Approach to the Ethical Review

Size: px

Start display at page:

Download "Approach to the Ethical Review"

Melina Underwood
5 years ago
Views:

1 Harlan Laboratories Approach to the Ethical Review Contract Research Services Markus Josten 04-May-2009

2 Who are we? Well known for our research models, diets, bedding and research model services, with a 70-year history Diversification to include Swiss CRO RCC and UK-based SafePharm Laboratories Today we are Harlan Laboratories A diverse global company with a local presence Non-clinical contract research, research models, animal diets and services Services to the pharmaceutical, biotech, medical device, agrochemical and chemical industries Over 3000 employees in 12 countries Harlan Laboratories 2

3 Harlan Laboratories - a truly global Company Research Models and Services France Germany - 4 sites Israel - 3 sites Italy - 3 sites Mexico Netherlands UK - 3 sites US - 14 sites Contract Research Services Germany - 2 sites Israel Japan Korea Spain - 2 sites Switzerland - 2 sites UK US - 2 sites people on 41 sites in 12 countries Harlan Laboratories 3

4 Seven AAALAC- accredited sites within the group Swiss facilities AAALAC-accredited since 2000 Harlan Laboratories 4

5 Madison Indianapolis UK Spain Germany Switzerland Israel Korea Japan 11 Facilities worldwide in 8 countries 1,500 employees 70,000 sqm total space Top 5 global CRO Harlan Laboratories 5

6 The Swiss Approach Harlan Laboratories 6

7 The Swiss Approach: We differentiate in regulatory and non-regulatory studies. All regulatory studies are handled as follows: Harlan Laboratories must prepare a project license for each study which describes the purpose of the study and includes all details of the study design. The local Swiss authority* has the legal responsibility to approve of any study. * (the responsible cantonal veterinarian and a commission comprising scientists and lay people, including representatives of animal welfare organizations) This decision is subject to further approval by the Federal authorities. Any change to the agreed design must also be submitted in writing, with a justification, and similarly approved. Harlan Laboratories 7

8 The Swiss authorities have agreed, in principle, to accept all regulatory studies, according to published guidelines for chemicals and agrochemicals or specified designs for pharmaceuticals. To date, this has limited the role of the IACUC to a review of any non-regulatory study and internal consultative role concerning requests to change the design of regulatory studies. In addition, the Study Director has personal, legal responsibility, together with the principal license holder, for the maintenance of the animal welfare legislation. Harlan Laboratories 8

9 The IACUC performs biannual site visit which cover animal welfare and Occupational Health and Safety The compliance is controlled by the cantonal veterinarian with members of the commission during their unannounced, regular inspections. The cantonal veterinarian has the legal authority to stop any study which does not comply. We do not see a conflict of interest between the scientific and animal welfare responsibilities of a Study Director. Harlan Laboratories 9

10 All project licenses are due for renewal by 31-Dec-2009 and will be reviewed during this procedure. The review will be documented and subject to the approval of the full IACUC. Amendments to existing regulatory study licenses will be similarly approved. Harlan Laboratories 10

11 All license applications for non-regulatory studies are already reviewed by the full IACUC and need approval. These protocol applications must be reviewed by at least two members of the IACUC (one of them a vet). If requested by at least one of the reviewers, the application is submitted to the IACUC for approval prior to submission to the authorities. The presence of 50% of all members of the IACUC is sufficient (a quorum) to make a decision. If the IACUC does not give its approval of the study plan, the study will not be performed. Harlan Laboratories 11

12 Harlan Laboratories 12

Division of Research University Policy

Division of Research University Policy SUBJECT: Effective Date: Policy Number: SATELLITE ANIMAL HOUSING FACILITIES June 24, 2016 Supersedes: August 22, 2014 1 5 Responsible Authorities: Vice President,