Ethics Committees and Quantitative Research: Confessions of a jobbing researcher or “How I learned to stop worrying, and

1. Ethics Committees and Quantitative Research:Confessions of a jobbing researcher or “How I learned to stop worrying, and just enjoy doing the research” Dr. Craig JacksonSenior Lecturer in Health PsychologySchool of Health and Policy Studieswww.hcc.uce.ac.uk/craig_jackson

2. 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

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

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 documented ethical approval is required for all research involving (i) people (ii) medical records (iii) anonymous human tissue (Nuffield Council on Bioethics) Fully informed consent should always be sought If not possible (deceptive studies) a research ethics committee 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 to deny autonomy and violate bodily integrity in public interest • the systemof justice • public safety • public policy considerations • danger • civil liberties • individual autonomy • lives and liberties of citizens

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

8. Ethical Committees (My understanding of them anyway…) • NHS LREC must be applied to if research involves: • 1. NHS Patients • 2. NHS Staff * • 3. People (not patients) recruited in via NHS • * Some LRECs do not include this criteria • Military Ethics Committees must be applied to if research involves: • 1. Any serving military personnel

9. Ethical Committees (My understanding of them anyway…) NHS MREC must be applied to if research involves: 1. NHS Patients 2. NHS Staff * 3. People (not patients) recruited in via NHS 4. Data collected from >1 Health Authority Area 5. Project coordinated by agents based in >1 Health Authority Area

10. What Quantitative Research Requires Numerical / Quantifiable data Probability-based Nomothetics Sufficiently large sample size (to detect statistically significant effects) Randomised sampling of a population (cannot guarantee a random sample) Statistical analyses of data

11. Pet Hates #1The 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

12. Pet Hates #2Correspondence and Rebuttal Power imbalance Reiterating application and protocol Time consuming Unfair and unreasonable demands Invitation to meetings – impractical unproductive kangaroo style

13. get student’s name wrong statistical procedures not effecting sample size any jurisdiction? • 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

14. 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

15. 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)

16. The Importance of Sample Size • Apparently forgotten in many studies • Little consideration given • Appropriate size needed to confirm / refute hypotheses • Small samples far too small to detect anything but the grossest difference • Non-significant results are reported – Type 2 errors occur • Too large a sample – unnecessary waste of (clinical) resources • Ethical considerations – waste of patient time, inconvenience, discomfort • Essential to make assessment of optimal sample size before starting • investigation

17. Issues LRECs Need to Understand No. 1 Offering 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)

18. Issues LRECs Need to Understand No. 1 Some “unethical” practices proved to increase 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)

19. Issues LRECs Need to Understand No. 2 Diminishing Returns 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

20. Issues LRECs Need to Understand No. 2 Diminishing Returns Researcher Potential Sample 1000 people 540 consents 540 questionnaires Under-powered studyn = 210 210 questionnaires

21. Issues LRECs Need to Understand No. 3 Knowledge of the Non-Responders Postal Surveys may accrue poor response rates (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

22. Issues LRECs Need to Understand No. 3 Knowledge of the 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 Steganography & Cryptography can be combined together if needed Steganogrpahy arouses less suspicion in questionnaire respondents

23. Issues LRECs Need to Understand No. 4 Ethical Concerns 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

24. My LREC 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 and confidentiality of participants • LRECs to act less like a gateway and more like advice-givers • Openness re: membership and qualifications • More consistency between different LRECs

25. Conclusions Defer to nobody – you’re the expert! “A little humility would suit you better” Spend time getting the application right first time “Kill ‘em with kindness” Use the following references . . .

26. References Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies World Health Organisation, Geneva 1991. Nuffield Council on Bioethics. Human tissue: Ethical and legal issues. Nuffield Council on Bioethics, London 1995. World Medical Association. Ethical Principles for Medical Research Involving Human Subjects. Declaration of Helsinki, 2002. (Washington Amendment).