Ethical Aspects of Research

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Ethical Aspects of Research
Dr Sheila A Simpson
30 May
2006
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Ethics ..or how to behave properly
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Ethics..a matter of general principles, even
rules.. but largely a matter of judgement, of
reasoning, of having the right feeling at the
right time.. and every time is different.

Mary Warnock
An intelligent Persons Guide to Modern
Ethics
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• Ethics in Medicine
• Respect for autonomy
• Including protection of those
  with diminished autonomy
• Beneficence
• Non Malificence
• Justice
• fairness, equity, distributing the
  benefits and burdens
• of healthcare in society

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• There is a foreseeable contribution to human good
  that justifies
• clinical research
• It is unethical for clinical research NOT be be
  open and accountable
• It is unethical NOT to disseminate results
• Registration of trials/clinical research is
  necessary
• 
  
• prevents duplication of effort
• and ensures both positive and
  negative results are made public

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Ethics Committeeshave a Legal Obligation

• European Directive 2001/20/EC
• The Medicines for Human Use (Clinical Trials)
  Regulations 2004
• Implemented into UK law on 1st May 2004

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Implications Of EU Directive

• March 2004 Central Office of Research Ethics
  Committees (COREC)
• One national Research Ethics Application Form
• 1st issue of Standard Operating Procedures for
  Research Ethics Committees
• Introduction of central allocation system (CAS),
  for booking multi site applications
• Introduction of national Research Ethics Data
  Base (RED)
• 2005 Warner Report

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Is Ethical Approval RequiredResearch, Audit or
Service Evaluation (1 of 2)(from COREC, ethics
consultation e-group)
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Is Ethical Approval RequiredResearch, Audit or
Service Evaluation (2 of 2)(from COREC, ethics
consultation e-group)
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The Committee

• Expert members
• Clinical and non-clinical research
• Qualitative or other research methods applicable
  to health services, social science social care
• Clinical practice including
• Hospital and community staff
• General practice
• Statistics relevant to research
• Pharmacy
• Lay members (one third of the committee)

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The Committee

• There should be a sufficiently broad range of
  experience and expertise, so that the scientific,
  clinical and methodological aspects of a research
  proposal can be reconciled with the welfare of
  research participants, and with broader ethical
  implications.
• (Governance arrangements for Research Ethics
  Committees 6.1)

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"No man is an island, entire of itself everyman
is a piece of the continent, a part of themain.
If a clod be washed away by the sea,Europe is
the less, as well as if a promontorywere, as
well as if a manor of thy friend's orof thine
own were any man's death diminishesme, because
I am involved in mankind, and therefore never
send to know for whom the bells tolls it tolls
for thee."
John Donne (1572 - 1631)
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The Meeting

• VALIDITY
• Can the proposal be justified
• Is the research question important
• Is the design of the study capable of answering
  the question.and with what confidence (power,
  quantitative studies)
• An invalid study at best wastes resources, at
  worst places subjects at risk
• (Professor John Sanders, Cambridge 2005)

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Committee meeting

• WELFARE
• Will the subject be protected
• Minimal risk
• Consent

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Time Frame for an Application
Completion of COREC form supporting
documentation
Dependant on researcher
Application meeting deadline
2 weeks
Committee meeting
Approximately 1 week
Rejected
Decision letter issued
Full approval
Provisional opinion, request for further
information
Dependant on researcher
Further information received
Approximately 1 to 2 weeks
Can go round further Information Loop 1, 2 or 3
times
Information reviewed by office/ committee chair
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Committee Meeting

• Three decisions can be awarded
• Approved
• Provisional opinion, request for further
  information
• Rejected

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Common Ethical Application Issues
cont

• Time to decide to participate in study
• - minimum of 24 hours, unless full explanation
• Accessing of patient records if not part of
  normal work
• - ensure appropriate permission sought
• Research on certain group of participants
• - ensure still alive before sending the
  invitation letter

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Caldicott Report (Dec 1997) and Executive Letter
(Jan 1999) Dame Fiona Caldicott was
commissioned by Chief Medical officer to review
uses made of patient identifiable data for non
clinical purposes .were these uses
justified? .were patients protected?
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• The Report
• Her report led to increased awareness of the need
  to control access
• to patient information
• Caldicott Guardians appointed
• Data protection officers appointed

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The Six Principles (compatible with data
protection Act, 2000) 1. Any use or transfer of
data should be scrutinised by guardian of
that data 2. Do not identify patients if not
necessary 3. Use minimum identifiable data 4.
Access to such data should be on a need to know
basis 5. All should be aware of their
responsibilities 6. All such activity should be
lawful
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• What about the creation of information?
• The existence of a database needs to be
  registered to comply
• with the law
• If the database concerns patient management ie
  the diabetic clinic
• list with recall information, then no permission
  from the patient is
• deemed necessary
• If the database concerns research, or if the
  clinical database is to be
• used for research, then patient consent must be
  sought

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Use of Data In general, records created for one
purpose should not be used for another purpose
without the patients consent
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• Who should seek the consent from the patient?
• The database manager (or responsible clinician)
• Not a researcher who does not know the patient

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A35/A36 - Indemnity And Compensation In The Event
Of Harm (Information From COREC Application)

• Indemnity is the provision by bodies sponsoring
  research that, in event of a claim by a patient,
  the arrangements are in place to make a payment
• Compensation is a mechanism for helping
  participants who may suffer as a consequence of
  taking part in research
• Compensation arising from Negligent harm is
  normally the responsibility of the employer of
  the local researcher. The employer must therefore
  be adequately insured or indemnified
• Non-negligent harm carries no legal liability.
  The possibility of compensation for non-negligent
  harm will depend on the policy of the sponsor.

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A35/A36 - Indemnity And Compensation In The Event
Of Harm (Information From COREC Application)For
NHS Employees

• It is never acceptable to state not applicable
• NHS indemnity applies to all research sponsored
  by NHS bodies and to research activities by NHS
  staff in research sponsored by others, provided
  management permission has been obtained ( R D
  approval)
• A35, negligent harm
• NHS indemnity applies
• A36, non-negligent harm
• No compensation arrangements are available under
  the NHS, however ex gratias payments would be
  considered

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A44- For How Long Will The Data Of The Study Be
Stored (Information From COREC Medical Research
Council, Ethics Series)

• Is the retention period subject to any policy or
  guidance from your employing organisation
• With the exception of Clinical trials there is no
  legislation on document retention period
• Medical Research Council (MRC) guidelines
  recommend
• 10 years for primary research data
• 20 years for records relating to clinical or
  public health studies

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A59- Has The Funder Of The Research Agreed To Act
As Sponsor As Set Out In The Research Governance
Framework?  (Information From COREC Application)

• The sponsor
• individual, company, institution or organisation,
  which takes on ultimate responsibility for the
  initiation, management and/or financing for that
  research.
• takes primary responsibility for ensuring the
  design of the study meets appropriate standards
• that arrangements are in place to ensure
  appropriate conduct and reporting

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Common Ethical Application Issues

• Participants confidentiality, anonymity in
  collected data
• Codes are preferred to names
• First approach to participants
• should be by someone known to them

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The Most Common Problems With Applications

• Lack of supporting documentation i.e.
  supervisor's CV, Participant Information Sheet,
  Questionnaires, indemnity arrangements
• Participant Information Sheets, Consent forms not
  in recommended COREC format
• No Age appropriate information of under 16s

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The Most Common Problems With Applications

cont

• Application not signed by all the appropriate
  people
• Application not locked
• Questions which require further information, no
  information given
• Not written in lay language

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• The Most Common Problems With Applications
• Not supplying further information, supporting
  documentation
• Participant anonymity
• Indemnity (A35, A36)
• Site Specific Exemption (A6)

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Application Decisions, April 2004 to March 2005
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To summarise

• Why have Ethics Committees
• To protect all actual and potential research
  participants
• The Ethics application process
• COREC on line application form
• Ethics Committees comment on validity of the
  research and welfare of participants
• Allow a minimum of 2 months

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The Ethics Office always there to help!
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God and doctor we adore on the brink of danger,
not before. The danger past, all is
requited God is forgotten, the doctor slighted
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And finally.. Let us not forget the researcher
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