Radiation Protection and Professional Ethics

1. Radiation Protection andProfessional Ethics Jim Thurston

2. 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

3. History of Medical Ethics & Development of International Framework

4. 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

5. 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

6. 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

7. 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

8. The Declaration of Geneva • Declaration by the General Assembly of the World Medical Association formulated and agreed in 1948 • Otherwise known as the Physician’s 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

9. Physician’s 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

10. 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

11. 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

12. Legal  Ethical • Just because something is legal doesn’t 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!

13. 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?

14. 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??

15. 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)

16. 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

17. 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

18. Question • How can we be sure that the benefits and risks as described in getting consent have been fully understood? • If we can’t be certain, is it ethical to continue with the practice?

19. 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?

20. Professional Ethics

21. 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

22. 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

23. 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

24. 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 employer’s 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.

25. 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

26. 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

27. 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?

28. 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

29. 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 • Shouldn’t our Duty of Care and any written Code of Professional Ethics extend to that requirement?

30. 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

31. 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 professional’s Duty of Care means that one cannot blindly follow the guidance!

32. 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 don’t agree with the choices we make?Democratic / Cultural Issues

33. Any Questions?