The heterogeneity of rare diseases, combined with the small number of patients for each disorder, often precludes conventional discovery approaches. To facilitate international data sharing, coordinated consent processes between research centers is crucial. While an International Framework for Data Sharing and accompanying policies have been developed by the Global Alliance for Health (GA4GH), practical and procedural tools for consent elements in the context of rare diseases are lacking, in particular, model consent clauses for pediatric rare disease research. To address these challenges, the joint IRDiRC and GA4GH Model Consent Clauses (MCC) Task Force had the objective to gather rare disease research policy experts to develop model consent clauses specific to rare diseases that are comprehensive, harmonized, readily-accessible, and internationally applicable, enabling the recruitment and consent of rare disease research participants around the world.
The MCC Task Force members met on September 6-7, 2018, at the Rare Diseases Platform in Paris (France). The meeting started with background presentations of both IRDiRC and the GA4GH as well as an historical analysis of the evolution of consent forms used in rare disease research over the past 8 years. The group identified the aspects of research that require consent and that are specific and crucial for rare disease research. Based on a compilation of already existing consent form language, the experts then developed model consent clauses specific to rare diseases considering international socio-ethical, legal and cultural differences as well as keeping the patient’s perspective in mind.
A paper is currently under development, which will lay out the state of play for consents for rare disease research, the model consent clauses designed during this workshop, and considerations regarding the impact of new diagnostics/therapeutics technologies on the consents of participants in the future. Hopefully, this resource will further benefit both IRDiRC’s and GA4GH’s aim to promote and catalyze collaborative multi-national studies through interoperable and responsible research practices.