Biomedical research

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Politics

In this section you find information on policy and legal aspects surrounding pharmacogenetics.

 

Pharmacogenetics falls under rules for research on human subjects and genetic research (including regulations concerning the use of biobanks), but there are also distinctive guidelines.


Many organizations have presented their own statements:

  • Council for International Organizations of Medical Sciences - Pharmacogenetics. Towards improving treatment with medicines
     
  • Human Genome Organisation- HUGO Statement on Pharmacogenomics (PGx): Solidarity, Equity and Governance. This directive emphasizes the importance that research be guided by a concern for equity rather than solely for financial interests. It also articulates the importance of developing good governance practices so that research is carried out in an effective manner and in the best interests of the community. 
     
  • European Federation of Pharmaceutical Industries and Associations (EFPIA): Pharmacogenetics in Medicinal Product Research and Development, Positon Paper. 
     
  • See also Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group (PWG). PWG is a voluntary association of pharmaceutical companies involved in clinical drug trials and genotyping whose goal is to advance the understanding and development of pharmacogenetics by addressing non-competitive ethical, regulatory, and legal issues.

Source: modified from CODEX- rules & guidelines for research

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