Most research studies involving human subjects or their tissue requires the informed consent of those subjects.

It is a process that involves an information exchange between the researcher and the potential subject. It is ongoing, even after the signing of an Informed Consent Form, and consent may be withdrawn at any time and for whatever reason.

Sometimes the information a researcher wants to impart to potential subjects is complex and requires some time for them to fully understand and appreciate what the study is about. This is the case with Clinical Trials of Investigational Medicinal Products (CTIMPs). Participants need to appreciate the risks and responsibilities inherent with taking part.

Under GCP potential participants must be provided with the subject information sheet and be given adequate time for consideration and discussion before being asked if they wish to take part in the studies. Where appropriate, subjects need to be encouraged to discuss their possible participation with family members, and/or close friends, or GPs. They may also need to discuss the study with the researcher on more than one occasion. When the participant agrees to take part it is important that they sign the Informed Consent Form with a clear understanding of the study, the risks and the responsibilities involved in their participation.

It should be clear therefore that Consent should not be rushed. People need time to assimilate what it is they are being asked, they should at no time feel they have been hurried into completing a form, answering a question.

In any study, the researcher should allow a period of time to elapse between imparting the information about the study and requesting a signature on the consent form. The only time when this would be difficult is in studies involving emergency situations, where consenting procedures will be agreed prior to study start up.

Remember that Informed Consent is a process; the Informed Consent Form provides evidence of agreement to take part but is not the process and should not be used as a substitute for discussion. The process of informed consent should be documented.


Study Management

 

Consent and recruitment Progress and Safety Reporting Management and Monitoring Inspection and Audit End of Study Analyse Data Final Reports