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Sébastien 16:16, 27 July 2010 (UTC)

Legal and Ethical Issues

Introduction

Carrying out an FOT give rise to a considerable number of legal and ethical issues. It is not possible to provide a comprehensive guide to all the legal issues that can arise in a particular FOT, as these may be very dependent on the system(s) to be tested and on the study design adopted. It is therefore necessary that the project obtain legal advice at an early stage. It should be noted that the regulations and laws vary from country to country and that even where there are European laws and regulations the interpretation of these may vary between countries. Thus projects carrying out FOTs in more than one country or carrying out FOTs that potentially involve cross-border traffic may need to consider the legal implications in all relevant countries. Another aspect is that projects fully consider health and safety aspects. It should be noted that not carrying out a prior risk assessment and therefore not giving proper consideration to the safety risks that may result from an FOT can expose an organisation to risks.

The differences in laws and regulations between the countries are not addressed here. As an example of what can arise on a national level, the view of one German lawyer with a high degree of knowledge in the area is included in Annex A for consideration and can not be considered in any event as a final opinion on the German Law.

In terms of the project timeline, legal and ethical issues need to be considered from the beginning to the end (and indeed afterwards in terms of data protection). So the discussion here does not neatly follow the FOT chain.

The FOT Implementation Plan, discussed in Chapter 2 and presented in table form in the Annex B , provides information about when in the FOT process the various legal and ethical issues need to be considered. The project plan needs to clearly identify who are the persons responsible for ensuring compliance.

It should be underlined that, in case of accident, identifying responsibilities is not a simple task, especially when the involved vehicle was modified with prototype and/or supplementary measuring systems.

Participant recruitment

In recruitment it is essential to ensure that participants have legal entitlement to drive the vehicles in question and are eligible for insurance. It may be wise to have insurance coverage for the fleet as a whole. If the participants are to drive their own vehicles or vehicles that belong to a fleet not under the control of the handling organisation, then insurance coverage needs to be confirmed. Coverage when travelling to other countries may be relevant.

In some countries, it may be a requirement for the participants to undergo a medical examination to prove their capability to take part. In any case, it would probably be sensible to ascertain if they have any medical conditions that might affect their ability to participate.

Participant agreement

There is a need to formalise the arrangement between the organisations responsible for the relationship with the participants and those participants themselves. The participants need to be informed in advance about the purpose of the FOT, the risks they may incur, the costs that are covered and not covered (and so have to be borne by them), whom to contact in case of breakdown, etc. It is not necessarily the case that the relationship with the participants will be set in the form of a legal contract; alternatively it may take the form of a letter of agreement. A lawyer can provide advice on this and should definitely be consulted. The agreement or contract may need to cover the potential liabilities and which party is responsible. One liability to consider is what happens in the event that a participant commits a traffic offence and/or incurs a traffic penalty (speeding ticket, parking ticket, etc.). Another liability is who is responsible for minor damage to the vehicle and payment of any insurance excess.

The issue of who is allowed to drive, e.g. other household members, and under what circumstances also needs to be considered. Only the participants will have been properly informed about their responsibilities. There is no way to ensure that any third parties are properly briefed.

Data protection and data ownership

Data protection is stipulated by an EU directive of 1995 and is enshrined within the national laws of the various member states. These national laws may state specific requirements. There is no doubt that an FOT will give rise to data protection and privacy issues. No disclosure of the data, in such a way as to give rise to identification of the persons involved, can normally take place without prior consent. This can cause problems, even when the participants have been informed of in-vehicle video recording. If that video is subsequently passed on to a third party and the participant can be recognised from that video, there may be a problem.

Video recording (and also audio recording) can give rise to other problems. Passengers will not normally have given prior consent to being recorded, so it is questionable whether it is appropriate to have in-vehicle cameras with coverage of the passenger seats. More details are provided in [ Annex A], if this cannot be avoided.

The data server must be protected from intrusion, and normally any personal ID information should be kept completely separate from the man database and stored with additional protection such as encryption. It has to be recognised that, even when data has been anonymised, it may be possible to deduce who has participated, e.g. from [ GIS] data in the database.

Data ownership and data sharing relates to stakeholder interests. Some stakeholders will regard data as strategic or sensitive. For example data can be used to compare systems, and this is usually not in the interest of the system producers or OEMs while on the contrary for policy-makers and road operators the effectiveness of specific systems is an objective that is relevant. To deal with these stakeholder interests, agreements on how to address these issues should be proposed as far as possible in advance. This can be done on two levels:

Agreements on how to deal with data ownership and re-use as such
Procedures on how to change or introduce new research issues based on the collected data
Address ownership of data in the tendering procedures or contracts with the (public) organisation providing the grant.

Data collected from the CAN bus represent a special case. Some of the data may reveal information that is confidential to the manufacturer, who may not want to share these data with third parties. Proper data filtering could be implemented in order to make available to the relevant partners only the data that are necessary to the FOT analysis.

Risk assessment

The project needs a comprehensive risk assessment plan and will need to be able to demonstrate subsequently that the identified hazards have been properly managed. Organisations will normally have a safety management process for this.

System safety

It is obviously incumbent on those conducting an FOT to ensure that the equipment that they have installed in a vehicle and the modifications that have been made to the vehicle systems do not give rise to any undue hazards. Hazards can arise from radio and electrical interference (where electro-magnetic compatibility tests should be conducted), from reducing vehicle crashworthiness (installations on the dashboard, interference with airbag deployment, and so on) and from [ HMI] designs that cause distraction. The potential for failures to arise from modifications to and interaction with in-vehicle [ systems][FW] needs to be handled by means of a formal [ system][FW] safety assessment.

Approval for on-road use

Vehicles are subject to Whole Vehicle Type Approval processes and to Construction and Use regulations. Before it is certain that it is legal to operate a modified vehicle on public roads, a check must be made with the appropriate authorities, who may be the national government or a designated approval agency. Once a vehicle is certified to be legal to operate in one European country, it can normally be driven legally in other countries.

Insurance

Insurance requirements extend beyond the insurance of the vehicles and possibly of the participants. There is also a need for indemnity insurance to cover the [ FOT][FW] as a whole. This may be provided by an employing organisation’s professional indemnity insurance, but it is vital to confirm that the large risks are covered.

Responsibilities

There are no very precise rules about responsibilities, but each contributor should be responsible of the component that he has realized or integrated. In the case that an accident occurs, damaging people and/or goods, as normally happens in any such event, an investigation is opened in order to establish:

The dynamics of the accident (this could be facilitated by the recorded data)
The cause (driver, third parties, vehicle fault, road equipment fault, road problems, missing signs, ..)
In the case of driver failure contributing to the accident, the experimental [ systems][FW] may have negatively influenced the driver and then these [ systems][FW] could be indirectly a cause.
In the case of vehicle fault a complex technical analysis should be made in order to identify the component originating the fault which may depend on design, poor manufacture or incorrect installation.

Video data collection

Video data collection within the vehicle has been covered in section 3.4. However, there are some additional points to consider. For example, there may be locations encountered where it is illegal or prohibited to video externally — border crossing, military locations, private premises. The possibility of this happening needs to be considered; it is likely to be more of a problem in truck [ FOT]s[FW].

External video may give rise to the same data protection issues as internal video. Many countries have regulations on the collection of outdoor video.

Ethical approval

Ethical approval to conduct an [ FOT][FW] may be even more difficult to obtain than legal approval. In many countries and in many organisations there are strict ethical approval and human subject review procedures. These procedures can be very time-consuming, so that time for the process needs to be considered in the project plan. Human rights legislation is also relevant, as is the Helsinki Declaration of 1964 and its subsequent revisions. This declaration enshrines the right of the individual to be informed and provide prior consent. The individual’s protection and rights supersede any interests of scientific progress.

Iteration

Considering ethical and legal issues may influence the outcomes of the different phases of the [ FOT][FW] chain. It may be necessary to re-think some phases and to abandon choices made earlier. For example, if it is not possible to collect certain data due to legal or ethical issues, it may no longer be possible to test certain [ hypotheses][FW] or to use certain [ performance indicators][FW].

Provider	Tool Name	Category	Purpose	Release Date
CTAG	Datalogger II	CAN Data acq.	---	---

Last Update	Operating System/Platform	GUI	Size	Price	Usage in FOT
---	---	---	32x108x80 mm	---	euroFOT, TeleFOT

Contact
David Sanchez

Specific Information

Hardware:

# of CAN channels	Memory	GPRS/GSM	GPS	USB
4	SDHC	yes	yes	---

WLAN	LAN	Interfaces	Casing	Input
no	no	4 x CAN, GPRS, GPS, USB, Serial Bus	Aluminium Box, Automotive Connector	9V - 18V, 18V - 30V

Other:

Other inputs	Other outputs	Consumption idle	Consumption on	Energy Save
no	no	30 mA	350 mA	yes

Filtering	Trigger	Diagnose	Audio
yes	yes	yes	no

User talk:S.mure

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