FESTA handbook Legal and Ethical Issues
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- 1 3. Legal and Ethical Issues
- 1.1 3.1 Introduction
- 1.2 3.2 Participant recruitment
- 1.3 3.3 Participant agreement
- 1.4 3.4 Data protection and data ownership
- 1.5 3.5 Risk assessment
- 1.6 3.6 System safety
- 1.7 3.7 Approval for on-road use
- 1.8 3.8 Insurance
- 1.9 3.9 Responsibilities
- 1.10 3.10 Video data collection (specific issues)
- 1.11 3.11 Ethical approval
- 1.12 3.12 Iteration
3. Legal and Ethical Issues
Carrying out an FOTs usually means to ask participants to give insight in their mobility behaviour. Although participants may be given some form of (financial) compensation, or in the case of fleet drivers it may form part of their job, usually participants join in order to help advance road-safety, mobility and innovation. An FOTs project should therefore value their participants and treat their data and privacy with respect. Not only legal rules should be followed, but also ethical principles, defines as respect for the person[ality] and his or her autonomy, dignity and self-determination, should be a major guideline for conducting the FOTs. Risks for participants should be minimalised as much as possible. Next to care for participants, the rights of non-participants, affected by the FOT should be taken into account. These may, for example, be passengers in the participating vehicle or other road-users who are videoed. Human rights legilstaion 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 on a voluntary basis. The individual's protection and rights supersede any interests of scientific progress.
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 systems to be tested and on the study design adopted. 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 not only the participants, but also an organisation to risks.
Legally, when undertaking an FOT, it is very important to understand the need to seek legal advice at national level (i.e. in the respective Member State) taking the concrete test design into account. The first version of the FESTA - Handbook already identified this aspect Annex A and sensitized further by pointing out a number of legal aspects requiring special attention (from the author's point of view - a German author). It must be made clear that even now - since FOT - Net 2 has additionally compiled legal information from Spain, Italy, Netherlands and France on FOT -relevant issues- the legal advice still remains at an abstract level. The review -which has led to a substantial increase in details on these countries- will only allow for a first estimate of what needs to be considered. On the other hand this information is the basis for planning subsequent procedures in timelines. It must, however, be pointed out that information provided therein is not a final opinion on the law of these Member States since details on the single case are decisive. Furthermore, important differences in national law make it crucial to involve legal expertise at the level of every Member State affected by the FOT and on the basis of predefined data logging facilities and specific systems/applications.
In terms of the project timeline, legal and ethical issues need to be considered in parallel from the beginning to the end (and indeed afterwards in terms of data protection especially if the data are planned to be re-used in new projects). So the discussion in so far does not neatly follow the FOT chain. As these issues are complex and it is not always easy to find a good solution, it may be useful to consult (next to legal experts) other, comparable FOTs that dealt successfully with them and learn from their experience.
The FOTIP, 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 or involving legal expertise in the respective Member State.
3.2 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. However, in some countries, data privacy requirements will not allow to ask about medical details so that this will then need to be solved by positively informing on requirements for participation in participant agreement as FOT/NDS termination criteria (for the individual participant).
3.3 Participant agreement
There is a need to formalize the arrangement between the organisations responsible for the relationship with the participants and those participants themselves. This arrangement is legally a contract according to civil law. Even when this arrangement is made in the form of e.g. "a letter of agreement", this will not alter the legal character of the document which influences the legal relationship between the participant and the handling organisation. Issues potentially relevant between the handling organisation and the test participant should be regulated in a contract to provide for legal certainty on both sides (e.g. on obligations, liabilities, insurance issues, information on the logging of personal data requiring informed consent, which parties will use the data, data sharing after the project including the use of personal data etc.). In this respect, legal validity of the arrangements must be considered. This is an issue touching the general rule of freedom of contract as a limiting exception. By way of illustration the common limitation that the handling FOT - organisation cannot prompt participant to agree (in a legally effective way) to fully exclude liability, may in so far serve as an example common in several EU Member States. Again the legal situation in this respect can differ strongly which requires dedicated legal expertise at Member State level to achieve legal certainty.
A lawyer can provide advice on this and should definitely be consulted. Further issues of relevance to be considered and covered in this agreement are what shall happen in the event that a participant commits a traffic offence and/or incurs a traffic penalty (speeding ticket, parking ticket, etc.). Another 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.
3.4 Data protection and data ownership
Data protection in general 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. The general approach to data acquisition in the majority of FOTs will be to ask the participants for his/her informed, consent. The information provided thereby describes the scope of processing intended over the lifetime of data, including potential re-use of data after the project. No additional processing (e.g. disclosure of the data that might lead to identification of the person involved) can normally take place without prior consent. Another issue of high relevance in respect to video data is the issue of the cameras directed to the vehicle surroundings: There are two legal privacy issues associated with such cameras: the recognisability of other road users and registration numbers. Both are definitely critical in respect of data privacy regulations in place in several Member States Annex A and FOT-Net 2 D3.2. A solution that will avoid complications is low camera resolution that does not allow for any identification of the above-mentioned items. Otherwise a solution must be sought at national level either by contacting the national data protection agencies or (possibly as a first approach) by involving the respective legal advisor for the project at Member State level. Obviously video data must be treated with special care in the information society:Any video recording can potentially be made available over the internet or passed on to third parties. This will obviously cause substantial problems. It is therefore important that personnel handling and analysing the data are given appropriate education on personal integrity issues.
Furthermore, with respect to video recording (and also audio recording) 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. Special issues arise in case minors. As far as video data is affected, it can be a possible solution to apply very low camera resolution not allowing for identification of persons. More details are provided in Annex A. Legal advice at Member State level needs to be sought in this respect if applicable.
The data server must be protected from intrusion, and normally any personal ID information should be kept completely separate from the main 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. All data transfers including personal data should be made using encryption.
Data ownership and data sharing relates to stakeholder interests. We have already mentioned the participant agreement, where the participant can agree to re-use of of the collected data. 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 in three ways:
- 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. This includes also procedures for potential re-use of the data by third parties.
- 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. An overview and recommendations addressing the abovementioned issues, also from a data sharing and re-use perspective, can be found in FOT-Net 2 D3.2.
3.5 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.
3.6 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 needs to be handled by means of a formal system safety assessment.
3.7 Approval for on-road use
Vehicles are generally 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. This again should be subject to the legal advice sought in respect of the specific FOT.
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 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. Insurances and liabilities tend to differ greatly between the EU Member States. It is therefore advisable to seek legal advice in the highly risk-sensitive aspect.
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 may have negatively influenced the driver and then these systems 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.
These issues can be handled safely beforehand on the basis of sound legal treatment (via contract, insurances, etc.). It is therefore important to involve legal expertise at the level of the EU Member States affected by the FOT.
3.10 Video data collection (specific issues)
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 FOTs.
3.11 Ethical approval
Ethical approval to conduct an FOT 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. However, the information provided so far for Germany Annex A and Spain, Italy, Netherlands and France reveal no strict requirements for an ethical approval (FOT-Net 2 D3.2). If ethical approval is required, 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.
Considering ethical and legal issues may influence the outcomes of the different phases of the FOT 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 or to use certain performance indicators.