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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 Jackson Senior Lecturer in Health Psychology School of Health and Policy Studies www.hcc.uce.ac.uk/craig_jackson.

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slide1

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

slide2

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

slide3

Good research should be...

Justified

Well planned

Appropriately designed

Ethically approved

Ethical misconduct not to meet this standard?

slide4

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

slide5

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

slide6

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
slide7

PatientsStaffHealthy

Quantitative Research Designs

Laboratory

Experimental

RCT

approach

Case - control

Epidemiology

Cohort study

Observational

Survey

Postal questionnaire

slide8

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
slide9

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

slide10

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

slide11

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

slide12

Pet Hates #2Correspondence and Rebuttal

Power imbalance

Reiterating application and protocol

Time consuming

Unfair and unreasonable demands

Invitation to meetings – impractical unproductive kangaroo style

slide13

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
slide14

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
slide15

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)
slide16

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
slide17

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)

slide18

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)

slide19

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

slide20

Issues LRECs Need to Understand No. 2

Diminishing Returns

Researcher

Potential Sample

1000 people

540 consents

540 questionnaires

Under-powered studyn = 210

210 questionnaires

slide21

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

slide22

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

slide23

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

slide24

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
slide25

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 . . .

slide26

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).