Reading a consent form

A consent form can run to twenty pages. You do not have to absorb it in one sitting, and you are entitled to take it home before deciding anything.

What the form is for

The consent form is the written version of everything the team has told you about a study. Signing it says that you understand what will happen and agree to it. It is not a contract that locks you in: you can leave at any point, for any reason, and keep the care you would otherwise receive.

The sections to look for

• Purpose. What the study is trying to find out, in a paragraph or two.

• Procedures. Every visit, test and sample, and how long each takes.

• Risks and discomforts. Known side effects, how often they happen, and the unknowns.

• Benefits. Often “none expected for you”. That honesty is normal.

• Alternatives. The other options open to you if you do not take part.

• Costs and payments. What the study covers and anything you might be paid.

• Privacy. Who will see your information and how it is protected.

• Contacts. Who to call about the study, and who to call about your rights.

Lines worth reading twice

Look closely at what happens if you are injured during the study and who pays for that care. Check whether samples will be stored for future research, and whether you can say no to that while still joining. Note how long the study runs and whether there is follow-up after the last visit.

Questions to bring back

• Can I take this form home and talk it over before I sign?
• Which parts of the study are optional?
• What happens if new information about the treatment comes out while I am taking part?
• Who do I call at night or at the weekend if something goes wrong?

After you sign

You should receive a copy of the signed form to keep. If the study changes in a way that might affect your decision, the team must tell you and may ask you to sign an updated version.