Legal bases and Tasks

In addition to general administrative requirements, the activities of the Coordination Office for Human Research (kofam) of the Federal Office of Public Health (FOPH) cover the corresponding provisions of the Federal Act on Research involving Human Beings (Human Research Act, HRA; SR 810.30), the Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, CTO; SR 810.305) and the Organisation Ordinance to the Human Research Act (Organisation Ordinance HRA, OrgO-HRA; SR 810.308). In detail, these are:

 

HRA:

Art. 55 Coordination and Information

1 The Federal Office of Public Health (FOPH) ensures the coordination between the ethics committees as well as with additional authorisation authorities.  It may transfer this task to third parties.

2 The ethics committees provide the FOPH with an annual report of their activity, in particular on the type and number of assessed research projects and the processing times.

3 The FOPH publishes a directory of the ethics committees and informs the public of their activity on a regular basis.

4 It may, after consultation with the ethics committees and additional concerned authorisation authorities, issue recommendations on appropriate harmonisation of the procedures and the assessment practice.

 

CTO:

Art. 67 Portal

1 Public access to information on clinical trials carried out in Switzerland is ensured by computerised access to a register or a plurality of registers (portal).

2 The portal makes possible, in particular:

a. linking the data from the additional databank of the Federation with those of the permitted register pursuant to Article 64 para 1;

b. keyword oriented search for clinical trials.

2 Operation of the portal and the additional databank of the Federation is ensured by the Coordination Office according to Article 10 of the Organisation Ordinance HRA, of 20 September 2013.

 

OrgO-HRA:

2. Chapter: Coordination Office

Art. 10

1 The Federal Office of Public Health (FOPH) controls the Coordination Office pursuant to Article 55 HRA.

2 The Coordination Office has the following tasks, in particular:

a. It ensures a regular exchange between the involved authorisation authorities.

b. It ensures a regular exchange with research agencies and institutions.

c. In collaboration with the ethics committees and if need be additional involved authorisation authorities, it provides recommendations for the authorisation and notification procedures and individual aspects of the decision practice.

d. It contributes to the conception and implementation of training and development curricula for members of the ethics committees.

e. It informs the public, in particular it draws up a summary of the annual report of the ethics committees and a statistical review of the authorised research projects.

3 In the context of operating the portal and the additional databank of the Federation, it may, pursuant to Article 67 CTO, allow the electronic exchange of documents of the authorisation and notification procedures between applicants and authorisation authorities.

4 Pursuant to Article 55 para 2 HRA, it provides guidelines on the content of the reporting of the ethics committees.

 

Hence, the kofam pursues in particular three core tasks: the coordination of the authorisation authorities as well as the harmonisation of their implementation processes, informing the public on human research, as well as the operation of the study portal and the additional databank.

 

Coordination of the authorisation authorities

According to the Human Research legislation the authorisation authorities include

  • the current seven cantonal ethics committees for research;
  • the Swiss Agency for Therapeutic Products Swissmedic; and
  • the FOPH: Radiation Protection Division and Transplantation.

 

For certain research projects the ethics committees or Swissmedic request opinions from the following authorities:

  • The Federal Office for the Environment (FOEN);
  • The Swiss Expert Committee for Biosafety (SECB); and
  • The FOPH, Biosafety, Genetics Section and Reproduction Medicine Section

The objective of the coordination activity of kofam consists in particular, to contribute to the best possible uniform and efficient implementation practices and in regard to current questions, to find meaningful solutions for all involved parties. Kofam primarily provides this service by means of appropriate meetings in various formats, wherein the subject matter in the main is chosen by the involved authorisation authorities. Up to now the kofam has waived its right after consultations with the authorisation authorities to provide recommendations on harmonisation of procedures and assessment practices (Art. 55 para 4 HRA).

 

Informing the General Public

The cantonal ethics committees have to provide an annual report of their activities to kofam. Kofam, on the basis of these reports, itself provides an annual summary to the general public. Additional authorisation authorities are included on a voluntary basis.

In this way the general public obtains an insight to the work of the authorisation authorities, and at the same time an overview of the research projects approved in Switzerland each year.

 

Operating the Study Portal and Databank

The internet site www.kofam.ch offers on the one hand information and support offers for researchers, and on the other hand it addresses itself to the general public. Accordingly, it supports the objectives of the Act by contributing to transparency in human research (Art. 1 para 2 let. c HRA).

 

Organisation

Kofam is in the Public Health Directorate of the FOPH for the Biomedical Department and is more closely associated with the Human Research and Ethics Section. Bethina Ley MSc MBA is head of the Coordination Office and is supported in specific subject areas by co-workers of the Section.