Declaration of Interest and Confidentiality Agreement (DOI)

Prior to any engagement in a EUnetHTA joint product, each individual needs to sign a Declaration of Interest (DOI) and EUnetHTA Confidentiality Agreement (ECA) form. EUnetHTA has developed a Procedure Guidance for handling the Declaration of Interest (DOI) form. This form is designed to specifically address conflict of interest (COI) and assist in the decision-making process concerning the involvement of individuals in EUnetHTA JA3 activities, whether as internal (EUnetHTA task) representatives or as external experts, based on a transparent assessment of interests declared within the form.

EUnetHTA is responsible for the creation and maintenance of a database for completed DOI forms that relate to EUnetHTA activities, and for informing individuals of the status of relevant DOI submissions in terms of form expiry and the need, where required, to resubmit or update forms.

The DOI Database and our process

Throughout the input process, EUnetHTA and its partners are committed to the highest levels of transparency. The information we collect in our DOI Database – our comprehensive digital database storing DOI and ECA forms – is subject to strict quality and data control procedures in order to ensure the information provided via DOI and ECA forms remains confidential. The following text provides some information on the governance of the DOI Database and the Conflict of Interest Assessment Process.

Processing the DOI and ECA forms

When a DOI or ECA form is received, it is uploaded to the DOI Database.

Each form is then assessed by the Conflict of Interest Committee (COIC) who evaluate the form and approves the individual for inclusion within a EUnetHTA joint product. The Committee is made up of individuals from the following organisations: ZIN, AIHTA, G-BA, HAS.

Access to the DOI Database

The Secretariat endeavours to minimise access to the complete DOI Database as much as possible. Thus, only individuals who require access to the full database are granted it.

Each individual who handles DOI/ECA forms or has access to the DOI Database completes a non-disclosure agreement (NDA) covering their use of the depository. COIC members also complete an NDA. This completion of this form is in addition to the rules which bind these individuals to confidentiality as part of their employment at EUnetHTA partner organisations.

The NDA completed by individuals who have access to the DOI Database or select information within it is different from the DOI and ECA forms that are completed by individuals involved in EUnetHTA products.

Currently, 21 individuals across our partner organisations handle DOI and ECA forms or have access to the DOI Database. Some handlers have full access to DOI/ECA information and some have limited access.