Investigations Involving the Use of Pharmaceutical Drugs

Loughborough University
Ethical Advisory Committee

Guidance Notes for Investigators
Investigations Involving the Use of Pharmaceutical Drugs

Investigators are advised that where an investigation involves the use of a pharmaceutical drug (particularly if that drug has not been considered previously by the Committee in connection with another study) the Committee will consider the following criteria before approval is granted:

1.	Insurance implications.
2.	Current medical opinion on the use of the drug, including whether any research has been undertaken into possible side effects (short and long term).
3.	Other expert witness statements (where appropriate).
4.	Appropriate exclusion criteria for participants in the investigation based on known side effects of the drugs, any medical conditions that may be aggravated by the drugs [contra-indications] or potentially harmful drug interactions. Is the health screening process adequate to ensure that these exclusion criteria are met?
5.	Is an up-to-date certificate of analysis included in the proposal?
6.	Does the proposal hypothesis justify the use of the drug in the study, taking into account all the other information that is known about the drug?
7.	Does the participant information sheet include detailed information regarding the possible risks, side effects, contra-indications and drug interactions?

Back to Main EAC page

Back to EAC - Additional Information and Resources page