Ethics & Ethicality in Scientific Research Good Practice Prof. Craig Jackson

1. Ethics & Ethicality in Scientific Research Good Practice Prof. Craig Jackson Head of Psychology Division School of Social Sciences BCU health.bcu.ac.uk/craigjackson craig.jackson@bcu.ac.uk

2. Design & Ethical Approval Good research should be... Justified Well planned Appropriately designed Ethically approved Ethical misconduct not to meet this standard?

3. Brief Research History Mental Health of UK Farmers using OP Pesticides (X2) -- 1997-2000 (Epidemiological Surveys) Neurobehavioural Performance of desert-based Oil Drillers -- 1998-2000 (Clinical assessment) Temporary Hearing Loss in Student Bar Staff – 2000-2002 (Epidemiological Survey) Benefits of Occupational Health Advice in Primary Care Settings -- 2001-2004 (Randomised Controlled Trial) Smaller-Scale projects – (Tri-Services, NHS Personnel, NHS Patients) (Cross-sectional Surveys, Clinical Trials) Multiple roles of psychologist, statistician, and methodology designer

4. Design & Ethical Approval Research should be driven by protocol Pilot studies should have a written rationale Protocols should answer specific questions Not just “collecting data” Protocols must be agreed by all contributors & participants Keep the protocol as part of the Research record / log

5. Design & Ethical Approval • Statistical issues should be considered before data collection • Power calculations are becoming essential • Formal approval required for all research involving: • people • medical records • anonymous human tissue • Human tissue studies - Nuffield Council on Bioethics • Fully informed consent should always be sought • If not possible (deceptive studies) a REC should decide

6. Research Ethics Checklist • people’s rights and claims • different sorts of interestsand their relative strength • human well-being • loss of life • what would be good or bad for people • democratic acceptance • consultation • sensitive moments • benefits and harms • griefand distress • an obligation to make sacrifices for the community; • entitlement of the community • the systemof justice • public safety & danger • public policy considerations • civil liberties • individual autonomy • lives and liberties of citizens

7. PatientsStaffHealthy Quantitative Research Designs Laboratory Experimental RCT approach Case - control Epidemiology Cohort study Observational Postal questionnaire Survey

8. What Quantitative Research Requires Numerical / Quantifiable data Probability-based Nomothetics Sufficiently large sample (to detect statistically sig. effects) Randomised sampling a pop. (can't guarantee a random sample) Statistical analyses of data

9. The Application Procedure Too long Prescriptive Expertise of LREC panel? Monthly meetings “Interview Panel” Assumes that “the researcher doesn’t know best” or at best is unscrupulous Outsourcing for specialist information Confusion between Anonymity and Confidentiality

10. Correspondence and Rebuttal • Power imbalance • Reiterating application and protocol • Time consuming • Unfair and unreasonable demands • Invitation to meetings: • impracticalunproductivekangaroo style

11. any jurisdiction? statistical procedures not effecting sample size get student’s name wrong • Correspondence and Rebuttal: • The Placental Blood Flow Example • Student applies to committee (application, protocol, 2 supervisors) • Committee loses application • Committee contacts student – raises 4 questions • Student addresses 4 questions • Committee responds – satisfied with 3 answersNot happy with statistical procedures • Student responds with clarifications • Committee responds – final satisfactionCaveat: student must report to LREC after 1 year

12. Correspondence and Rebuttal: • The Post-Partum Depression Study • Students apply to committee • (application, protocol, supervisor) • Committee concerned over 2 widely used psychometric questionnairesGHQ 28Edinburgh Post-Natal Depression Scale • Concerned the “depressive nature” of items may be “too much”Q.25 “Have you thought of the possibility you might make away with yourself?” • Students respond to LREC with references of previous work involving such psychometrics

13. When you’re right . . . You’re right! • The Strengths of LRECs • Sample Size Issues • Power of Study Calculations • Statistical Analyses • Student Sub-Committees (e.g South Birmingham)

14. The Importance of Sample Size • Apparently forgotten in many studies • Little consideration given • Appropriate size needed to confirm / refute hypotheses • Small samples too tiny to detect anything but grossest diff. • Non-significant results are reported – Type 2 errors occur • Too large a sample – unnecessary waste of resources • Ethical – waste of patient time, inconvenience, discomfort • Make assessment of optimal sample size before starting

15. Incentives to Participants Sheep Farmers and OP Study 1996: farmers and Quarry workers contacted consent forms entered into Raffle for £200 not permissible under LREC / MREC Student Hearing Loss Study 2000: student bar staff contacted participants offered 5 lottery tickets not permissible under Birmingham University Guidelines Evidence shows incentives do not unduly bias choice of participants (Edwards et al. 2002)

16. Incentives and Response Rates TechniqueLikelihood of response Cash incentive X 2(Brown, et al. 1997, Roberts et al. 2000) Warn respondents of follow up (need linkage) X 1.4 Drop out must be explained by the respondent X 1.3 Choice to opt out given to respondents X 0.7 (Edwards et al. 2002)

17. Diminishing Returns & Attrition 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

18. Diminishing Returns & Attrition Researcher Potential Sample 1000 people 540 questionnaires 540 consents 210 questionnaires Under-powered studyn = 210

19. Non-Responders Postal Surveys may accrue poor responses (e.g. 20%) from pop. May need to re-write to pop. to re-recruit bigger sample Inefficient to write to all pop. again Need to re-write to non-responders and NOT responders Impossible in anonymous studies with no linkage Can be done with confidential studies

20. Non-Responders Steganography Secret communication of a message by hiding it’s existence Steganos, meaning covered. Gk Graphein, meaning to write. Gk If message is discovered it is easily read because of no encryption Cryptography Secret communication of a message by hiding it’s meaning Kryptos, meaning hidden. Gk Message established using known protocol, to be decrypted by the receiver

21. Linkeage Indications from participant of clinical concern: Psychiatric problems / thresholds Social problems Clinical / Well-being issues Need method of linkage to connect concerning data with respondent

22. Ethical Committee wish-list • Better understanding of novel small-scale pilot studies • More allowance for deceptive studies • Greater freedom for “one-stop approach” to surveys • Better understanding of multiple measurements • Freedom to choose between anonymity or confidentiality • LRECs to act less like a gateway and more like advice-givers • Openness re: membership and qualifications • More consistency between different LRECs

23. Design & Ethical Approval If participants can't give fully informed consent, research should follow international guidelines (Council for International Organizations of Medical Sciences) Animal experiments require full compliance with local, national, ethical, and regulatory principles, along with local licensing arrangements Formal supervision should be provided for all research projects, Including: frequent review quality control long term retention of records (up to 15 years) Precise roles and tasks of contributors should be agreed as soon as possible

24. Data Analysis Data should be appropriately analysed Inappropriate analysis does not amount to misconduct (yet) Fabrication and Falsification of data do constitute misconduct

25. Data Analysis • All sources & methods used to obtain data should be disclosed • Includes electronic pre-processing • Explanations should be given for any exclusions • Methods of analysis must be explained in detail • Referenced if not in common use • Post-hoc analysis of subgroups is acceptable if disclosed • Failure to disclose some analysis was post hoc is unacceptable • Discussion should mention issues of bias which have been • considered, and explain how they have been dealt with

26. Authorship There is no universally agreed definition As min. authors should be responsible for at least one section of the study Balances intellectual contributions to the conception, design, analysis, and writing of the study, against the collection of data and other routine work No task = No credit Decide early: who will be authors vs. who will be acknowledged Public responsibility for the content of the work by all If uncertain, read the target journal’s “advice to authors”

27. Conflict of Interests • May not be fully apparent to all concerned • Impartial opinion sought • May influence the judgement of authors, reviewers, or editors • “Those facts, which when revealed later, would make a • reasonable reader feel misled or deceived” • Personal, commercial, political, academic, or financial • Financial conflicts may include: • employment funding • stock / share ownership honorariums • travel consultancies etc.

28. Plagiarism Ranges from un-referenced use of others’ (un)published ideas May occur at any stage of planning, research, or writing Applies to both print and electronic formats All sources should be disclosed If large amounts of other peoples’ written or illustrative material is to be used permission must be sought

29. Media Relations Research of increasing interest to the print & broadcast media Journalists may attend scientific meetings Where preliminary research findings are presented, may lead to premature publication in mass media Authors approached should give as balanced account of work as possible: point out where evidence ends and guessing starts Simultaneous pub. in mass media &peer review journal best Authors should help journalists to produce accurate reports

30. Media Relations Refrain from supplying additional data Participants in research should be informed of results by authors before the mass media, especially if clinical implications Authors insist in being advised in advance if journalists are attending scientific meetings Authors should ask journals where their work appears if any media policies are operating

31. References & Sources

32. References & Sources Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies. Geneva: WHO, 1991. Nuffield Council on Bioethics. Human tissue: Ethical and legal issues.nLondon: Nuffield Council on Bioethics, 1995