Deliverable 11.2 POPD Requirement No. 2 · V1.0 09.01.2017 Anna Anund (VTI) and Pia Brink (VTI)...

Adaptive ADAS to support incapacitated drivers Mitigate Effectively risks through tailor

made HMI under automation

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

research and innovation programme under grant agreement No 688900

Deliverable 11.2 – POPD – Requirement No. 2

Deliverable Identity

Work Package No. WP11

Work Package Title Management

Activity No. A11.2

Activity Title POPD – Requirement No. 2

Dissemination level CO = Confidential

Main Author(s) Anund, Anna (VTI)

Brink, Pia (VTI)

File Name ADASANDME_11.2.doc

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

Ref. Ares(2017)376556 - 24/01/2017

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

ADAS&ME (688900) D11.2 - POPD – Requirement No. 2

January 2017 of 18 Version 2.0

Version History

Version history

Version Date Main author(s) Summary of changes

V1.0 09.01.2017 Anna Anund (VTI) and Pia

Brink (VTI)

First draft send for

peer reivew.

V2.0 19.01.207 Anna Anund (VTI) and Pia

Brink (VTI)

Revised after peer

reivew.

Name Date

Prepared Anna Anund, Magnus Hjälmdahl, Pia Brink

and Katerina Touliou

28.12.2016

Reviewed Iordanis Kavathatzopoulos, UU

Anders Jansson, UU

Martin Castor, Scania

18.01.2017

Revised Anna Anund 24.01.2017

Circulation

Recipient Date of submission

European Commission 24.01.2017

Consortium 24.01.2017

Authors (full list)

Anund, Anna, Statens väg och transportforskningsinstitut (VTI)

Brink, Pia, Statens väg och transportforskningsinstitut (VTI)

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]

ADAS&ME (688900) D11.2 - POPD – Requirement No. 2

January 2017 of 18 Version 2.0

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 present document is a draft. 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

ADAS&ME (688900) D11.2

November 2016 of 18 Version 0.1

Table of Contents

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

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

EXECUTIVE SUMMARY ..................................................................................................................................... 6

1 INTRODUCTION ................................................................................................................................. 7

2 AIM ........................................................................................................................................................ 8

3 DATA PROTECTION OFFICER ........................................................................................................ 9

4 PERSONAL SENSITIVE DATA ........................................................................................................ 10

5 INFORMED CONSENT ..................................................................................................................... 11

6 ANNEXES ........................................................................................................................................... 12

ADAS&ME (688900) D11.2


Index of Tables

TABLE 1: OVERVIEW OF DATA PROTECTION LEGISLATION ON A NATIONAL LEVEL FOR PARTNERS DOING TESTS/EVALUATIONS

IN ADAS&ME

ADAS&ME (688900) D11.2


Executive Summary

ADAS&ME will perform tests and evaluations involving humans. This will be done in

compliance with the ethics requirements at international and national level described in D10.3

Ethics Manual.

This deliverable D11.2 POD - Requirement No. 2 is asked for by the EC. It covers the

requirement of confirmation by the competent Institutional Data Protection Officer, the

Templates of the informed consent forms and information sheet. In addition, it respond to the

requirement that the applicant must explicitly confirm that the data used are publicly

available.

ADAS&ME (688900) D11.2


1 Introduction

ADAS&ME will perform tests and evaluations involving humans. This will be done in

compliance with the ethics requirements at international and national level. In ADAS&ME

D10.3 Ethics Manual the procedures, responsibilities etc. will be clearly defined.

In addition, the EC requires three deliverables to make sure that ADAS&ME are full filling all

ethical requirements available.

D11.1 H - Requirement No.1

D11.2 POD - Requirement No. 2

D11.3 POPD - H EPQ - Requirement No. 3

This deliverable is focused on D11.2.

ADAS&ME (688900) D11.2


2 Aim

It is very important to ensure that data will be handled correctly within the bodies dealing with

the participant’s personal data in ADAS&ME. In order to do this, this deliverable will amongst

all define some basic concepts in the directive 95/46/EC. Attached is a confirmation by data

protection officer at VTI regarding handling of ethical and personal data within ADAS&ME.

The aim for the deliverable is defined by the EC as:

“Copies of opinion or confirmation by the competent Institutional Data Protection Officer

and/or authorization or notification by the National Data Protection Authority must be

submitted (which ever applies according to the Data Protection Directive (EC Directive 95/46,

currently under revision, and the national law). If the position of a Data Protection Officer is

established, their opinion/confirmation that all data collection and processing will be carried

according to EU and national legislation, should be submitted. Justification must be given in

case of collection and/or processing of personal sensitive data. Templates of the informed

consent forms and information sheet must be submitted. The applicant must explicitly confirm

that the data used are publicly available.”

Directive 95/46/EC

At the present the following directive is valid: Directive 95/46/EC of the European Parliament

and of the Council of 24 October 1995 on the protection of individuals with regard to the

processing of personal data and on the free movement of such data.

Regulation (EU) 2016/679

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on

the protection of natural persons with regard to the processing of personal data on the free

movement of such data, and repealing Directive 95/46/EC, will enter into force May 25 2018.

In Sweden, as well as in other countries in EU, there are ongoing investigations regarding the

impact on certain areas where the regulation leaves the decision to national legislation. In

Sweden this investigation will be done in May 2017.

ADAS&ME (688900) D11.2


3 Data Protection Officer

Directive 95/46/EC

According to Directive 95/46/EC on the protection of individuals with regard to the processing

of personal data and on the free movement of such data, it is possible for the controller (this is

voluntarily), i.e. the natural or legal person, public authority, agency or other body which alone

or jointly with others determines the purposes and means of the processing of personal data, to

let a person within the organisation – the data protection officer, be responsible that the

controller’s data is handled correctly (note 49 in the directive).

In Sweden, there is a possibility for a controller to appoint a data protection officer in order to

avoid unsuitable administrative formalities, for example exemptions from the obligation to

notify where processing is unlikely adversely to affect the rights and freedoms of data subjects.

The data protection official must be in a position to exercise his functions in complete

independence.

Data protection officer’s task

According to article 18 in the directive 95/46/EC the personal data protection official is

responsible in particular for ensuring in an independent manner the internal application of the

national provisions taken pursuant to the directive, and for keeping the register of processing

operations carried out by the controller, containing the items of information referred to a register

of processing operation notified shall be kept by the supervisory authority – thereby ensuring

that the rights and freedoms of the data subjects are unlikely to be adversely affected by the

processing operations.

At this time it is only the coordinator in ADAS&ME (VTI) who has an appointed data

protection officer. According to Regulation (EU) 2016/679 it will be mandatory from May 25

2018 that every public authority in EU and also every corporation that handles personal data

must have a data protection officer, i.e. it will not be voluntarily as it is in the directive

95/46/EC.

Attached is a confirmation from the data protection officer at VTI, regarding data collection

and processing of personal data.

ADAS&ME (688900) D11.2


4 Personal sensitive data

The directive 95/46/EC defines personal data as “any information relating to an identified or

identifiable natural person (‘data subject’); an identifiable person is one who can be identified,

directly or indirectly, in particular by reference to an identification number or to one or more

factors specific to his physical, physiological, mental, economic, cultural or social identity”

(article 2). Personal data that can be handled in some cases are personal sensitive data, that is

“personal data revealing racial or ethnic origin, political opinions, religious or philosophical

beliefs, trade-union membership, and the processing of data concerning health or sex life”

(article 8 point 1).

The procession of personal sensitive date is permitted when the data subject has given his

explicit consent to the processing of those data; processing is necessary for the purposes of

carrying out the obligations and specific rights of the controller in the field of employment law;

processing is necessary to protect the vital interests of the data subject or of another person

where the data subject is physically or legally incapable of giving his consent; processing is

carried out in the course of its legitimate activities with appropriate guarantees by for example

a foundation or association with a political, philosophical, religious or trade-union aim an on

condition that the processing relates solely to the data subject and the processing relates to data

which are manifestly made public by the data subject or is necessary for the establishment,

exercise or defence of legal claims (article 8 point 2).

Processing is permitted in some other cases as well. For instance, when the data is required for

the purposes of preventive medicine, medical diagnosis and some other cases relating to health-

care services. Also, when it comes to data relating to offences, criminal convictions and security

measures, processing of data can be permitted under the control of official authority (article 8,

point 3 and 5).

If the project ADAS&ME collects any personal sensitive data this will be handled according to

directive 95/46/EC and national regulations.

ADAS&ME (688900) D11.2


5 Informed consent

The directive 95/46/EC defines the data subject’s consent as “any freely given specific and

informed indication of his wishes by which the data subject signifies his agreement to

personal data relating to him being processed” (article 2). Article 7 states that personal data

may be processed only if the data subject has unambiguously given his consent. There exist a

number of other cases when procession of personal data is permitted as well, but the starting

point is informed consent. Moreover the controller must make sure that the participate in the

experiment has informed about the identity of the controller and of his representative, the

purposes of the processing for which the data are intended and any further information such as

the recipients or categories of recipients of data; whether the information replies to the

questions are obligatory or voluntary, as well as the possible consequences of failure to reply;

the existence of the right of access to and the right to rectify the data concerning him (article

10).

Every participant in the experiments have to sign an informed consent form. The basic elements

of the ADAS&ME informed consent will include:

1. The objective of the study, its duration and methodology

2. Possible risks, discomforts and side-effects (also related to traffic safety)

3. Privacy and data protection procedures

4. The possibility to decline the offer and to withdraw at any point of the process (and without

consequences)

5. Contact person

The template of the informed consent form as well as the information sheet are included in

D11.1 and also in Annex 2 and Annex 3 in this document.

All data used are publicly available as long as it is not in conflict with what has been agreed in

the Consortium Agreement of ADAS&ME and as long as it is treated in line with directive

95/46/EC.



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

research and innovation programme under grant agreement No 688900

6 Annexes

ADAS&ME (688900)

[12, 2016] of 18 [VTI]

ANNEX 1: Confirmation by data protection officer at VTI



ADAS&ME (688900)

[12, 2016] of 18 [VTI]

ANNEX 2: Informed Consent of ADAS&ME



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

ADAS&ME (688900)

[12, 2016] of 18 [VTI]

The confidentiality of my personal data was assured to me. Personal

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.

Yes No

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: ____________________________

ADAS&ME (688900)

[12, 2016] of 18 [VTI]

ANNEX 3: 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 18 [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?

ADAS&ME (688900)

[12, 2016] of 18 [VTI]

ANNEX 4: Overview of data protection legislation in involved countries.

Table 2: Overview of data protection legislation on a national level for partners doing tests/evaluations in ADAS&ME

Questions Greece Italy Sweden Germany Spain

Is there an established Data Protection Act

which you must follow before performing tests

with human participants and their personal data

(see footnote 1)

Yes, Protection

of Individuals

with regard to

the Processing of

personal data

(law 2472/1997)

Yes, Data Protection

Act 1996 (no.

675/1996

Yes, National Data

Privacy Law (PUL

1998:204)

Yes, Federal Data

Protection Act

(20.12.1990)

Yes, National data

privacy law (LO

15/1999)

Do you have an appointed intuitional data

protection officer in your organisation?

No No Pia Brink

[email protected]

Claus Pecha

[email protected]

unhofer.de

No

At this point the legal

representative of

IDIADA Automotive

Technology S.A is in

charge

Deliverable 11.2 POPD Requirement No. 2 · V1.0 09.01.2017 Anna Anund (VTI) and Pia Brink (VTI)...

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