Ethical Guidelines
Published: Mon, 16 Aug 2010 13:52:48 GMT   Updated: Tue, 10 Apr 2012 10:32:08 GMT
All programme activities funded by the Unit for Research Cooperation must be carried out in compliance with fundamental ethical principles as outlined below. It is the responsibility of each applicant to ensure compliance with international conventions and declarations on ethical considerations and intellectual property rights.

The following section outlines the guidelines for organisations applying for regional and international research support from the Unit for Research Cooperation.

1) Ethical approval of medical or health research projects is required as follows:

For projects carried out in their entirety in Sweden, Swedish regulations shall apply. For projects carried out in other countries the following rules shall apply:

Projects involving human subjects require ethical approval by a responsible authority in the country concerned. Where Swedish researchers or institutions participate, approval is also required from a Swedish ethical committee.

Projects involving clinical trials of drugs, vaccines or other pharmaceutical preparations require, in addition, approval by a drug regulatory authority or other responsible authority in the country concerned. Where Swedish researchers/institutions participate or Swedish products are tested, approval shall also be obtained from the Medical Products Agency (Läkemedelsverket) in Sweden.

­Projects involving experiments with animals should, whenever possible, be approved by a responsible authority in the country concerned. Where Swedish researchers or institutions participate, approval is also required from a Swedish ethical committee for animal experiments.

When changes or additions are made to the original project plan renewed ethical approval is required.

­The recipient scientist/institution is responsible for ensuring that ethical approval in accordance with the above-mentioned rules is obtained before the study is started. Sida retains the right to require that the recipient scientist/institution produce proof of ethical approval before the grant is disbursed.

2) Intellectual Property Rights

As regards patents and know-how the participating Swedish and collaborating country institutions and researchers co-operating in the research project shall have access to all results and know-how obtained within the collaborative projects mentioned in the Agreement. Each party that has participated in the co-operation shall have the right to the patent in their own name and at their own expense.

The registration fees for the patent in Sweden and collaborating country shall be divided equally between the participating institutions. The participating institutions shall decide whether or not the patent is to be registered in a third country.

Should UNIV/INST choose not to exercise its right to apply for a patent, the other institutions are to be given the option to do so in their own name and at their own expenses.

­The participating institutions shall have the right to equal shares of the revenue derived from grant of user licences to third parties if the patent is registered by mutual Agreement. The grant of user licences and patent(s) shall be determined in each case by mutual Agreement between the participating institutions provided the participating institutions provided the participating institutions agree in delegating such a task to one party.

 
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