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Code of Conduct

MR Subjects' Rights by MR Subjects Type

W. Patients

Patients

19.1

When researching existing or future potential medical treatments with patients, care should be taken not to:

  • Raise unfounded hopes of treatment of specific medical problems.
  • Mislead respondents with regard to the safety of a product.
  • Encourage members of the public/patients to ask their doctor to prescribe a product.
  • Offer advice on the specific therapy area under discussion.

19.2
Interpretation of national legislation on data protection and patient anonymity in Finland and Sweden appears to suggest that direct use of patient records for market research is prohibited, even if the data is anonymised, unless written consent from the patient has been secured.  It is acceptable for physicians to complete patient record forms from memory although great care must be taken to ensure that the patient cannot be identified directly or indirectly.  EphMRA strongly advises that the sponsoring pharmaceutical company's legal department seek local advice on the matter.


19.3
In Greece, the SfEE’s Code of Ethics states (within the English translation) that:
  • "The data collected from HCPs and referring to patients must be cumulative.  No personal patient data must be collected during market research, since this is regarded as a non-interventional/pharmaco-epidemiological study, governed by the rules described in article 26 of the present Chapter of the Code.”


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