Table 3 Set of core principles as approved by the consensus meeting

1

2, 18

All potential harms of the intervention should be listed. This includes the following:

  - Common as well as rare potential harms

  - Indirect potential harms (for example, to conceiving a child, pregnancy or breastfeeding)

2

15

The harms should be separated into serious (life-threatening, causing permanent damage) and less serious (like a mild headache that goes away quickly)

3

17

The fact that not all potential harms are known needs to be explicit. Also, sometimes, harms are discovered after the trial begins. As soon as they are discovered, participants need to be told about them

4

7, 8, 9, 10

All potential benefits of the intervention should be listed. This includes the following:

  - General potential benefits (such as ‘the medicine may help you and your cancer’) should be described

  - Concrete, specific potential benefits (such as ‘this medicine is designed to enable you to walk farther before becoming breathless’) should be described

  - Likely benefits to the participant (including embryos, foetus, nursing infants) should be described

5

3

Potential benefits and harms of a clinical trial need to be compared with what happens if the participant does not take part in the trial

6

20

Suitable visual representations are recommended where appropriate to describe potential intervention benefits and harms, such as pictograms of faces

7

Negated 24

Information about potential benefits and harms should not be presented apart by one or more pages