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What is the initiative called?

Code of Conduct for Health Research.

What does the EU GDPR say about codes of conduct?

The EU GDPR specifies in Article 40 that “the Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises.”

What is the aim of the Code of Conduct for Health Research?

The aim is to reach a sector-specific code that explains how the GDPR applies in practice. With regards to clinical trials, it will focus on the secondary use of data that are not regulated within the Clinical Trials Directive. The Code has to be comprehensive to non-legal experts.

Who is leading the initiative?

The initiative is led by BBMRI-ERIC.

Who is currently involved and how?

By September 2017, 130 individuals representing 80 organisations in the field of health research have indicated their interest and support for the Code of Conduct for Health Research. Indicating interest in the initiative does not mean that you as an individual or your organisation endorses the Code. It means that you see a benefit in the development of such a code and are interested in partaking in the process.

Who can get involved?

This is a non-exclusive initiative. We welcome representatives from sector-specific organisations interested in a Code of Conduct for Health Research, who are committed to its development to get involved.

How can you get involved?

Please send an email to contact@code-of-conduct-for-health-research.eu and/or sign up to the Code of Conduct for Health Research mailing list at the top of this page.

What forms of involvement exist?

The Code of Conduct for Health Research differentiates between three groups:

  • The Code of Conduct Forum: comprised of individuals & organisations committed to the Code’s aims.
  • The Code of Conduct Drafting Group: typically consists of legal experts who contribute their insight and expertise, as well as biological and medical science research infrastructures, patient advocacy groups, learned societies and international organisations, who are able to commit time and in-kind resources for drafting the Code of Conduct for Health Research.
  • The Code of Conduct Reference Groups: include experts to be consulted on an ad-hoc basis to inform the drafting of specific sections.
How do the Drafting Group, Reference Groups and Forum interact?

Discussions in the Forum determine the general orientation of the Code, which in turn informs the Drafting Group as they put these key concepts on paper. The Drafting Group will propose a first draft to the Forum in Autumn 2018 and obtain further input from the Forum and experts from ad-hoc Reference Groups.

Who is part of the Drafting Group?

M. Mayrhofer (BBMRI-ERIC), I. Schlünder (BBMRI-ERIC/TMF), F. Molnar-Gabor (Heidelberger Akademie der Wissenschaften/EMBL), D. Mascalzoni (EURAC/RD-Connect), M.Verlinden (EORTC), Anastassia Negrouk (EORTC), A.Kent (Genetic Alliance UK/Stakeholder Forum), D. Townend (University of Maastricht/Global Alliance), M. Matei (ECRIN), A. Bahr (EFPIA/Sanofi), M. de la Paz (EFPIA/Novartis), C. Becker (European Society of Radiology), and E.  van Veen (MedLawconsult/CESSDA). Members’ institutional affiliation(s) are noted in brackets. This list comprises of the names and affiliations of the members of the Drafting Group. This list does not indicate whether or not the respective organisation the member is affiliated with endorses the Code.

How can you comment on the draft Code of Conduct?

Shortly after the final Drafting Group meeting, a first draft will be presented to the Code of Conduct Forum. The input received will allow further refinement of the content. An elaborated version will be published and opened for public consultation in spring 2019. We especially invite comments from delegates representing the relevant Committees, Working Parties and Networks, international organisations and academic institutions. Please expect further specifications of how to comment and get involved in late autumn 2018.

Will participation be acknowledged?

Yes. Participation in meetings and other activities will be published in the log book on this website in the following form:

XX/0X/201X – name of meeting
Meeting format: TC, Forum Meeting etc.
Participants (affiliations):

How can you endorse the final document?

Once consensus on the final document has been reached, organisations are invited to support the Code in line with Article 40 of the EU GDPR. All Forum members will be invited to do so.

How will the Code be sumbitted?

To date, the exact process  of submitting the Code under the EU GDPR to the European Commission is unclear. This section will be updated as soon as further information regarding procedural matters has been made available by Working Party 29.  European Commission.