Ethics

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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_at_bcu.ac.uk
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Design Ethical Approval Good research should
be... Justified Well planned Appropriately
designed Ethically approved Ethical misconduct
not to meet this standard?
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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
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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
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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
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• Research Ethics Checklist
• peoples rights and claims
• different sorts of interests and 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
• grief and distress
• an obligation to make sacrifices for the
  community
• entitlement of the community
• the system of justice
• public safety danger
• public policy considerations
• civil liberties
• individual autonomy

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PatientsStaffHealthy
Quantitative Research Designs
Laboratory
Experimental
RCT
approach
Case - control
Epidemiology
Cohort study
Observational
Postal questionnaire
Survey
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Ethical Committees 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 gt1 Health Authority
Area 5. Project coordinated by agents based in
gt1 Health Authority Area
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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
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The Application Procedure Too long Prescriptive
Expertise of LREC panel? Monthly
meetings Interview Panel Assumes that the
researcher doesnt know best or at best is
unscrupulous Outsourcing for specialist
information Confusion between Anonymity and
Confidentiality
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Correspondence and Rebuttal Power
imbalance Reiterating application and
protocol Time consuming Unfair and
unreasonable demands Invitation to
meetings impracticalunproductivekangaroo style
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• 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

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• 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 muchQ.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

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• When youre right . . . Youre right!
• The Strengths of LRECs
• Sample Size Issues
• Power of Study Calculations
• Statistical Analyses
• Student Sub-Committees (e.g South Birmingham)

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• 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

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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)
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Incentives and Response Rates Technique Like
lihood 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)
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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
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Diminishing Returns Attrition
Researcher
Potential Sample
1000 people
540 questionnaires
540 consents
210 questionnaires
Under-powered studyn 210
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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
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Non-Responders Steganography Secret
communication of a message by hiding its
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 its meaning Kryptos, meaning
hidden. Gk Message established using known
protocol, to be decrypted by the receiver
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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
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• 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

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