**Introduction**

The Made4You project is committed to high quality output and responsible
research and innovation. Thus, this document defines a set of procedures that
the consortium is committed to adhere to and to improve in the course of the
project.

Openness and transparency are two of the guiding principles that the reader
will see reflected in the different processes and methods described. At the
same time there is a strong awareness within the consortium related to privacy
and data protection of individual citizens. These core principles underlying
the research work in Made4You correspond with the practices related to
Responsible Research and Innovation (RRI).

Section 2 below describes the management structures, including the nominees
for the various boards. Section 3 is dedicated to specific quality management
procedures, including communication structures and tools, the peer reviewing
process for high quality deliverables as well as risk management, SWOT and
other quality assurance means. In Section 4 the technical infrastructure for
communication and collaboration is presented. Section 5 presents the RRI
policies and identifies the most relevant aspects for Made4You. It includes
the ethical approach and guidelines that the project is following (together
with deliverables D8.1 and D8.2). In Section 6 the consortium’s strategy
towards openness is described and relates to open source in terms of software
as well as open access in terms of publications and other project results.
Finally, Section 7 draws the conclusions that are relevant for a high quality
implementation of the project.

The appendix includes examples of templates mentioned throughout the document.

**2**

**Management structure**

Both the Grant Agreement (GA) and the Consortium Agreement (CA) specify a
number of bodies for the management of the project. Though the GA and CA,
being legal documents, take precedence over this handbook, the following
sections specify the operational view of these bodies.

Made4You is a large-scale innovation action aiming at a wide community on a
global scale. Therefore, the management structure and procedures work in a
**flexible manner** in order to:

  * Achieve integration of all consortium members and to mobilise their expertise, knowledge and networks in every stage of the project 

  

  * Efficiently coordinate the processing of the work plan in a collaborative environment 

  

  * Continuously involve contextual expertise and knowledge of relevant stakeholders (patients, families, healthcare professionals, makers) and their networks 

  

Our approach is a combination of integration and decentralisation strategies.
_Integration_ is achieved through the composition of a consortium with
complementary skills and knowledge, the development of a joint framework, the
agreement on common guidelines for co-design activities, the joint work on the
platform and community development, and project workshops and meetings. The
resources of all partners will be mobilised by _decentralisation of
responsibilities_ through the assignment of leadership for work packages and
defined work package tasks with a clear task sharing based on the different
competence fields of the partners.

**Figure 1: Made4You – Management Structure: responsible roles in management**

The management structure defines the basic roles and responsibilities. The
Coordinator (Dr. Barbara Kieslinger, ZSI) is responsible for the overall line
of actions and the day-to-day management carried out by the project.
Additional ZSI staff is providing financial and administrative support to the
coordinator.

The Project Coordinator is supported by the WP leaders in the strategic
coordination of the innovation action. In addition, the Community Manager, who
is also coordinating the dissemination and exploitation WP, is responsible for
the coordination of the Made4You extended network. In close cooperation with
the project manager the community manager will take care of the broad
visibility of the project, amongst specific stakeholder groups and will have a
special interest in the exploitation and transferability of the project
results.

##  2.1 Work Package (WP)

The work package (WP) is the building block of the project. The WP leader

  * organizes the WP and coordinates the different tasks, 

  

  * prepares and chairs WP meetings, 

  

  * organizes the production of the results of the WP, • represents the WP in the Project Management Board. 

  

Each work package has been appointed a Work Package Leader who is responsible
for the progress within the work package and who is supported by task leaders
and other members of the consortium involved in each of the WPs. Clear
responsibilities (based on the competences of each partner) are described in
the Work Package Description. Current WP leaders are shown in Table 1.  
  
<table>  
<tr>  
<th>

**Workpackage**

</th>  
<th>

**Lead partner**

</th>  
<th>

**Name**

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

WP1 Engagement & Community Growth

</td>  
<td>

WAAG

</td>  
<td>

Jurre Ongering

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

WP2 Pilot Open Solutions

</td>  
<td>

MAKEA

</td>  
<td>

Daniel Heltzel

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

WP3 Platform & Tooling

</td>  
<td>

OPEN

</td>  
<td>

Enrico Bassi

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

WP4 Evaluation & Impact Assessment

</td>  
<td>

ZSI

</td>  
<td>

Teresa Schäfer

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

WP5 Dissemination & Outreach

</td>  
<td>

GIG

</td>  
<td>

Sandra Mamitzsch

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

WP6 Lethal & Ethical Aspects

</td>  
<td>

KUL

</td>  
<td>

Erik Kamenjasevic

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

WP7 Project Management

</td>  
<td>

ZSI

</td>  
<td>

Barbara Kieslinger

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

WP8 Ethical requirements

</td>  
<td>

ZSI

</td>  
<td>

Barbara Kieslinger

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

**Table 1 Current WP leaders**

##  2.2 Project Management Board (PMB)

The project is managed through the Project Management Board (PMB). It provides
the overall direction for the project, both strategic and operational. The PMB
maintains the project directions and obtains advice from the Work Package
Leaders, to ensure that the project meets its stated and implied goals. The
PMB ultimately supervises all project management processes, including
initiation, planning, execution, control, and closure of project phases.
Within this framework, the Work Package Leaders coordinate the detailed
planning, execution and control of the technical tasks to meet the project’s
scientific and technical objectives relevant to their work packages.

The Project Management Board is responsible for the proper execution and
implementation of the decisions of the General Assembly and makes suggestions
to the General Assembly on pending decision such as:

  * Accept or reject changes to the work plan, changes in the Grant Agreement and amendments to the Consortium Agreement 

  

  * Make changes in the Project Management structure 

  

The PMB is chaired by the Project Coordinator and composed of the Work Package
Leaders plus a representative from partners not leading a work package. The
PMB is currently composed of the persons listed in **Table 2** below.  
  
<table>  
<tr>  
<th>

Partner

</th>  
<th>

Partner manager

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

ZSI

</td>  
<td>

Barbara Kieslinger

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

WAAG

</td>  
<td>

Jurre Ongering

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

OPEN

</td>  
<td>

Enrico Bassi

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

GIG

</td>  
<td>

Sandra Mamitzsch

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

MAKEA

</td>  
<td>

Daniel Heltzel

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

WEV

</td>  
<td>

Richard Hulskes

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

KUL

</td>  
<td>

Erik Kamenjasevic

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

TOG

</td>  
<td>

Chiara Nizzola

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

**Table 2: Partner managers**

##  2.3 General Assembly (GA)

The General Assembly is the ultimate decision-making body of the consortium
and functions as highest authority, as last resort of all relevant project
decisions. The body consists of one representative per partner.

A face-to-face general assembly comprising all project consortium partners
will take place at least once a year, to coordinate overall project work.
Additional extraordinary meetings can be held at any time upon request of the
PMB or 1/3 of the members of the GA. Within the project, the general assembly
will function as highest authority, as last resort of all relevant project
decisions.

Decisions taken by the General Assembly include the content, e.g. changes in
the Description of Action (DoA), finances and intellectual property rights.
This body also has the right to decide on the evolution of the partnership
(e.g. entry of new partner), and the project as such (e.g. termination of the
project).

##  2.4 Made4You Advisory Board

The Made4You Advisory Board (MAB) is a group of persons from outside the
project. The MAB will be consulted for important decisions that affect the
direction of research and/or are related to adoption of the results from the
Made4You project.

The MAB members are listed in Table 3.  
  
<table>  
<tr>  
<th>

**MAB member**

</th>  
<th>

**Affiliation**

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

Sherry Lassiter

</td>  
<td>

President of Fab Foundation, MIT

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

John Schull

</td>  
<td>

Co-founder eNABLE

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

David Ott

</td>  
<td>

Global Humanitarian Lab

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

Raul Krauthausen

</td>  
<td>

Sozialhelden

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

**Table 3: MAB members**

During the Kick-off meeting it was decided that this group of external experts
can still be expanded with 2-3 persons for strategic purpose.

##  2.5 Consortium Agreement (CA)

Before the start of the project a consortium agreement has been signed by all
partners. It defines the specific operational procedures for the different
project bodies described above. This includes, amongst other aspects, the
responsibilities of the parties and their liabilities towards each other as
well as the governance structure, financial provision and Intellectual
Property Rights (IPR) issues. The consortium agreement also describes the
decision making structures and defines the General Assembly as the ultimate
decision making body.

#  3 Quality procedures and Code of Conduct

Quality assurance is of high priority in collaborative research, such as
Made4You, and the consortium is committed to a set of quality procedures to
guarantee high quality project output. Measures to ensure good quality include
e.g. the definition of internal communication structures, regular internal
reflections on risks and a proper SWOT analysis (Strengths, Weaknesses,
Opportunities and Threats Analysis) as well as a defined peer review process
for any project deliverable. The detailed procedures will be described in more
detail in the following sections.

##  3.1 Internal communication structures & procedures

Internal communication is first and foremost based on the concept of openness
and transparency. An active communication strategy is implemented to establish
a strong project identity in order to obtain maximum transparency for all
partners involved, and to increase synergy in cooperation.

Daily communication among the WPs, the partners, etc. is established mainly
through

. e-mails and a central mailing list including all project partners,

. a Slack group for quick communication across teams and partners,

. a project space hosted at the ZSI (Nextcloud) for internal exchange and
online storage of all documents as well as offline communication;
https://wolke1.zsi.at/,

. web-conferencing (Skype) for regular online meetings,

. face-to-face communication (during physical project meetings).

The consortium partners meet approximately every three to four months face-to-
face (at synchronisation points) to coordinate the progress.Each month, at
least one virtual consortium meeting takes place via video conferencing,
currently Skype. These meetings ensure the internal communication among
partners, allow the WP Leaders/thematic leaders to coordinate the various
tasks, and report the progress of work to the team members.

During the meeting “live minutes” will be produced and are made accessible to
all partners, to view at a later time. Each team reports about latest updates
before a meeting in a shared document, all participants are invited to get an
update before the meeting starts and the most relevant issues are then
discussed during the meetings. The minutes are available on the Nextcloud.

In addition to these virtual consortium meetings, thematic groups (similar to
WPs, but overlapping in some cases) have started to emerge during the kick-off
meeting and virtual meetings are organised by these working groups. Similar to
the consortium meetings notes and recordings are available on the Nextcloud
and each member of the consortium is invited to attend any of these meetings.

##  3.2 External communication structures & procedures

The communication strategy also aims to effectively communicate with parties
outside the consortium, especially since Made4You is an innovation action that
aims at reaching and engaging a broad audience to create impact.

Stakeholders will be addressed via the community engagement and communications
strategy, which is coordinated in a collaborative effort by WP1 and WP5. The
“ComCom” working group is elaborating the details for the external
communication in terms of procedures and material. Basically different
communication options will be elaborated for the different target groups.

Most importantly, it should be mentioned that Made4You decided to promote the
name of the platform, **Careables (http://www.careables.org)** , and to use
the project name Made4You mainly for administrative purposes.

##  3.3 Quality of (non-)deliverables and peer review

A **peer-review process** for the Made4You project is set up in order to
obtain and guarantee the quality of the deliverables (documentation, reports,
prototypes, etc.) that will be produced during the course of the project and
delivered to the European Commission, offered to the Made4You stakeholders and
more globally to the general public. This section describes standards for the
Made4You deliverables and presents the peer-review procedure. A checklist for
the deliverables and a template for peer-review reports are given in
Appendices to this document.

###  3.3.1 Deliverables

Made4You deliverables serve different purposes. They are a communication means
within the consortium and communication with other people outside the
consortium. They are aimed at transferring the know-how, to exploit the
results and knowledge generated by the project. Deliverables should be written
with their target readers in mind. They should be concise and easy to follow.
The readability of a document is a vital ingredient for its success. The
following general structure should be followed and is as such provided in the
deliverable template of the project:

  * Cover page 

  

  * Amendment History 

  

  * List of Authors/Contributors 

  

  * Table of Contents 

  

  * Abbreviations/Acronyms 

  

  * Executive summary 

  

  * Introductory part 

  

  * Core part 

  

  * References 

  

  * Annexes (optional) 

  

Annex I includes a checklist that should serve as a guideline when preparing a
deliverable. A Made4You deliverable may be comprised of one or more volumes
and may consist of the following parts:

  * The _Main part_ is the part that summarises the results for high-level executives, technical managers and experts with decision-making competence. It is typically one document and may contain Appendices 

  

  * _Annexes_ are optional and have detailed technical information for experts and implementers. They are added to the main part at the end of the document 

  

Project deliverables may be classified according to different confidentiality
levels, such as public (PU), restricted (RE) or confidential (CO). Following
an open access strategy, which the project partners are committed to, all
Made4You deliverables have been classified as PU regarding their dissemination
level in the DoA. PU means completely public access and thus, all deliverables
will be made available on the project website and/or specific open
repositories (see data management plan further below. In the case consortium
members want to change the level of confidentiality of any of the deliverables
this requires a decision by the General Assembly and needs to be convincingly
argued.

In the following, steps to be taken for publishing a deliverable are listed:

  1. These parts form the basis for the deliverable 

     * Title and description of the project deliverables 

  

     * The name(s) of the deliverables editor(s) 

  

     * The deliverable history including names(s) of contributors and internal reviewer(s) in charge of the peer review for the deliverable 

  

  

  2. The people appointed to generate parts of the Deliverable – the authors – provide their contribution to the editor. 

  

  3. The editor(s) prepare draft 0.1 of the Deliverable by assembling and integrating all contributions. This draft is discussed with all authors. It is recommended to involve the internal reviewers already at this stage. 

  

  4. When the editors and the authors are satisfied with the results achieved, the editor issues draft 1.0 and puts it on the Made4You Nextcloud and sends a note to the consortium. 

  

  5. They inform the internal reviewers and ask for a quality check, opinions and constructive comments within a defined deadline (normally one week). 

  

  6. The editor deals with all the comments and problems raised, if necessary with the help of the authors. This is a critical phase due to the many interactions involved. It may be necessary to have a meeting (physical, audio- or video conference) in order to speed up the process for reaching a consensus on the amendments. 

  

  7. The editor prepares draft 2.0, puts it on the Made4You Nextcloud and informs the project manager (Dr. Barbara Kieslinger) and the whole consortium that the deliverable has reached final status and can be submitted to the EC and the reviewers. 

  

  8. The deliverable is sent to the PO and the EC reviewers only by the project manager. 

  

  

###  3.3.2 Peer review process

One of the feasible means to enhance the quality of the project deliverables
is an internal peer review system. Made4You deliverables shall be evaluated by
2-3 reviewers so as to gather diversified and balanced viewpoints.
Deliverables can be reviewed by members of the core project team or colleagues
from the partner institutions as well invited external experts, for example
Advisory Board members.

Peer reviewers should be nominated by the editor(s) at least 3 weeks before
the due date of the deliverable and communicated to the consortium. Nominated
peer reviewers can turn down the invitation with clear justification (e.g.
lack of expertise) and would thus be requested to nominate another candidate.

Consented peer reviewers are required to produce a peer review feedback within
7-10 days after receiving the deliverable from the editor. In case of any
expected delay, peer reviewers should notify the editor and the project
manager immediately. During the review process, peer reviewers are encouraged
to discuss the problems identified in the deliverable with the main
author/editor. Peer reviewers are advised to pay particular attention to the
following points:

  * Is the deliverable aligned with the objectives of the project and relevant work packages? 

  

  * Does the deliverable make a significant contribution to the project or not? 

  

  * Is the content of the deliverable focused on the intended purpose? Is the content of the deliverable presented in a precise and to-the-point manner? 

  

  * Is the length of the deliverable justified? Are there superfluous or irrelevant parts that should be deleted? Are there overlong parts that should be shortened? Are there any parts that are written in flowery language and/or that are unspecific or redundant? 

  

  * Are there many grammatical errors and/or typographical errors and/or incomprehensive sentences? Specifically, clear annotations indicating errors and suggested corrections are very helpful for the authors of the deliverable. The annotated deliverable may be sent back to the editor/authors via email together with the peer review report. 

  

  * Does the deliverable require substantial revision or rewriting? If yes, it will facilitate the revision process if some concrete suggestions on how to improve the deliverable are given. 

  

Peer review results are described in a peer review report/e-mail (see Annex
III), which contains the following information:

  * Basic information about the deliverable, author and peer reviewer 

  

  * Comments on the length and content of the deliverable 

  

  * Major strengths and weaknesses of the deliverable 

  

  * Review summary 

  

If minor or substantial revisions are necessary, authors of the deliverable
should make changes and produce the final version of the deliverable before
due submission date. The final responsibility for the content of the
deliverable remains with the editor and authors and it is thus their final
decision about how to address and integrate the feedback from the peer

reviewers. The review reports will be made available internally for the
consortium only.

**Figure**

**2**

**:**

**Peer review process**

###  3.3.3 Non-deliverables

For non-deliverables, such as publications and dissemination material, the
procedure for deliverables will be used where applicable and with a timeline
that fits the material.

Since there are many types of material, this handbook cannot provide details
for all cases. We distinguish the following broad categories of material.

  * Dissemination material (flyer, website, leaflets, popular science publications, etc.) Default reviewer is the communication manager, supported by project manager. 

  

  * Scientific publication or conference presentation 

  

Reviewed by one or more team members according to focus and contributions

##  3.4 Internal surveys

Made4You is committed to a **continuous improvement process** on the project
management level. In addition to open and transparent communication and
decision-making, the project management uses anonymous surveys for specific
input on process management, risks and critical issues. These surveys are kept
brief to ensure broad participation by each project member. The survey is
distributed according to needs (no pre-defined schedule), but at least once a
year (ideally before a GA meeting) to cover the following:

  * _Project management._ In this section, participants are asked to share their positive and negative observations about the project management processes. 

  

  * _Current topics._ The second section focuses on topics that are currently important within the project. This can range from collaboration infrastructure, to satisfaction about certain results, or specific WP-level topics. A recurring topic will be questions regarding Responsible Research and Innovation (RRI) in order to sensitise project partners for the most relevant aspects of RRI for Made4you. 

  

  * _Expectations and perceived risks_ . The third section focuses on the future and asks participants to share their perception about risks and expectations. 

  

An essential element of this survey process is that the results are discussed
and reflected upon in the consortium, preferably during a face-to-face
meeting. This allows for reacting to arising issues quickly and addressing
them collaboratively, e.g., by adapting the agenda.

##  3.5 Risk management

As stated above, internal surveys and discussions are used to check perceived
concerns and risks by all consortium partners. In addition, the quarterly
reports that each partner submits online (on Nextcloud) also include a section
on possible risks, deviations or corrective actions to be reported to the
project management.

The basic risk management methodology to be followed in the project consists
of four subsequent steps:

  * Risk identification – areas of potential risk are identified and classified. 

  

  * Risk quantification – the probability of events is determined and the consequences associated with their occurrence are examined. 

  

  * Risk response – methods are produced to reduce or control the risk, e.g. switch to alternative technologies. 

  

  * Risk control and report – lessons learnt are documented. 

  

Risks with medium or high probability and severe impact are handled with
particular caution during the project. At this point, it is expected that the
project safely achieves its expected results. This is also supported by the
preliminary risk analysis. Normal project risks are managed via “good-
practice” project management and rely on the experience from the successful
research projects that the partners have been performing. The close
supervision and tight control both by the project management and by the
various Boards ensure that results are available in time and with adequate
quality.

At the kick-off meeting a first risk analysis was performed for each of the
work packages. Before the kick-off, all partners were asked to reflect on
“dreams” and “fears” that they would associate with the work packages. The
following two images summarise on the one hand the dreams and expectations and
on the other hand the fears and risks associated with each of the work
packages. Work package leaders will follow up on these aspects and reflect on
contingencies should any of the identified risks, or emerging risks, start
having an influence on the activities progress.

In the course of the project, management is responsible for close monitoring
of the overall progress and risk identification. Risk identification is
however also collaboratively encouraged as part of reflective sessions during
the project meetings. Early communication of risks is encouraged as well as
discussions, in order to achieve a profound understanding of risks. The
project management promotes an open communication culture to openly discuss
any issues arising.

##  3.6 SWOT

A mid-term analysis of strengths, weaknesses, opportunities and threats (SWOT)
will be performed on the team and the project. This will be done during a
plenary meeting and is to be used to refocus, if needed, the project in the
second half of the project.

The SWOT analysis is a structured planning method to evaluate the Strengths,
Weaknesses Opportunities and Threats of a particular undertaking, be it for a
policy or programme, a project or product or for an organization or
individual. It is generally considered to be a simple and useful tool for
analysing project objectives by identifying the internal and external factors
that are favourable and unfavourable to achieving that objective. Strengths
and weaknesses are regarded internal to the project while opportunities and
threats generally relate to external factors.

Strengths can be seen as characteristics of the project that give it an
advantage over others while weaknesses are regarded as characteristics that
place the team at a disadvantage relative to others. Opportunities comprise
elements that the project could exploit to its advantage whilst threats
include elements in the environment that could cause trouble for the project.

Question to be answered during the SWOT analysis comprise:

_Strengths (S):_

  * What do we do well? What are our assets? 

  

  * What advantages does the project have? What do we do better than anyone else? What unique resources can we draw upon that others can't? 

  

  * What are our core competencies? What is the Unique Selling Proposition (USP)? 

  

  * What do other people see as our strengths? _Weaknesses (W)_ : 

  

  * What could we improve? What can we do better? 

  

  * What should we avoid? 

  

  * Where do we lack resources? 

  

  * Which factors minimise the outcome? 

  

  * What are external people likely to see as weaknesses? 

  

_Opportunities (O)_ :

  * Which good opportunities can we spot? What are the emerging political and social opportunities? 

  

  * What interesting trends are we aware of? What are the economic trends that benefit us? 

  

  * What new needs of PES and other future users could we meet? 

  

_Threats (T):_

  * What obstacles do we face? 

  

  * Where are we vulnerable? 

  

  * Could any of our weaknesses seriously threaten our results? What are the negative political and social trends? 

  

To develop strategies that take into account the SWOT profile, a matrix can be
constructed. The SWOT matrix (see below) includes strategies that make best
use of strengths and opportunities and minimise weaknesses and threats. SO-
Strategies pursue opportunities that are a good fit to the strengths. WO-
Strategies overcome weaknesses to pursue opportunities. ST-Strategies identify
ways in which the project can use its strengths to reduce its vulnerability to
external threats. WT-Strategies establish a defensive plan to prevent the
weaknesses from making it highly susceptible to external threats.  
  
<table>  
<tr>  
<th>

**SWOT Matrix**

</th>  
<th>

**Strengths**

</th>  
<th>

**Weaknesses**

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

**Opportunities**

</td>  
<td>

SO-Strategies

</td>  
<td>

WO-Strategies

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

**Threats**

</td>  
<td>

ST-Strategies

</td>  
<td>

WT-Strategies

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

**Figure 5: SWOT Matrix**

After the first matrix has been drawn from the answers by the consortium, the
following questions should be answered during the discussion and establishment
of the project strategy:

  * How to make best use of strengths and opportunities? 

  

  * How to best minimise weaknesses by making best use of opportunities? 

  

  * How to make best use of strengths by reducing risk of threats? 

  

  * How to best minimise weaknesses even with the expected threats? 

  

While SWOT can be a good complementary tool for analysing the project and
redefining strategy, it has also several blind spots. These comprise, for
instance that SWOT is a linear analysis and an expert's or group’s monophonic
analysis. In the case of the Made4You project some external view, e.g. from
the Advisory Board would give an important complementary interpretation of the
project development. Overall, SWOT is an easy usable tool that provides quick
access to the positive and negative aspects of a project and its environment
and seems appropriate for the Made4You project to be performed mid-term.

##  3.7 Project templates

Made4You intends to use a consistent ‘project style’. This is implemented by
providing templates for deliverables and reports, presentations, posters and
other dissemination and communication material. More project style templates
can be produced by the communication and outreach team when needed.

At the kick-off meeting the consortium decided to name the central platform of
the project “Careables”. Thus, the main message in any promotional material
will focus on the advertising Careables (http://www.careables.org).

All available project style templates are available on the shared workspace on
Nextcloud.

#  4 Tools and collaboration infrastructure

While the previous section was concerned with the processes of communication
and collaboration there is also a technical side to this and a number of
technical tools are used to provide the Made4You collaboration infrastructure.
It consists of several pieces:

  * **Made4You mailing list** is used for project-wide asynchronous communication. The address of the mailing list is: _made4you@lists.zsi.at_

  

  * **Slack** for ad-hoc communication to the whole team as well as to different subgroups and individual team members; 

  

  * **Skype** is used for regular web conferencing (monthly meetings) 

  

  * **Nextcloud** (https://wolke1.zsi.at/) is used for sharing files and for real-time cocreation of documents 

  

  * **e-mail and telephone** are used for bilateral communication 

  

  * **Careables Website** (http://www.careables.org) is the main portal for sharing open healthcare solutions and also used for presenting our work to the public 

  

The choice for this collaboration structures has been made taking into
consideration practical

aspects as well as privacy and data protection issues related to

the

EU

General

Data Protection

Regulation (GDPR).

**Figure**

**6**

**:**

**Nextcloud Workspace for Made4You**

**5**

**Responsible research and innovation (RRI)**

5.1

What is RRI?

Responsible Research and Innovation (RRI) has been formulated and widely
promoted

as guiding

principle and policy concept by the European Commission to better align
science with society and to meet the so called grand challenges  1  . It has
been promoted as a cross-cutting issue within the H2020 research programme. A
widely accepted definition describes RRI as “a transparent, interactive
process by which societal actors and innovators become mutually responsive to
each other with a view on the (ethical) acceptability, sustainability and
societal desirability of the innovation process and its marketable products”
(Schomberg, 2013). Others’ definitions of RRI (c.f. Jacob et al., 2013; Owen
et al., 2013) might slightly differ from Von Schomberg’s but as described by
Wickson & Carey (2014) the overall common accordance is that responsible
research and innovation should (1) address significant socio-ecological needs
and challenges, (2) actively engage different stakeholders, (3) anticipate
potential problems and assess available alternatives and reflect on underlying
values and beliefs and (4) to adapt according to these ideas. Generally
speaking, RRI is doing science and innovation with and for society by re-
imaging the science-society relationship.

According to the European Commission (Jacob et al., 2013), RRI comprises the
following key dimensions  2  :

  1. **Governance** : Governance of policymakers to prevent harmful or unethical developments in research and innovation 

  

  2. **Open Access** : Open access to research results and publications to boost innovation and increase the use of scientific results 

  

  3. **Ethics** : Research must respect ethical standards and fundamental rights to respond to societal challenges 

  

  4. **Gender** : Gender equality and in a wider sense diversity 

  

  5. **Public Engagement** : Engagement of all societal actors (researchers, industry, policy makers, civil society) in a reflective research process 

  

  6. **Science education** : Enhancement of current education processes to better equip future researchers and society as a whole with the necessary competences to participate in research processes 

  

  

In addition to these key dimensions, which are reflected in the European
policy agendas, RRI can also be defined with regards to its process
requirements which include **openness and transparency, anticipation and
reflection, responsiveness and adaptive change and diversity and inclusion.**
Figure 7, which stems from the RRI-Tools project  3  where the ZSI has been a
core partner, shows an integrative view on these tow perspectives, which
complement each other.

2

A different operationalisation is described by Wickson and Carew (2014) who
describe RRI from a process perspective

with the following quality criteria: 1. Socially relevant and Solution
oriented; 2. Sustainability centered and Future scanning; 3. Diverse and
Deliberative; 4. Reflexive and Responsive; 5. Rigorous and Robust; 6. Creative
and Elegant; and 7. Honest and Accountable

3 http://www.rri-tools.eu

**Figure 7: Overview of key dimensions and process requirements of RRI
according to RRI-Tools project**

In the following, we briefly describe the six key dimensions and how they
related to Made4You.

##  5.2 Governance

Among the six key dimensions of RRI, governance has a slightly different
function compared to the others, as it is rather an organising and steering
principle that determinates the success of all other RRI dimensions. In other
words, RRI relies on good governing structures for the promotion of RRI.
Governance methods range from foresight techniques (scenario studies, value
sensitive design, etc.), assessment (ethical committees, needs assessment,
technology assessment, etc.), agenda setting (consultation, co-creation, etc.)
to regulation (code of conduct, policies, funding guidelines, etc.).

Currently, governance of RRI is rarely seen on a project level; it is rather
applied on funding level or within organisations, e.g. to call for
organisation-wide RRI guidelines and policies. The **Made4You project** can be
perceived as an attempt to tackle RRI on a project level. However,
comprehensive RRI guidelines for projects are still missing and thus this
handbook together with the deliverables D8.1 and D8.2 will aim at meeting this
need. Also, it has to be acknowledged that governance structures need to be at
least on institutional level in order to be sustainable. On a project level
however, it makes sense to break down what RRI in the specific context means
and how it can be adapted to the project particularities.

##  5.3 Open access

In the narrower sense, open access is about enabling or giving access to
research results and publications to the public. It addresses only the final
stage of research activity, the publication and dissemination phase. With the
launch of Horizon 2020 it has become mandatory to follow open access
publication strategies (European Commission, 2012) .

Open access, in the narrow sense, is different from open science, open
innovation and open data, although there are obvious overlaps. For instance,
in contrast to open access, open science implies opening up the whole science
process in real time to the public, from choosing areas to investigate in,
formulating the research questions to choosing the methods, collecting data
and finally discussing the results. Open science means democratising science
and research, usually through ICT.

When talking about open access in the context of Made4You we refer to open
access in the narrower sense. Our project will basically follow an open access
publication strategy, but will also make data available to the public at an
earlier stage where suitable (c.f. chapter 6).

##  5.4 Ethics

The European Commission defines ethics as key dimension of RRI as follows:

_“European society is based on shared values. In order to adequately respond
to societal challenges, research and innovation must respect fundamental
rights and the highest ethical standards. Beyond the mandatory legal aspects,
this aims to ensure increased societal relevance and acceptability of research
and innovation outcomes. Ethics should not be perceived as a constraint to
research and innovation, but rather as a way of ensuring high quality
results.” (p.4)_ 2

Ethics thereby shall not be perceived as a constraint but rather as a guiding
principle to help ensure high quality outcomes and to justify decisions. This
is also the case for Made4You. A specific work package (WP6) is dedicated to
legal and ethical aspects. We will deal with the three main aspects of ethics
as defined by the European Commission (2015), namely 1) Research integrity and
good research practice, 2) Research ethics for the protection of research
objects, and 3) Societal relevance and ethical acceptability of research and
innovation outcomes.

Ethics further implies social justice and inclusion aspects: The widest range
of societal actors and civil society shall benefit from research and
innovation outcomes. In other words, products and services as a result of
Research & Innovation (R&I) activities shall be acceptable and affordable for
different social groups, which is also a special goal of Made4You.

Ethics is an integral part of responsible research, from the conceptual phase
to the publication of research results. The consortium of Made4You is clearly
committed to show appreciation of potential ethical issues that may arise
during the course of the project and has as such defined a set of procedures
on how to deal with ethics in a responsible way.

The main aspects the project is dealing with in regards to ethics are the
protection of identity, privacy, obtaining informed consent and communicating
benefits and risks to the involved target groups. The activities performed in
Made4You may include data collection from individuals and organisations
remotely as well as on site. In the following, we outline the basic processes
of ethical compliance of the project with a general view on the scientific
data collection. Complementary, there is also Deliverable D8.2, which
describes in more detail how the patient data collection, processing and
storing on the Made4You platform, called “Careables”, is compliant with the
GDPR.

###  Data protection and privacy

During any data collection process, data protection issues with regards to
handling personal data will be addressed by the following strategies:

Participants, who volunteer to being enrolled in our activities, will be
exhaustively informed so that they are able to autonomously decide whether
they consent to participate or not. The purposes of the research, the
procedures as well as the handling of their data (protection, storage) will be
explained. For online interviews these explanations will be a part of the
initial briefing of interviewees. For face-to-face interventions, informed
consent (provided in D8.1) shall be agreed and signed by both, the study
participants as well as the respective research partner.

The data exploitation will be in line with the respective national data
protection acts. Since data privacy is under threat when data are traced back
to individuals – they may become identifiable and the data may be abused – to
mitigate this risk, we will anonymise all data.

Data gathered through questionnaires, interviews, observational studies, focus
groups, workshops and other possible data gathering methods during this
research will be anonymised and therefore the data cannot be traced back to
the individual. Data will be stored only in anonymous forms so the identities
of the participants will only be known by the research partners involved. Raw
data like interview protocols and audio files will be shared within the
consortium partners only after having signed the confidentially agreement (See
Annex I). Reports based on interviews, focus group and other data gathering
methods will be based on aggregated information and will comprise anonymous
quotations respectively.

The collected data will be stored on password-protected servers at the partner
institution responsible for data collection and analysis. The data will be
used only within the project and will not be made accessible for any third
party, unless anonymised. Sensitive data or personal will not be stored after
the end of the project (incl. the time for final publications) unless required
by specific national legislation.

The stored data do not contain the names or addresses of participants and will
be edited for full anonymity before being processed (e.g. in project reports).

###  Communication strategy

Study participants will be made aware of the potential benefits and identified
risks of participating in the project at all times.

The main means of communicating benefits and risks to the individual is the
informed consent (see Deliverable D8.1). Prior to consent, each individual
participant in any of the studies in MADE4YOU will be clearly informed of its
goals, its possible adverse events, and the possibility to refuse to enter or
to retract at any time with no consequences. This will be done through a
project information sheet or the informed consent form and it will be
reinforced verbally.

In order to make sure that participants are able to recall what they agree
upon when signing, the informed consent forms will be provided in the native
language of the participants. In addition, the consortium partners will make
sure that the informed consent is written in a language suitable for the
target group(s). Different informed consents will be made available, e.g.
consent of adult participants, parental consent, informed assent for
children/minors.

For media material (e.g. photos, videos) produced during any of the Made4You
events a **media** **waiver** will be distributed to participants to make sure
that participants are aware of this and agree/disagree to the production and
use of such material by the project partners. A template for the waiver is
provided in the Annex IV of this document.

###  Informed consent/informed assent

As stated above informed consent/assent will be collected from all
participants involved in Made4You studies. The declaration of consent forms is
provided in the deliverable D8.1. _**Relevant regulations and scientific
standards** _

The consortium is following European regulations and scientific standards to
perform ethical research. The following lists some of the basic regulations
and guidelines.

The Made4You project will fully respect the citizens’ rights as reported by
EGE and as proclaimed in the Charter of Fundamental Rights of the European
Union (2000/C 364/01), having as its main goal to enhance and to foster the
participation of European citizens to education, regardless of cultural,
linguistic or social backgrounds. Regarding the personal data collected during
the research the project will make every effort to heed the rules for the
protection of personal data as described in Directive 95/46/EC  3  .

In addition, the consortium is following the following European Regulations
and Guidelines:

  * The Charter of Fundamental Rights of the European Union: 

  

  * European Convention on Human Rights http://www.echr.coe.int/Documents/Convention_ENG.pdf 

  

  * Horizon 2020 ethics self-assessment http://ec.europa.eu/research/participants/portal/doc/call/h2020/h2020-msca-itn- 

  

2015/1620147-h2020_-_guidance_ethics_self_assess_en.pdf

  * EU Code of Ethics: 

  

  * European Textbook on Ethics in Research https://ec.europa.eu/research/sciencesociety/document_library/pdf_06/textbook-on-ethics-report_en.pdf 

  

  * European data protection legislation 

  

  * RESPECT Code of Practice for Socio-Economic Research 

  

  * Code of Ethics of the International Sociological Association (ISA) 

  

###  National and Local Regulations and Standards

In addition to the more general and EU-wide guidelines, project partners have
to adhere to, and respect, national regulations and laws as well as to
research organisational ethical approval as requested by the own institutions.
All partners are aware of their responsibilities in that respect and will
follow the respective guidelines.

##  5.5 Gender

Gender equality generally means equal rights, opportunities, and
responsibilities for both genders so that individuals can exploit and realise
their full potentials independently from their sex.

Gender equality as key dimension of RRI comprises two main aspects (European
Commission, 2015), namely to strive for gender balanced teams in research and
innovation (at operational as well as at decision making level) and the
inclusion and integration of gender perspectives in research and innovation
content and process. Gender analysis and gender monitoring throughout the
project shall aim at looking at both aspects of gender equality, at the human
capital dimension (where possible, apart from institutional conditions) and
the research aspect of gender (Föger et al., 2016).

In Made4You gender is mostly relevant when it comes to internal processes,
such as the composition of project teams, of work package leaders, of advisory
group, the use of gender sensitive language and the awareness of producing
gender sensitive content. We are aware of the current imbalance in the
advisory board and we will consider gender specifically in any new
allocations.

In line with the Toolkit on Gender in EU-funded research (European Commission,
2009) Made4You will strive at doing gender-sensitive innovation. Particularly
in the following project steps gender has to be addressed and taken into
account:

  * Project design and methodology: we will make sure that for any of our approaches in co-design and other engagement activities, we will aim at representative data in the sense that different gender perspectives will be described, where relevant. 

  

  * Project implementation: Data-collection tools such as questionnaire, interview guidelines, etc. need to be gender sensitive and use gender-neutral language and have to allow for differentiation between gender perspectives. In the evaluation data analysis we will particularly pay attention whether there are differences between males and females, for instance, in terms of artefacts that are produced, in terms of communicating and sharing, etc. 

  

  * Dissemination phase – reporting of data: We will use gender-neutral language in our publications. Furthermore, we will sensitively decide which visual materials to use. In addition, we will aim at publishing gender specific results. 

  

###  Science Education

Science education under the RRI umbrella is meant to meet several objectives
(European Commission, 2015; Föger et al., 2016):

  1. To empower the society to critically reflect and to improve on their skills to be able to challenge research, thus to make them “science-literate” (in this sense, there is a great overlap with the key dimension of public engagement) 

  

  2. To enhance future researchers and other societal actors to become good RRI actors 

  

  3. To make science attractive to children and teenagers with the purpose to promote science careers, especially in STEM (Science, Technology, Engineering, and Mathematics) 

  

  4. To close the gap between science and education. There is still a significant distance between the two areas. 

  

  

Co-design is regarded as a possible empowering tool for science education as
it enables participants to shape the development of certain technologies or
services according to the RRITools project. In Made4You we plan to include
children in the co-design process for certain cases. In addition, educational
activities and student engagement are part of the WP1 activities. They are
targeted at students in the field of medicine, paramedical professions, design
& arts, biomedical engineering and Fab Academy and aim to familiarise them
with co-design processes. Also, the maker spaces involved in the Made4You
project regularly offer educational activities to young people and schools as
the maker movement has started to get attention from schools and educational
authorities.

##  5.6 Public Engagement

In recent years, science communication has moved from the one-way-
communication approach to basically inform the general public towards public
engagement, which means more elaborate and active involvement of citizens
leading to collaboration and empowerment.

There is a vast range of tools and methods with different levels of
participation available, e.g. public consultations, public deliberations for
decision making, public participation in R&I processes, Citizen Science, etc.
The goal by opening up research and innovation processes to the public is to
better meet the values, needs and expectations of society and thus to improve
R&I and to find solutions to the so called grand challenges that society is
facing (Cagnin, Amanatidou, & Keenan, 2012).

Thus, realising this key dimension of RRI is an important goal in Made4You and
two work packages are jointly working together to reach high quality public
engagement. WP1 and WP5 are closely working on a joint strategy and have
created a working team at the kick-off meeting to jointly define and execute
the engagement and communication strategy of the project.

##  5.7 RRI management in Made4You

The notion of Responsible Research and Innovation does not offer a checklist
or one universal guideline how to do RRI. It is also not in the spirit of RRI
to have such set of measures, as RRI is rather perceived as a process that
requires continuous questioning and reflection. Thus, mechanisms have to be
installed and embedded in the project by work package 6 and 7 to stimulate
reflection of the consortium and to keep these alive throughout the lifetime
of the project.

We would like to point out that not all key dimensions are equally relevant
for Made4You as can be inferred from the discussion above. In the following we
will therefore concentrate on these key dimensions which will be dealt with in
more detail. However, also the remaining dimensions shall remain in our mind-
sets as we would like so continuously stimulate reflection and discussion on
RRI.

In order to stimulate reflection and deliberation on Responsible research and
innovation and to keep these alive we have foreseen several instruments:

  * **Ethical and legal questionnaire** : a questionnaire addressing specific ethical and legal aspects has been distributed to all project partners at the beginning of the project. Questions range from the data that is being stored at the Careables platform to the data being collected to the compliance of the platform with the GDPR as well as data subjects’ rights. This questionnaire especially informs the deliverables D8.1 and D8.2 and partially also this handbook. 

  

  * **RRI Self-Reflection-Tool** : The RRI-Tools project has developed the so called “RRI SelfReflection-Tool”. It is an online tool for different stakeholder groups and for people with different levels of knowledge on RRI. The tool is meant to comprise food for thought and to sensitise for RRI and to stimulate reflection on RRI key dimensions and process requirements. Participants can choose which questions they would like to reflect upon (since not all of them will be relevant) and receive suggestions at the end how to further improve in terms of RRI. Further resources such as best practice examples, tools or literature will be recommended. In Made4You we will invite the project partners to regularly make use of the SelfReflection –Tool. 

  

  * **Legal and ethics workshop** : At selected consortium meetings WP6 is running a legal and ethics workshop to discuss relevant topics based on the results of the questionnaire and the experiences made by the consortium. 

  

To summarise, the main instruments for implementing RRI are the following:

  * ethical guidelines, including forms for informed consent and confidentiality agreement 

  

  * open data management plan 

  

  * RRI self-assessment tool 

  

  * RRI-related legal and ethics workshops 

  

#  6 Open access and open research data

The project firmly believes in openness to be a major factor for innovation
and this was also one of the main motivations for Made4You, which promotes
openness in healthcare. Openness has many facets. The most important ones for
the Made4You consortium are, following Carlos Moedas’s (European Commissioner
for Research, Science and Innovation) strategy of the 3 Os, Open Science, Open
Innovation and Open Data  4  :

  * **Open project collaboration.** All partners are committed to developing (working) relationships with external partners for mutual benefit. Making contacts with similar projects and establishing collaboration is considered beneficial for all. Open collaboration in Made4You is understood in a trans-disciplinary way, opening innovation processes to the wider public and allowing new form of collaboration as intended in the co-design activities of the project. 

  

  * **Open source technology.** From a technology perspective, the project fosters the sharing of open healthcare solutions to be shared on the Careables platform. A main aim is to share the co-designed technological artefacts with the community. Business models and exploitation strategies are not based on locking down access to project results, but on providing added value through services. 

  

  * **Open access to scientific results.** From a scientific perspective, the consortium clearly favours open access to its scientific output, which is supported by several project members’ internal policies of supporting open access in general. 

  

  * **Open access to research data.** Made4You is part of a pilot action on open access to research data and is thus committed to providing access not only to project results and processes, but also to data collected during that process. Although Made4You is an innovation action according to the work programme definition and not a research action, some research related data will be collected, mainly from an evaluation perspective. Although the general policy of the Made4You project is to apply “open by default” to its research data, we have to handle privacy issues with special care. Legal rules on anonymity, as described above (chapter 6), are thus highly relevant and need to be agreed with each of the participants. In case of a doubt, data privacy of our participants always prevails over open data policy. 

  

Made4You is part of the H2020 Open Research Data Pilot (ORDP), a pilot action
on open access to research data, which requires projects to define and execute
a data management plan. This deliverable includes the open data management
plan for Made4You. The open access strategy will be detailed in the following
sections.

##  6.1 Open access strategy for publications

In line with the EC policy initiative on open access  5  , which refers to the
practice of granting free Internet access to research articles, the project is
committed to follow a publication strategy considering a mix of both 'Green
open access' (immediate or delayed open access that is provided through self-
archiving) and 'Gold open access' (immediate open access that is provided by a
publisher) as far as possible.

All deliverables labelled as “public” will be made accessible via the Made4You
website (careables.org). The publications stemming from the project work will
also be made available on the website as far as it does not infringe the
publishers rights as well as on the OpenAIRE platform .

All outcomes of the project labelled as “public” will be distributed under
specific free/open license, where the authors retain the authors’ rights but
the users can redistribute the content freely. The following are a few
relevant sources for deciding on the specific license for each outcome:

  * Data: 

  

◦ A definition of Open Data: ◦ Licenses:

  * Software: 

  

◦ Free Software

▪ The definition:

▪ Licenses:

◦ Open Source Software:

▪ The definition: ▪ Licenses:

  * Reports, publications, media: ◦ Creative Commons ▪ Explanation: 

  

▪ Licenses:

▪ Choose a license:

◦ Sharing publications on the project website and via OpenAIRE

##  6.2 Data management plan (DMP)

This is a first version of the DMP for Made4You, which provides an analysis of
the main aspects to be followed by the project’s data management policy. The
DMP evolves in the course of the project and will be updated accordingly as
data is collected. However, we would like to stress once more that Made4You is
an innovation action and large collection of research data is thus not the
focus of the project.

This data management plan refers mainly to the data collected for the
achievement of the project objectives, namely co-designing a platform for
sharing open healthcare. Complementary to this data management plan,
Deliverable D8.2. (POPD) refers to the handling of personal (sensitive)
patient data. Please not that this is not addressed here.

At the time of writing it is expected that the project will produce the
following data:

  * WP1: secondary data from stakeholders. e.g. other open healthcare initiatives, associations, healthcare providers, etc. 

  

  * WP2: secondary and primary data from pilot participants, e.g. demographic data 

  

  * WP3: platform usage data from Careables.org 

  

  * WP4: feedback data from participants in activities of other WPs, interview and questionnaire data, log data from the Careables platform, social media data and observational analysis 

  

  * WP5: data from other open healthcare projects regarding Dissemination, Exploitation, Communication of the Made4You project 

  

  * WP6: feedback data from participants in activities of other WPs, interview and questionnaire data 

  

This initial list includes primary (empirical) and secondary (desk-top,
aggregated) data. For the currently identifiable primary research data sets,
that the project will produce, we follow the requested template description as
define by the European Commission  6  :  
  
<table>  
<tr>  
<th>

**Data set reference & name **

</th>  
<th>

**Data set description**

</th>  
<th>

**Standards & metadata **

</th>  
<th>

**Data sharing**

</th>  
<th>

**Archiving & preservation **

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

DOI_1

Made4You_Co-design_X

</td>  
<td>

Feedback documented directly during co-design sessions regarding the codesign
process itself as well as documentation

standards

</td>  
<td>

As indexed on the sharing platform e.g. Zenodo, it will have publication data,
Digital Object Identifier (DOI), keywords, collections,

license, uploaded by

</td>  
<td>

Shared on Zenodo, open digital

repository; license will be most probably:

Creative Commons Attribution Share-

Alike

</td>  
<td>

Zenodo is developed by under the EU FP7 project (grant agreement no.

283595); the service is free of charge for those without ready access to an
organized data centre; if this policy changes

Made4You will provide the data accessible via its website for the duration of
at least 5 years after project end.

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

DOI_2

Made4You_Survey_X

</td>  
<td>

Survey data being collected across the pilot participants and external
stakeholders; the data will be anonymised and will refer to aspects of
evaluation (e.g. usability and usefulness, process feed-back, etc.) and
sustainability (e.g. interest in sharing open healthcare, etc.)

</td>  
<td>

As indexed on the sharing platform e.g. Zenodo, it will have publication data,
DOI, keywords, collections,

license, uploaded by

</td>  
<td>

Shared on Zenodo, open digital

repository; license will be most probably:

Creative Commons Attribution Share-

Alike

</td>  
<td>

Zenodo is developed by under the EU FP7 project (grant agreement no.

283595); the service is free of charge for those without ready access to an
organized data centre; if this policy changes

Made4You will provide the data accessible via its website for the duration of

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

</th>  
<th>

</th>  
<th>

</th>  
<th>

</th>  
<th>

at least 5 years after project end.

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

DOI_3

Made4You_Interview_X

</td>  
<td>

Interviews conducted with individuals being associated to any of the pilots
needs to be stored anonymously; sometimes only in aggregated from, if too many
details would allow to deduced a specific person.

The data may be in the following format (depending on the interviews and the
specific cases):

  * audio files 

  

  * transcripts 

  

  * aggregated files 

  

  * interview 

  

guidelines

</td>  
<td>

As indexed on the sharing platform e.g. Zenodo, it will have publication data,
DOI, keywords, collections,

license, uploaded by

</td>  
<td>

Shared on Zenodo, open digital

repository; license will be most probably:

Creative Commons Attribution Share-

Alike

</td>  
<td>

Zenodo is developed by under the EU FP7 project (grant agreement no.

283595); the service is free of charge for those without ready access to an
organized data centre; if this policy changes

Made4You will provide the data accessible via its website for the duration of
at least 5 years after project end.

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

DOI_5

Made4You_PlatformUsage_X

</td>  
<td>

Platform usage data from Careables.org (anonymous data); the data includes:

Communication pattern, usage patterns, uploads, downloads, etc.

</td>  
<td>

As indexed on the sharing platform e.g. Zenodo, it will have publication data,
DOI, keywords, collections,

license, uploaded by

</td>  
<td>

Shared on Zenodo, open digital

repository; license will be most probably:

Creative Commons Attribution Share-

Alike

</td>  
<td>

Zenodo is developed by under the EU FP7 project (grant agreement no.

283595); the service is free of charge for those without ready access to an
organized data centre; if this policy changes

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

</th>  
<th>

</th>  
<th>

</th>  
<th>

</th>  
<th>

Made4You will provide the data accessible via its website for the duration of
at least 5 years after project end.

</th> </tr> </table>

D7.1 Data management plan & handbook

To summarise, the main open access points for Made4You data, publications, and
innovation are:

  * The project website: 

  

  * Zenodo: 

  

  * OpenAIRE for depositing publications and research data 

  

##  6.1 Open access and open data handling process

The internal procedures to grant open access to any publication, research data
or other innovation stemming from the Made4You project (e.g. technology), are
following a lightweight structure, while respecting ethical issues at all
time.

The main workflow starts at the WP level, where each team is responsible for
respecting ethical procedures at all times during the data gathering and
processing steps. The WP/working team members are also responsible for any
data anonymization, if applicable. Agreement has to be reached within the team
for making any outcome openly available; the final approval is done by the
Project Management Board (see Figure 8):

**Figure**

**8**

**Open Access work flow**

**:**

Collecting

data

Preparing

p

ublication

Ethical guidelines, informed consent

Approval by

Project Management Board

Developing

standards

Open Repository &

www.careables.org

Approval

within

team

Anonymization

…

.

Due to the nature of the project, the Data Management Plan may have to be
revised during the course of project activities. As the co-design approach is
a rather dynamic methodology it is not possible to clearly specify all data
sources and collected outcomes from the beginning.

**Conclusions**

This handbook describes the main procedures of the Made4You project to operate
successfully and effectively in order to achieve high quality project results
following a responsible research and innovation (RRI) approach. Open access,
ethics, and engagement of all societal actors are amongst the key elements of
the European RRI framework (European Union, 2012). Made4You is clearly
committed to respond to societal challenges in a responsible way by itself,
given its main objective of open healthcare, and by the way the actions in the
project are conducted.

While this handbook is provided in the form of a report and deliverable, it is
a living document in the sense of being updated and challenged by the
consortium in the course of the project. The processes described in here are
implemented in the daily work of the consortium and most of the elements (e.g.
the forms for informed consent, data management plan, etc.) are separately
available on the collaboration infrastructure such as Nextcloud.

D7.1 Data management plan & handbook

The management reports will include updates on any crucial changes in the
handbook as well as on the results of specific measures such as the SWOT
analysis or any additional elements added to the project structure related to
high quality responsible research.