Bioequivalence and Bioavailability Forum

Hi Norah,

❝ […] a BE study where I planned to perform a drug (cannabis, THC, ... ) screening to volunteers before confinement. The Ethic committee rejected this because local laws require the person who discovers a consumer to declare him for imprisonment.

Interesting. Since the job of the ethics committee is to protect volunteers from risks, this makes sense. The WHO’s guideline states:

3.2 Ethics committee
When reviewing a clinical trial proposal the ethics committee should consider the following:
b) The suitability of the protocol including the objectives of the study and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the subjects and/or others …
3.3 Informed consent
b) The subject must be made aware and consent that personal information may be scrutinized during monitoring, auditing or inspection of the trial by properly authorized persons, the sponsor or relevant authorities, and that participation and personal information in the trial will be treated as confidential and will not be publicly available. This principle may be modified by national laws and regulations.

Getting imprisoned is inconvenient at least.

❝ Is the drug screening mandatory??

Not mandatory but I never ever have seen a BE study without one.