Healthy volunteer studies
Some University staff and students are involved in research that involves healthy volunteers. The University must ensure these studies are conducted to appropriate ethical and safety standards.
A healthy volunteer in this instance involves anyone who is recruited to a research study without reference to a medical illness or condition and without making use of any NHS facilities.
Sponsorship and Approval
You should contact the Research Regulation and Compliance Office at the earliest opportunity when you think the University should act as sponsor for a healthy volunteer study. The Research Regulation and Compliance Office will consider the proposed study and together with the investigator record details of the study, finances, personnel and University facilities involved.
University Ethical Approval for Healthy Volunteer Studies is always required. Details of this process can be found via the University Ethics Committee web pages. Investigators conducting Healthy Volunteer studies should also be aware of potential insurance issues regarding their study. Please refer to the Insurance and Indemnity section of these webpages for more information.
Amendments and Completion
Investigators should inform the Research Rgulation and Compliance Office and the appropriate University Ethics Committee of any amendements to the original protocol.
At the end of the study investigators should inform the Research Regulation and Compliance Office and the Ethics Committee and arrange for the essential study documents to be archived. The University requires documents to be retained for a minimum of ten years.
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