Health services users must participate in health technology assessment (HTA) activities. Users, caregivers, and citizens have the practical experience of healthcare and social services. HTA outputs are more useful when values and preferences of patients, caregivers, and citizens are taken into account. Despite this, the best methods of stakeholders’ involvement, timing for doing so, selection of participants, and the type of users to recruit depending of methods and contexts remain unspecified. Herein, an involvement policy has been developed to formalize the participation of users, caregivers and citizens in the services offering of a regional HTA unit.

A steering committee composed of stakeholders (i.e. user, caregiver, citizen, User Experience Service representative, manager, provincial HTA body representative, HTA unit members) was constituted to discuss user involvement in a regional HTA unit. A preliminary vision statement emerged from this committee, and included objectives and principles for users, caregivers, and citizens participation. This statement was deliberated using a Delphi consensus method. Three rounds of deliberations were needed to reach a strong consensus.

Four objectives and four principles that should underlie the development of an involvement policy reached consensus. Participants agreed that users, caregivers, and citizens should: i) propose principles of involvement for each HTA projects; ii) co-realize evaluations with HTA professionals; iii) contribute to evaluation processes; and, iv) be involved in some management decisions of regional HTA units. Four principles to formalize users, caregivers and citizens’ involvement in regional HTA units also emerged. These principles were about utility and feasibility of involvement as well as ethical and methodological considerations.

Users, caregivers, and citizens must participate in the activities of regional HTA units. Each of them have different roles and can contribute to evaluation processes. Their involvement in HTA activities is warranted for co-producing better evaluation more adapted to users’ needs in healthcare and social services.