicate submissions -- Declaration that the work has Declaration that the work has not been published, or is not being considered for not been published, or is not being considered for publication, by another journalpublication, by another journal

Integrity in Research PublishingIntegrity in Research Publishing

Intellectual honesty in reporting researchIntellectual honesty in reporting researchAccuracy in representing contributions of other Accuracy in representing contributions of other scientists scientists Collegiality in scientific interactions, including Collegiality in scientific interactions, including communications and sharing of informationcommunications and sharing of informationTransparency in conflicts of interest or potential Transparency in conflicts of interest or potential conflicts of interestconflicts of interestProtection of human subjects in the conduct of Protection of human subjects in the conduct of researchresearchHumane care of animals in the conduct of researchHumane care of animals in the conduct of researchAdherence to the mutual authorship responsibilities Adherence to the mutual authorship responsibilities between investigators and their research teams.between investigators and their research teams.

Adapted from Institute of Medicine (2002)Adapted from Institute of Medicine (2002)

Facilitators and TopicsFacilitators and Topics

Kerstin SteniusKerstin Stenius

Elise LangdonElise Langdon--NeunerNeunerShirin HeidariShirin Heidari

Thomas Thomas BaborBabor

The seven deadly sins in The seven deadly sins in scientific publishingscientific publishingI am an author I am an author –– or am I or am I not?not?How to correctly deal How to correctly deal with study participantswith study participantsGuidelines for resolving Guidelines for resolving ethical dilemmasethical dilemmas

The Deadly Sins in The Deadly Sins in Scientific Publishing and Scientific Publishing and

How to Avoid ThemHow to Avoid Them Kerstin SteniusKerstin Stenius


Why Ethical Issues Why Ethical Issues are Importantare Important

Ethical violations, especially less serious Ethical violations, especially less serious infractions, are prevalentinfractions, are prevalentRates of detection are low, but when detected Rates of detection are low, but when detected consequences are seriousconsequences are seriousEthical violations affect the quality and integrity Ethical violations affect the quality and integrity of scienceof scienceCompliance review and journal requirements are Compliance review and journal requirements are increasing (e.g., human subjects committees, increasing (e.g., human subjects committees, conflict of interest statements)conflict of interest statements)

Ethical Issues: Ethical Issues: AuthorsAuthors’’ Seven Deadly SinsSeven Deadly Sins

SinSin ExamplesExamples

11 CarelessnessCarelessness Citation bias, understatement, negligenceCitation bias, understatement, negligence

22 Redundant publicationRedundant publication Same tables or literature review reported Same tables or literature review reported without noting prior sourcewithout noting prior source

33 Unfair authorshipUnfair authorship Failure to include eligible authors, Honorary Failure to include eligible authors, Honorary authorsauthors

44 Undeclared Conflict of InterestUndeclared Conflict of Interest Failure to cite funding sourceFailure to cite funding source

55 Human/animal subjects violationsHuman/animal subjects violations No approval from Review Board or Ethics No approval from Review Board or Ethics CommitteeCommittee

66 PlagiarismPlagiarism Reproducing othersReproducing others’’ work or ideas without as work or ideas without as oneone’’s owns own

77 Other FraudOther Fraud Fabrication of falsification of data, Fabrication of falsification of data, Misappropriation of others ideas or plans given Misappropriation of others ideas or plans given in confidencein confidence

A failure to adequately review the literature on a A failure to adequately review the literature on a topic topic Citation of articles without having read the primary Citation of articles without having read the primary sources sources Selective citation of only those articles that support Selective citation of only those articles that support a particular point of view a particular point of view Selective citation to enhance one's reputation, Selective citation to enhance one's reputation, epitomized by selfepitomized by self--citation. citation. Lack of candor or completeness in describing one's Lack of candor or completeness in describing one's research methods research methods Presentation of data that are based on faulty Presentation of data that are based on faulty statistical analyses statistical analyses

1. Negligent Carelessness1. Negligent Carelessness and Citation Biasand Citation Bias

Consequences of Negligent Consequences of Negligent CarelessnessCarelessness

and Citation Biasand Citation Bias

SinSin ExamplesExamples PunishmentsPunishments

11 CarelessnessCarelessness Citation bias, understatement, Citation bias, understatement, negligencenegligence

Request for correction, letter Request for correction, letter to editorto editor

Preventing Carelessness Preventing Carelessness and Citation Biasand Citation Bias

Read what you citeRead what you citeCite criticallyCite criticallyMinimize selfMinimize self--citationcitationAvoid other selection biases (e.g., language or Avoid other selection biases (e.g., language or cultural preferences)cultural preferences)

2. Redundant Publication2. Redundant Publication


22 Redundant Redundant publicationpublication

Same tables or literature review Same tables or literature review reported without noting prior sourcereported without noting prior source

Rejection of manuscript. Rejection of manuscript. Copyright infringementCopyright infringement

3. Unfair Authorship3. Unfair Authorship


33 Unfair authorshipUnfair authorship Failure to include eligible authors, Failure to include eligible authors, Honorary authorsHonorary authors

Angry colleagues, complaints Angry colleagues, complaints to editor or employerto editor or employer

4. Undeclared Conflict of Interest4. Undeclared Conflict of InterestA conflict of interest is a situation or relationship in which A conflict of interest is a situation or relationship in which professional, personal, or financial considerations could be professional, personal, or financial considerations could be seen by a fairseen by a fair--minded person as potentially in conflict with minded person as potentially in conflict with independence of judgement (FARM 1997). independence of judgement (FARM 1997). A conflict may be A conflict may be personal, commercial, political, academic or financial personal, commercial, political, academic or financial

•• Personal conflicts include Personal conflicts include ““petpet”” theories, validation of onetheories, validation of one’’s own s own ideas, achieving publishable results, and gaining recognition foideas, achieving publishable results, and gaining recognition for r a discoverya discovery

•• ““FinancialFinancial”” interests may include employment, research funding, interests may include employment, research funding, stock or share ownership, payment for lectures or travel, stock or share ownership, payment for lectures or travel, consultancies, and company support for staff (COPE 2001)consultancies, and company support for staff (COPE 2001)

•• Conflict of interest is not in itself wrongdoing (FARM 1997)Conflict of interest is not in itself wrongdoing (FARM 1997)

Conflict of InterestConflict of InterestThe potential for conflict of interest in the addiction field isThe potential for conflict of interest in the addiction field is enhanced by relationships or funding connected with enhanced by relationships or funding connected with industry, forindustry, for--profit health care systems, profit health care systems, ““social aspect social aspect organizationsorganizations”” and governments. and governments. There are two levels of conflict of interest: There are two levels of conflict of interest:

•• A A realreal conflict of interest means that the author, or the conflict of interest means that the author, or the administrative unit with which the author has an employment administrative unit with which the author has an employment relationship, has a financial or other interest that unduly relationship, has a financial or other interest that unduly influence the authorinfluence the author’’s position with respect to the subject matter s position with respect to the subject matter being considered. being considered.

•• An An apparentapparent conflict of interest exists when an interest would not conflict of interest exists when an interest would not necessarily influence the author but could result in the authornecessarily influence the author but could result in the author’’s s objectivity being questioned by others. objectivity being questioned by others.

Conflict of Interest: Conflict of Interest: ISAJE GuidelinesISAJE Guidelines

•• Each author should declare to the editor any Each author should declare to the editor any interests that could constitute a real, potential or interests that could constitute a real, potential or apparent conflict of interest with respect to his/her apparent conflict of interest with respect to his/her involvement in the publication, between involvement in the publication, between

(1) commercial entities and the participant personally(1) commercial entities and the participant personally

(2) commercial entities and the administrative unit with which (2) commercial entities and the administrative unit with which the participant has an employment relationship. the participant has an employment relationship.

•• Sources of funding for the study, review, or other Sources of funding for the study, review, or other item should be declared in the final publicationitem should be declared in the final publication

Consequences of Undeclared Consequences of Undeclared Conflicts of InterestConflicts of Interest


44 Undeclared conflict Undeclared conflict of interestof interest

Failure to declare support from Failure to declare support from pharmaceutical industrypharmaceutical industry

Notification in the journal, Notification in the journal, possibly retraction of the possibly retraction of the article, mistrust among article, mistrust among colleaguescolleagues

5. Violations of human and 5. Violations of human and animal subjects policiesanimal subjects policies

Ethical review a necessary requirement for all Ethical review a necessary requirement for all scientific research on human subjects in many, scientific research on human subjects in many, but not all, countriesbut not all, countries

6. Plagiarism6. Plagiarism•• Plagiarism ranges from the unreferenced use of Plagiarism ranges from the unreferenced use of

othersothers’’ published and unpublished ideas to published and unpublished ideas to submission under submission under ““newnew”” authorship of a complete authorship of a complete paper, sometimes in a different language. It may paper, sometimes in a different language. It may occur at any stage of planning, research, writing, or occur at any stage of planning, research, writing, or publication; it applies to print and electronic versions.publication; it applies to print and electronic versions.

•• All sources should be disclosed through appropriate All sources should be disclosed through appropriate citation or quotation conventions, and if a large citation or quotation conventions, and if a large amount of other peopleamount of other people’’s written or illustrative material s written or illustrative material is to be used, permission must be sought (COPE is to be used, permission must be sought (COPE 2001).2001).

SelfSelf--Plagiarism:Plagiarism:Author is not allowed to reAuthor is not allowed to re--use previously published material use previously published material when rights have been assigned to the publisher (as they are in when rights have been assigned to the publisher (as they are in most cases)most cases)Many journals are not interested in reproducing previously Many journals are not interested in reproducing previously published material because it consumes valuable space.published material because it consumes valuable space.Use without permission is a violation of copyrightUse without permission is a violation of copyright

How to avoid selfHow to avoid self--plagiarismplagiarism

Short quotes from a previously published article should be set oShort quotes from a previously published article should be set off ff in quotation marks and original version citedin quotation marks and original version citedPermission must be requested when large sections are Permission must be requested when large sections are reproducedreproducedMethods and literature reviews should be paraphrased Methods and literature reviews should be paraphrased

Griffin GC. DonGriffin GC. Don’’t plagiarize t plagiarize -- even yourself. even yourself. Post Graduate Post Graduate MedicineMedicine 1991: 89:151991: 89:15--1616

Consequences of PlagiarismConsequences of Plagiarism


66 PlagiarismPlagiarism Reproducing othersReproducing others’’ work or ideas work or ideas without as onewithout as one’’s owns own

Retraction of manuscript &Retraction of manuscript &notification of employernotification of employer

7. Other 7. Other Scientific MisconductScientific Misconduct

•• ““TrimmingTrimming””:: altering onealtering one’’s datas data•• ““CookingCooking””:: selective reporting of oneselective reporting of one’’s datas data•• ““ForgingForging””: : making up the datamaking up the data

Charles Babbage (1830)Charles Babbage (1830)

Consequences of Consequences of Scientific MisconductScientific Misconduct


77 Other FraudOther Fraud Fabrication of falsification of data, Fabrication of falsification of data, Misappropriation of others ideas or Misappropriation of others ideas or plans given in confidenceplans given in confidence

Retraction of manuscript, Retraction of manuscript, notification of employer & notification of employer & publication banpublication ban

Biomedical AuthorshipBiomedical AuthorshipElise LangdonElise Langdon--NeunerNeuner

http://www.emwa.org/, click journal, then free sample copy of TWS

Who is an author?Who is an author?

The person who writes a document ? The person who writes a document ?

Authorship in biomedicine is more complicatedAuthorship in biomedicine is more complicated

OverallOverall: : An author must have substantially An author must have substantially contributed intellectually to the studycontributed intellectually to the study

+ be able to take responsibility for it or + be able to take responsibility for it or parts of itparts of it

ICMJE Guidelines ICMJE Guidelines ((www.icmje.orgwww.icmje.org))

Used to determine which contributions = authorshipUsed to determine which contributions = authorship

A substantive intellectual contributionA substantive intellectual contributionConceived or designed study Conceived or designed study oror

Acquired data Acquired data oror

Analysed or interpreted dataAnalysed or interpreted data

AndAnd

Drafted the article or revised it for intellectual Drafted the article or revised it for intellectual content content andand

Approved final version to be publishedApproved final version to be published

ICMJE exclude from authorshipICMJE exclude from authorshipSomeone who Someone who justjust

•• is the departmental chairis the departmental chair

•• acquired fundingacquired funding

•• provided general supervisionprovided general supervision

•• collected datacollected data

•• provided purely technical supportprovided purely technical support

•• provided writing assistance provided writing assistance -- AcknowledgementAcknowledgement

What are guest andWhat are guest and ghost authors?ghost authors?

A guest author: is an author A guest author: is an author but but shouldnshouldn’’tt bebe

A ghost author: is not an author A ghost author: is not an author but but should beshould be

Who are guest authors?Who are guest authors?Named authors whoNamed authors who do not do not meet authorship meet authorship criteriacriteria

Why?Why?Departmental heads Departmental heads

pressure to publish/conventionpressure to publish/conventionboost acceptance chancesboost acceptance chances

Other guests Other guests mutual support to pad out biographiesmutual support to pad out biographiescondition for providing samples/patientscondition for providing samples/patients

Who are ghost authors?Who are ghost authors?PeoplePeople not listednot listed on the paper whoon the paper who dodo meet meet authorship criteriaauthorship criteria

Why?Why?To avoid a dilution of creditTo avoid a dilution of credite.g.e.g. junior faculty memberjunior faculty member

To hide a potential pharma company influence To hide a potential pharma company influence e.g.e.g. sponsor employee, medical writer, statistician sponsor employee, medical writer, statistician

WhatWhat’’s wrong with guest/ghost s wrong with guest/ghost authorship?authorship?

Guest authorship isGuest authorship isUnfairUnfair——junior authors do not receive the junior authors do not receive the credit they deservecredit they deserve

DangerousDangerous——department head can be held department head can be held responsible for a juniorresponsible for a junior’’s unethical s unethical behaviour behaviour

Ghost authorshipGhost authorshipLeaves readers unaware of possible biasLeaves readers unaware of possible bias

Avoids accountability for the workAvoids accountability for the work

Who decides authorship and Who decides authorship and when?when?

ICMJE:ICMJE:The group should jointly decide about The group should jointly decide about contributors/authors before submitting contributors/authors before submitting the manuscript for publicationthe manuscript for publication

The corresponding author should be The corresponding author should be prepared to explain the presence and prepared to explain the presence and order of these individualsorder of these individuals

Who checks authorship?Who checks authorship?Office of Research Integrity Office of Research Integrity (ORI)(ORI)

excludes authorship issues from its official excludes authorship issues from its official purviewpurviewconsiders authorsconsiders authors’’ institutions are responsible for institutions are responsible for authorshipauthorship

•• Journals Journals -- also consider authorsalso consider authors’’ institutions are institutions are

responsible for determining authorshipresponsible for determining authorship

How to prevent authorship How to prevent authorship problems problems

Develop institutional policies that are Develop institutional policies that are fair and establish transparencyfair and establish transparency

Distribute and discuss an outline Distribute and discuss an outline before finalising the paperbefore finalising the paper

How to prevent authorship How to prevent authorship problems problems

Decide on authorship at the beginning Decide on authorship at the beginning of each studyof each study

Compile an inventory of contributions Compile an inventory of contributions to be revisited in the middle and end of to be revisited in the middle and end of the study the study

Circulate manuscript for approval Circulate manuscript for approval before submissionbefore submission

Who is a contributor?Who is a contributor?Someone who added usefully to the workSomeone who added usefully to the work

ICMJE:ICMJE:editors should have a editors should have a contributorshipcontributorship policypolicy

+ identify who is responsible for the integrity of + identify who is responsible for the integrity of the work (guarantor)the work (guarantor)

•• In reality contributors usually In reality contributors usually = listed authors= listed authors

Contributor statementsContributor statements•• Some journals require authors to sign Some journals require authors to sign contributor statements andcontributor statements and

-- provide checklist orprovide checklist or

-- ask authors to state contribution in their own ask authors to state contribution in their own wordswords

•• Some journals will ask questions if Some journals will ask questions if suspicioussuspicious

ReportingReporting ethicsethics in in scientificscientific publicationspublications

Shirin HeidariShirin Heidari

ReportingReporting ethicsethics in in scientificscientific publicationspublications

Peer-reviewer: ‘The editor will

have checked this’

Author: ‘Who checks this anyway?’

Editor: ‘Checking this willtake too much time’

Whose responsibility?

Adopted from European Science Editing Vol35(1) February 2009

Guidelines on the ethics of biomedical Guidelines on the ethics of biomedical research with human subjectresearch with human subject

From Emanuel et al. JAMA.2000; 283: 2701-2711

Nuremberg Code and Helsinki Nuremberg Code and Helsinki DeclarationDeclaration

‘’‘’Authors, editors and publishers all have ethical Authors, editors and publishers all have ethical obligations with regard to the publication of the results of obligations with regard to the publication of the results of research.research.’’’’ Helsinki DeclarationHelsinki Declaration

AuthorsAuthors: : accountableaccountable for for completenesscompleteness and and accuracyaccuracy. .

Editors: Editors: rejectreject researchresearch not in accordance not in accordance withwith ethicalethicalprinciplesprinciples. .

PeerPeer--reviewersreviewers: expert : expert judgementjudgement relatedrelated to to fieldfield and and regionregion

ProtectProtect life, life, healthhealth, , dignitydignity, , integrityintegrity, , right to selfright to self--determinationdetermination, , privacyprivacy, , confidentialityconfidentiality of of researchresearchparticipants.participants.

7 ethical requirements7 ethical requirements

1. Social and Scientific value2. Scientific validity3. Fair subject selection4. Favorable risk – benefit ratio5. Independent review 6. Informed consent7. Respect for potential and enrolled

subject

EthicalEthical reportingreporting startsstarts atat the the ‘‘beginningbeginning’’whatwhat youyou do not havedo not have…… youyou cannotcannot reportreport

Design phaseDesign phase: : ObtainObtain ethicalethical clearance. clearance. ‘‘InstitutionalInstitutional reviewreview boardsboards’’ or or ‘‘committeescommittees on on humanhuman subjectssubjects’’ reviewreviewand and approveapprove ethicsethics//safetysafety of of researchresearch proposalproposal. Helsinki . Helsinki DeclaractionDeclaraction..

ImplementationImplementation phasephase: : ObtainObtain participantparticipant’’ss consent.consent.WrittenWritten informedinformed consent consent legallylegally protectsprotects the the authorauthor and the and the journal/journal/publisherpublisher..

DisseminationDissemination phasephase: Report : Report ethicalethical clearance and patient consent clearance and patient consent in publication and in publication and protectprotect confidentialityconfidentiality..

Adopted from Framework for Operations and Implementation Research in Health and Disease Control Programs

EthicalEthical reviewreviewExists to protect the rights, safety, dignity and wellExists to protect the rights, safety, dignity and well--being of research being of research participants; participants; ANDAND

To To facilitatefacilitate and and promotepromote ethicalethical researchresearch thatthat isis of of potentialpotential benefitbenefit to to participants, science and society.participants, science and society.

ElementsElements of a of a reviewreview: : ScientificScientific design and design and conductconduct of of studystudyRecruitmentRecruitment, care and protection of , care and protection of researchresearch participantsparticipantsProtection of Protection of confidentialityconfidentialityInformedInformed consent consent processprocessCommunityCommunity considerationsconsiderations

In In theorytheory: all : all researchresearch thatthat involvesinvolves humanhuman subjectssubjects requiresrequires ethicalethical approvalapprovalNational guidelines National guidelines differdiffer

ReviewReview boardsboards cancan alsoalso grantgrant waiverswaivers

WHO guidelines (elements)National Research Ethics Service (UK)

ParticipantParticipant’’ss consentconsentAnyAny researchresearch thatthat studiesstudies humanshumans maymay pose a pose a riskrisk (e.g. (e.g. sideside--effectseffects) and ) and alwaysalways inflictsinflicts a a costcost (e.g. time). More (e.g. time). More ‘‘invasiveinvasive’’ studiesstudiescarry a carry a greatergreater riskrisk

‘‘The The voluntaryvoluntary consent of the consent of the humanhuman subjectsubject isis absolutelyabsolutely essentialessential’’ First First principleprinciple of the Nuremberg Code.of the Nuremberg Code.

Important to noteImportant to note: Consent : Consent legallylegally protectsprotects authorsauthors/ / journalsjournals/ / publisherspublishers, but , but ‘‘failsfails to to protectprotect the the participantparticipant fromfrom future future personalpersonalnegativenegative consequencesconsequences of of beingbeing the the subjectsubject of a report.of a report.’’

The The needneed for an for an informedinformed decisiondecision by the participant varies:by the participant varies:

•• have have sufficientsufficient knowledgeknowledge ––includingincluding potentialpotential risksrisks and and harmsharms-- and and comprehensioncomprehension of the of the studystudy. . VoluntaryVoluntary, , knowingknowing and and competentcompetent??

•• Consent to Consent to participateparticipate in in researchresearch isis not the not the samesame as consent to publication as consent to publication i.e. sharing of i.e. sharing of individualindividual data.data.

•• To To considerconsider: : minorsminors//disabilitydisability, , languagelanguage, , educationeducation levellevel, time for questions, , time for questions, withdrawalwithdrawal clause, publication information.clause, publication information.

Adopted from Informed Consent for Case Reports Levine&Stagno J Psychoter Pract Res 2001+ Framework for Operations and Implementation Research in Health and Disease Control Programs

+ Nuremberg Code + Declaration of Helsinki.

Protection throughPRIVACY

Legal Ethical

Protection of Protection of studystudy participantsparticipants

Confidentiality Security

Storage Transfer Use Physical Electronic Procedural

2001 Declaration of Commitment on HIV/AIDS included:Enforce legislation, regulations and other measures to ensure rights of people living with HIV, including privacy and confidentiality.

ParticipantParticipant’’ss anonymityanonymityEveryEvery precautionprecaution must must bebe takentaken to to protectprotect privacyprivacy, , ensureensure

confidentialityconfidentiality, , minimizeminimize impact. impact. (Helsinki (Helsinki DeclarationDeclaration))

How to do How to do thisthis……

First First stepstep isis ‘‘ConsentConsent’’..

IdentifyingIdentifying information information shouldshould not not bebe publishedpublished unlessunless essential essential for for scientificscientific purposespurposes. Non. Non--essential essential detailsdetails of participants of participants shouldshould bebe omittedomitted..

InformedInformed consent in case of identifiable participants consent in case of identifiable participants requiresrequires the the manuscriptmanuscript to to bebe sharedshared priorprior to publication.to publication.

ButBut……participantparticipant’’ss data data shouldshould nevernever bebe falsifiedfalsified to to obtainobtainanonymityanonymity. . AlterationsAlterations needneed to to bebe statedstated on on submissionsubmission and and verifiedverified not to not to distortdistort scientificscientific meaningmeaning..

Adopted from BMJ 1995 311:1272 Protection of patients’ rights to privacy+ Council of Science Editors: 3.1.1 Mistreatment of Research Subjects.

Editorial Editorial reviewreviewThe The editoreditor’’ss dilemmadilemma::

Journal Journal requirementsrequirements vs local vs local regulationsregulations

CriteriaCriteria for for reviewreview::ScientificallyScientifically validvalid and and clearlyclearly presentedpresentedConfoundingConfounding factorsfactors//biasesbiases have been have been excludedexcluded or or consideredconsideredEthicalEthical harmsharms have been have been minimisedminimisedBenefitsBenefits outweighoutweigh the the harmsharmsLocal Local regulationsregulations have been have been followedfollowedPeerPeer--reviewerreviewer expert expert adviceadvice

Adapted from guidance for editors from COPE

ReportingReporting correctlycorrectly

ClinicalClinical trial registrationtrial registration: : anyany researchresearch studystudy thatthat prospectivelyprospectivelyassignsassigns humanhuman subjectssubjects to to healthhealth relatedrelated interventions (e.g. interventions (e.g. drugsdrugs) ) to to evaluateevaluate healthhealth outcomesoutcomes. . RegisterRegister withwith a a publiclypublicly accessible accessible registryregistry, trial registration , trial registration numbernumber -- last line of the abstract.last line of the abstract.

EthicalEthical clearanceclearance: : ApprovalApproval or or approvedapproved waiverwaiver statedstated withwith detailsdetailsof of grantinggranting body in body in methodsmethods section.section.

Patient consentPatient consent: To : To bebe statedstated in in methodsmethods section, how section, how informedinformed, , verbal/verbal/writtenwritten consent consent waswas obtainedobtained, , alsoalso information on information on compensation.compensation.

ConflictConflict of of interestinterest: : DisclosureDisclosure of of anyany potentialpotential conflictsconflicts of of interestinterest, , alsoalso part of part of seekingseeking ethicalethical clearance. clearance. PersonalPersonal gains gains thatthatcompromise compromise integrityintegrity. .

Adapted from JIAS instructions to authors. Helsinki Declaration.

PUBLICATION ETHICS:PUBLICATION ETHICS:

Guidelines for Resolving Ethical Guidelines for Resolving Ethical Dilemmas in the Real WorldDilemmas in the Real World

Thomas Thomas BaborBabor

Scientific issues embrace three Scientific issues embrace three ethical realmsethical realms

The individual, coThe individual, co--workers, and research workers, and research participantsparticipantsThe institutionThe institutionProfessional field, science and societyProfessional field, science and society

Publication Ethics Draws from Publication Ethics Draws from Many SourcesMany Sources

Ethical principlesEthical principlesEthics codesEthics codesScientific valuesScientific valuesProfessional guidelinesProfessional guidelinesProcedures to implement ethical principles Procedures to implement ethical principles and professional guidelinesand professional guidelines

The PhilosopherThe Philosopher’’s Questions Question

““Can you tell me Can you tell me SocretesSocretes, is virtue , is virtue something that can be taught? Or does it something that can be taught? Or does it come by practice? Or is it neither teaching come by practice? Or is it neither teaching nor practice that gives it to a man, but nor practice that gives it to a man, but natural aptitude or something else?natural aptitude or something else?””

••Ethics of virtue and character (Ethics of virtue and character (““being goodbeing good”” owing to traits of integrity, honesty and owing to traits of integrity, honesty and compassion)compassion)

••Ethics of individual acts and rights (Ethics of individual acts and rights (““doing doing goodgood”” by applying principles such as fairness by applying principles such as fairness and justice)and justice)

Ethical TraditionsEthical Traditions Applicable to Applicable to


General Ethical PrinciplesGeneral Ethical PrinciplesRespect for personsRespect for persons Autonomy and selfAutonomy and self--determinationdetermination

Meaningful informed and voluntary consentMeaningful informed and voluntary consent

BeneficenceBeneficence Maximizing benefits by promoting the wellMaximizing benefits by promoting the well-- being of being of subjects and societysubjects and society

NonNon--maleficencemaleficence Minimizing harmMinimizing harm

JusticeJustice Persons bearing burden of research should Persons bearing burden of research should receive appropriate benefits: subjectsreceive appropriate benefits: subjectsshould not be placed at risk merely becauseshould not be placed at risk merely becauseof their compromised positionof their compromised position

AutonomyAutonomy Respect peopleRespect people’’s choicess choices

StewardshipStewardship Use resources efficiently and justlyUse resources efficiently and justly

FairnessFairness Avoid discrimination and exploitationAvoid discrimination and exploitation

(Belmont Report 1979)(Belmont Report 1979)

A Procedure for Ethical Analysis and A Procedure for Ethical Analysis and DecisionDecision--making making

(White & (White & PopovitsPopovits, 2001), 2001)Borrows from major traditions, guidelines Borrows from major traditions, guidelines and principlesand principlesDesigned to stimulate critical thinking Designed to stimulate critical thinking about ethical complexity, rather than about ethical complexity, rather than provide definitive answersprovide definitive answers

Ethical analysis requires asking Ethical analysis requires asking three questionsthree questions

1.1. Whose interests are involved and who is Whose interests are involved and who is likely to be harmed?likely to be harmed?

2.2. What principles apply to this situation and What principles apply to this situation and what course of action is suggested by what course of action is suggested by these principles?these principles?

3.3. What laws, standards, policies, practice What laws, standards, policies, practice guidelines, historical practices should guidelines, historical practices should guide us in this situation?guide us in this situation?

Checklist for Analysis of Checklist for Analysis of Critical Incidents Critical Incidents

1 Whose interests are involved; who can be harmed?1 Whose interests are involved; who can be harmed?

Which interests, if any, are in conflict?Which interests, if any, are in conflict?

interests and interests and vulnerabilitiesvulnerabilities

significantsignificant moderatemoderate minimal / noneminimal / none

yourselfyourself

coco--workersworkers

institutioninstitution

professional professional fieldfield

science / science / societysociety

Application of Universal ValuesApplication of Universal Values

____ Autonomy (freedom over one's own destiny)____ Autonomy (freedom over one's own destiny)____ Beneficence (do good; help others)____ Beneficence (do good; help others)____ ____ NonmaleficenceNonmaleficence (don't hurt anyone)(don't hurt anyone)____ Justice (be fair; distribute by merit)____ Justice (be fair; distribute by merit)____ Obedience (obey legal and ethically permissible directives)____ Obedience (obey legal and ethically permissible directives)____ Conscientious refusal (disobey illegal or unethical directi____ Conscientious refusal (disobey illegal or unethical directives)ves)____ Gratitude (pass good along to others)____ Gratitude (pass good along to others)____ Competence (be knowledgeable and skilled)____ Competence (be knowledgeable and skilled)____ Stewardship (use resources wisely)____ Stewardship (use resources wisely)____ Honesty and candor (tell the truth)____ Honesty and candor (tell the truth)____ Fidelity (keep your promises)____ Fidelity (keep your promises)____ Loyalty (don't abandon)____ Loyalty (don't abandon)____ Diligence (work hard)____ Diligence (work hard)____ Discretion (respect confidence and privacy)____ Discretion (respect confidence and privacy)____ Self____ Self--improvement (be the best that you can be)improvement (be the best that you can be)____ Restitution (make amends to persons injured)____ Restitution (make amends to persons injured)____ Self____ Self--interest (protect yourself)interest (protect yourself)____ Other culture____ Other culture--specific valuesspecific values

Ethical Analysis ExerciseEthical Analysis Exercise

Read the caseRead the caseUse checklist to answer the discussion Use checklist to answer the discussion questionsquestionsCompare your answers to an ethicistCompare your answers to an ethicist’’s s analysis of the caseanalysis of the case

How How diddid wewe do?do?

PleasePlease taketake a minute to a minute to fillfill out out ourourevaluationevaluation formform..

ManyMany thanksthanks for for youryour participationparticipation..

Have a Have a guessguess……

AverageAverage numbernumber of of authorsauthors per per paperpaper??


AverageAverage numbernumber of of authorsauthors per per paperpaper??3.6 3.6 authorsauthors//paperpaper

Record Record numbernumber of of authorsauthors for for scientificscientificpublication? publication?


AverageAverage numbernumber of of authorsauthors per per paperpaper??3.6 3.6 authorsauthors//paperpaper

Record Record numbernumber of of authorsauthors for for scientificscientificpublication? publication? Precision Electroweak Measurements on the Z Resonance. – Physics Report 427[5-6]: 257-454 (2006).2512 authors (18 of the pages of the paper is a list of authors...)

Courtesy of Linus Svensson

ParticipantParticipant’’ss consentconsentAlsoAlso requiredrequired for identifiable for identifiable humanhuman materialmaterial or or data (collection, data (collection, analysisanalysis, , storagestorage, , rere--use)use)

Evidence: Evidence: mostmost commonlycommonly a signature a signature testifyingtestifyinginformedinformed, , writtenwritten consent, consent,

nonnon--writtenwritten consent must consent must bebe formallyformally documenteddocumentedand and witnessedwitnessed

Impossible or Impossible or impracticalimpractical cases cases –– stillstill requirerequireapprovalapproval of of researchresearch ethicsethics committeecommittee. .

ValidatingValidating youryour researchresearch

Construct Specify therapeutic elementsActive ingredient

Internal Detail population and measurementsParameters

Statistics Analyse statistical powerSample size, which numbers?

External Discuss in contextGeneralizability

Adapted from AIDS Education and Prevention 16(4)341-52, 2004, Flores et al

•• Copyright lawsCopyright laws•• Review Board/Ethics Committee standardsReview Board/Ethics Committee standards•• Professional policy documentsProfessional policy documents

What Laws, Standard, Policies, Practice What Laws, Standard, Policies, Practice Guidelines, Historical Practices Guidelines, Historical Practices

should guide us in this situation?should guide us in this situation?

LimitationsLimitationsLimitations are ok, but Limitations are ok, but theythey needneed to to bebe acknowledgedacknowledged..

BiasBias: The : The studystudy populationpopulationResearcherResearcher: : selectionselection biasbias

•• Control or Control or referencereference groupgroup

•• Comparable and Comparable and representativerepresentative studystudy groupsgroups

SubjectsSubjects: participation : participation biasbias + + reportingreporting biasbias

•• People People whowho participateparticipate in a in a studystudy maymay bebe more stable, more stable, healthyhealthy, , atat lowerlower riskrisk..

•• HIV HIV sexualsexual riskrisk behavioursbehaviours, social stigma and , social stigma and illegalillegal drugdrug use use cancan influence influence reportingreporting

To To includeinclude: : selectionselection criteriacriteria, , refusalrefusal rate, rate, lostlost to to followfollow--upup

What laws, standards, policies, practice What laws, standards, policies, practice guidelines, historical practices should guidelines, historical practices should guide us in this situation?guide us in this situation?

•• Copyright lawsCopyright laws•• IRB standardsIRB standards•• Professional policy documentsProfessional policy documents

Towards a moral compassTowards a moral compass

Patients/participantsPatients/participantsDo no harmDo no harmBenefit the participantBenefit the participant

The scientific communityThe scientific communityTransparencyTransparencyHonestyHonestyAccuracyAccuracy

workshop scientific integrity and ethical issues in publishing

Documents