Risks, benefits and informed consent
For some people with conditions such as MS, which are currently 'incurable' or where standard therapies are not effective, involvement in a clinical trial is seen as a way of receiving promising new treatments that otherwise would not be available to them.
Whilst there are a number of benefits that are associated with being involved in a clinical trail there are also some risks:
Risks
- Experiencing side effects
- Receiving ineffective treatment that may turn out to be worse than not being treated
- You may be assigned to a control group where you will not receive the treatment being studied
- You may be required to attend more frequent hospital visits and undergo more treatment, tests and hospital stays.
Benefits
- Being actively involved in your medical care
- Having access to new treatments that are not currently available
- Receiving care from experts in the field
- Contributing to the advancement of medical research and scientific knowledge.
Informed consent
Before entering a clinical trial you will be required to give your informed consent. This is a voluntary confirmation of your willingness to participate and documentation of this verbal agreement.
Informed consent should only be requested after you have been given full information in both verbal and written format and you have been given an opportunity to ask question and discuss any concerns you may have.
The information made available to you should include:
- Why the research is being done
- The trial treatment and the probability of receiving it
- What will be done during the trial and the timescales
- Your responsibilities
- What risks are involved
- The reasonably expected benefits
- What other treatments are available
- Compensation in the event of trial related injury
- Confirmation that participation is entirely voluntary and that you have the right to refuse to participate or withdraw from the trial at any point without it affecting your ongoing medical care
- The details of the person to contact for further information regarding the trial and the rights of those participating and in the event of a trial related injury.
- Feedback of trial results
If you are considering involvement in a clinical trial it is important that you fully understand what you are committing to.
More information on questions to ask.