Conflict of Interest Committee (COIC)

COIC

The Conflict of Interest Committee (COIC) is a neutral independent committee that reviews the declarations of participants involved in JCA and JSC production activities to assess whether they have any conflict of interest. If such conflict of interest is identified the committee will provide guidance on how the participation of such individual would need to be approached or if the factors are leading to an exclusion of such individual.

The DOI Database and our process

To participate in joint production, all individuals employed by consortium partners should be assessed for potential conflicts of interest (COI) and needs to sign a Declaration of Interest (DOI) and EUnetHTA Confidentiality Agreement (ECA) form. The COI Committee is responsible for the creation and maintenance of a database for completed DOI forms related to EUnetHTA activities, and for informing individuals of the status of relevant DOI submissions. The Secretariat and the COIC will also carry out the necessary updates to the DOI/ECA forms. The COI Committee will be involved in assessing the DOI information of each individual involved in any type of joint work (i.e. JCA and/or JSC production). Management of COI will be conducted throughout the entire EUnetHTA 21 service contract.

Processing the DOI and ECA forms-transparency

The COI committee is a strong element of the consortiums quality management system and ensures a neutral, transparent, pragmatic and responsible approach to COI management. The information we collect in 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. Each form is assessed by the COI Committee taking into account the rules necessary for all, which is followed by the Committee’s decision on the inclusion or exclusion of an individual within the EUnetHTA joint product.

Access to the DOI Database

The COI Committee consist of three members (G-BA, HAS, ZIN) and has one Chair (NIPN). Each individual who handles DOI/ECA forms or has access to the DOI Database must complete a non-disclosure agreement (NDA). DOI database is only accessible to a limited number of individuals within EUnetHTA 21. Some handlers have full access to DOI/ECA information and some have limited access. The data collection through DOI and ECA forms is GDPR compliant. Data providers are informed their rights and asked to express their explicit consent to their data handling.

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.

 

Last updated | 16 March 2022

Current versions of the EUnetHTA Procedure Guidance for handling Declaration of Interest, Confidentiality Agreement are available here:

Procedure Guidance for handling Declaration of Interest (DOI) and EUnetHTA 21 Confidentiality Agreement (ECA) forms 

Declaration of Interest (DOI) form

EUnetHTA 21 Confidentiality Agreement (ECA) form