deliverable 11.2 popd requirement no. 2 · v1.0 09.01.2017 anna anund (vti) and pia brink (vti)...
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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
ADAS&ME (688900) D11.2 - POPD – Requirement No. 2
January 2017 Page 2 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]
ADAS&ME (688900) D11.2 - POPD – Requirement No. 2
January 2017 Page 3 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 Page 4 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
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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
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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
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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.
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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.
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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
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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.
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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.
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
6 Annexes
ADAS&ME (688900)
[12, 2016] Page 13 of 18 [VTI]
ANNEX 1: Confirmation by data protection officer at VTI
Adaptive ADAS to support incapacitated drivers Mitigate Effectively risks through tailor
made HMI under automation
ADAS&ME (688900)
[12, 2016] Page 14 of 18 [VTI]
ANNEX 2: Informed Consent of ADAS&ME
Adaptive ADAS to support incapacitated drivers Mitigate Effectively risks through tailor
made HMI under automation
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] Page 15 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] Page 16 of 18 [VTI]
ANNEX 3: Information to be added in the information sheet to
participants
Adaptive ADAS to support incapacitated drivers Mitigate Effectively risks through tailor
made HMI under automation
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] Page 17 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] Page 18 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
Claus Pecha
unhofer.de
No
At this point the legal
representative of
IDIADA Automotive
Technology S.A is in
charge