#  Introduction

This deliverable, due in the sixth month of the project, provides a first
version of the EnTIRE data management plan (DMP). The document describes how
the collected and generated data will be handled during and after lifecycle
the project. The DMP will be updated, where necessary during the EnTIRE
project. This document is based on the Template for the ERC Open Research Data
Management Plan (DMP)  1  .

#  Background

The EnTIRE project aims at providing a mapping of the Research Ethics (RE) and
Research Integrity (RI) normative framework which applies to scientific
research conducted in the EU and beyond. The mapping in this project generates
various forms of data. The data includes but is not limited to RE+RI rules and
procedures, educational materials, best practices, and illustrative case
studies in Europe. Organizing and disseminating this data is the primary
objective of this project. During this project the scope of the data will be
decided upon by the stakeholders (WP2). The data will be compiled from
existing closed and open data sources. New data will also be produced, mostly
in relation to the interpretation of existing data. The size of the data is
expected to gradually increase and reach approximately 2,500 items after 4
years.

#  Data summary

##  Purpose of the data collection/generation

The overall aim of the data collection within the project is to map the RE+RI
normative framework and make it freely available and (re)usable. For this
purpose Work Package (WP) 2, 3, 4 and 5 are dedicated to data collection.

The purpose of this data collection is:

  1. to explore RE+RI experiences and practices, defining the boundaries of data to be collected, and developing a mapping structure adapted to user needs (WP 2, stakeholder consultation). 

  

  2. to gather information on: relevant normative elements, including RE+RI rules and procedures, educational materials, illustrative cases, and relevant institutions across EU countries (WP 3‐4‐5). 

  

  

##  Relation to the objectives of the project

Organizing and disseminating the data is the primary objective of this
project. This will be achieved by developing a Wiki platform which will
collect all the data gathered during the project and present them in a
user‐friendly and needs‐oriented way. The data collected are mostly publicly
available but not easily findable or searchable. The goal of the project is to
retrieve those data from different sources and make them available on one
platform (purpose 2), owned by the community of users and tailored to its
specific needs (purpose 2).

##  Types and formats of data generated/collected

For a detailed overview of the types and formats of data collected and
generated please see Annex1 (Detailed DMP). Where data will be made publicly
available, FAIR principles are followed as indicated.

The mapping in this project generates mainly textual data. Other forms of
produced data include software modifications that will be used to employ and
optimize the platform. This data will be made publicly and freely available on
current open source repositories according to the original licenses of the
software packages (e.g. Semantic MediaWiki). For each WP a short description
of the types and formats of data collected is provided here below:

  1. WP2: Stakeholder consultation 

  

  

The data collected in WP 2 consists of focus group recordings, transcripts,
and basic data from a survey (using EUSurvey tool) of focus groups
participants’ basic background characteristics.

  2. WP3: Guidelines and regulations on RE&RI in the European Union 

  

  

The data collected in Work package 3 will be composed of text files which are
part of the public domain. These data will be composed by: guidelines,
standards, laws, and codes in European countries.

  3. WP4: Resources for RE+RI 

  

  

The data collected in Work package 4 will be composed of publicly available
data on 1) training opportunities for Research Ethics and Research Integrity
(RE+RI), 2) existing RE+RI bodies in Europe and 3) RE+RI experts.

  4. WP5: Cases, casuistry and scenarios 

  

  

The data collected in Work package 5 will be composed by RE+RI case references
(including web URLs, DOIs and standard academic citations) and case tags,
which will result from searches in different potential sources, e.g. academic
literature, reports of RE+RI committees, professional regulators, grey
literature, media outlets and the blogosphere .

##  Origin of the data

Most of the data will be gathered from existing sources (closed and open
ones). New data will also be produced (e.g. when consulting stakeholders and
creating casuistry for educational purposes).

A general description of the origin of the data can be found here below:

  1. WP2: Stakeholder consultation 

     * Face‐to‐face focus groups and in an online survey from 16 people in each of the following countries: Spain, the Netherlands and Croatia; 

  

     * Online focus groups and in an online survey from approximately 350 people from other EU countries. 

  

  

  2. WP3: Guidelines and regulations on RE &RI in the European Union 

     * Google, Google Scholar and PubMed; 

  

     * Relevant RE RI organization across Europe. 

  

  

  3. WP4: Resources for RE+RI 

     * Scientific articles, reviews, books, examples and training materials, available on MEDLINE and SCOPUS databases (current output from pilot search strategies include 22426 and 16194 publications, respectively); 

  

     * Specialized sites, like ORI (Office for Research Integrity) website ( _https://ori.hhs.gov/_ ) and RRI Tools ( _https://www.rri‐tools.eu/_ ); 

  

     * Website from universities; websites of EU projects, identified in EU project website _http://cordis.europa.eu/_ ; 

  

     * Data from networks of RE+RI bodies in Europe, such as ENRIO – European Network of Research Integrity Offices ( _http://www.enrio.eu/_ ) and EURECNET – network of national Research Ethics Committees (RECs) associations ( _http://www.eurecnet.org/index.html_ ); 

  

     * Webpages of EU projects addressing RE+RI (such as ENERI ( _http://eneri.eu/_ ), 

  

  

  

DEFORM ( _https://www.deform‐h2020.eu/_ ), PRINTEGER

( _https://printeger.eu/_ );

  * Public information on RE+RI experts from the above sources. 

  

  4. WP5: Cases, casuistry and scenarios 

     * Academic Literature; 

  

     * Reports by RE+RI Committees and Regulatory Bodies; 

  

     * Grey Literature; 

  

     * Media Outlets; 

  

     * The Blogosphere; 

  

     * Online Repositories; 

  

     * WP2’s Focus Group Sessions. 

  

  

  

##  Expected size of the data

The data uploaded on the final platforms is expected to gradually increase and
reach approximately 2,500 unique persistent items after 4 years (WP 3‐ 5 will
each produce approximately 500 unique content items). The community will be
expected to produce a thousand items. As multiple formats will be allowed
(e.g. textual data, images, video, sound), the expectation is that the
resulting database will be around 2.5 Gigabytes in size.

##  Outline the data utility

The collected data will be relevant for the stakeholders (RI+RE community).
This means that the data collected will be relevant both for researchers, who
will find support for good research practices in the content available on the
EnTIRE platform, and for the general public, who will be able to use the
platform to find easily accessible and user friendly information on research
subject related information. Moreover the software modification data will be
available for future knowledge management EU founded projects.

#  FAIR data

The project will use FAIR data principles  2  where possible for public data.
An analysis was performed on all data generated. A detailed analysis can be
found in Annex 1.

##  Making data findable, including provisions for metadata

###  Discoverability of data (metadata provision)

Data can be found in multiple ways. Common search engines can be employed to
search through the data, but the dataset will also be made available on the
platform for offline analysis. A description of metadata and an instruction
for (re)use will be made available on the platform.

###  Identifiability of data

Two main provisions will be used. The URL naming on the platform is persistent
for content. Also, Digital Object Identifiers will be employed for reviewed
content to make data entries persistent and easily retrievable and citable to
scientists.

###  Naming conventions

The naming convention used will be based on the analysis of terminology in
RE+RI, as will result from the work from WP3‐WP5.

###  Approach towards search keyword

Three main approaches will be employed:

  1. Keywords will be included in the page of the online platform to increase searchability by common search engines. These keywords will be based on the analysis of terminology in RE+RI. 

  

  2. Users on the platform will be given the opportunity to add tags to content. This folksonomy approach is more flexible and dynamic and ensures that over the longer term, keywords match what people are looking for themselves. 

  

  3. The search of users on the platform will be analyzed to investigate what users are looking for and if they found it. This analysis can be used to tailor the keywords to match what users are searching for on the platform. 

  

  

###  Approach for clear versioning

The Mediawiki software has a versioning system which tracks every modification
made on the platform. This overview of modifications (an identification number
together with a data) will be made available online. This ensures that when
cited, the specific version of the document can be traced back.

###  Metadata creation

For the interpretation of existing data, metadata and vocabularies of metadata
will be created. These will conform to existing vocabularies where possible.
We will investigate if standards are present in the RE+RI field. The system of
creating the metadata and vocabularies is currently under development. The
approach taken will include a systematic search for current vocabularies and
metadata in science and RE+RI which would be appropriate to annotate the data.
Their suitability will be reviewed and these will be employed, or adapted and
extended where necessary. In the future, folksonomy will also be employed by
having the community tag content, to improve flexible re‐use, searchability
and analysis of data.

##  Making data openly accessible

In principle all data produced in the project will be made openly available on
the platform (this includes raw data, metadata, research protocols research
outcomes). All different WP leads are responsible for uploading the data on
the platform.

All data can be accessed and interpreted on the platform itself or can be
downloaded from the platform and analyzed with open source or feely available
software. The platform itself will have a written instruction, including an
explanimation how to work with the data and how to easily upload new data. For
open source software, other avenues will be used (e.g. Github  3  ). For a
detailed overview of publication of the data, see Annex 1. In general, the
platform will be the primary avenue for data publication. All different WP
leads are responsible for uploading the data on the platform.

###  Ethical concerns related to publication

For sensitive data which will not be made publicly available, researchers can
contact the relevant Work Package lead. Contact details and instructions will
be present on the platform.

In order to avoid the risk of participants’ personal knowledge of deviant
cases being exposed to others the data collected by WP2 (stakeholder
consultation) and WP5 (cases casuistry and scenarios) will not be fully
published. Special measures will be adopted to ensure the protection of
privacy and confidentiality:

  1. Cases and quotes from the focus groups will be anonymized and published only after written consent; 

  

  2. Full transcripts of the face‐to‐face and online focus groups interview will not be published and will only be accessible for authorized study personnel; 

  

  3. Audio recordings of face‐to‐face focus groups will be destroyed after they have been transcribed and quality checks have been conducted. A data erasure software will be used in order to assure permanent erasure. 

  

  4. Any sensitive data collected will be stored electronically in ‘Dark Storage’, a maximum security data storage facility at VUmc. 

  

  5. Cases collected from RECs and regulatory bodies will be made publicly available via the online platform only after written consent. 

  

  

Moreover in order to protect the intellectual property of the authors grey
literature, such as government reports, will be made publicly available by WP5
only after written consent by the author.

Foreseeable privacy and related and ethical concerns are also addressed in
Annex 1.

###  Methods or software tools are needed to access the data

The data can be accessed using a conventional internet browser or a an open
source (i.e. Python  4  ) or closed source software package (Matlab  5  ,
Mathematica  6  ). Data will be available on the platform but it will also be
possible to export documents and data for on and offline use. All members of
the community working on the platform will commit data based on the latest
Creative Commons License (4.0) ensuring an open data and open access approach.
This adheres to the license requirements of Wikimedia  7  . Documentation
which includes the instructions to handle the data will be available on the
platform.

##  Making data interoperable

In general, all data gathered and produced in the project will be viewable and
interoperable. In order to facilitate interoperability semantic MediaWiki
system will be used. In general, data, metadata and vocabularies will be
generated (see above, section 2.1.4). The system of creating the metadata and
vocabularies is currently under development.

The identification of relevant topics and concepts relating to textual data
will be encoded in metadata. The topics and concepts which will be used for
the metadata structure are not common. They will be developed through
collaboration between experts and the community of users. The resulting
metadata vocabularies will be available on the platform.

For a detailed overview, see Annex 1.

##  Increase data re‐use (through clarifying licenses)

All the data uploaded on the platform will be made available through the
Creative Commons License structure where applicable. In cases of copyright,
data will be linked to instead and deduced work will be made available under
the Creative Commons License where possible.

The data will be available from early on in the project. It is estimated that
the first data to be available is at the 1 year time point (May 2018).

Except for some exceptions where privacy concerns outweigh data availability
(for the specifics, see section 2.2.1 and Annex 1), all data will be made
available for re‐use. No commercial re‐use of the data will be allowed prior
to written consent from the consortium lead (WP1).

###  Data quality assurance processes

A continuous evaluation of the quality of the data uploaded on the platform is
part of WP 6 (Platform development and maintenance). WP 7 (Community
engagement communication and dissemination) will involve curators who will
review and invite to edit sections of data on the platform.

#  Allocation of resources

In this project the data is FAIR by design. This will in the long term reduce
the upkeep costs of the platform. No additional costs are associated with FAIR
data management. As the availability of the data can be expected to be
valuable to many stakeholders, a plan will be created to ensure long term
preservation and distribute the long‐term upkeep costs amongst the
stakeholders (WP 7).

Data management is initially the primary responsibility of project
co‐ordination (WP 1).

During the project, this responsibility is gradually distributed to the
community (WP 7).

#  Data security

##  Data recovery, secure storage and transfer of sensitive data

The ICT partner, gesinn.it (nr.2 GI) (expert for automating information and
knowledge management based in Germany) will be responsible for data security
on the platform. Standard measures such as data backup and good computer
security practices will be used to ensure data security. In order to guarantee
data security, user authentication (SHA‐512) and SSL (HTTPS) will be used.

In case of a data breach, affected users of the community will be contacted,
the server will be taken offline and leaks in the platform will be solidified
within 48 hours. Any breach of the integrity of the IT system will be reported
to the national and/or international governing bodies.

Long term preservation of data will be ensured by storing the platform and its
data on certified open source repositories. For this purpose a Europe based
provider with twostage authentication, SSL and AES‐256 bit encryption
conforming to the latest standard in IT will be selected.

Transfer of sensitive data will be made by establishing a secure connection
(SSL). Any sensitive data which might result from the stakeholder consultation
(WP2) will be stored in ‘Dark Storage’, a maximum security data storage
facility at VUmc (NL).

#  Ethical aspects

Most of the data collected within the project come from the public domain.

However, the project involves research with human participants (questionnaire,
focus groups). Participants will not be exposed to the risk of physical
injury, financial, social or legal harm, and potential psychological risks
will not exceed the daily life standard.

Privacy and confidentiality of research participants and of the members of the
community on the platform will be protected. Before publishing information on
the EnTIRE platform, confidentiality and privacy issues will always be
addressed. If necessary, informed consent will be obtained (as specified in
section 2.2.1 and Annex 1). We are not aware of and do not expect any
potentially critical ethical implications of the research results such as the
protection of dignity, autonomy, integrity and privacy of persons,
biodiversity, protection of the environment, sustainability or animal welfare.
The proposed research does NOT include research activity aimed at human
cloning, intended to modify the genetic heritage of human beings, to create
human embryos, or involving the use of human embryos or embryonic stem cells.
This research proposal does NOT include any security sensitive issues.

Data will primarily be stored in Europe based servers. No primary results will
be exported to the US without their primary location being on the EU soil.
Ethical standards and guidelines of Horizon2020 will be rigorously applied,
regardless of the country in which the research is carried out.

The Ethics deliverables have been submitted on September 30th and attached to
this document (Annex 2).

**APPENDIX 1**

**Detailed data management plan**

**APPENDIX 2**

**Ethics deliverables**

This project has received founding from the European Union H2020 research
**14** and innovation programme under the grant agreement n. 741782.

Mapping Normative Frameworks of

EThics and Integrity of REsearch

**Ethics Requirements: H –**

**Requirement N**

**o**

**. 1**

WP 8 H – Requirement No 1.  
  
<table>  
<tr>  
<td>

**Project details**

</td>  
<td>

</td> </tr>  
<tr>  
<td>

**Project:**

</td>  
<td>

Mapping Normative Frameworks of EThics and Integrity of REsearch

</td> </tr>  
<tr>  
<td>

**Project acronym:**

</td>  
<td>

EnTIRE

</td> </tr>  
<tr>  
<td>

**Project start date:**

</td>  
<td>

01.05.2017

</td> </tr>  
<tr>  
<td>

**Duration:**

</td>  
<td>

48 months

</td> </tr>  
<tr>  
<td>

**Project number:**

</td>  
<td>

741782

</td> </tr>  
<tr>  
<td>

**Project**

**Coordinator:**

</td>  
<td>

Vrije Universiteit Medisch Centrum (VUmc) Amsterdam

</td> </tr> </table>  
<table>  
<tr>  
<td>

**Deliverable details**

</td>  
<td>

</td> </tr>  
<tr>  
<td>

**Work Package:**

</td>  
<td>

WP 8 Ethics Requirements

</td> </tr>  
<tr>  
<td>

**Deliverable description:**

</td>  
<td>

H – Requirement No 1.

</td> </tr>  
<tr>  
<td>

**Work package leader:**

</td>  
<td>

Vrije Universiteit Medisch Centrum (VUmc) Amsterdam

</td> </tr>  
<tr>  
<td>

**Responsible for the deliverable:**

</td>  
<td>

Natalie Evans

</td> </tr>  
<tr>  
<td>

**Submission date:**

</td>  
<td>

30.09.2017

</td> </tr> </table>

**Description of deliverable**

EnTIRE conducts a mapping of the Research Ethics and Research Integrity
(RE+RI) normative framework which applies to scientific research conducted in
the EU and beyond. For the purpose of this project, it is necessary to gather
data on and with humans, including: experiences and attitudes regarding RE+RI;
opinions on the online platform; case studies regarding research
misbehaviours; and best practice examples.

Primary data will be collected through questionaires and focus groups during
the stakeholder consultation (WP2) and secondary (publically available) data
will be collected by the work package gathering cases, casuistry and scenarios
(WP5).

This deliverable provides:

  1. Detailed information on the informed consent procedures that will be implemented for the participation of humans in the proposed activities (e.g. stakeholder consultation). 

  

  2. Templates of the informed consent forms and information sheet 

  

  3. Copies of the ethics approval or waiver forms for the stakeholder consultation from the Netherlands, Croatia and Spain. 

  

  4. Details about the approach for publishing publically available cases 

  

  

**Stakeholder consultation (Work package 1)**

EnTIRE’s stakeholder consultation will identify the RE+RI issues of concern to
the stakeholders, practical experience with regulations and guidelines and
other professional, institutional and national norms, resources, and existing
best practices. The consultation will also be used to generate, and to reflect
on, instructive cases from local practice.

The stakeholder consultation has been described in detail in Deliverable 2.1
‐“Protocol for the phased multi‐country stakeholder consultation”. The
consultation consists of face‐toface and online focus groups. Further details
on the informed consent procedure, privacy and confidentiality, data
management and ethics approval are given below.

**Informed consent procedure**

**Participant information letter**

####  _Face‐to‐face focus groups_

Stakeholders interested in participating in the face‐to‐face focus groups will
be sent the below information sheet. Information in red must be adapted
depending on the location of the focus group.

**Invitation to participate in focus groups for the stakeholder consultation
‘Mapping the**

**Normative Framework of Ethics and Integrity of Research (EnTIRE)’** Dear
Sir/Madam,

We at the EnTIRE project aim to create an online website that makes
information about research ethics and research integrity easily accessible to
the research community. This European Commission funded project seeks to
include all stakeholders in a participatory way. As such, we are conducting an
in‐depth stakeholder consultation amongst people involved in research. We aim
to consult: researchers, journal editors, national and local ethics/integrity
committees, policy makers, representatives from industry (including
pharmaceutical companies), and representatives from research funding
organisations.

We would like to invite you to participate in these focus groups. By agreeing,
you commit to participating in two separate discussions approximately one week
apart in (insert city). They will be led by researchers from VU University
Medical Center (in collaboration with The University of Split Medical
School/European University of Madrid). As this is a Europe‐wide consultation,
the language of the focus groups will be English. Furthermore, one third of
participants from the Dutch/Spanish/Croatian focus groups will be invited to
participate in an additional focus group in Amsterdam that will bring together
participants from parallel studies in (insert the two other countries) to
discuss similarities and differences between countries.

All focus group discussions will take place in Autumn 2017. This letter
contains details about the project and the stakeholder consultation so you can
make an informed decision whether you would like to participate in the focus
groups or not.

  1. **Aim of the focus groups**

  

  

In the first focus group, we will discuss your experiences of research ethics
and research integrity issues. This will allow us to develop an understanding
of any difficulties you might encounter as well as ideas you might have on how
you could be better supported in the future, particularly in regard to
informational needs. For example, if researchers say they do not know data
management guidelines, or the procedure for raising concerns about integrity
of research practices, or, alternatively, have suggestions for improvement, we
can identify those issues and suggestions as relevant for gathering
information and putting this on the website.

The second focus group, taking place approximately two weeks later, will
involve a presentation of the pilot version of the website and a discussion
about its content and presentation. This will further help us understand if we
need to collect any information additional to the preliminary data collection
categories of: guidelines, codes, legislations, and standards; committees,
training courses and expert advice and contacts; cases, casuistry and
scenarios. Participants will also help us understand if we are presenting
information in an optimal way or how this might be improved.

The third, potential, focus group, will bring participants together from the
Netherlands Spain, and Croatian to discuss similarities and differences
between countries. This will provide us with an understanding of the diversity
of informational needs across different EU countries, and with suggestions on
how to deal with them in presenting data on the website.

  2. **What is involved?**

  

  

If you would like to participate, we will invite you to two focus group
sessions at the VUmc, Amsterdam. The preliminary dates are:

Round 1. date of first focus group

Round 2. date of second focus group

Each of these focus groups will take about 2 hours.

There is also the possibility that you will be invited to a day‐long workshop
held at the VUmc,

Amsterdam, that will bring together one third of the participants from the
focus groups in the Netherlands, Spain, and Croatia.

Round 3. date of third focus group

If you cannot make these dates but would like to join the focus groups, we
would still like to hear from you as we might conduct individual interviews
with stakeholder groups under‐represented in the focus group discussions.

Before attending the focus group, we will ask you to complete a short
questionnaire (sent via email and taking about 15 minutes) about your
background: gender, age, role (depending on the stakeholder group – e.g.
academics will be asked their area of expertise (biomedical, social sciences,
natural sciences, applied sciences) and position (PhD student, Research
Associate, Assistant Professor, Professor, Head of Department), years of
experience, nationality and country of residence. The questionnaire will also
include a couple of open questions about what you know about research ethics
and research integrity and what support is currently available to you.

  3. **Benefits and risks of participating**

  

  

The direct benefits of participating in the research are that participants can
share experiences and contribute to the development of the platform, thus
being able to actively bring in and broaden their knowledge and experience;
mostly, however, the benefits are indirect, they will be accrued by the
research community as a whole which will benefit from access to a website that
makes information about research ethics and research integrity easily
accessible. The website will also potentially foster the uptake of ethical
standards and responsible conduct of research in Europe, and ultimately
support research excellence and strengthen society’s confidence in research
and its findings. One risk associated with the focus group is other people
knowing the details about any research misconduct you might describe. Efforts
to minimize this risk include asking all participants to return
confidentiality agreements, and to avoid the use of identifying
characteristics. In addition, the time commitment required for two (and
potentially three) focus groups discussions may prove inconvenient.

  4. **If you do not want to join or want to stop the group conversation**

  

  

Participation is voluntary. If you do not want to participate, you do not have
to do anything and you are not required to let us know. If you decide to
participate, you must sign the attached informed consent form and return it
via email prior to the focus group. If you have agreed to participate but
change your mind, you can of course withdraw at any point (including during
the focus group discussions), we would ask you kindly to inform us if this is
the case.

  5. **Use of data and dissemination of research findings to participants**

  

  

The focus groups will be recorded. These recordings will be destroyed after
they have been transcribed. Personal data, such as informed consent forms and
answers to the questionnaire, will be stored separately from the discussion
transcripts. Personal data will be destroyed within 6 months of the end of the
focus group discussions. The transcripts of the focus groups will be kept for
up to 15 years after the end of the study (in accordance with EU and
Dutch/Spanish/Croatian data protection laws). All data is anonymised for
analysis. The findings from the stakeholder consultation will also be
published and made publically available on the Project’s page on the European
Commission research information portal:
_http://cordis.europa.eu/project/rcn/210253_en.html_

  6. **Financial aspects**

  

  

There is no fee paid for participation, however all travel expenses will be
reimbursed. If you are invited to the third, international focus group, your
travel and accommodation will be reimbursed according to local university
rules and you will receive 70 euros per diem to cover your expenses in the
country.

  7. **Do you have any questions?**

  

  

Please do not hesitate to contact the consultation project coordinator, Dr.
Natalie Evans _n.evans@vumc.nl_ , if you have any hestions.

####  _Online focus groups_

Online focus group participants will receive a similar information sheet to
the face‐to‐face focus group participants, but tailored to the online
procedure:

**Invitation to participate in focus groups for the stakeholder consultation
‘Mapping the**

**Normative Framework of Ethics and Integrity of Research (EnTIRE)’** Dear
Sir/Madam,

We at the EnTIRE project aim to create an online website that makes
information about research ethics and research integrity easily accessible to
the research community. This European Commission funded project seeks to
include all stakeholders in a participatory way. As such, we are conducting an
in‐depth stakeholder consultation amongst people involved in research. We aim
to consult: researchers, journal editors, national and local ethics/integrity
committees, policy makers, representatives from industry (including
pharmaceutical companies), and representatives from research funding
organisations.

We would like to invite you to participate in this stakeholder consultation
via participation in online focus groups.

By agreeing, you commit to participating in two online discussions, one
focusing on your perspectives and experiences of research ethics and research
integrity issues, the other focusing on your opinions about the proposed
website. Each will take place over a period of two weeks, with a period of two
weeks inbetween, with a new question posted every two days. You will receive
an email each time a new question is posted.

You will interact with other participants anonymously and discussions will be
facilitated and moderated by researchers from VU University Medical Center. As
this is a Europe‐wide

consultation, the language of the focus groups will be English.

All focus group discussions will take place Jan‐March 2018. This letter
contains details about the project and the stakeholder consultation so you can
make an informed decision whether you would like to participate in the online
discussions or not.

  1. **Aim of the focus groups**

  

  

In the first focus group, we will discuss your experiences of research ethics
and research integrity issues. This will allow us to develop an understanding
of any difficulties you might encounter as well as ideas you might have on how
you could be better supported in the future, particularly in regard to
informational needs. For example, if researchers say they do not know data
management guidelines, or the procedure for raising concerns about integrity
of research practices, or, alternatively, have suggestions for improvement, we
can identify those issues and suggestions as relevant for gathering
information and putting this on the website.

The second focus group, taking place approximately two weeks later, will begin
with a short video about our proposed website, followed by a discussion about
its content and presentation. This will further help us understand if we need
to collect any information additional to the preliminary data collection
categories of: guidelines, codes, legislations, and standards; committees,
training courses and expert advice and contacts; cases, casuistry and
scenarios. Participants will also help us understand if we are presenting
information in an optimal way or how this might be improved.

  2. **What is involved?**

  

  

If you would like to participate, we will invite you to two online discussions
taking place over a two week period (with two weeks in between).

Round 1. date of first focus group

Round 2. date of second focus group

Before participating, we will ask you to complete a short questionnaire (sent
via email and taking about 15 minutes) about your background: gender, age,
role (depending on the stakeholder group – e.g. academics will be asked their
area of expertise (biomedical, social sciences, natural sciences, applied
sciences) and position (PhD student, Research Associate, Assistant Professor,
Professor, Head of Department), years of experience, nationality and country
of residence. The questionnaire will also include a couple of open questions
about what you know about research ethics and research integrity and what
support is currently available to you.

  3. **Benefits and risks of participating**

  

  

The direct benefits of participating in the research are that participants can
share experiences and contribute to the development of the platform, thus
being able to actively bring in and broaden their knowledge and experience;
mostly, however, the benefits are indirect, they will be accrued by the
research community as a whole which will benefit from access to a website that
makes information about research ethics and research integrity easily
accessible. The website will also potentially foster the uptake of ethical
standards and responsible conduct of research in Europe, and ultimately
support research excellence and strengthen society’s confidence in research
and its findings. One risk associated with the focus group is other people
knowing the details about any research misconduct you might describe. Efforts
to minimize this risk include: anonymous interaction within the online
discussion; asking all participants to return confidentiality agreements; and,
asking participants to avoid using details that migth identify themselves or
others. In addition, the time commitment required to respond to online
comments may prove inconvenient.

  4. **If you do not want to join or want to stop the group conversation**

  

  

Participation is voluntary. If you do not want to participate, you do not have
to do anything and you are not required to let us know. If you decide to
participate, you must sign the attached informed consent form and return it
via email prior to the focus group. If you have agreed to participate but
change your mind, you can of course withdraw at any point (including during
the focus group discussions), we would ask you kindly to inform us if this is
the case.

  5. **Use of data and dissemination of research findings to participants**

  

  

Data from the online discussion threads will be collected by [name of online
focus group provider], who have been selected based on their compliance with
EU data protection acts and their ability to guarantee that participants can
interact anonymously. Personal data, such as informed consent forms and
answers to the questionnaire, will be stored separately from the discussion
transcripts. Personal data will be destroyed within 6 months of the end of the
focus group discussions. The discussion transcripts will be kept for up to 15
years after the end of the study (in accordance with EU and Dutch data
protection laws). All data is anonymised for analysis. The findings from the
stakeholder consultation will also be published and made publically available
on the Project’s page on the European Commission research information portal:

_http://cordis.europa.eu/project/rcn/210253_en.html_

  6. **Financial aspects**

  

  

There is no fee paid for participation, however all travel expenses will be
reimbursed. If you are invited to the third, international focus group, your
travel and accommodation will be reimbursed according to local university
rules and you will receive 70 euros per diem to cover your expenses in the
country.

  7. **Do you have any questions?**

  

  

Please do not hesitate to contact the consultation project coordinator, Dr.
Natalie Evans _n.evans@vumc.nl_ , if you have any hestions.

**Informed consent and confidentiality agreement**

On agreeing to participate, stakeholders from both the face‐to‐face and online
focus groups will be sent a short online questionnaire (for details see
Deliverable 2.1) and an informed consent and confidentiality agreement (see
below) via email.

**Informed consent and confidentiality agreement**

Please read the statements below in connection with the research **‘** Mapping
the Normative Framework of Ethics and Integrity of Research (EnTIRE):
stakeholder consultation’ and sign if you are in agreement with all of the
statements.

‐ I have read the information sheet.

‐ I was given the opportunity to ask any questions and any questions I did
have were sufficiently answered.

‐ I had enough time to decide if I would join.

‐ I know that participation is voluntary. I also know that I can decide at any
time that I would like to withdraw my participation and quit the study. I do
not have to give any explanations.

‐ I give permission to make the sound recording.

‐ I give permission for collecting and using my data in the way and for the
purposes stated in the information letter.

‐ I want to participate in this research.

‐ **I agree to maintain the confidentiality of the information discussed by
all participants and researchers during the focus group session.**

Name:

Signature: Date: __ / __ / __

The questionnaire and informed consent and confidentiality agreement need to
be completed before participation.

**Privacy and confidentialty**

One risk associated with the focus group discussions is other people knowing
the details about any research misconduct described. Efforts to minimize this
risk include: anonymous interaction within the online discussion; asking all
participants to return confidentiality agreements; and, asking participants to
avoid using details that migth identify themselves or others. Participants
will also be reminded to respect privacy and confidentiality at the beginning
of each and every focus group (both face‐to‐face and online).

**Data management**

The burden of responsibility for data protection lies with the Dutch partner
(VUmc).

_Face‐to‐face focus groups_

Audio recordings of face‐to‐face focus groups will be destroyed after they
have been transcribed and quality checks have been conducted, and only the
transcripts will be archived.

_Online focus groups_

Data from the online discussions will be collected through third party
software. A suitable party will be chosen in the next months, and will be
selected based on their compliance with EU data protection acts and their
ability to guarantee anonymity. A data processing agreement with this party
will be constructed and signed.

Face‐to‐face and online focus group transcripts will have any identifying
information removed as much as possible, and will only be accessible to
authorized study personnel. Any sensitive data collected will be stored
electronically in ‘Dark Storage’, a maximum security data storage facility at
VUmc.

**Ethics approval**

Ethics approval or excemption documents have been obtained in the Netherlands
(for the Dutch face‐to‐face and the multi‐country online focus groups), Spain
(for the Spanish faceto‐face focus groups) and Croatia (for the Croatian
face‐to‐face focus groups).

**Case, casuistry and scenarios (Work package 5)**

The data collection work package ‘Cases, casuistry and scenarios’ will collect
publically available information about published RE+RI cases. Some of these
may contain identifying data, however this will be removed before being
published on the online platform.

15

Mapping Normative Frameworks of

EThics and Integrity of REsearch

**Ethics Requirements: POPD –**

**Requirement N**

**o**

**. 2**

WP 8 POPD – Requirement N  o  2\.  
  
<table>  
<tr>  
<td>

**Project details**

</td>  
<td>

</td> </tr>  
<tr>  
<td>

**Project:**

</td>  
<td>

Mapping Normative Frameworks of EThics and Integrity of REsearch

</td> </tr>  
<tr>  
<td>

**Project acronym:**

</td>  
<td>

EnTIRE

</td> </tr>  
<tr>  
<td>

**Project start date:**

</td>  
<td>

01.05.2017

</td> </tr>  
<tr>  
<td>

**Duration:**

</td>  
<td>

48 months

</td> </tr>  
<tr>  
<td>

**Project number:**

</td>  
<td>

741782

</td> </tr>  
<tr>  
<td>

**Project**

**Coordinator:**

</td>  
<td>

Vrije Universiteit Medisch Centrum (VUmc) Amsterdam

</td> </tr> </table>  
<table>  
<tr>  
<td>

**Deliverable details**

</td>  
<td>

</td> </tr>  
<tr>  
<td>

**Work Package:**

</td>  
<td>

WP 8 Ethics Requirements

</td> </tr>  
<tr>  
<td>

**Deliverable description:**

</td>  
<td>

POPD – Requirement N  o  2\.

</td> </tr>  
<tr>  
<td>

**Work package leader:**

</td>  
<td>

Vrije Universiteit Medisch Centrum (VUmc) Amsterdam

</td> </tr>  
<tr>  
<td>

**Responsible for the deliverable:**

</td>  
<td>

Natalie Evans

</td> </tr>  
<tr>  
<td>

**Submission date:**

</td>  
<td>

30.09.2017

</td> </tr> </table>

2