EASL Consortium for the study of Drug and Herbal & Dietary Supplement-Induced Liver Injury” (DHILI)

1.- Founding & Mission

Drug-induced liver injury (DILI) is an uncommon and potentially severe adverse drug reaction following an exposure to medications, herbal products or dietary supplements. Idiosyncratic DILI is attributable to medicinal products taken in a therapeutic dose and has been described in association with over 650 drugs used in clinical practice.

The EASL DHILI Consortium is a multidisciplinary network of clinicians, scientists, patients, industry partners, and regulators, all with an interest in the study of Drug and Herbal & Dietary Supplement-induced Liver Injury.

Our objectives are:

• To develop a shared understanding of the key issues related to adverse reactions related to drugs, herbal and dietary supplements in all settings relevant to the members of the consortium and society.

• To promote, participate and lead research in topics related to drugs, herbal and dietary supplement-induced liver injury.

• To generate, synthesise and disseminate evidence that prevents drug-induced liver injury (DILI) and improves care of patients with DILI.

• To facilitate national and international research and educational activities related to DILI.

• To set up an international network of centres to harmonise nationally and internationally funded research activities towards a common goal of providing bench, bedside and population perspectives in DILI.

2. Rights and Obligations of the Members

Members participate in EASL DHILI Consortium activities according to their scientific interests. They are asked to act in a collaborative fashion, to contribute, by this way, to the scopes of the network. It is mandatory for members to respect an ethical code of conduct in respect of the rules acknowledged by the international scientific community. Rights and obligations are summarized in the following table:

To participate to EASL DHILI Consortium studiesTo respect the aims and scopes of the network and the statement of research integrity as a global guide to the responsible conduct of research
To promote and coordinate EASL DHILI Consortium studiesTo act with a collaborative attitude, and professional responsibility: honesty, accountability, courtesy and fairness, good stewardship  
To participate to EASL DHILI Consortium meetingsTo respect the collective decisions on the activities of the network
To have access to EASL DHILI Consortium knowledge and information sharingTo respect the international rules on the scientific ethical conduct

The network is open to international collaborations; non-European scientists can apply to become an EASL DHILI Consortium external collaborators, which allows to participate to the scientific activities of the network. External collaborators are not eligible to be selected for the EASL DHILI Consortium steering committee (see below).

3. Governing Structure

The DHILI Consortium is constituted by research groups, centres or institutions (from now on “Centres”), with established experience in the knowledge field of DILI.

Investigators belonging to the Centres are members of the Consortium are represented by their Coordinators. Membership of the Consortium does not preclude participation to other research networks.

The Coordinators of the participating Centres meet in an Assembly on a yearly basis minimum.

The DHILI Consortium is coordinated by a designated Managing Board, composed by the Consortium Chair and Vice-Chair. A Steering Committee (SC) will be implemented, composed by the Working Groups (WGs) leaders, an Early Career Investigators Coordinator, a Gender Balance Coordinator and a Scientific Coordinator. The SC is responsible for the coordination of the overall strategy and the Consortium reports and the allocation of funds, and will coordinate the preparation of proposals for future EU programme. The SC will verify and approve all operational and day-to-day decisions, synchronize scientific activities, and will help the Chair and Vice-Chair in smooth running of the Consortium. They will establish efficient communication through emails and teleconferences.

The rotation of governing bodies of the Consortium will be done each five years. The Coordinators of the Consortium Centres will elect the Managing Board members and the Steering Committee.  The EASL DHILI Consortium is fully committed to promoting gender and regional equality among the rotation of the governing bodies.

Members of the governing bodies of a Consortium should also be EASL members.

4. Centres

The participating Centres join the Consortium voluntarily.

They should consist in clinical and/or biomedical research units devoted to DHILI and based at Institutions with facilities for clinical and/or biomedical research.

They join the research programs proposed by the Consortium on a voluntary basis, if they meet the requirements of a specific program.

The centres interested in joining the Consortium will have to follow the admission process by filling out a specific form available on our webpage. The steering committee will evaluate the adequacy of the candidates.

5. Assembly

The Assembly is composed of all the Coordinators of the Centres of the Consortium. It proposes candidates for the Chair and other governing bodies if existing. These candidates should belong to Centres provided with infrastructures for clinical and translational research. It approves the overall policy of the Consortium. It can propose amendments, deletions or additions to the statutes of the Consortium.

6. Studies

The EASL DHILI Consortium promotes any scientific study with an interest in drug-induced liver injury or herb-induced liver injury. Any EASL DHILI Consortium member is entitled to propose collaborative studies to which other members are free to participate according to their scientific interest. Studies are preferably proposed in the course of the EASL DHILI Consortium annual meeting; alternatively, proponents can send a research proposal to the EASL DHILI Consortium steering committee for evaluation and dissemination. Proponents (and participants according to the case) must raise the funds needed for the study.

7. Authorship

Authorship of EASL DHILI Consortium studies must respect the rules acknowledged by the scientific community, in terms of ethics, equity and contribution.

Manuscripts originated by collaborative studies need to list all who contributed to the study, with a priority in the list of authors given by the extent of contribution. The senior author is supposed to be the proponent/coordinator, unless differently agreed by the authors. The principal leader of the study is supposed to be the first author, unless differently agreed by the authors.

For studies involving analysis of databases and/or patient samples, the priority in the list of authors needs to take into account the number of cases provided. Similarly, the number of cases provided to the study should reflect the number of authors of the same group considered in the list.

Any manuscript originated by a EASL DHILI Consortium collaborative study must report in the acknowledgments the sentence: “Under the auspices of the European Association for the Study of the Liver- Drug and Herbal & Dietary Supplement-induced Liver Injury – (EASL DHILI) Consortium”.

When a collaboration includes network resources (e.g., patient registry), the authors should adhere to journal guidelines. If contribution/participation is NOT at the level as NAMED author, participants will be listed under a “European Association for the Study of the Liver- Drug and Herbal & Dietary Supplement-induced Liver Injury –(EASL DHILI) Consortium» list, which will include name and affiliation(s).

8. Gender Equality

The EASL DHILI Consortium is fully committed to promoting gender equality and supporting both talented women and men in research and innovation. The EASL DHILI Consortium strongly encourages gender balance of research networks, as well as the take up of leadership positions by (young) women  EASL DHILI Consortium participants. As such, The EASL DHILI Consortium aims to ensure equal opportunities and gender-friendly career advancement.

Advancing gender equality in research and innovation is a key objective of the European Union’s gender equality policy. Across Europe the numbers have increased over the last years (women are indeed a majority among PhD graduates), however, only a third of women are scientists, a phenomenon especially visible in STEM (Science, Technology, Engineering and Mathematics) where women are even less represented.