Ethical / Social Dimensions Imaging Asymptomatic People for IHA

Professor Jim Malone

Trinity College, Dublin

jfmalone@tcd.ie

Layout

• Ethics: ICRP and Medical

Judgment in ICRP 103, 36 (B,17; M,0)

• Social/Legal Considerations

• Scenarios: Individuals/Patients

• Reflection and Conclusions re IHA in Future

• Dose Issues

Ethics: ICRP and Medical Systems

• ICRP purpose built; Ethics Implied, not explicit.

• Detached from scholarship. Low recognition.

• Medical Ethics: scholarship; but ignores radiological.

• RP, separate; advantages; but isolating.

• IRPA and ICRP consultations

• Who Cares? EC, HERCA, IAEA, WHO, ILO, IRPA, NEA, ICRP et al. Many Don’t.

• Dose Issues

Ethics: Effective RP Value Themes for Medicine Core

Themes/Values

Dignity and Autonomy

Non-

Maleficence including

Beneficence

Justice, access, etc.

Additional

Themes

Prudential/ Precautionary

Openness, Transparency

etc IHA/HTA

Screening Utilitarian

Beauchamps and Childress 7th edition since1979 The values are a set.

Zolzer, Malone et al, Lochard, Oughton

Values, Emphasis and Reflection • Dignity and Autonomy

• Individual is the key player, information and consent

• Nuanced application a must

Precautionary Ple

•Rooted in a “common morality” --

“not relative to cultures or

individuals,-- it transcends both”

– Earth Summit, Rio 1992

– EC 2000

– World Com on Ethics of

Scientific Knowledge and Tech

2005

•“Potential for irrreversible harm –

lack of full scientific knowledge shall

not ---”

•Must be applied with conviction and

vigour

Social/Market Impact

• Un regulated Market in IHA will be obstacle to appropriateness.

• Strong regulation essential (IAEA)

• Market is international (HERCA Survey), hence --

• EC and non Medical Exposures

• HTA lacks ethical basis and hence not a reliable basis for appropriateness.

Scenarios 4: IHA/Self Referral

• Dr B, Interventional Cardiologist. Private rooms with imaging facility.

• Explains the radiation (and other) hazards of procedures.

• Explains radiation risk is unproven.

• IHA and unreferred worried well

• Procedure on request w consent

• Fee for consultation + for imaging.

• Dr B is shareholder in facility.

Auton--

Benef-- Justice Precaut-

OTA HTA

Y - - - Y

N N N N N N

Conclusions

• Well developed sensitive ethics systems available.

• >Alert to contemporary social and legal issues than ICRP.

• IHA prohibition problematic under dignity/autonomy

• Isolation/sidelining of IHA?

• Underregulation of market will undermine IHA controls

• EC definition of NON medical exposures, an opportunity.

• Dignity and Autonomy, missing in RP and Radiology.

• Combine with Justice, Precautionary Ple, and non maleficance all important.

Levels of Governance and Risk

Level Type of

structure/supporting

guidelines & policies

Responsibility and/or

implementation

1. No structures Activity distributed. No

guidelines

Dependent on (limited?) peer

pressures to identify issues

2. Individual institutions Guidelines adopted locally Either ad hoc or standing

committee

3. Agency/Professional

Body

Policy/guidelines from

professions or other agency

Regional or national agency,

and/or professional body

4. Local with national

oversight

Policy/guidelines agreed

nationally.

National Body oversight but

local implementation

5. National National legislation/charter National Office or Standing

Committees

Le

ve

l o

f ri

sk

Low

High

Precautionary Ple: Risks and Evidence

The ICRP position seems incompatible with the Precautionary Principle.

ICRP supports LNT model for risk extrapolation

– Yet “… calculation of the number of cancer deaths based on collective effective doses from trivial individual doses should be avoided.“ This is justified by saying that such calculations would be “biologically and statistically very uncertain” (ICRP)

Scenarios 2: Orthopoedic Clicic

• Orthopoedic surgeon Mr A, public clinic in hospital Y, weekly. New, follow up. Injuries and elective.

• He insists every patient attends be sent to radiology by the nurse, and will not see a patient without a film folder from radiology.

• Similar for insistence on pre op Chest

• Tallaght Incident/ Pre Op chest

Auton--

Benef-- Justice Precaut- OTA HTA --

- (y) (y) - - -

N N N N N N

SCENARIOS 1: Doctor’s Knowledge

• Many radiologists; eg:

• 50% of Physicians in 2 UK teaching centres

• 20 – 45% of radiologists inappropriate

• Specialties even higher, eg low back pain investigations, and cardiac cath.

Chest X-Rays

% Cardiolog

0.5 9

1 13

3 49

500 29

Auton--

Benef--

Justice Precaut-

OTA HTA UTIL---

- (Y) - - -

N N N N N

• Department policy : ask patients at reception if they are pregnant.

• Does not check or follow a “10day” type rule as these are “time consuming/inconvenient”.

• Patient has elective pelvic CT and turns out to be 10 weeks pregnant.

• She is ++ distressed and considers seeking a termination.

• ICRP: exposure of foetus during examination of the mother is regarded as a medical exposure.

Scenarios 3: Pregnant Patient

Auto--

Benef--

Justice Precaut- OTA HTA UTIL---

(y) (Y) - - - ?

N N N N N N