#  1\. Data management plan in the context of H2020

##  1.1 Introduction

The European Commission (EC) is running a flexible pilot under Horizon 2020
called the Open Research Data Pilot (ORD pilot). This pilot is part of the
Open Access to Scientific Publications and Research Data Program in H2020. The
ORD pilot aims to improve and maximize access to and re-use of the research
data generated by Horizon 2020 projects and takes into account the need to
balance openness and protection of scientific information, possible
commercialization and Intellectual Property Rights (IPR) protection, privacy
concerns, security as well as data management and preservation issues.
According to the EC suggested guidelines, participating projects are required
to develop a Data Management Plan (DMP). The DMP describes the types of data
that will be generated or gathered during the project, the standards that will
be used to generate and store the data, the ways how the data will be
exploited and shared for verification or reuse, and how the data will be
preserved. In addition, beneficiaries must ensure that their research data are
Findable, Accessible, Interoperable and Reusable (FAIR).

DMP of project INDEX will be set according to the article 29.3 of the Grant
Agreement “Open Access to Research Data”. Project participants can deposit
their data in a research data repository and take measures to make the data
available to third parties. The third parties should be able to access,
search, exploit, reproduce and disseminate the data. This should also help to
validate the results presented in scientific publications. In addition,
Article 29.3 suggests that participants will have to provide information, via
the repository, about tools and instruments needed for the validation of
project outcomes.

On the other hand, Article 29.3 incorporates the obligation of participants to
protect results, security and to protect personal data and confidentiality
prior to any dissemination. Article 29.3 concludes: “ _As an exception, the
beneficiaries do not have to ensure open access to specific parts of their
research data if the achievement of the action's main objective, as described
in Annex I, would be jeopardized by making those specific parts of the
research data openly accessible. In this case, the data management plan must
contain the reasons for not giving access_ .”

In line with this, the INDEX consortium will decide what information will be
made public according to the analysis of aspects as potential conflicts
against commercialization, IPR protection of the knowledge generated (by
patents or other forms of protection), risk for obtaining the project
objectives/outcomes, etc.

##  1.2 Scope of the document

This document is a deliverable of the INDEX project, which is funded by the
European Union’s.

Horizon 2020 Programme under Grant Agreement number 766466. It describes what
data the project will generate, how they will be produced and analysed. It
also aims to detail how the data related to the INDEX project will be
disseminated and afterwards shared and preserved. It covers: I. the handling
of research data during and after the project.

  2. what data will be collected, processed or generated. 

  

  3. what methodology and standards will be applied. 

  

  4. whether data will be shared/made open and how. 

  

  5. how data will be curated and preserved. 

  

  

The DMP is not a fixed document. On the contrary, it will have to evolve
during the lifespan of the project. This first version of the DMP includes an
overview of the datasets to be produced by the project, and the specific
conditions that are attached to them.

An updated version of the DMP will get into more detail and will describe the
practical data management procedures implemented by the INDEX project.

##  1.3 Dissemination policy

The DMP for INDEX focuses on the security and robustness of local data storage
and backup strategies, and on a plan for this repository-based data sharing,
where and when appropriate and is based on the guidelines provided by the EU
in the DMP template document.

Effective exploitation of INDEX research results depends on the proper
management of intellectual property. A Consortium Agreement was signed by all
the parties in order to inter alia specify the terms and conditions pertaining
to ownership, access rights, exploitation of background dissemination of
results, in compliance with the Grant Agreement. The Consortium Agreement is
based on the DESCA Horizon 2020 Model with the necessary adaptations
considering the specific context and the parties involved in the project.

Its basic principles are as follows:

###  1) Ownership of the results

Results are owned by the Party that generates them. Joint ownership is
governed by Grant Agreement Article 26.2 with the following additions:

Unless otherwise agreed:

  * each of the joint owners shall be entitled to use their jointly owned results for non-commercial research activities on a royalty-free basis, and without requiring the prior consent of the other joint owner(s), and 

  

  * each of the joint owners shall be entitled to otherwise Exploit the jointly owned Results and to grant non-exclusive licenses to third parties (without any right to sub-license), if the other joint owners are given: 

  

(a) at least 45 calendar days advance notice; and (b) Fair and Reasonable
compensation.

###  2) Access rights

During the Project and for a period of 1 year after the end of the Project,
the dissemination of own Results by one or several Parties including but not
restricted to publications and presentations, shall be governed by the
procedure of Article 29.1 of the Grant Agreement subject to the following
provisions. Prior notice of any planned publication shall be given to the
other Parties at least 45 calendar days before the publication. Any objection
to the planned publication shall be made in accordance with the Grant
Agreement in writing to the Coordinator and to the Party or Parties proposing
the dissemination within 30 calendar days after receipt of the notice. If no
objection is made within the time limit stated above, the publication is
permitted.

It is noteworthy that INDEX project will involve the use of easily accessible
human biological samples

(biological fluids, primarily blood derivatives). All personal data collection
in INDEX will be done within the remit of formal ethics clearances obtained
from Scientific Ethical Committee of Central Denmark (M20090237) and the
Danish Data Protection Agency (2007-58-0015) and granted by the relevant
university and/or local health officials. Thus, any patient-related data, such
as data from pre-exiting health record data will fall under the ethics
clearance.

The legal basis for the personal data processing will be the participant’s
consent, obtained in accordance with the rules to which the collecting partner
is subject.

The most relevant standards regarding data handling, in this experimental
context with patients, concern the area of ethics, data protection and
privacy.

They are listed below:

  * the Charter of Fundamental Rights of the European Union (signed in Nice, 7 December 2000, 

  

2000/C 364/01) in particular Article 3 “Right to the integrity of a person”
and Article 8 “ Protection of Personal Data”;

  * Decision 1982/2006/EC of the European Parliament and the Council concerning the Seventh Framework Programme of the European Community for research, technological, development and demonstration activities (2007-2013); 

  

  * Council Directive 83/570/EEC of 26; 

  

  * Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data; 

  

  * Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.