Ethics & EthicalityEthics & Ethicalityin Scientific Researchin Scientific Research

Good Practice Good Practice

Prof. Craig Jackson Head of Psychology Division

School of Social SciencesBCU

health.bcu.ac.uk/craigjackson@workplace_prof

@bcu_psychology

craig.jackson@bcu.ac.ukcraig.jackson@bcu.ac.uk

Design & Ethical ApprovalDesign & Ethical Approval

Good research should be...Good research should be...

JustifiedJustified

Well plannedWell planned

Appropriately designedAppropriately designed

Ethically approvedEthically approved

Ethical misconduct not to meet this standard?Ethical misconduct not to meet this standard?

Brief Research HistoryBrief Research History

Mental Health of UK Farmers using OP Pesticides (X2) -- 1997-Mental Health of UK Farmers using OP Pesticides (X2) -- 1997-2000 2000 (Epidemiological Surveys)(Epidemiological Surveys)

Neurobehavioural Performance of desert-based Oil Drillers -- Neurobehavioural Performance of desert-based Oil Drillers -- 1998-2000 1998-2000 (Clinical assessment)

Temporary Hearing Loss in Student Bar Staff – 2000-2002 Temporary Hearing Loss in Student Bar Staff – 2000-2002 (Epidemiological Survey)

Benefits of Occupational Health Advice in Primary Care Settings Benefits of Occupational Health Advice in Primary Care Settings -- 2001-2004 -- 2001-2004 (Randomised Controlled Trial)

Smaller-Scale projects – (Tri-Services, NHS Personnel, NHS Smaller-Scale projects – (Tri-Services, NHS Personnel, NHS Patients) Patients) (Cross-sectional Surveys, Clinical Trials)

Multiple roles of psychologist, statistician, and methodology Multiple roles of psychologist, statistician, and methodology designerdesigner

Design & Ethical ApprovalDesign & Ethical Approval

Research should be driven by protocolResearch should be driven by protocol

Pilot studies should have a written rationalePilot studies should have a written rationale

Protocols should answer specific questionsProtocols should answer specific questions

Not just “collecting data”Not just “collecting data”

Protocols must be agreed by all contributors & participantsProtocols must be agreed by all contributors & participants

Keep the protocol as part of the Research record / logKeep the protocol as part of the Research record / log

Design & Ethical ApprovalDesign & Ethical Approval

Statistical issues should be considered before data collectionStatistical issues should be considered before data collection

Power calculations are becoming essentialPower calculations are becoming essential

Formal approval required for all research involving:Formal approval required for all research involving: peoplepeople

medical recordsmedical recordsanonymous human tissueanonymous human tissue

Human tissue studies - Nuffield Council on BioethicsHuman tissue studies - Nuffield Council on Bioethics

Fully informed consent should always be soughtFully informed consent should always be soughtIf not possible (deceptive studies) a REC should decideIf not possible (deceptive studies) a REC should decide

Research Ethics ChecklistResearch Ethics Checklist

• people’s rights and claimspeople’s rights and claims• different sorts of interestsdifferent sorts of interests and their relative strengthand their relative strength• human well-beinghuman well-being• loss of lifeloss of life

• what would be good or bad for peoplewhat would be good or bad for people

• democratic acceptancedemocratic acceptance

• consultationconsultation

• sensitive momentssensitive moments• benefits and harmsbenefits and harms• griefgrief and distressand distress• an obligation to make sacrifices for the community;an obligation to make sacrifices for the community;

• entitlement of the communityentitlement of the community• the systemthe system of justiceof justice• public safety & dangerpublic safety & danger• public policy considerationspublic policy considerations• civil libertiescivil liberties• individual autonomyindividual autonomy• lives and liberties of citizenslives and liberties of citizens

Quantitative Research DesignsQuantitative Research Designs

approach

Observational

Experimental

Survey

Epidemiology

Case - control

Cohort study

Postal questionnaire

Laboratory

RCT

PatientsStaff

Healthy

What Quantitative Research RequiresWhat Quantitative Research Requires

Numerical / Quantifiable dataNumerical / Quantifiable data

Probability-basedProbability-based

NomotheticsNomothetics

Sufficiently large sample (to detect statistically sig. effects)Sufficiently large sample (to detect statistically sig. effects)

Randomised sampling a pop. (can't guarantee a random sample)Randomised sampling a pop. (can't guarantee a random sample)

Statistical analyses of dataStatistical analyses of data

The Application ProcedureThe Application Procedure

Too longToo long

PrescriptivePrescriptive

Expertise of LREC panel?Expertise of LREC panel?

Monthly meetingsMonthly meetings

““Interview Panel”Interview Panel”

Assumes that “Assumes that “the researcher doesn’t know bestthe researcher doesn’t know best” or at best is ” or at best is unscrupulousunscrupulous

Outsourcing for specialist informationOutsourcing for specialist information

Confusion between Anonymity and ConfidentialityConfusion between Anonymity and Confidentiality

Correspondence and RebuttalCorrespondence and Rebuttal

Power imbalancePower imbalance

Reiterating application and protocolReiterating application and protocol

Time consumingTime consuming

Unfair and unreasonable demandsUnfair and unreasonable demands

Invitation to meetings:Invitation to meetings:impracticalimpracticalunproductiveunproductivekangaroo stylekangaroo style

Correspondence and Rebuttal:Correspondence and Rebuttal:The Placental Blood Flow ExampleThe Placental Blood Flow Example 1.1.Student applies to committee (application, protocol, 2 Student applies to committee (application, protocol, 2

supervisors)supervisors)

2.2.Committee loses applicationCommittee loses application

3.3.Committee contacts student – raises 4 questionsCommittee contacts student – raises 4 questions

• Student addresses 4 questionsStudent addresses 4 questions

• Committee responds – satisfied with 3 answersCommittee responds – satisfied with 3 answersNot happy with statistical proceduresNot happy with statistical procedures

• Student responds with clarificationsStudent responds with clarifications

3.3.Committee responds – final satisfactionCommittee responds – final satisfactionCaveat: student must report to LREC after 1 year Caveat: student must report to LREC after 1 year

get student’s name wrongget student’s name wrong

statistical statistical procedures not procedures not effecting sample effecting sample sizesizeany any jurisdiction?jurisdiction?

Correspondence and Rebuttal:Correspondence and Rebuttal:The Post-Partum Depression StudyThe Post-Partum Depression Study

1.1.Students apply to committee Students apply to committee (application, protocol, supervisor)(application, protocol, supervisor)

2.2.Committee concerned over 2 widely used psychometric Committee concerned over 2 widely used psychometric questionnairesquestionnairesGHQ 28GHQ 28Edinburgh Post-Natal Depression ScaleEdinburgh Post-Natal Depression Scale

• Concerned the “depressive nature” of items may be “too Concerned the “depressive nature” of items may be “too much”much”Q.25 “Have you thought of the possibility you might make away with Q.25 “Have you thought of the possibility you might make away with yourself?”yourself?”

1.1.Students respond to LREC with references of previous work Students respond to LREC with references of previous work involving such psychometricsinvolving such psychometrics

When you’re right . . . You’re right!When you’re right . . . You’re right!The Strengths of LRECsThe Strengths of LRECs

1.1.Sample Size IssuesSample Size Issues

2.2.Power of Study CalculationsPower of Study Calculations

3.3.Statistical Analyses Statistical Analyses

•Student Sub-Committees (e.g South Birmingham)Student Sub-Committees (e.g South Birmingham)

The Importance of Sample SizeThe Importance of Sample Size

• Apparently forgotten in many studiesApparently forgotten in many studies

• Little consideration givenLittle consideration given

• Appropriate size needed to confirm / refute hypothesesAppropriate size needed to confirm / refute hypotheses

• Small samples too tiny to detect anything but grossest diff.Small samples too tiny to detect anything but grossest diff.

• Non-significant results are reported – Type 2 errors occurNon-significant results are reported – Type 2 errors occur

• Too large a sample – unnecessary waste of resourcesToo large a sample – unnecessary waste of resources

• Ethical – waste of patient time, inconvenience, discomfortEthical – waste of patient time, inconvenience, discomfort

• Make assessment of optimal sample size before starting Make assessment of optimal sample size before starting

Incentives to ParticipantsIncentives to Participants

Sheep Farmers and OP Study 1996:Sheep Farmers and OP Study 1996:farmers and Quarry workers contactedfarmers and Quarry workers contactedconsent forms entered into Raffle for £200 consent forms entered into Raffle for £200 not permissible under LREC / MRECnot permissible under LREC / MREC

Student Hearing Loss Study 2000:Student Hearing Loss Study 2000:student bar staff contactedstudent bar staff contactedparticipants offered 5 lottery ticketsparticipants offered 5 lottery ticketsnot permissible under Birmingham University Guidelinesnot permissible under Birmingham University Guidelines

Evidence shows incentives do not unduly bias choice of Evidence shows incentives do not unduly bias choice of participantsparticipants(Edwards (Edwards et al.et al. 2002) 2002)

Incentives and Response RatesIncentives and Response Rates

TechniqueTechnique Likelihood of responseLikelihood of response

Cash incentive Cash incentive X 2X 2 (Brown, (Brown, et al.et al. 1997, Roberts 1997, Roberts et al.et al. 2000) 2000)

Warn respondents of follow up (need linkage)Warn respondents of follow up (need linkage) X 1.4X 1.4

Drop out must be explained by the respondentDrop out must be explained by the respondent X 1.3X 1.3

Choice to opt out given to respondentsChoice to opt out given to respondents X 0.7X 0.7

(Edwards (Edwards et al.et al. 2002) 2002)

Diminishing Returns & Attrition Diminishing Returns & Attrition

LRECs insisting on:LRECs insisting on:

Contacting sample and requesting consent BEFORE any questionnaires sent

Serious implications for reduction in sample sizes

Any process involving respondents’ effort will lose participants

Diminishing Returns & AttritionDiminishing Returns & Attrition

ResearcherResearcher Potential SamplePotential Sample

1000 people

540 consents

540 questionnaires

Under-powered studyn = 210

210 questionnaires

Non-RespondersNon-Responders

Postal Surveys may accrue poor responses (e.g. 20%) from pop.Postal Surveys may accrue poor responses (e.g. 20%) from pop.

May need to re-write to pop. to re-recruit bigger sampleMay need to re-write to pop. to re-recruit bigger sample

Inefficient to write to all pop. againInefficient to write to all pop. again

Need to re-write to non-responders and NOT respondersNeed to re-write to non-responders and NOT responders

Impossible in anonymous studies with no linkageImpossible in anonymous studies with no linkage

Can be done with Can be done with confidentialconfidential studies studies

Non-RespondersNon-Responders

SteganographySteganography

Secret communication of a message by hiding it’s Secret communication of a message by hiding it’s existenceexistence

SteganosSteganos, meaning , meaning coveredcovered. . Gk Gk

GrapheinGraphein, meaning , meaning to write. Gkto write. Gk

If message is discovered it is easily read because of no If message is discovered it is easily read because of no

encryptionencryption

CryptographyCryptography

Secret communication of a message by hiding it’s Secret communication of a message by hiding it’s meaningmeaning

KryptosKryptos, meaning , meaning hiddenhidden. . GkGk

Message established using known protocol, to be decrypted by Message established using known protocol, to be decrypted by

the receiverthe receiver

LinkeageLinkeage

Indications from participant of clinical concern:Indications from participant of clinical concern:

Psychiatric problems / thresholdsPsychiatric problems / thresholds

Social problemsSocial problems

Clinical / Well-being issuesClinical / Well-being issues

Need method of linkage to connect concerning data with Need method of linkage to connect concerning data with respondentrespondent

Ethical Committee wish-listEthical Committee wish-list

1.1.Better understanding of novel small-scale pilot studiesBetter understanding of novel small-scale pilot studies

2.2.More allowance for deceptive studiesMore allowance for deceptive studies

3.3.Greater freedom for “one-stop approach” to surveysGreater freedom for “one-stop approach” to surveys

4.4.Better understanding of multiple measurementsBetter understanding of multiple measurements

• Freedom to choose between anonymity or confidentialityFreedom to choose between anonymity or confidentiality

1.1.LRECs to act less like a gateway and more like advice-giversLRECs to act less like a gateway and more like advice-givers

2.2.Openness re: membership and qualificationsOpenness re: membership and qualifications

• More consistency between different LRECsMore consistency between different LRECs

Design & Ethical ApprovalDesign & Ethical Approval

If participants can't give fully informed consent, research shouldIf participants can't give fully informed consent, research shouldfollow international guidelines follow international guidelines (Council for International Organizations of Medical Sciences)(Council for International Organizations of Medical Sciences) Animal experiments require full compliance with local, national,Animal experiments require full compliance with local, national,ethical, and regulatory principles, along with local licensingethical, and regulatory principles, along with local licensingarrangementsarrangements

Formal supervision should be provided for all research projects, Formal supervision should be provided for all research projects, Including: Including: frequent reviewfrequent review

quality controlquality controllong term retention of records (up to 15 long term retention of records (up to 15

years)years)

Precise roles and tasks of contributors should be agreed as Precise roles and tasks of contributors should be agreed as soon as possiblesoon as possible

Data AnalysisData Analysis

Data should be appropriately analysed Data should be appropriately analysed

Inappropriate analysis does not amount to misconduct (yet)Inappropriate analysis does not amount to misconduct (yet)

Fabrication and Falsification of data do constitute misconductFabrication and Falsification of data do constitute misconduct

Data AnalysisData Analysis

All sources & methods used to obtain data should be disclosedAll sources & methods used to obtain data should be disclosed

Includes electronic pre-processingIncludes electronic pre-processing

Explanations should be given for any exclusionsExplanations should be given for any exclusions

Methods of analysis must be explained in detail Methods of analysis must be explained in detail Referenced if not in common useReferenced if not in common use

Post-hoc analysis of subgroups is acceptable if disclosedPost-hoc analysis of subgroups is acceptable if disclosed

Failure to disclose some analysis was post hoc is unacceptableFailure to disclose some analysis was post hoc is unacceptable

Discussion should mention issues of bias which have been Discussion should mention issues of bias which have been considered, and explain how they have been dealt with considered, and explain how they have been dealt with

AuthorshipAuthorship

There is no universally agreed definitionThere is no universally agreed definition

As min. authors should be responsible for at least one sectionAs min. authors should be responsible for at least one sectionof the studyof the study

Balances intellectual contributions to the conception, design,Balances intellectual contributions to the conception, design,analysis, and writing of the study, against the collection of dataanalysis, and writing of the study, against the collection of dataand other routine workand other routine work

No task = No creditNo task = No credit

Decide early: who will be authors vs. who will be acknowledgedDecide early: who will be authors vs. who will be acknowledged

Public responsibility for the content of the work by allPublic responsibility for the content of the work by all

If uncertain, read the target journal’s “advice to authors”If uncertain, read the target journal’s “advice to authors”

Conflict of InterestsConflict of Interests

May not be fully apparent to all concernedMay not be fully apparent to all concerned

Impartial opinion soughtImpartial opinion sought

May influence the judgement of authors, reviewers, or editorsMay influence the judgement of authors, reviewers, or editors

““Those facts, which when revealed later, would make aThose facts, which when revealed later, would make areasonable reader feel misled or deceived”reasonable reader feel misled or deceived”

Personal, commercial, political, academic, or financialPersonal, commercial, political, academic, or financial

Financial conflicts may include:Financial conflicts may include:employmentemployment fundingfundingstock / share ownershipstock / share ownership honorariumshonorariumstraveltravel consultancies consultancies etc.etc.

PlagiarismPlagiarism

Ranges from un-referenced use of others’ (un)published ideasRanges from un-referenced use of others’ (un)published ideas

May occur at any stage of planning, research, or writingMay occur at any stage of planning, research, or writing

Applies to both print and electronic formatsApplies to both print and electronic formats

All sources should be disclosedAll sources should be disclosed

If large amounts of other peoples’ written or illustrative material If large amounts of other peoples’ written or illustrative material is to be used permission must be soughtis to be used permission must be sought

Media RelationsMedia Relations

Research of increasing interest to the print & broadcast mediaResearch of increasing interest to the print & broadcast media

Journalists may attend scientific meetings Journalists may attend scientific meetings

Where preliminary research findings are presented, may lead toWhere preliminary research findings are presented, may lead topremature publication in mass mediapremature publication in mass media

Authors approached should give as balanced account of workAuthors approached should give as balanced account of workas possible: point out where evidence ends and guessing startsas possible: point out where evidence ends and guessing starts

Simultaneous pub. in mass media &peer review journal bestSimultaneous pub. in mass media &peer review journal best

Authors should help journalists to produce accurate reportsAuthors should help journalists to produce accurate reports

Media RelationsMedia Relations

Refrain from supplying additional dataRefrain from supplying additional data

Participants in research should be informed of results by authorsParticipants in research should be informed of results by authorsbefore the mass media, especially if clinical implicationsbefore the mass media, especially if clinical implications

Authors insist in being advised in advance if journalists are Authors insist in being advised in advance if journalists are attending scientific meetingsattending scientific meetings

Authors should ask journals where their work appears if any Authors should ask journals where their work appears if any media policies are operatingmedia policies are operating

References & SourcesReferences & Sources

References & SourcesReferences & Sources

Council for International Organizations of Medical Sciences Council for International Organizations of Medical Sciences (CIOMS). (CIOMS).

International Guidelines for Ethical Review of Epidemiological International Guidelines for Ethical Review of Epidemiological Studies. Geneva: WHO, 1991.Studies. Geneva: WHO, 1991.

Nuffield Council on Bioethics. Human tissue: Ethical and legalNuffield Council on Bioethics. Human tissue: Ethical and legalissues.nLondon: Nuffield Council on Bioethics, 1995issues.nLondon: Nuffield Council on Bioethics, 1995