Rare Disease Patient and Ethics Council (RD-PEC)

1. Rare Disease Patient and Ethics Council (RD-PEC) Pauline McCormack, Policy, Ethics & Life Sciences Research Centre, Newcastle University, on behalf of the Patient and Ethics Councilpauline.mccormack@ncl.ac.uk @paulinemacco Ethics workshop at Sitges • Rare Disease Patient and Ethics Council – RD-PEC • The PEC (pronounced pek) is a forum for members of the Ethics Committees of RD Connect, Neuromics, EURenOmics and members of the Patient Advisory Council to collaborate on examining ethical and social issues arising out of the work of the three projects. The PEC is a voluntary, multidisciplinary group which forms part of the governance of RD Connect. Operational aspects Specific questions and answers Firstly the PEC provides a publicly available question and answer forum where anyone with an ethical, social or legal query concerning the work of EURenOmics, Neuromics and RD Connect can submit their question. These will be debated by the PEC members and a summary, consensus answer will be made available on the PEC website. PEC online question form can be found at Broad issues of interest Secondly, the PEC can give opinion on broad issues of interest which arise through the developments undertaken by EURenOmics, Neuromics and RD Connect. PEC members have so far commented on the Data Sharing Charter which regulates data and materials sharing for the three projects. http://rd-connect.eu/platform/ethics/rd-pec/ Membership of the PEC by role Background and rationale Based on best practice from similar large RD networking projects, the PEC aims to be a reactive and responsive resource which can examine contemporary, pragmatic, sometimes urgent issues around the ethics of research and focus on useful, problem solving for patient groups, researchers and clinicians. It will encourage a bottom-up approach, generating knowledge triggered by empirical questions, with relevant results publicly available through the RD Connect website. Rather than being a source of formal or technical guidance on points of law, regulation and governance, the PEC will take a deliberative, reflexive approach to questions posed. Meetings/reporting The PEC meets face to face at the annual joint meetings of the three projects and reports its activities to the EC every 12 months. PEC Members Jean-Jacques Cassiman; Megan Fookes; Emma Heslop; Joseph Irwin; Anna Kole; Chantal Loirat; Milan Macek; Deborah Mascalzoni; Pauline McCormack (chair); Caron Molster; MaritaPohlschmidt; Daniel Renault; Peter Reussner; Balthasar Schaap; Inge Schwersenz; Volker Straub; Johanne van Delden; Marieke van Meel; Urban Weising; Simon Woods Conclusions New approaches to health technologies, such as those being explored in RD Connect, Neuromics and EURenOmics can raise issues that are not fully covered by existing ethical guidelines. The PEC helps to provide the institutional capacity to identify, clarify and evaluate emerging ethical tensions in their practical contexts. In addition it allows the inclusion of patient perspectives in these interdisciplinary debates.