Adaptive ADAS to support incapacitated drivers Mitigate ... · v0.1 28.12.2016 Anna Anund (VTI)...

This project has received funding from the European Union’s Horizon 2020

research and innovation programme under grant agreement No 688900

Adaptive ADAS to support incapacitated drivers Mitigate Effectively risks through tailor

made HMI under automation

D11.1 - H – Requirement No. 1

Work Package No. WP11

Work Package Title Ethics Requirement

Activity No. A11.1

Activity Title H – Requirement No. 1

Dissemination level CO = Confidential, only for members of the consortium

(including the Commission)

Main Author(s)

Anna Anund, VTI

Magnus Hjälmdahl, VTI

Pia Brink, VTI

Katerina Touliou, CERTH HIT

File Name ADASANDME_D11.1.doc

Online resource http://www.adasandme.com/link-to-deliverable

Ref. Ares(2017)376535 - 24/01/2017

http://www.adasandme.com/link-to-deliverable

ADAS&ME (688900) D11.1 – H-Requirement No. 1

[Month, Year] of 26 Version [No]

Revision and history sheet

Version history

Version Date Main author(s) Summary of changes

v0.1 28.12.2016 Anna Anund (VTI) Magnus

Hjälmdahl (VTI) and Katerina

Touliou (CERTH HIT)

First draft

29.12.2016 Send to Anders Jansson, UU

and Katerina Touliou received

V0.2 30.12.2016 Revised according to input

from Anders Jansson, UU and

Katerina Touliou received

Spelling mostly

V0.2 30.12.2016 Send for Peer review to QM

V0.3 19.01.2017 Revised after Peer review,

revisions made by Anna

Anund, VTI

Updated table 3,

updated in line with

comments from

CQIR.

Name Date

Prepared Anna Anund, Magnus Hjälmdahl, Pia Brink

and Katerina Touliou

28.12.2016

Reviewed Iordanis Kavathatzopoulos, UU

Anders Jansson, UU

Raffaele Alfonsi, CTL

18.01.2017

Revised Anna Anund 24.01.2017

Circulation

Recipient Date of submission

European Commission 20.01.2017

Consortium 20.01.2017

Authors (full list)

Anna Anund, VTI

Magnus Hjälmdahl, VTI

Pia Brink, VTI

Katerina Touliou, CERTH HIT

Project Coordinator

Dr. Anna Anund

Research Director / Associate Professor

VTI - Olaus Magnus väg 35 / S-581 95 Linköping / Sweden

Tel: +46-13-20 40 00 / Direct: +46-13-204327 / Mobile: +46-709 218287

E-mail: [email protected]

mailto:[email protected]


[Month, Year] of 26 Version [No]

Legal Disclaimer The information in this document is provided “as is”, and no guarantee or warranty is given that

the information is fit for any particular purpose. The above referenced authors shall have no

liability for damages of any kind including without limitation direct, special, indirect, or

consequential damages that may result from the use of these materials subject to any liability

which is mandatory due to applicable law. The sole responsibility for the content of this

publication lies with the authors. It does not necessarily reflect the opinion of the European

Union. Neither the INEA nor the European Commission is responsible for any use that may be

made of the information contained therein.

© 2016 by ADAS&ME Consortium



Table of Contents

TABLE OF CONTENTS ................................................................................................................................ 4

INDEX OF FIGURES .................................................................................................................................... 5

INDEX OF TABLES ...................................................................................................................................... 5

GLOSSARY .................................................................................................................................................... 6

EXECUTIVE SUMMARY ............................................................................................................................. 7

1. INTRODUCTION ................................................................................................................................. 8

2. ETHICAL RISK MANAGEMENT .................................................................................................... 11

3. ETHICAL APPROVALS .................................................................................................................... 14

4. LIST OF EXPERIMENTS .................................................................................................................. 16

5. DETAILS OF INCIDENTAL FINDINGS POLICY .......................................................................... 20

6. TEMPLATES OF INFORMED CONSENT AND INFORMATION SHEETS. ................................ 21

7. ANNEXES ........................................................................................................................................... 22


[January, 2017] of 26

Index of Figures

FIGURE 1: THE PROCEDURE AND FLOW OF INFORMATION FORM ETHICS BOARD TO PILOT SITE. ............................. 10

Index of Tables

TABLE 1: CONSIDERATIONS REGARDING ETHICAL RISK MANAGEMENT IN ADAS&ME ....................................... 12 TABLE 2: OVERVIEW OF ETHICAL REQUIREMENTS ON A NATIONAL LEVEL RELEVANT FOR TESTS/EVALUATIONS IN

ADAS&ME ................................................................................................................................................. 15 TABLE 3: INDICATIVE LIST OF TESTS/EXPERIMENTS IN ADAS&ME. ..................................................................... 17



Glossary

ADAS Advanced Driver Assistance Systems

ADAS&ME Adaptive ADAS to support incapacitated drivers Mitigate Effectively

risks through tailor made HMI under automation

EB Ethics Board

QM Quality Manager



Executive Summary

The objective of this deliverable is to specify and structure the ethical procedures in order to

guarantee a sound and correct ethical treatment of human participants. The content of the

deliverable is aligned with the EC H – Requirement No. 1 and include, except for an

introduction the following aspects:

Details information of the informed consent procedures.

List of experiments

Templates of informed consent and information sheets.

Details of incidental findings policy

In line with the DoA all tests/evaluations that will take part in ADAS&ME will present their

initial pilot plans in M12. In some cases, data collections to support the algorithm developers

will be a bit earlier and indicative tests are identified. None of them will start preparing before

M7 and the first ethical approvals is planned for M9. Hence, no ethical approvals can be

submitted to the EC at this point. This document need to be updated as soon as they have been

approved.



1. Introduction

ADAS&ME is a “user oriented” project where the participation of humans is essential for a

successful outcome. A sound and correct ethical treatment of participants is therefore of great

importance for ADAS&ME. To achieve that one part of the management structure involves an

ethical board led by the coordinator and the technical manager. The purpose of the Ethics Board

(EB) is to ensure that the planned evaluations and test are following respective national

regulations.

In ADAS&ME there are five countries involved responsible for experiments with human

participants are carried out (Sweden, Germany, Spain, Italy and Greece). In ADAS&ME there

is a Deliverable (D10.3 Ethics Manual) were the ethical framework and requirements are in

detailed described. We tried to avoid overlapping information between this deliverable (D11.1)

and D10.3, but in some cases it was not possible.

The objective of this deliverable is to specify and structure the ethical procedures in order to

guarantee a sound and correct ethical treatment of human participants. The content of the

deliverable is aligned with the EC H – Requirement No. 1 and include, except for an

introduction the following aspects:

Details information of the informed consent procedures.

List of experiments

Templates of informed consent and information sheets.

Details of incidental findings policy

Ethical Board

In ADAS&ME the Ethics Board (EB) are composed of six persons: three external members,

the Coordinator, Technical and Quality Manager. All EB external members are trained

psychologists, thus, they have received training about Ethics and have to follow the code of

practice (e.g. http://www.apa.org/ethics/code/). In addition, they have all a long record of

experiments involving humans and are trained in ethical concerns.

Dr. Torbjörn Åkerstedt, Karolinska Institutet, Sweden

Professor in Psychology, Karolinska Institutet, and Director of the Stockholm Stress Center.

Former President of the European Sleep Research Society and General Secretary of the World

Federation of Sleep Research and Sleep Medicine Societies.

Dr. Anders Jansson, Uppsala Universitet, Sweden

Professor in Human-Computer Interaction, Associate Professor in Psychology, Uppsala

University. Researcher specializing in Human Factors, Cognitive Ergonomics and Human-

Automation Interaction, and the leader of the Technology in Human Reasoning (TiHR) Group.

Dr. Michal Regan, ARRB, Australia

Professor, Australian Road Research Board (ARRB Group), Chief Scientist in Human Factors

& Safe Systems Department, Adjunct Professor University of NSW in Sydney, Australia.

The EB will act as supervisors of the ethical activities of the project and the local ethics

committees at each pilot site, in order to take into account both European and national ethical

and legal requirements.

http://www.apa.org/ethics/code/



The ADAS&ME Ethics Board has a duty to monitor that project partners responsible for

evaluations and tests obey the following ethical principles:

Protect private and sensitive information and ensure that participants will not be

harmed during the pilots. Collected data will be anonymous and treated as

confidential.

Respect participant’s free will and treat them as intelligent being who decide for

themselves about any type of gathered data that are indeed outcomes of their

participation.

Inform in full about how data will be collected, processed shared, and disposed before

signing the consent form.

Communicate their findings through open-access journals to other researchers and

academic communities.

All used assessment tools and protocols within ADAS&ME pilots will be verified beforehand

by the EB, regarding their impact to users’ well-being before being applied to the pilot sites. At

least three renowned experts in the field, chaired by an experienced ethics coach, constitute the

project Ethical Board, assisted by further external experts, if needed. The EB works for

implementing and managing the ethical and legal issues of all procedures in the project,

ensuring that each of the partners provides the necessary participation in ADAS&ME and its

code of conduct towards the pilot participants. The EB constantly updates the Ethics Manual

(D10.3) leading to the recognition of key ethical and legal issues. Especially the core ethical

issues will be tackled.

The diagram in Figure 1 presents the procedure of ethical considerations from planning to

realisation of a test/evaluation. The EB will supervise and ensure that the ethics guidelines of

the project are followed, this is done in close collaboration with the Evaluation Manager (WP7

leader). The responsible partner for a test / evaluation will be responsible for the submission

and approval of the pilot research protocol to the local/regional and/or institute ethics’ Board

required in each country. The external members of the EB are all persons with valuable

experience in projects related to pilot testing and evaluations with humans. The QM of

ADAS&ME is the one responsible for keeping track of the process. The ethics Board will

arrange online meetings in case a need arises. If any conflicts with regards data treatment,

storage and analysis exists, they will hold a meeting and a consensual agreement will be reached

a documented in the meeting(s) minutes. These minutes will be annexed in the ADAS&ME

Annual report.



Figure 1: The procedure and flow of information form ethics board to pilot site.



2. Ethical risk management

As defined in Part B section 5 the main target user groups of ADAS&ME are experienced,

active, and healthy individuals. The participants need to have the competence to understand the

informed consent information. In the unlikely case that they are unable to do so, they will be

excluded from any tests or evaluations within ADAS&ME. The scenarios will only include

participants with competence to understand the informed consent information and a valid

driving license.

ADAS&ME will not touch any of the following fields of research:

research activity aiming at human cloning for reproductive purposes,

research activity intended to modify the genetic heritage of human beings which could

make such changes heritable

research activities intended to create human embryos solely for the purpose of

research or for the purpose of stem cell procurement, including by means of somatic

cell nuclear transfer.

Furthermore, ADAS&ME does not include any research involving:

the use of human embryonic tissue, human foetuses, human foetal tissue, other human

tissues,

genetic information,

people unable to give consent,

pregnant women,

animals

Only the principal investigator, at each pilot site, will have access to personal information.

People who will analyse data will receive anonymised and coded information. Any recorded

data will be available only in anonymised format. Participants who will consent for video

recording (e.g. face recognition) will participate in testing and their results will be used only for

scientific purposes, in an anonymised manner. Analysts who will be responsible for video data

will not have access to any other private information (e.g. name, address, etc.). These pieces of

information will be stripped out from video data and these files will be coded before uploaded

to the database. Involvement of human participants is ethical, and information will be provided

at each stage of involvement for all phases they will be part of.

The principles of the European Convention of Human Rights, the rules of the Convention of

the Council of Europe for the protection of individuals with regard to automatic processing of

personal data and especially the European Directive 95/46/EC, for the protection of personal

data will be strictly followed when addressing the ethical questions of ADAS&ME.

Core ethical issues within ADAS&ME are related to:

Privacy protection and confidentiality

Informed consent

Incidental findings

Transparency of the collected data management by the final system and during

baseline and pilots

Traffic safety and secure use of sensors

Risk assessment (Insurance)



Delegation of control

Incentives (Financial inducements, etc.)

The proper management of these issues is carefully investigated and any relevant principles and

the main procedures regarding privacy, data protection, security, legal issues and ethical

challenges has been defined and presented in D10.3 and an overview of consideration regarding

ethical risk management is given in Table 1.

Table 1: Considerations regarding Ethical Risk Management in ADAS&ME

Ethical and

Social risks

Description Ethical Risk Management in ADAS&ME

Ethical and legal

framework

applied

All relevant legislation, regulation and ethical

codes will be taken into account; they are defined

how they are met in terms of processes, timing

and responsibilities (D10.3 ADAS&ME Ethics

Manual).

ADAS&ME Ethics (and Quality Control)

Board will oversee the ethical concerns

involved in the project.

Transparency

and consent of

the end-user

The informed consent aims at ensuring that the

user accepts participation and is informed about

all relevant aspects of the research project; it

should be given in written form after the users

have been provided with clear and understandable

information on their role (including rights and

duties), the objectives of the research, the

methodology used, the duration of the research,

the possibility to withdraw at any time,

confidentiality and safety issues, risks and

benefits.

The basic elements of the ADAS&ME

informed consent will include:

The objective of the study, its duration and

methodology

Possible risks, discomforts and side-

effects (also related to traffic safety)

Privacy and data protection procedures

The possibility to decline the offer and to

withdraw at any point of the process (and

without consequences)

Contact person

Privacy and data

protection

Only anonymised data will be processed and,

therefore, no personal data will be collected in

relation to specific user. The name will not be

connected to other characteristics (e.g. age, sex,

nationality and health condition). Participants will

be recorded only if they provide consent. All this

information falls under the European legislation

for the lawful processing of personal data.

Special attention is also given to national

legislation. These provisions have to be respected

even if the users have given their consent for the

processing of their personal data. Especially

regarding sensitive data, like physical or mental

health, sexual orientation and ethnic origin, more

restrictions apply.

To avoid risks related to the processing of

personal data such as identity theft,

discriminatory profiling or continuous

surveillance, the principle of proportionality has

to be respected. Data can be used only for the

initial purpose for which they were collected, if

nothing else is agreed in the ethical approval.

Anonymisation or pseudonymisation is a way to

prevent violations of privacy and data protection

rules. Processing has to be limited to what is truly

necessary and less intrusive means for realising

the same end have to be considered.

The project identifies which data

protection rules apply and establishes a list

of risks and potential solutions; taking due

account of the following:

What kind of data will be processed?

What is the purpose of the processing?

Will the data exceed the purpose of the

study?

Are there procedures ensuring that data is

processed only for the originally identified

purposes?

Who is the owner of the data?

Is data connected to other information?

Will data be commercially exploited?

What is the duration of the storage of the

data?

Where will the data be stored and

according to which national legislation?

Who will access the data? Are they

secured?

Will the user be recorded?

Which biometrics will be implemented?

Who will supervise the data protection?



Ethical and

Social risks

Description Ethical Risk Management in ADAS&ME

Incidental

findings

Treatment of incidental findings related to

driver’s health state and or any traffic violations.

Any findings that are related to driver’s

health (i.e. excessive stress, leading to

chronic stress, diagnosis of sleep apnoea,

narcolepsy, or other sleep related

disorders, etc.) during the tests will be

communicated in writing to the test

participants. Such incidental medical

findings, as well as any traffic rules’

violations during the tests will not be

communicated to 3rd parties (including

insurances, authorities, etc.); as the driver

is driving “ as he/she will do when along”

and assumes fully legal responsibility on

his/her acts. Written exception (included

in the informed consent form) will be

made for deliberate criminal acts on behalf

of the driver or/and related to an eventual

accident during the tests.

Safety Data collection and evaluations should not entail

any undue risk for participants

Testing of technologies is supervised;

sensors and systems will be verified and

validated prior to any use. The integrated

systems do not pose any safety risk for

participants. A driver instructor will be

always present at the passenger seat which

has gas and brake pedals, in case of on-

road experiments.

Participants’

engagement

Research has to be inclusive and representative of

different driver types. The selection and

recruitment of participants is a crucial part of the

involvement process, as it will impact on the

quality of the outcomes and the sustainability of

the research or policymaking process. At this

stage a satisfactory number of users and

combination of drivers’ characteristics is sought;

gender balance and equality is addressed.

ADAS&ME will target drivers in the large

sense: Specific inclusion criteria will

apply (i.e. at least five years since

obtaining driving license, driving more

than 10 000 km per year, and using their

car at least two times per week; coming

from different digital literacy backgrounds

with a well-balanced gender sample).

Recruitment will be based on existing

databases from previous studies (i.e. for

those participants who have provided their

consent to be contacted from previous

studies) and a well-established network

with Drivers’ Associations at the pilot

sites. Participants will be screened prior

recruitment. Participants with mood,

personality, sleep disorders and physical

impairments are excluded from testing, as

also are drivers who are under medication

that might affect driving performance (e.g.

antidepressants) or the influence of

alcohol. The substantial number of users

will ensure a wide trial perspective,

including: i) different age groups, ii)

balanced female/male ratio iii) various

social backgrounds. The Ethics Board of

ADAS&ME will oversee the selection of

participants.



3. Ethical approvals

The first experiments involving human participant’s takes place in WP7.2 supporting mainly

WP4.2 and WP4.3 with data for algorithm development, this start at month 8. The first

experiments are thus anticipated to commence around month 12. Ethical approval is typically

prepared 3-4 months in advance which is why only the routines and procedures for ethical

approval is provided in this deliverable. However, involved partners have been conducted in

order to ensure that they will manage to obtain ethical approval on time and if any particularities

exist (e.g. in case they have to submit an ethics approval to a regional body that meets only in

scheduled dates). The information was gathered through the completion of the ethics

questionnaires (Table 2).

The routines for ethical approval differ between different countries and in ADAS&ME the

following countries are involved in test/experimental activity: Greece (WP4, WP5, WP7)

Italy (WP4)

Sweden (WP4, WP5, WP7)

Germany (WP4, WP5, WP7)

Spain (WP7)

A questionnaire among partners involved in tests/evaluations was distributed. The template was

used to gather information about national legislative and ethical requirements, on overview is

presented in Table 2.



Table 2: Overview of ethical requirements on a national level relevant for tests/evaluations in ADAS&ME

Country

Questions Greece Italy Sweden Germany Spain

Is there an Ethics control body in your

country/region/institution?

Yes,

Centre/ Organization

level

Yes,

National

Yes,

Regional

Yes,

Regional

Yes,

Regional

Is there an international or national legislation, which you

must follow when performing test with human participants?

Yes,

και 3471/2006 για τις

ηλεκτρονικές

επικοινωνίες

Yes,

Legislative Decree

no 196/2003

Yes,

Svensk författningssamling

2003:460

Yes,

www.satoriproject.eu/m

edia/4.e-Country report-

Germany.pdf

Yes,

Spanish law 14/2007

Is there an ethics controlling body in your country/region or

institution?

Yes,

CERTH Bioethics

committee

Yes,

Italian Data

protection authority

Yes,

Swedish

Etikprövnings nämnd

(ethical vetting)

http://www.epn.se/en/start/

Yes,

German Research

Foundation

Yes,

National Spanish

committee.

Is there requirement of insurance for participants in your

country/region/institution?

No,

however driver of any of

the research vehicles

owned by CERTH, are

insured.

No Yes,

Legal financial and

Administrative Agency

Yes, Sozialgezetsbuch Yes,

Spanish law 14/2007

Is there any ethics controlling committee within your

organisation?

Yes,

CERTH Bioethics

committee

Yes,

Ethic committee

No No Yes,

Applus+

Is there established ethical control procedure which you

must follow before performing test with human participants?

Yes,

Approval is required

before any testing takes

place. The requirements

and procedure are set up

by CERTH Bioethics

committee

No Yes,

a template with annexes

provided by EPN.

No Yes,

The Code of Good Scientific

Practices provided by the

Spanish National Research

Council (CSIC

Do you follow written procedures to protect privacy? 1 No No Yes Yes Yes

Do you follow any official national or international

guideline on protecting privacy? (see footnote 1)

Yes

No Yes Yes Yes

For conducting results ethically and manage risk, do you

need to involve other organisations (unit, divisions,

department etc.) that also control and decide your research

activity?

No No No No No

1 this applies also to digitally transmitted, system-collected, and web based data

http://www.satoriproject.eu/media/4.e-Country%20report-Germany.pdf



http://www.epn.se/en/start/



4. List of experiments

ADAS&ME aims to develop Advanced Driver Assistance Systems (ADAS) that incorporate

driver/rider state, situational/ environmental context, and adaptive interaction to automatically

transfer control between vehicle and driver/rider and thus ensure safer and more efficient road

usage.

In ADAS&ME experiments with humans will be carried out in WP7.2 (Data collection for

algorithm developments in WP4), WP5 (Iterative HMI testing) and WP7 (Realization of use

case evaluations). Pre-pilots to the WP7 experiments will be carried out within WP6 but the

ethical approval is carried out in conjunction with the WP7 experiments. As agreed in DoA all

tests/evaluations that will take part need to have a written Pilot plan. The first draft is for M12

and is Milestone 14 (MS14) in ADAS&ME.

In WP1 different stakeholders view in relation to the identified Use Cases will be gathered.

Since there is no available concept about automated functions, visualisations will be used to

show the Use Cases to the stakeholders. The visualization will be done with help of a web based

tool and the users will be invited through internet, a response will be considered as an

acceptance to participate and no ethical approval apart from the ADAS&ME internal ethical

review will be needed.

In addition, focus groups with a combination of stakeholders will be used to discuss the different

Use Cases. The participants will receive written information beforehand and a short verbal

introduction before the discussion starts. They will be informed that nothing of what is said will

be possible to connect to them as a person. There is no interest of who said what, only the

content of the discussion is of interest. Before starting they will be asked to sign an informed

consent.

In WP4 data for development of algorithms is needed. The aim is to gather data useful for

identification of indicators and thresholds of driver fatigue/sleepiness, attention/distraction,

stress, rest and emotions. The data will be both on driver physiological and on driving

behaviour. The data collection will be done in WP7.2 with a random sample of real drivers

involved. All studies will be ethically approved before running the experiments taking into

account the Helsinki declaration and National regulations. All involved drivers will receive both

written and a verbal information about the aim of the study, how data will be used and stored,

but also about their right to withdraw without explanation. They have to sign an informed

consent.

In WP5 the HMI strategy and concept will be developed and evaluated in short loops with a

small number of participants representing HMI experts. These studies will take part in

simulators and/or laboratory settings. The data is gathered in order to capture the potential

drivers view and experience. No physiological data or driving behaviour data will be gathered,

instead questionnaires and interviews will take part. The users are highly involved, but more

from a technical perspective and as experts. The studies do not need ethical approval, but will

follow the Helsinki declaration. The users will have written and verbal information beforehand

and will sign informed consent.

In WP7 (A7.3) evaluations of the Use Cases will take part. This will be done for each of the

Use Cases with drivers of truck, cars, motorcycle and buses involved, driving on test tracks



and/or on real roads, expect for the bus Use Case evaluation that will take part in a driving

simulator. In total, approximately 40-50 drivers will be involved, driving repeatedly in the Use

Case scenarios. All evaluations will be ethically approved in the country where they are run and

the Helsinki declaration and National ethical regulations will be taken into account. All

involved drivers will receive both written and verbal information about the aim of the study,

how data will be used and stored, but also about their right to withdraw without explanation.

They have to sign an informed consent. Final evaluations will take part mainly in Spain close

to or at IDIADAS test track. In order to guarantee that the user face a well prepared test

environment pre-studies will take part with a small number of volunteers from each responsible

organisation.

The planning of tests and evaluations have started following the time line described in the DoA

of ADAS&ME, ending up with initial Pilot plans ready for month 12 (M12). This means that

no ethical approval has been possible to submit since details are not decided at this early stage

(M5). However, to the best of our knowledge, based on DoA and work archived so far in

especially WP4 and WP5 an indicative list of planned tests/evaluations have been put together,

see Table 3.

Table 3: Indicative list of tests/experiments in ADAS&ME.

Preparation

Start Month

UC Ethical

approval

ready / start of

test

Experiment

description

Participants Ethical

considerations

Resp.

partner

Country

WP7.2 – supporting WP4

M7

&

M15

A

M9

&

M17

Physiological

measurements for

algorithms and

questionnaires about

stress/rest/attention

and emotions.

16 truck

drivers; real

road

An application

needs to be

send to the

Regional

ethical in

Sweden.

SCANIA Sweden

M7

B

M11

Physiological

measurements and

questionnaires for

algorithms about

anxiety.

16 passenger

e-car drivers.

An application

needs to be

send to German

Research

Foundation

VALEO Germany

M7

&

M21

C-D

M11

&

M23

What automation

parameters should be

adaptive/adaptable

from drivers’

perspective?

Physiological

measurements and

questionnaires for

algorithms about

stress/rest/attention

and emotions, and

questionnaires.

16 passenger

car drivers;

Simulator in

Braunschweig

and/or

Track near

Braunschweig

An application

needs to be

send to the

German

Research

Foundation.

DLR Germany

M7 E-F M12

Physiological

measurements and

questionnaires for

algorithms about

fatigue, inattention,

stress, confusions,

dehydration,

frostbite, and

questionnaires.

16 riders An application

needs to be

send to CERTH

Bioethics

committee.

CERTH Greece



Preparation

Start Month

UC Ethical

approval

ready / start of

test

Experiment

description


considerations

Resp.

partner

Country

M10 G

M12

Physiological

measurements and

questionnaires for

algorithms about

stress//attention and

emotions, and

questionnaires.

16 city bus

drivers

An application

needs to be

send to the

Regional

ethical in

Sweden.

VTI Sweden

M23 NA M25

Overall

validation/functional

check of WP4 Driver

State Module.

5-10 passenger

car driver

FORD Germany

M15 NA M18

Overall

validation/functional

check of WP4

Personalization

Module

5-10 passenger

car driver

SE Sweden

WP7.3 – Final evaluations in WP7.3 including pre-tests in WP6

M35 A

M37

Evaluation of the

integrated system for

long haul trucking.

The evaluation will

be done at IDIADAS

test facilities.

Driver state in focus

are: fatigue, focus of

attention, level of

physiological

arousal/Attention,

mental effort /

workload, state of

rest (yes/no),

emotions

state/valence, stress

20 truck

drivers

An application

needs to be

send to the

Regional

ethical in

Sweden.

SU / VTI Spain

M35 B

M37

Evaluation of the


e-car drivers with

focus on anxiety

measurement

algorithms, Eco

driving analysis and

its effect on driver

style.

16 drivers An application

needs to be

send to German

Research

Foundation

TUC Spain

M35

C-D

M37

Evaluation of the


smooth and safe

automation

transitions and

emergency

manoeuvre.

16 drivers An application

needs to be

send to German

Research

Foundation

DLR Spain

M35

E-F

M37

Evaluation of the


long range attentive

touring and for rider

faint. The evaluation

will be done at

IDIADAS test

facilities.

16 riders An application

needs to be

send to CERTH

Bioethics

committee.

CERTH Spain



Preparation

Start Month

UC Ethical

approval

ready / start of

test

Experiment

description


considerations

Resp.

partner

Country

M35 G M37

Evaluation of the

integrated system

“docking” of bus

stop. The evaluation

will be done in VTIs

bus simulator. Driver

state in focus are

inattention, stress and

fatigue, eco driving

and smooth

transitions.

16 city bus

drivers

An application

needs to be

send to the

Regional

ethical in

Sweden.

VTI

Sweden



5. Details of incidental findings policy

It is not possible to conceive a procedure, investigation, or process which would be without any

risk. One of the most important factors in the assessment of risk is the perception of the

prospective participant of the importance of risk. The participant’s life situation may

substantially influence the way in which a risk is perceived. The end point of the process is the

consent given by the person to be part of the research project, having considered all aspects of

the process and asked all relevant questions. All relevant information will be given to the

participants. This means that the project ADAS&ME will be carefully explained. A detailed

and specific information sheet will be prepared specifically for recruitment activities that will

be prepared in advance of the pilots. The choice that is made and the consent that is given will

be without coercion or undue pressure being applied.

Categories of risk:

Physical risks stemming from traffic safety issues will be minimised (through the

existence of double pedals and driving instructors) and is expected to be at the same

level as that experienced by the average driver throughout their daily driving when in

a hurry, fatigued, stressed, etc.

Psychological consequences will be carefully examined and risk will be minimised.

Social inconveniences will be minimised (no additional stress than similar to daily

driving conditions, cost reimbursement for additional transport costs, etc.).

Research and test vehicles will be insured to protect participants.

The participants will be driving in dedicated traffic segments and all precautions will

be taken.

Traffic segments will have very low to minimal traffic and no pedestrians will be

involved.

Participants will be able to take the control at any time.

Since we are about to measure physical status of the drivers it might be the case that unhealthy

conditions in a person are identified. However, in no case a diagnosis is involved as these are

not medical studies. In case this happens, we will inform the participant about the findings and

recommend them to contact a medical doctor for further investigation. The pilot responsible

partners will not reach a diagnosis and/or make any judgments upon a participant’s health

conditions unless they are trained medical professionals. Even in this case, they will be advised

to discuss this further with their GP.



6. Templates of informed consent and information sheets.

For each country involved requirements regarding informed consent will be followed. This will

be checked by the EB. For all experiments in all countries involved a mandatory minimum

template is prepared, see Annex 1.

Depending on the aim with the studies the information presented verbally and written will

differ. A mandatory minimum template with information is prepared, see Annex 2.



7. Annexes



ANNEX 1: Informed consent Template



This part will be filled by both participant and investigator. Research participants' identity and dated signatures of the participant affirming that consent was given

The information shown below identifying the participant should be entered in the designated

spaces at the time of execution of the consent document.

Name: _________________________________

DoB: ___________________

Anonymisation Code:____________________

Participant Consent Form

Title of the study:

Place of the study:

Please circle

as necessary

I was informed about the effect to be expected, about possible

advantages and disadvantages as well as about possible risks

verbally and in writing by the test leader about the aim, course of

the study.

Yes No

I have read and understood the written information handed out for

the study mentioned above. My questions in connection with the

study have been answered satisfactorily. I can keep the written

information and receive a copy of my written declaration of

consent.

Yes No

I had sufficient time to take my decision Yes No

In case an incident arises contrary to expectation an insurance

consists for me in the legally specified scale. The insurance was

constructed by …………… for this study.

Yes No

I have spoken to: Dr./Mr./Ms.

I understand that I am free to withdraw from the study

at any time

without having to give a reason for withdrawing

and without affecting my future medical care

Yes No

I agree to take part in the study?

Yes No

The confidentiality of my personal data was assured to me. Personal Yes No

ADAS&ME (688900)

[12, 2016] of 26 [VTI]

date will used anonymised at the publication of the studies results.

I approve of the fact however under a strict compliance with the

confidentiality that the responsible experts of the authorities and the

ethic commission may take look for examining and control

purposes in my original data.

I accept my face, voice, physiological biosignals and driving

behaviour parameters to be recorded and the information to be used

in reports with no other personal information attached

Yes No

If after effects appear, I will contact Dr./Mr./Ms.

Signed ................................................................

Date.......................................

Name (in block letters)....................................................................................……….

Investigators' confirming statement

I have given this research participant information on the study, which in my opinion is accurate

and sufficient for the participant to understand fully the nature, risks and benefits of the study,

and the rights of a research participant. There has been no coercion or undue influence. I have

witnessed the signing of this document by the participant.

Investigator's Name: ___________________________

Investigator's Signature:________________________________

Date: ____________________________



ANNEX 2: Information to be added in the information sheet to participants



INFORMATION ABOUT THE RESEARCH STUDY

Title of the study:

The purpose of this research study:

You are asked to take part in a research study under the direction of

_______________________________. These investigators are undertaking a research study to

determine whether ___________________________. We expect to find

_________________________________________, which could lead to better methods of

monitoring / detection and treatment to ensure safe transitions between the driver and a vehicle

under automation.

Who can take part in this study?

Why should I consider joining this study as a research participant?

Do I have to become a participant in this study?

If I joined the study, can I change my mind and drop out before it ends?

What exactly will be done to me, and what kinds of treatments or procedures will I receive, if I

agree to be a research participant in this study?

What kinds of harm can I experience in this study, and what will the investigators do to reduce

the chances of harm?

What will the investigators do to make sure that the information they will collect on me will

not get in wrong hands?

What kinds of benefit can I expect personally from taking part in this study?

What kinds of benefit to others can come out of this study?

What will the investigators do, if I get injured in the study?

Will I get paid for taking part in this study?

ADAS&ME (688900)

[12, 2016] of 26 [VTI]

Will I or my health insurance company be charged for any of the costs of this study?

Once I start in this study as a participant, what do I do if I want to find out more about the study,

or to complain about the way I get treated?

If I decide not to become a participant in this study, what may happen to me, or what other

choices do I have if I need treatment.

Adaptive ADAS to support incapacitated drivers Mitigate ... · v0.1 28.12.2016 Anna Anund (VTI)...

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