Declaration of Interest and Confidentiality Agreement (DOI)

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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 respsonsible 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 Declaration of Interest (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. 

 

Full access is defined as individuals permitted to view all DOI and ECA forms submitted to EUnetHTA via the DOI Database.  

Limited access is defined as individuals who have restricted access to DOI and ECA forms. This access is variable, is assessed on a project-by-project basis, and is purely for administrative indexing purposes. Individuals who have limited access do not have access to the complete DOI Database. 

Agency name Acronym Country Number of handlers who have full access  Number of handlers who have limited access
Instituto De Salud Carlos III AETS-ISCIII Spain 0 2
National Agency for Regional Health Services AGENAS Italy 0 1
Austrian Institute for Health Technology Assessment AIHTA Austria 2 0
Galician Agency for HTA AVALIA-T Spain 0 1
Gemeinsamer Bundesausschuss G-BA Germany 1 0
French National Authority for Health (Haute Autorité de Santé) HAS France 1 3
Health Information and Quality Authority HIQA Ireland 0 1
Ministry of Health of the Republic of Croatia MIZ Croatia 0 1
The Norwegian Institute of Public Health NIPHNO Norway 0 3
Zorginsitituut Nederland

(Secretariat)

ZIN  The Netherlands 2 0
Zorginsitituut Nederland

(Joint Production)

ZIN The Netherlands 3 0

Last updated | 23 April 2020

The onset and completion of assessments may mean project managers who require access to the database may change from time to time. Any changes will be reflected in the list above up to a maximum of five working days after the user has been granted access.

Current versions of the EUnetHTA Procedure Guidance for handling Declaration of Interest (and Confidentiality Agreement), the step-by-step template form, and a list of Frequently Asked Questions, are available here:

EUnetHTA Procedure Guidance for handling Declaration of Interest (DOI) form

Declaration of Interest (DOI) form

EUnetHTA Confidentiality Agreement form

Frequently Asked Questions