#  1.2. Re-using existing data

The partners in the HybridHeart consortium have previously gained experience
in their respected fields of research and therefore will together lead to
successful development of a soft actuated biocompatible heart. We have
explored the potential of reusable data but at this stage, we see no potential
of re-using the existing data, however this will be further discussed along
the course of the project.

#  1.3. The expected size of the data

The expected size of the data generated in WP 2 is 200 GB, whereas WP 3
expects to generate approximately 400 MB data. The other WPs and partners
cannot yet predict the size of the data. This information will be updated in
the subsequent version of DMP.

#  1.4. The data utility

The HybridHeart Proof-of-Principle established in this project will set a
baseline for the feasibility of novel artificial motile organ development
based on soft robotics technology combined with TE and wireless energy
transfer to follow. As such, this project will change the future of organ
replacement, using the latest advancement and new applications of soft
robotics and TE technologies, which will cause a foundational shift in
transplantation research and medicine with unlimited availability of safe,
biocompatible and off-the-shelf solutions for all patients.

The consortium envision that the data will be useful for the following
stakeholders:  
  
<table>  
<tr>  
<th>

**Target audience**

</th>  
<th>

**Essential stakeholders**

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

Medical community

</td>  
<td>

Cardiologists, cardiac surgeons, researchers in the field of TE, professional
organizations such as the European Society of Cardiology, TERMIS.

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

Soft robotics community

</td>  
<td>

Researchers and scientific organizations, such as IEEE Robotics & Automation
Society, and Technical Committees on Soft Robotics.

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

Medical device companies

</td>  
<td>

Companies interested in novel types of artificial organs, such as Medtronic,
Heartware, Syncardia, Carmat, Thoratex, St Jude Medical.

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

Patient advocacy groups

</td>  
<td>

Patient organizations such as the European Heart Network and national
organizations.

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

Regulatory bodies

</td>  
<td>

Notified bodies.

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

Healthcare payers

</td>  
<td>

Health insurance companies at national level.

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

General public

</td>  
<td>

Governments, standardization institutes (OECD, ISO), press.

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

#  2\. Findable, Accessible, Interoperable, and Reusable (FAIR) Data

**2.1. Making data findable, including provisions for metadata**

##  Discoverability of the Data (metadata provision)

Digital object identifier will be generated for all publications, related
documents (e.g. study protocol, data transfer agreements, data access
policies) as well as the datasets. During the course of the project all data
will be recorded in lab journals and stored digitally and locally in the
secure internal drive of the consortium. We will look at  www.fairsharing.org
and  https://bioportal.bioontology.org/  for existing databases, standards,
metadata, and ontologies that can be used for type of data that will be
generated in the project. If no metadata provision is available each partner
will create a codebook or file explaining the variable names, calculations
used to analyze the data, exact scripts for calculations used with analysis of
the data, parameter settings, detailed methodology, etc. this code book will
be linked to the generated data.

##  Naming and keywords of the data

The data will be named as follows:

WP number/Institution name/Task or deliverable
number/Subtasknumber/filename/year

Example:

WP6/AMC/D6.3/D6.3.1/Datamanagementplan.2018.v1.0

Keywords will also be available to ensure data discoverability **,** following
existing standards such as the Medical Subjects Headings (MeSH) terms.

###  2.2. Making data openly accessible

The data that will be generated and collected for development and validation
of the artificial heart is in accordance with the General Data Protection
Regulation (Regulation (EU) 2016/679). All partners will own the full
intellectual property (IPR) relating to their own proprietary technologies.
Access to the existing IPR between the partners and terms and condition
regarding ownership of IP generated in the project will be agreed upon in a
prearranged consortium agreement (CA). IP generated within the project shall
be disclosed in confidence to the other partners in the consortium.

When a partner wishes to commercially exploit knowledge of which (part of) the
IPR is in the hands of another consortium partner, the exploiting partner will
pay royalties or another appropriate form of remuneration. After protection of
findings, results will be disseminated via (high-impact) peer-reviewed
articles following the ‘green’ or ‘gold’ standard according to the EC Open
Access policy. To ensure accessibility of the publications we will also
publish the author version on partners’ institutions website and/or the
HybridHeart website.

Each partner/member of the consortium will make their own decision on when to
open their datasets, but the data will be at latest in the public domain when
a related publication a peerreviewed journal is available. Restriction made to
the open access will be voluntarily. There are no specific software tools
needed to access the data (standard file formats readable in open source
software will be used).

###  2.3. Making data interoperable

Similar to what was previously stated in section 2.1. to enhance data
interoperability, we will search for existing metadata, standards, and
ontologies at  _www.fairsharing.org_ and  _https://bioportal.bioontology.org/_
. This information will be updated in the next version of DMP. Somewhere
during the course of the project the consortium will discuss the potential of
placing the open access publications and the data set (including the
associated metadata) at data repositories such as  _www.zenodo.org_ and
_www.re3data.org_ . However this will not change the obligations to protect
the result, the confidentiality obligations and the security obligations.

###  2.4. Increase data re-use (through clarifying licenses)

We will ensure the accessibility of the published articles by either
publishing it open access journal or made the author version available on our
website or partners’ websites. We will look into using available repositories
such as  _www.zenodo.org_ to increase the discoverability of the data. During
the next general assembly meeting, we will discuss the term and the extent of
reusing data generated in this project. It is possible that access to certain
datasets will be restricted and can only be granted upon submission of
research proposal and subsequent approval from the consortium. The data
produced can be of interest to other researchers in the medical, soft robotics
and tissue engineering communities as well as for medical devices companies.

Each consortium members will be responsible for the quality assurance of how
his or her data will be reused. Prior to submitting deliverables or
publications, we will perform internal reviewer process within the consortium
to ensure the quality of the data/publications.

#  3\. Allocation of resources

The individual beneficiaries and partner organizations will be responsible for
the data management of the HybridHeart project. Data generated will be stored
locally in the internal server of the partner that generated and owned the
data. Long term preservation: collected data will be stored for up to 10 years
at each of partner organization. Costs for data storage and preservation will
be estimated at a later stage by using the “Data management costing tool”
provided by the UK Data Service
(http://www.dataarchive.ac.uk/media/247429/costingtool.pdf).

#  4\. Data security

All generated data will be digitally and locally stored in the internal server
of each partner organizations. This local storage underlie the EU roles and
national rules, which will be followed and to protect the data. According to
the standard protocols, the data will be regularly back-up.

#  5\. Ethical aspects

The HybridHeart project will comply with ethical principles and if applicable
international, EU and national law (in particular, EU Directive 2004/23/EC).
The consortium confirms that it will follow these ethical principles
regardless where the research is performed.

The consortium ensures to:

  * Keep track of the material imported/exported between EU members of states and associated countries. 

  

  * Obtain the necessary accreditation/designation/authorization/licensing for using animal in research.