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Research and new methods

Voluntary (informed) consent

Before you join, everything must be explained to you and written consent obtained. Consent is not a one-off signature but a process that lasts the whole trial.

Last updated: ~1 min read
Hands of an older woman signing a paper form with a pen
Figure 1.A pen and a document

01Short answer

The consent document describes the trial's aim, procedures, duration, risks, possible benefits, alternatives, privacy and contacts. You have the right to take it home, discuss it with family and ask as many questions as you like. If new information emerges, you must be told and asked for consent again. For children, parents give consent and the child gives their own agreement (assent).

02Simple explanation

Everything is explained.

No need to hurry.

Questions are normal.

The process continues.

03Scientific explanation

NCI: informed consent is the process of learning key facts about a trial and deciding whether to take part.

NCI: new treatments are tested step by step, from the laboratory to clinical trials; only those proven safe and beneficial become standard care.

04What happens in the body?

What the document covers

Aim, risks, alternatives and privacy.

A conversation
Figure 2.A conversation — Voluntary (informed) consent

Your rights

Time, questions, a copy and leaving at any time.

Freedom
Figure 3.Freedom — Voluntary (informed) consent

How to read the news

Research news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.

Talk to your doctor

Show your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

05From research news to a conversation: four steps

Read, check, ask, decide together.

Read — From a trusted source.1ReadFrom a trusted source.
Check — Phase, participants, result.2CheckPhase, participants, result.
Ask — Show your doctor.3AskShow your doctor.
Decide — Together, without rushing.4DecideTogether, without rushing.
SourceA trusted site.
DoctorA personal explanation.
SafetyNot changing treatment yourself.

06Key points at a glance

TopicIn brief
What the document coversAim, risks, alternatives and privacy.
Your rightsTime, questions, a copy and leaving at any time.
How to read the newsResearch news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.
Talk to your doctorShow your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

07Key terms

Informed consent
A voluntary decision based on full information.
Assent
A child's own agreement.
Clinical trial
Testing a new treatment with volunteers.
Evidence
A result confirmed by reliable research.

08Key points

  • Learn.
  • Ask your doctor.
  • Write it down.
  • Check the source.
  • Talk to your doctor.

09Frequently asked questions

Do I have to sign?

No, joining is entirely voluntary.

What if I do not understand the document?

Ask for a simple explanation; you can also request an interpreter.

Is this advance right for me?

Only your treating doctor can say, based on your diagnosis, stage and condition.

10Questions for your doctor

Take these questions to your appointment. The ones you save are collected on the “My questions” page and stay on this device only.

  1. Do I have to sign?

  2. What if I do not understand the document?

  3. Is this advance right for me?

My questions

12Sources

  1. National Cancer Institute. Informed Consent in Clinical Trials
  2. National Cancer Institute. NCI Dictionary of Cancer Terms: informed consent
  3. National Cancer Institute. Patient Safety in Clinical Trials
  4. National Cancer Institute. What Are Clinical Trials?
  5. National Cancer Institute. Phases of Clinical Trials
  6. National Cancer Institute. Using Trusted Resources
  7. National Cancer Institute. Placebos in Cancer Clinical Trials
  8. National Cancer Institute. NCI Dictionary of Cancer Terms: control group
  9. National Cancer Institute. Randomization in Clinical Trials
  10. National Cancer Institute. NCI Dictionary of Cancer Terms: randomized clinical trial
Medical disclaimerThis information is for educational purposes only and does not replace medical advice.
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