Use of Pharmaceutical Drugs in Studies

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 Ethics Review Sub-Committee in connection with another study) the Sub-Committee will consider the following criteria before a favourable decision is granted:

  • Insurance implications.  Confirmation of insurance cover will be required.
  • Current medical opinion on the use of the drug, including whether any research has been undertaken into possible side effects (short and long term).
  • Other expert witness statements (where appropriate).
  • 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. Whether the health screening process adequate to ensure that these exclusion criteria are met.
  • Whether an up-to-date certificate of analysis is included in the proposal.
  • 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.
  • Does the participant information sheet include detailed information regarding the possible risks, side effects, contra-indications and drug interactions.