Limitations, challenges and ethics

4. Informed Consent

Informed consent is the process where people give their consent to take part in a research project or a clinical trial. Clinical study volunteers give their consent based on an understanding of what the research involves, i.e. they are informed before they give their consent.

Biobanks contain large numbers of samples and data that are extremely useful forfurther research that goes beyond the initial research project that the volunteers have participated in. So there is a question about what exactly the volunteers are consenting to.

A study volunteer can give consent only for a specific a clinical trial or research project. This means that it can be impossible to do more valuable research on the same samples and the same data for other purposes after the clinical study or research project is done. If researchers want to use the samples or data for other purposes or projects, they will have to re-contact the hundreds or thousands of study volunteers to obtain consent for such additional research. This may be difficult or impossible, if volunteers have moved, or died for example. One common solution to this problem is to ask volunteers for a general consent which is not limited to one specific research project or study.

Another important issue is ‘disclosure’, i.e. whether research results are given to study volunteers or people who have taken part in research and how these results are given. This should be clearly explained as part of the informed consent process.