Agreement on the establishment of the Ethics Committee of Eastern Switzerland (EKOS) (EKOS)

1. The Agreement Cantons designate the Ethics Committee Eastern Switzerland (EKOS) as the joint ethics committee pursuant to Art. 54 para. 2 of the Human Research Act of September 30, 2011.

2. EKOS is based in the city of St. Gallen. The Canton of St. Gallen operates EKOS and its office.

1. The EKOS is particularly responsible for the assessment and approval of

a) Research involving humans according to the Federal Human Research Act of 30 September 2011;

b) The further use of biological material or health-related personal data for research purposes when consent or information about the right of objection is lacking according to the Federal Human Research Act of 30 September 2011;

c) Research involving embryonic stem cells according to the Stem Cell Research Act of 19 December 2003.

2. For this purpose, it may review all documents relevant to the experiment.

1. A canton becomes a member of the EKOS by waiving its own ethics committee and signing this agreement.

2. The admission of a new contracting canton into the EKOS is achieved through a unanimous decision by the health directorates of the existing contracting cantons.

1. The EKOS prepares an annual budget and annual financial statements.

2. The audit authority is the Financial Control of the Canton of St. Gallen. It examines the accounting system and the annual financial statements of the EKOS.

1. The EKOS shall annually report to the health directorates of the contracting cantons, particularly regarding

a) the budget;

b) the annual financial statement;

c) the nature, number, and processing times of the assessed research projects for each contracting canton;

d) the sites of the assessed research projects within the contracting cantons.

2. It shall inform the health directorate of the contracting canton, where the main research site of the respective research project in question is located, about serious adverse events in approved projects.

1. The EKOS drafts a set of rules of procedure regarding its organization and operation.

2. The rules of procedure require the approval of the health departments of the agreeing cantons.

1. The health departments of the signatory cantons are responsible for

a) Approval of the EKOS rules of procedure;

b) Receipt of the budget and annual financial statements, including the audit report;

c) Receipt of the annual report on the activities of EKOS.

2. The Department of Health of the Canton of St. Gallen is additionally responsible for

a) Election of the President of EKOS;

b) Election of two Vice Presidents;

c) Election of at least five and at most seven additional members of EKOS;

d) Approval of the budget and annual financial statements, including the audit report;

e) Supervision of the activities of EKOS as well as the members elected by the Department of Health of the Canton of St. Gallen.

3. The Department of Finance and Social Affairs of the Canton of Thurgau is additionally responsible for

a) Election of one Vice President;

b) Election of an additional member of EKOS;

c) Supervision of members elected by the Department of Finance and Social Affairs of the Canton of Thurgau.

1. In proceedings before the EKOS, where no provisions are contained in the federal Human Research Act, the EKOS Rules of Procedure, or this Agreement, the Law on Administrative Procedure of the Canton of St. Gallen dated May 16, 1965, shall be applied accordingly.

1. The procedure for appeals against decisions of the EKOS is governed by the cantonal procedural law of the agreement canton where the main examination location of the respective application in question is situated, as well as by the general provisions on federal judicial procedures.

1. **The EKOS funds its operations through the fees it collects and the contributions of the contracting cantons. The Canton of St. Gallen ensures the financing of the remaining costs.**

1. The agreement cantons shall make the following contributions per year

a) Canton of Thurgau CHF 25,000;

b) Canton of Appenzell Ausserrhoden CHF 6,000;

c) Canton of Appenzell Innerrhoden CHF 1,000.

2. The payment due date is each year on June 30.

3. The amount of contributions shall be reviewed every three years. The health departments of the agreement cantons may adjust the contributions by mutual decision and determine contributions for new agreement cantons.

1. The ECOS issues a fee regulation. This is based on the recommended fee regulations of the Association of Swiss Ethics Committees for Research Involving Humans.

1. The agreement is concluded for an indefinite period.

2. It may be terminated with six months' notice at the end of a calendar year.

1. The agreement replaces existing agreements between the cantons of agreement in connection with the operation of ethics committees. These agreements shall be terminated as of the commencement of enforcement of this agreement.

1. This Agreement shall apply from June 1, 2016.