Guide
The Informed Consent Form, section by section
You can take the form home, read it slowly and ask questions before signing. Here is what each part usually covers.
What is informed consent in a clinical trial?
Informed consent is the process of learning about a study, asking questions and deciding whether to join. The form records that decision. Signing it does not take away your right to change your mind.
Before signing, the study team should explain what will happen, the possible risks, other treatment choices and who to contact. Ask for a copy of the signed form. If anything is unclear, ask for more time or a clearer explanation.
Purpose of the study+
Why the study is being done and what researchers hope to learn. Ask: is this a new medicine, a new dose, or a comparison with standard care?
Study procedures+
Everything that will happen to you — visits, tests and treatments, usually listed in a schedule of assessments. Ask your consultant to walk you through it.
Randomisation and placebo+
You may be assigned by chance to a group. Some studies use a placebo (an inactive treatment). The form should say your chances.
Risks and side effects+
Known and possible side effects, how common they are, and what will be done if they happen.
Possible benefits+
There may be no direct benefit to you. Benefits to future patients may be described.
Alternatives+
Other treatments available to you if you decide not to take part.
Confidentiality+
How your personal data and samples are stored, coded and who can see them.
Costs and compensation+
Whether travel, parking and meals are reimbursed and how you claim them, and what happens if you are harmed by the study. Ask your consultant about what you may be paid back.
Voluntary participation+
Joining is your choice. You can withdraw at any time without affecting your normal care.
Contacts+
Who to call with questions or in an emergency, and the ethics committee contact.
Questions to ask before joining a clinical trial
- How does the study treatment differ from my usual care?
- Could I receive a placebo, and what care would I still receive?
- Which risks are known, and which are still uncertain?
- How many visits are there, and how long could each visit take?
- Who should I contact if I feel unwell between visits?
- What happens to my care, samples and information if I withdraw?
Ask a consultant to walk you through the visit schedule and how long each visit may take, or request a free consultation to talk through the wording. Only the study team can explain the exact rules of your study.
About the money in your form
The costs section usually says whether travel, parking and meals are paid back and how you claim them. Reimbursement repays costs the study creates for you — it is not payment for taking part. A consultant can talk you through what to ask the study team before your first visit.
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