WO2006047832A1

WO2006047832A1 - Interactive consent system

Info

Publication number: WO2006047832A1
Application number: PCT/AU2005/001696
Authority: WO
Inventors: Stephen James Robson; Mohammed Khadra; Mitchell Read
Original assignee: Medical Consent Systems Pty Ltd
Priority date: 2004-11-05
Filing date: 2005-11-07
Publication date: 2006-05-11

Abstract

A computer based method is disclosed for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the method including (a) Providing an information database [24] containing event information relating to each event aspect, displayed to facilitate understanding of the event by the individual. (b) Displaying aspect information relating to each event aspect. [12] (c) Inquiring whether the individual has understood an event aspect or requires additional information. [13] (d) Displaying the additional information if needed. (e) Repeating (b) (c) & (d) for each event aspect [14] & [15] (f) Inquiring whether the individual has understood the whole event or requires additional information [16] (g) If the individual indicates that the event information is understood, displaying at least one question to test the • individuals understanding of the event. [18] . (h) If the individual gets the questions correct, inquiring whether the individual consents to the occurrence of each aspect of the event. [23]

Description

"INTERACTIVE CONSENT SYSTEM"

Technical field

This invention relates to an interactive consent system. The invention has particular but not exclusive application to a computer based interactive consent system by means of which an individual consents to the occurrence of an event, the consent being given in a manner which indicates that the individual has sufficient understanding of the event and of the various aspects of the event for the consent to be characterised as an informed consent.

As used herein the expression "event" is to be given a broad meaning and refers to any procedure, occurrence, happening or the like which impacts, concerns, affects, or in like manner, has a bearing on the individual, or has the potential to do so. A medical intervention by a medical practitioner on a patient, such as a treatment, an examination, investigation, operation, or other procedure is one example of an event. A particular investment strategy to be pursued by an investor on the advice of a financial adviser is another example of an event. As used herein the expressions "event aspect" and "aspects of the event" are to be given a broad meaning and refer not only to the nature of the event per se, but also to any other aspects such as, by way of illustrative and non-exhaustive example, types of alternative events which may be possible, and the risks, adverse consequences, side effects, complications and the like associated with the event.

As used herein the expression "consent" is to be given a broad meaning and refers to any indication that the individual agrees that the event should proceed or occur. A patient giving consent to an operation or other medical procedure is one example of a consent.

As used herein the expression "informed consenf is to be given a broad meaning and refers to consent given by an individual who is competent to make a decision, after having been given the information they require in the circumstances, and having considered and understood this information. It will therefore be appreciated that the invention has particular but not exclusive application to a computer based interactive consent system whereby a patient consents to a medical intervention in a manner which establishes that the consent is informed consent, and for practical purposes reference will be made throughout this specification to such application. However it will be readily apparent that the invention is applicable in fields other than medicine. Non-limiting examples of other applications where the invention can be utilised include professional disciplines such as engineering, law, architecture, dentistry, accountancy etc.

Background of Invention

It is well known that medical practitioners, ie doctors, surgeons etc require consent before commencing medical interventions. Obtaining such "legal" consent recognises patient rights but can also be effective in countering a charge of assault. Furthermore, as part of the medical practitioner's overall duty to exercise reasonable care and skill, there is a duty to disclose information to patients. To do this in a manner which shows that this has been done correctly can assist in establishing that the patient's consent was informed. This in turn can assist in defending any claims of medical negligence which may arise.

Known methods of discharging this duty of disclosing information in a manner such that a patient is sufficiently informed to be in a position to give informed consent to a proposed intervention, include extensive and often repeated consultations between the patient and the medical practitioner or a delegate, and the provision of information sheets, booklets, etc.

Summary of Invention The present invention aims to provide an alternative to known methods and systems for an individual to give informed consent to the occurrence of an event. This invention in one aspect resides broadly in a computer based method for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the method including:-

(a) providing a computer based information database for access by the individual, the information database containing event information relating to the event, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual;

(b) displaying aspect information relating to an event aspect;

(c) generating an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(d) if the individual indicates that additional aspect information is required, displaying the additional aspect information relating to the event aspect;

(e) repeating steps (b), (c), and (d) in relation to another event aspect;

(f) generating an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects;

(g) if the individual indicates that the event and the event aspects are understood, displaying at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and (h) generating an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (h) is generated only if the individual answers the at least one question in step (g) correctly.

It is preferred that the computer based method includes maintaining a record of the information displayed, the enquiries generated, and the indications and answers given by the individual in respect of the event and all event aspects; the record constituting evidence of informed consent by the individual to occurrence of the event.

It is preferred that an enquiry in accordance with step (f) is generated only if steps (b), (c), and (d) have been carried out in relation to all event aspects.

It is also preferred that the computer based method includes:-

(i) generating an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect; wherein step (e) is performed only if the individual indicated that the event aspect is understood. It is also preferred that the computer based method includes:-

(i) generating an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect, and (j) if the individual indicates that the specified event aspect is understood, displaying at least one question for answering by the individual to test the individual's understanding of the event aspect; wherein step (e) is performed only if the individual answers the at least one question in step (j) correctly.

It is also preferred that the computer based method includes:- (k) generating an enquiry whether the individual understands the nature of the event, and

(I) if the individual indicates that they understand the nature of the event, displaying the aspect information relating to an event aspect.

It is also preferred that the computer based method includes:-

(m) displaying information relating to risk levels; (n) generating an enquiry requiring the individual to indicate the level of risk to which the individual requires event information, wherein the aspect information displayed is that identified with the risk level indicated by the individual, and

(h) generating an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual. In one preferred embodiment access to the computer based information database is provided to the individual by a website. Alternatively, access to the computer based information database can be provided to the individual by a CD-ROM.

In another aspect this invention resides broadly in a computer based system for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the system including:- a computerised database containing event information relating to the event, the event information . including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual, and program means for controlling the operation of the system, the program means being operable to:-

(a) display aspect information relating to an event aspect; (b) generate an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(c) if the individual indicates that additional aspect information is required, display the additional aspect information relating to the event aspect;

(d) repeat steps (a), (b), and (c) in relation to another event aspect; (e) generate an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects;

(f) if the individual indicates that the event and the event aspects are understood, display at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and

(g) generate an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (g) is generated only if the individual answers the at least one question in step (f) correctly. It is preferred that the program means is operable to maintain a record of the information displayed, the enquiries generated, and the indications and answers given by the individual in respect of the event and all event aspects; the record constituting evidence of informed consent by the individual to occurrence of the event.

It is also preferred that the program means is operable such that an enquiry in accordance with step (e) is generated only if steps (a), (b), and (c) have been carried out in relation to all event aspects.

It is also preferred that the program means is operable to:-

(h) generate an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect; step (d) being performed only if the individual indicates that the event aspect is understood. It is also preferred that the program means is operable to:-

(h) generate an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect, and

(i) if the individual indicates that the specified event aspect is understood, display at least one question for answering by the individual to test the individual's understanding of the event aspect; step (d) being performed only if the individual answers the at least one question in step (i) correctly.

It is also preferred that the program means is operable to:-

(j) generate an enquiry whether the individual understands the nature of the event, and

(k) if the individual indicates that they understand the nature of the event, display the aspect information relating to an event aspect. It is also preferred that the computerised database contains information relating to risk levels, the event information being identified with the different levels of risk to an individual which are associated with the event; and that the program means is operable to:-

(I) display the information relating to risk levels;

(m) generate an enquiry requiring the individual to indicate the level of risk to which the individual requires event information, and

(o) generate an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual.

In a further aspect this invention resides broadly in a computer based method for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the method including:-

(a) providing a computer based information database for access by the individual, the information database containing event information relating to the event and information relating to risk levels, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual, the event information being identified with the different levels of risk to an individual which are associated with the event;

(b) displaying the information relating to risk levels;

(c) generating an enquiry requiring the individual to indicate the level of risk to which the individual requires event information;

(d) displaying aspect information relating to an event aspect, the aspect information displayed being that identified with the risk level indicated by the individual; (e) generating an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(f) if the individual indicates that additional aspect information is required, displaying the additional aspect information relating to the event aspect; (g) repeating steps (d), (e), and (f) in relation to another event aspect;

(h) generating an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual;

(i) generating an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects;

(j) if the individual indicates that the event and the event aspects are understood, displaying at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and

(k) generating an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (k) is generated only if the individual answers the at least one question in step (j) correctly.

It will be appreciated that the operational steps listed in the various embodiments of the invention are not necessarily listed sequentially, and that the alphabetic references to the steps are made for ease of reference and do not necessarily indicate the sequence in which the steps are performed. Thus by way of non-limiting example, step (h) in the embodiment listed immediately above could be carried out after any of steps (d), (f), (i) or (J)- Alternatively, in the embodiment in which a question(s) is asked of the individual immediately after information regarding each event aspect is displayed rather than after information regarding all event aspects has been displayed, step (h) can be carried out before or after that question(s).

In another aspect the invention resides broadly in a computer based system for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the system including:- a computerised database containing event information relating to the event and information relating to risk levels, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual, the event information being identified with the different levels of risk to an individual which are associated with the event; and program means for controlling the operation of the system, the program means being operable to:-

(a) display the information relating to risk levels;

(b) generate an enquiry requiring the individual to indicate the level of risk to which the individual requires event information;

(c) display aspect information relating to an event aspect, the aspect information displayed being that identified with the risk level indicated by the individual;

(d) generate an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(e) if the individual indicates that additional aspect information is required, display the additional aspect information relating to the event aspect; (f) repeat steps (c), (d), and (e) in relation to another event aspect; (g) generate an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual;

(h) generate an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects;

(i) if the individual indicates that the event and the event aspects are understood, display at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and

Q) generate an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (j) is generated only if the individual answers the at least one question in step (i) correctly.

Description of Drawings

In order that this invention may be more easily understood and put into practical effect, reference will now be made to the accompanying drawings which illustrate a preferred embodiment of the invention, wherein:- FIG 1 is a schematic flow chart diagram illustrating one embodiment of the present invention; FIGS 2A to 2G are illustrations of screens seen by a patient in accordance with the invention during the process of giving informed consent to a medical practitioner to conduct a medical intervention;

FIGS 3A to 3C are illustrations of the screens seen by the medical practitioner in relation to the medical interventions scheduled for selected patients and indicating whether informed consent has been given by the patients;

FIG 4 is a schematic flow chart diagram of another embodiment of the present invention which includes an individual risk level selector, and

FIG 5 is a diagrammatic representation of a screen presented to an individual for risk level selection by the individual.

Description of Preferred Embodiment of Invention

By way of explanation, the method and system of the present invention will be described by reference to the following preferred embodiment of the invention as applied to a medical practitioner obtaining informed consent from a patient to conduct a medical intervention.

If a patient consults a doctor with a medical problem and the doctor decides that the patient should be offered an intervention, the doctor requests that the patient consult the medical consent system of the invention (hereafter referred to as MCS). This may be done either on a website, or by access to CD-ROM.

After entry of a password provided to the patient by the doctor or his/her agent, the patient enters the MCS software system. The system describes the intervention recommended by the doctor and asks if the patient agrees that this is the intervention discussed by the doctor.

If the patient indicates yes, MCS presents a description of the nature of the intervention, possibly with diagrams. The patient is then asked if he/she understands the nature of the intervention. If the answer is yes, MCS presents a list of the potential complications and adverse outcomes of the intervention(s). The patient may 'click' on the complication and is then presented with more detailed information, possibly with diagrams. A condition of moving further through the session at the end of each presentation of information, is that the patient indicates that they understand the information just presented.

At the completion of the session with MCS, the patient is presented with a test of comprehension. The patient is asked a series of yes/no questions about the common but minor, rare but serious, and material risks of the procedure. If the answer to any question is incorrect, the patient is directed back to the relevant information for the procedure. Only when all questions have been answered correctly is the patient allowed to complete the interaction.

The system permits the process to be undertaken and completed over time, and the Patient may revisit it as often as they wish or as is required. Details of the interaction of patient with MCS, including the amount of time spent at each stage, are electronically logged and form a record. This record is sent electronically to the doctor. At the completion of this process, the patient sees the doctor again and signs a 'gold standard' consent form which the Doctor keeps as an indication that the patient has given informed consent.

If the process is not completed within a set time before the date of the proposed intervention, the doctor is notified. If the patient has questions, they can be recorded within the MCS program and forwarded to the doctor.

The computer database to be accessed by the patient contains information relating to the intervention, the information including information relating to several aspects of the intervention such as the nature of the intervention, complications, risks, side effects, alternative procedures etc, all of which is arranged such that its display facilitates understanding of the event by the patient.

The method is controlled by the system software to display information relating to one aspect of the intervention. An enquiry is then generated whether the patient requires additional information relating to that aspect of the intervention, or whether the patient understands that aspect. If the patient indicates that additional information regarding that aspect is required, this is displayed. The above steps are then repeated in relation to another aspect of the intervention.

An enquiry is generated whether the patient requires additional information relating to the intervention or relating to any aspect of the intervention, or whether the patient understands the intervention and all its aspects. If the patient indicates that the intervention and all its aspects are understood, at least one question is displayed for answering by the patient to test the patient's understanding of the intervention and its various aspects. If the patient correctly answers this question, or several questions as will more likely be the case in practice, an enquiry is generated whether the patient consents to the intervention proceeding.

Other various steps can occur in preferred embodiments of this method of the present invention as follows.

A record may be maintained of the information displayed, the enquiries generated, and the indications and answers given by the patient in respect of the intervention and all its aspects; the record constituting evidence of informed consent by the patient to occurrence of the intervention.

The enquiry as to whether the patient requires additional information relating to the intervention or relating to any aspect of the intervention, is generated only if the steps of displaying of information, enquiring as to whether the patient requires additional information or understands the aspect, and displaying additional information if required, have been completed for all aspects of the intervention. An enquiry may be generated whether the patient requires additional information relating to a particular aspect of the intervention or whether the individual understands that aspect. The steps of displaying of information, enquiring as to whether the patient requires additional information or understands the aspect, and displaying additional information if required, are proceeded with regarding other aspects of the intervention only if the patient indicates that the particular aspect is understood.

An enquiry may also be generated whether the patient requires additional information relating to a particular aspect of the intervention or whether the individual understands that aspect, and if the patient indicates that the particular aspect is understood at least one question for answering by the individual is displayed to test the individual's understanding of that particular aspect. The steps of displaying of information, enquiring as to whether the patient requires additional information or understands the aspect, and displaying additional information if required, are proceeded with regarding other aspects of the intervention only if the patient answers that question correctly.

An enquiry may also be generated whether the patient understands the nature of the intervention. Information of a particular aspect of the intervention is displayed if the patient indicates that they do understand the nature of the intervention.

Turning now to FIGS 2A to 2G which illustrate representative screens seen by a patient during the process of giving informed consent to a medical practitioner to conduct a medical intervention, in this case two procedures - a lobotomy and liposuction. It will be appreciated that the screens are intended to be no more than indicative to illustrate the system of the present invention, and do not correspond with actual information. The patient logs in on the screen seen in FIG 2A by entering the Doctor's ID number and the password given to the patient by the doctor. The FIG 2B screen appears informing the patient what procedures are scheduled and the status of the the patients consent in relation to each. In the case of the lobotomy the patient has already indicated that the details and potential complications of the operation have been understood and the patient can indicate that they are ready to proceed or review previous information by the CLICK HERE function. This provides the FIG 2C screen which allows the patient either to CLICK to confirm a go-ahead, or to seek further details regarding the operation or the possible complications. Detail of the screens for the operation and the complications are shown in FIGS 2D to 2F.

Regarding the liposuction procedure, the screen of FIG 2G shows details of a possible complication of stomach cramps, and asks questions regarding this complication. Correct answer to the questions permits progressing to view information regarding further possible complications.

As seen in FIGS 3A to 3C, a doctor may also log into the system on the FIG 3A screen by using his ID number and password. This allows the doctor to view upcoming operations or other procedures within a given date range , shows the procedures for a specified patient, and as seen in FIG 3B, indicates the status of the consent procedure. Patient details are available in the FIG 3C screen as shown. Turning now to the flow chart shown in FIG 1, and using general terminology corresponding to the more specific terminology in relation to a medico/patient interaction (thus an operation corresponds to an "evenf and a complication to an "aspect" of that event), it can be seen that upon commencement (11) of the interactive procedure for allowing a person to provide informed consent to an event occurring, information regarding a first aspect of the event is displayed (12). The information is provided from computer database 24. The user is then asked whether further information regarding this aspect is required (13). If YES, the system returns to stage (12). If NO, the system displays information regarding a second aspect of the event (14). The information is provided from computer database 24. The user is then asked whether further information regarding this aspect is required (15). If YES, the system returns to stage (14). If NO, the system displays information regarding any further aspects of the event and this procedure continues until all aspects of the event have been covered - as indicated by the dotted outline in the connecting lines.

Once there are no further aspects of the event regarding which the user requires further information, the question is asked whether all aspects of the event are understood (16). If NO, the user is asked which aspects require further explanation (17), and this is fed back to the appropriate stage (12), (14) etc. If YES, questions are displayed to test the user's understanding of the entire event (18). The questions are provided from computer database 24.

The system then checks whether the user has answered the questions correctly (19). If NO, the use is advised they have answered incorrectly (20), and the system recommences (11 ). If YES, the system then asks the user whether they give consent to the event occurring (21 ).

If the user does not give consent, the user is advised that they have not consented (22) and the system recommences (11 ). If the user gives consent, a consent form for the event is generated for signature by the user (23).

It will thus be seen that the computer based method of the invention allows an individual to provide informed consent to the occurrence of an event having a plurality of event aspects. A computer based information database 24 is provided for access by the individual, the information database containing event information relating to the event, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual. Aspect information relating to an event aspect is displayed (12) and an enquiry is generated whether the individual requires additional aspect information relating to the event aspect or whether the individual understands the event aspect (13). If the individual indicates that additional aspect information is required, the additional aspect information relating to the event aspect is displayed (Y loop to 12). These steps are repeated in relation to the other event aspects (14), (15) and (Y loop to 14). An enquiry is then generated whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect or whether the individual understands the event and the event aspects (16). If the individual indicates that the event and the event aspects are understood, at least one question is generated for answering by the individual to test the individual's understanding of the event and the event aspects (18). An enquiry is generated whether the individual consents to the occurrence of the event (21) only if the individual answers correctly the at least one question in stage (18).

Reference is now made to FIGS 4 and 5 which illustrate an alternative embodiment to that described above in which a user is first advised in general terms in relation to various risk levels and then asked to indicate to which of these risk levels he/she wishes to receive advice regarding the risks associated with the event. Turning first to FIG 5 which is a diagrammatic representation of a screen presented to the user, the arrow can be moved by the user to indicate the level of risk he/she wishes to be informed about. The arrow can typically be moved by a click and drag action on the computer. As the arrow passes the boxes on the right of FIG 5, a box is illuminated. Each box indicates a numerical probability or statistical risk level, and in a manner not illustrated, each box contains a descriptor giving a practical everyday indication of a situation which has the same statistical probability of occurring, or is the same mathematically, as the risk level for that box. Thus for the box with the probability 1 in 10,000,000 the notation could read 'This is the same as about 3 seconds in a year. It is the risk you have of dying on a passenger jet flight' . For the box with the probability 1 in 100 the notation could read 'This is the same as about half a week in a year. It is the risk you have of catching a cold this winter". Turning now to FIG 4, it can be seen that at a relatively early stage in the process the patient has information displayed regarding risk levels (25). A risk level indicator, such as that described above with reference to FIG 5, is displayed, and the user is required to indicate the level of risk associated with the operation or procedure for which information is required (26). The information, for example regarding complications associated with a medical procedure, is stored in database 24 with identifiers relating to the level of risk - ie how likely it is that a given complication will occur. When information is provided to the patient (12), the information provided is that associated with complications to the level of risk indicated by the patient.

Prior to completion of the information session, and before the user is asked whether they consent to the event occurring, the user is reminded of the level of risk they have previously selected and for which they have received information, they are again shown the various levels of risk, and they are asked (27) whether they are satisfied with that level or whether they wish to receive further information relating to a higher level of risk. If NO, questions are displayed to test the user's understanding of the entire event (18). If YES, the system returns to stage (12).

As has been indicated previously, this re-checking of the user's satisfaction with the risk level previously selected can occur at different times throughout the procedure before the user is asked whether consent is given to the event occurring, and not only before asking the question(s) to test the user's understanding of the entire event.

It will be appreciated that the system and method of the present invention has a number of advantages over known systems and methods for an individual to give informed consent to the occurrence of an event. With reference to a medical consent system, these advantages include the following.

• Specific testing is provided of the patient's comprehension of the information presented. • The consent process cannot proceed without the patient verifying that they have read and understood the content of any given section.

• The patient is able to receive information in as much depth as required to meet the individual needs of each patient.

• An electronic log of the interaction between the patient and the system is preserved to allow subsequent verification of the interaction in the event of legal proceedings.

• There are significant time savings for the doctor and staff.

• There is significant increase in the convenience and time available for patient to be completely satisfied that they are informed to their satisfaction in advance of any intervention.

• An individualised, gold standard consent document is generated. • The system database can be updated to provide the latest and most accurate information about the full range of interventions.

It will of course be realised that whilst the above has been given by way of an illustrative example of this invention, all such and other modifications and variations hereto, as would be apparent to persons skilled in the art, are deemed to fall within the broad scope and ambit of this invention as is herein set forth.

Claims

The claims defining the invention are as follows:-

1. A computer based method for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the method including:- (a) providing a computer based information database for access by the individual, the information database containing event information relating to the event, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual;

(b) displaying aspect information relating to an event aspect; (c) generating an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(e) repeating steps (b), (c), and (d) in relation to another event aspect; (f) generating an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects;

(g) if the individual indicates that the event and the event aspects are understood, displaying at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and

(h) generating an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (h) is generated only if the individual answers the at least one question in step (g) correctly.

2. A computer based method as claimed in claim 1 , and including:- maintaining a record of the information displayed, the enquiries generated, and the indications and answers given by the individual in respect of the event and all event aspects; the record constituting evidence of informed consent by the individual to occurrence of the event.

3. A computer based method as claimed in claim 1, wherein an enquiry in accordance with step (f) is generated only if steps (b), (c), and (d) have been carried out in relation to all event aspects.

4. A computer based method as claimed in claim 1 , and including:-

(i) generating an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect; wherein step (e) is performed only if the individual indicated that the event aspect is understood.

5. A computer based method as claimed in claim 1 , and including:-

6. A computer based method as claimed in claim 1 , and including:-

(k) generating an enquiry whether the individual understands the nature of the event, and (I) if the individual indicates that they understand the nature of the event, displaying the aspect information relating to an event aspect.

7. A computer based method as claimed in claim 1 , and including:-

(m) displaying information relating to risk levels;

(n) generating an enquiry requiring the individual to indicate the level of risk to which the individual requires event information, wherein the aspect information displayed is that identified with the risk level indicated by the individual, and (o) generating an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual.

8. A computer based method as claimed in claim 1 , wherein access to the computer based information database is provided to the individual by a website.

9. A computer based method as claimed in claim 1 , wherein access to the computer based information database is provided to the individual by a CD-ROM.

10. A computer based system for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the system including:- a computerised database containing event information relating to the event, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual, and program means for controlling the operation of the system, the program means being operable to:- (a) display aspect information relating to an event aspect;

(b) generate an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(c) if the individual indicates that additional aspect information is required, display the additional aspect information relating to the event aspect; (d) repeat steps (a), (b), and (c) in relation to another event aspect;

(e) generate an enquiry whether the individual requires additional event information relating to the event and/or additional aspect information relating to an event aspect, or whether the individual understands the event and the event aspects; (f) if the individual indicates that the event and the event aspects are understood, display at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and

(g) generate an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (g) is generated only if the individual answers the at least one question in step (f) correctly.

11. A computer based system as claimed in claim 10, wherein the program means is operable to maintain a record of the information displayed, the enquiries generated, and the indications and answers given by the individual in respect of the event and all event aspects; the record constituting evidence of informed consent by the individual to occurrence of the event.

12. A computer based system as claimed in claim 10, wherein the program means is operable such that an enquiry in accordance with step (e) is generated only if steps (a), (b), and (c) have been carried out in relation to all event aspects.

13. A computer based system as claimed in claim 10, wherein the program means is operable to:-

(h) generate an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect; step (d) being performed only if the individual indicates that the event aspect is understood.

14. A computer based system as claimed in claim 10, wherein the program means is operable to:-

(h) generate an enquiry whether the individual requires additional aspect information relating to an event aspect, or whether the individual understands the event aspect, and (i) if the individual indicates that the specified event aspect is understood, display at least one question for answering by the individual to test the individual's understanding of the event aspect; step (d) being performed only if the individual answers the at least one question in step (i) correctly.

15. A computer based system as claimed in claim 10, wherein the program means is operable to:- G) generate an enquiry whether the individual understands the nature of the event, and

(k) if the individual indicates that they understand the nature of the event, display the aspect information relating to an event aspect.

16. A computer based system as claimed in claim 10, wherein the computerised database contains information relating to risk levels, the event information being identified with the different levels of risk to an individual which are associated with the event; and wherein the program means is operable to:-

(I) display the information relating to risk levels;

(m) generate an enquiry requiring the individual to indicate the level of risk to which the individual requires event information, and (n) generate an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual.

17. A computer based method for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the method including:-

(b) displaying the information relating to risk levels;

(c) generating an enquiry requiring the individual to indicate the level of risk to which the individual requires event information; (d) displaying aspect information relating to an event aspect, the aspect information displayed being that identified with the risk level indicated by the individual;

(e) generating an enquiry whether the individual requires additional aspect information relating to the event aspect, or whether the individual understands the event aspect;

(f) if the individual indicates that additional aspect information is required, displaying the additional aspect information relating to the event aspect;

(g) repeating steps (d), (e), and (f) in relation to another event aspect;

(j) if the individual indicates that the event and the event aspects are understood, displaying at least one question for answering by the individual to test the individual's understanding of the event and the event aspects, and (k) generating an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (k) is generated only if the individual answers the at least one question in step (j) correctly.

18. A computer based system for an individual to provide informed consent to the occurrence of an event having a plurality of event aspects, the system including:- a computerised database containing event information relating to the event and information relating to risk levels, the event information including aspect information relating to each of the event aspects and being arranged such that display of the event information facilitates understanding of the event by the individual, the event information being identified with the different levels of risk to an individual which are associated with the event; and program means for controlling the operation of the system, the program means being operable to:- (a) display the information relating to risk levels;

(e) if the individual indicates that additional aspect information is required, display the additional aspect information relating to the event aspect; (f ) repeat steps (c), (d), and (e) in relation to another event aspect;

(g) generate an enquiry whether the individual is satisfied with the risk level previously indicated or whether the individual requires further event information associated with a higher level of risk to the individual;

(j) generate an enquiry whether the individual consents to the occurrence of the event; wherein the enquiry in accordance with step (j) is generated only if the individual answers the at least one question in step (i) correctly.