What a consent form covers, section by section

Section I

Key information first

Many recent forms open with a short summary of the most important points: that the study is research, that taking part is voluntary, the purpose, the time involved, the main risks and possible benefits, and the alternatives. Read this page twice. If anything in it surprises you, ask before reading further.

Section II

Purpose and background

This section explains why the study is being done and what is already known. It should say clearly that the treatment is being tested, not that it is proven to work. Look for how many people will take part and roughly how long the study lasts.

Section III

What will happen

The procedures section lists every visit, test and step, often with a table or calendar. It should distinguish standard care, which you would get anyway, from research-only steps. Note anything that involves time off work, fasting, extra blood draws or overnight stays.

Section IV

Risks and benefits

Risks are often listed by how common they are, such as “likely,” “less likely” and “rare but serious.” Some forms add risks to an unborn baby and the need for birth control. The benefits section is often short, and it may honestly say that you may not benefit personally.

Alternatives should appear near here, describing the other options you have if you decide not to join.

Section V

Costs, payments and injury

This part explains what the study pays for, what your insurer may be billed for, any payment for your time, and what happens if you are injured. Read it slowly. Ask the coordinator to show you an example of what a typical visit would cost you, if anything.

Section VI

Privacy, contacts and signatures

The privacy section names who can see your records and how long they are kept. The contacts section lists the study doctor, the coordinator and the ethics board. The signature page records your agreement, the date and the name of the person who explained the study. You should receive a copy.

Section VII

Optional parts and future use of samples

Many forms include short optional sections near the end. They might ask whether leftover blood or tissue can be stored for future research, whether your genetic information may be studied, or whether the team can contact you about later studies. Each of these usually has its own yes or no box or initials line. Saying no to an optional part does not affect your place in the main study.

Read these sections slowly, because the choices can last longer than the study itself. If stored samples might be shared with other researchers, the form should explain whether your name is removed first and how to ask for samples to be withdrawn later.

Section VIII

Reading a long form without losing heart

Long forms are tiring, so break the reading into sittings. Start with the key information page and the procedures table, then come back for the rest. Use a pencil to mark sentences you want explained, and keep a single sheet of questions to bring to the next conversation.

If the form refers to separate documents, such as an optional sample-storage form or a privacy authorization, ask to see them too. Each may need its own signature and each is a separate choice.

Section-by-section checklist

• Read the key information page twice
• Find the number of people and study length
• Mark research-only steps in the procedures table
• Note common and serious risks
• Read the alternatives
• Check costs, payments and injury coverage
• Find who can see your records
• Make sure you get a signed copy

Reference table

Terms used here

Key information page

A short summary at the start of a form.

Standard care

Treatment you would receive outside the study.

Research-only procedure

A step done only for the study.

Alternatives

Other options besides joining.

Stipend

Payment for time or expenses.

Signature page

The page recording your agreement.

Questions to put to the study team

1. Which steps in this table are for research only?
2. How common is each listed risk?
3. What alternatives do I have if I do not join?
4. What would I pay, and what does the study cover?
5. Who can see my records, and for how long?
6. Will I receive a signed copy of this form?