The challenges and issues presented by the task of gaining fully informed consent from participants is one of the most highly discussed and important elements, certainly from an ethics perspective, in the conduct of clinical research. There many different kinds of clinical research study (with interventional clinical trials only being one example) and therefore information sheets and consent forms need to be designed for the specific needs of an individual study. Certain standards must be met for clinical trials and there are different needs for other types of clinical research.
The editors of this site also believe that the process of obtaining consent is neither a single point in time (reading and signing a form) or merely based on the information and the form. Rather, there must be a wider consideration about what information should be conveyed, when and by whom. This then leads to the development of a trial-specific consent process, including a training plan and operating procedures, which can be just as important as the consent form itself.
When thinking through an appropriate consent process sites might wish to consider:
- What is the relative risk of the study (risk of intervention weighed up against the nature of the patient population)
- The design of the trial: complexity and duration
- Vulnerability of the population (e.g. children, literacy, morbidity)
- Experience of trial staff
- Perception of the community
We are developing pragmatic tools that can be adapted for use in different scenarios. These will comprise template information including consent SOP’s, training resources and guidance notes and consent forms for a range of research studies. Sites are encouraged to submit current templates and examples they are using in order share methods and improve practices.
You can download existing templates and tools, including numerous Informed Consent forms, from this link.