GCP Considerations: Informed Consent
Guidance on Informed Consent in Clinical Trials: UK
Note: Country-by-country guidance on consent requirements in Dementia can be found on the Alzheimers Europe Website
Informed consent is the key foundation of Good Clinical Practice and yet we still regularly see failings in this area as evidenced through audit and inspection findings. The hope is that by further educating clinical researchers we can reduce these failings and increase the rigour with which we conduct clinical trials.
Ultimately, our goal is always to ensure that the rights, safety and welfare of the trial subject are respected and protected. In human terms, you should ask yourself if you would do anything differently if it was your son, daughter, wife, husband, mother or father who was sitting before you during the informed consent discussion.
This short report provides an overview of the recent history which led to the drafting of the regulations as we know them today, as well as, providing a practical overview of the applicable UK regulatory framework.
Please click on the image above to download a complimentary copy of the GCP Considerations report on informed consent in clinical trials.
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Last Updated on: 12th March 2011
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