Information for participants

This section contains the following:

Introduction
Things to consider when writing a protocol
Illustrative examples - WHO calcium supplementation trial
Illustrative examples - Perinatal care trial
Illustrative examples - CRASH trial
Additional resources
Further reading

Introduction

The process of obtaining informed consent to take part in a trial (including a choice not to take part) requires steps to be taken to protect an individual’s right to make choices. These steps include:

Ensuring that the individual receives full disclosure of relevant information
Ensuring that the individual is competent to decide
Ensuring that the individual acts voluntarily in the consent process.

Researchers must also attend to the quality of a patient’s understanding as part of this process. This includes an understanding of:

The purpose & nature of the trial
What they have to do
Possible benefits
Possible risks

In obtaining informed consent, the investigator is required to comply with the applicable regulatory requirements, and should adhere to International Conference on Harmonization Guideline for Good Clinical Practice ( ICH GCP ) to the ethical principles that have their origin in the Declaration of Helsinki, and to any local ethical guidelines.

For most trials it is appropriate to have an information sheet or leaflet summarising key information about the trial. This information may be verbal, written, or pictorial and should be given to the person when they are approached about the trial. The information sheet/leaflet should also provide contact details for the trial. The wording should be comprehensible to participants in terms of both language and style. Consultation with consumer groups and people who have experienced the clinical condition is advisable. Before the trial starts, the investigator should receive written approval of any information sheets/leaflets to be provided to potential participants from an independent ethics committee.

At the end of the trial the investigator should notify participants of trial findings, provide information regarding which group they were assigned to and, if applicable, provide details of how to get the treatment which proved to be effective (see Notifying participants of trial findings).

Things to consider when writing a protocol

Provide a description of how information will be given to participants.
Provide a description of how patient understanding will be determined before consent to participate in the trial.
Outline how specific issues related to different patient groups will be handled e.g. non-literate populations and the translation of information sheets/leaflets into other languages.
Include copies of all information sheets/leaflets in an appendix.

Illustrative example - CRASH trial

Patients with head injury and impaired consciousness may be unable to give properly informed consent, and in this emergency situation it may not be medically appropriate to delay the start of treatment until proxy consent can be obtained. Hence, the doctor in charge should take responsibility for entering such patients, just as they would take responsibility for choosing other treatments. However, the requirements of the relevant ethics committee should be adhered to at all times. An information leaflet on the study for patients and their friends and relatives will be available in all drug packs. (CRASH Trial - go to protocol)

Additional resources

Sample information sheets/leaflets

These are a selection of information sheets/leaflets that have been previously used to recruit participants.

Developing written information for patients Good Practice Guidelines

These guidelines were developed to provide assistance with developing information resources for patients. Checklists are also provided to allow authors and others assess the information.

What makes a good leaflet?

This checklist highlights the key points that ensure a leaflet keeps the reader’s attention and is easily understood. It also allows you to assess how well the sheet/leaflet has been written, designed and illustrated.