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Risks, benefits and informed consent

two dices

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 result

Questions to ask before participating in a clinical trial

  • Here are some questions you might like to ask before deciding whether to take part in a trial.
  • General questions
  • What is the trial called?
  • What is the point of the trial and how will it help people?
  • Why have I been invited to take part?
  • What are the benefits of the trial for me?
  • How long is the trial expected to last?
  • Can I withdraw from the trial at any time? (The answer should always be yes.)
  • How long will it be before the results of the trial are known?
  • Will I be informed of the results?
  • What will happen at the end of the trial - will I be able to continue having the same treatment?

Practical questions

  • You may also want to ask some practical questions to make sure you're happy with any demands that the trial will make on you:
  • How much of my time will be needed?
  • Will I need to take extra time off work?
  • Will I need extra help from family and friends?
  • Will my fares to and from the trial centre be paid? If so, how can I claim the costs back?
  • What extra tests or appointments will I have?
  • Will I have to fill in questionnaires or keep a diary?
  • What are the possible side effects of the treatment?
  • How might the treatment affect me physically and emotionally?
  • Who can I contact if I have a problem? Will someone be available 24 hours a day?

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