Radiation Protection and Professional Ethics

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Radiation Protection andProfessional Ethics

• Jim Thurston

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Contents of Talk

• History of Medical Ethics
• Hippocratic Oath
• Experiments Pre- and During WWII
• Nuremberg Code, Declarations of Geneva and
  Helsinki
• Professional Ethics
• Professional Bodies and Codes of Conduct
• Statutory (State) Registration
• Duty of Care vs Professional Guidance
• Summary and Conclusions

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History of Medical Ethics Development of
International Framework
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Hippocratic Oath

• Written in 5th century BC and attributed to
  Hippocrates
• Includes Covenants to Apollo (the God of
  Medicine and Knowledge), to medical teachers, to
  medical students, and to patients
• Includes clauses (amongst others) on appropriate
  means, on limiting means, confidentiality and
  accountability
• Was the basis of Medical Ethics (with further
  input from Christian, Jewish and Muslim thinkers)
  right through to the 20th Century and a modern
  version is still sworn by many medical school
  students

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The Nazis and Medical Research

• Nazi clinicians carried out a range of
  experiments on human subjects before and during
  WWII
• (Other experimentation was carried out by the
  Imperial Japanese Army in China)
• Details of these experiments came to light during
  the Nuremberg Trials
• Defence at Trial was that there was no legal
  framework for such research, so it was not
  illegal
• The Nuremburg Code was formulated as a first
  attempt to address this issue

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The Nuremberg Code

• Code had 10 main requirements (1-5)
• Voluntary consent is absolutely necessary
• Experiment must yield useful results not
  otherwise obtainable by other means
• Study protocol must be designed to achieve those
  useful results
• Should be conducted to avoid suffering / injury
• No experimentation allowed where there is the
  expectation that death or serious injury could
  result

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The Nuremberg Code

• Code has 10 main requirements (6-10)
• Degree of risk must be outweighed by expected
  benefit in terms of solving problem
• Good preparation and appropriate facilities must
  be available
• To be conducted by scientifically qualified
  persons
• Volunteers are free to withdraw at any time
• Experiment must be terminated if new information
  makes the research redundant, or leads to an
  increase in the expectations of death / injury

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The Declaration of Geneva

• Declaration by the General Assembly of the World
  Medical Association formulated and agreed in 1948
• Otherwise known as the Physicians Oath
• Resulted directly from the same issues raised at
  Nuremberg
• Intended as a version of the Hippocratic Oath for
  the modern era
• Has been revised a number of times since most
  notably 1968, 1983 and 1994

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Physicians Oath

• The Oath within the Declaration of Geneva
  reinforces the framework for modern Medical
  Ethics
• Includes the values of
• Informed Consent
• Beneficence / Non-Maleficence
• Autonomy / Informed Decision-Making
• Respect for Human Rights / Non-Discrimination
• Justice
• Confidentiality

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The Declaration of Helsinki

• Declaration by the General Assembly of the World
  Medical Association (1964)
• It extended Declaration of Geneva to cover
  research as well as diagnosis and therapy
• Also held essentially same principles as
  Nuremberg
• Recognised that all medical procedures
  (diagnostic, therapeutic or research) involve
  hazards and risks
• Drew distinction between research aimed at
  specific increase in knowledge, and more pure
  research
• Also has been revised several times

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Framework for Review of Medical Practice
including Research

• Scientific - Evidence-Based / Peer Reviewed
• Legal - Employer must consider legality
• Ethical - Independent Committee or
  Professional Body (?)
• Logistics - Employer must confirm resources
  available to ensure safe practice

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Legal ? Ethical

• Just because something is legal doesnt make it
  ethical
• Similarly, it may be ethical but it may not be
  legal
• Example in medical research
• You could get ethical approval to carry out
  research into the effects of cannabis by
  labelling it with a radioactive compound and
  administering it to patients/volunteers. But the
  supply of cannabis to participants in the study
  could still be illegal!

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Benefit, Effective Doses and Risk

• For proper Justification, there must be some way
  to quantify or evaluate the benefit and risk from
  a practice for comparison
• A figure for the total (collective) Effective
  Dose as a result of the practice can be used as
  the risk of collective detriment using published
  data (ICRP etc.)
• Therefore the benefit must outweigh the risk the
  risk itself must be within accepted limits and
  then it must also be optimised (minimised) whilst
  the benefit is retained (JOL)
• Does achieving JOL automatically mean the
  practice is considered ethical?

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Question

• Is it ethical to introduce a practice that is
  based on the premise that the total benefit to
  some people, or society as a whole, is more than
  the detriment to some (other) people?
• e.g. The NHS Breast Screening Programme
• This is an example of an accepted form of ethics
  - Utilitarian Ethics
• Does that make it right??

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Conveying Information for Informed Consent

• Ultimately we must convey information on the
  benefits and risks of a practice to those
  affected by it to get fully informed consent
• However we must not tell staff, patients or the
  public
• What is not understood
• What cannot be remembered
• What is not believable
• What is not relevant. (Prof. Jim Malone)

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Disclosure on Data

• A Legal View
• Consent in writing requires that the data
  (evidence) supporting the statement of benefit
  and risk is also provided in writing for consent
  to be considered watertight in Law
• However, the best way then in Law to disclose the
  data is not to give the data itself, but to state
  the fact that it exists and that it is available
  for perusal

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Risk Comparison

• We may use a number of comparisons for describing
  radiation risks
• None on its own can be expected to fully convey
  the risk
• Examples
• Background radiation (e.g. BERT)
• Other everyday activities
• Other occupational risks where appropriate
• Other clinical risks where appropriate
• Natural occurrence (rate) of cancer

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Question

• How can we be sure that the benefits and risks as
  described in getting consent have been fully
  understood?
• If we cant be certain, is it ethical to continue
  with the practice?

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Question

• Is it ethical to introduce a practice involving
  radiation exposure, or indeed to change a
  practice, before it has been optimised?
• Do you need ethical review and approval before
  starting experimentation to arrive at an
  optimised practice?

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Professional Ethics
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Professional Ethics

• Introduction - A Definition
• Professional Body Membership Codes of Conduct /
  Ethics
• SRP IRPA IPEM etc
• Statutory Registration e.g. HPC
• Code, Fitness to Practice and Disciplinary
  Hearings
• CRadP
• Duty of Care
• Duty of Care vs. Professional Body Guidance

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Professional Ethics - Definition

• Professional Ethics can be applied to personal or
  organisational standards of practice
• Recognising the knowledge and skills of certain
  trained individual, it states that they are able
  to make judgements/choices/decisions that the
  public cannot make
• Therefore there must be core values such as
  honesty, integrity and objectivity set down to
  ensure confidence in the validity in those
  decisions

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Professional Body Code of Ethics

• Professional Bodies set down Rules (a Code) of
  Conduct for Members to adhere to, based on the
  idea of Professional Ethics and including aspects
  on competency, knowledge, CPD and fitness to
  practice.
• It should also be recognised that such Codes are
  set down not least so that the Body itself may
  not be brought into disrepute because of the
  actions of a Member.
• Failure to observe the Code can be referred to
  the Professional Body for possible sanctions

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SRP IRPA Codes

• It is obvious from reading the SRP Code (latest
  version 2011) and the IRPA Code (2004) that they
  cover essentially the same matters
• Examples of clauses in the Code for both SRP and
  IRPA are
• Members shall exercise their professional skill
  and judgement to the best of their ability and
  carry out their responsibilities with integrity.
• Members shall not allow conflict of interest,
  management pressures or possible self-interest to
  compromise their professional judgement and
  advice. In particular members shall not
  compromise public welfare and safety in favour of
  an employers interest.
• Members shall not undertake any employment or
  consultation that is contrary to the public
  welfare or to the law.
• Members shall protect the confidentiality of
  information obtained during the course of their
  professional duties, provided that such
  protection is not in itself unethical or illegal.

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Chartered Status

• CRadP Denotes competence, a high level of
  professionalism, and commitment to keep pace with
  developments in the field of RP
• Must already be a Corporate Member (MSRP or FSRP)
  or International Member adhering to SRP Code of
  Conduct
• i.e. also requires demonstration of CPD
• Not as yet a legal requirement for Employers to
  consult with a RP Professional holding CRadP

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Statutory Registration - HPC

• Code of Standards, Performance and Ethics
• A total of 14 clauses including, for example
• You must act in the best interests of service
  users.
• You must respect the confidentiality of service
  users.
• You must keep high standards of personal conduct.
• You must provide (to HPC and any other relevant
  regulators) any important information about your
  conduct and competence.
• You must keep your professional knowledge and
  skills up to date.
• You must act within the limits of your knowledge,
  skills and experience and, if necessary, refer
  the matter to another practitioner.
• If concerns are raised, and are substantiated
  through a disciplinary hearing process, it can
  lead to being struck off Register

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Question

• Is it acceptable to follow a practice because it
  is to a protocol agreed in guidance published by
  your professional body, even if you know that
  there is a better alternative?
• Would that be a defence in Law?

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Duty of Care Legal View

• If you know from your experience that what your
  professional body recommends is not the best
  practice, then you must NOT adopt it
• i.e. Professional Bodies do NOT determine
  acceptable standards of practice only guide
  such standards
• Neglect of Duty of Care by repetition of
  non-optimised practice following such
  professional body guidance does not cease to be a
  Neglect of Duty

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Duty of Care A Personal View

• RP implementation should be evidence-based to
  guarantee best practices adopted (as set out in
  Codes)
• However, it appears to me that not one of the
  Codes includes an explicit requirement for the
  Member/Registrant to inform their Professional
  Body of weaknesses in the current
  guidance/standards published by that Body, nor to
  act on their own better information
• Shouldnt our Duty of Care and any written Code
  of Professional Ethics extend to that requirement?

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Summary and Conclusions (1)

• A framework for ethical review of medical
  practices, including those involving radiation
  exposure has developed since WWII
• A wider review of practices will include the
  scientific, legal and logistical basis for those
  practices going ahead
• It will also, of course, have to conclude that
  the practice is justified, optimised and all
  subsequent resultant doses within appropriate
  limits

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Summary and Conclusions (2)

• Professional Bodies set down codes of behaviour
  for Members
• Statutory Registration also sets out a Code of
  Conduct for Registrants and sanctions if the Code
  is not met
• Professional Bodies can provide guidance to best
  practice, however.
• A RP professionals Duty of Care means that one
  cannot blindly follow the guidance!

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Some Final Reflections

• There are ethical challenges in applying a System
  of Radiation Protection.
• Do we have all the information to make the right
  choices? What about the uncertainties?
  Precaution / Prudence
• Are we trusted to make the right decisions?
• Do we make choices because of, or in spite of
  public mis-conceptions? Paternalistic choices? Or
  in public service?
• How much influence should social, economic and
  political factors have? Is it our choice or
  forced on us?
• What do we do about the views of those who dont
  agree with the choices we make? Democratic /
  Cultural Issues

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Any Questions?