Informed consent

When research involves humans, they are, with few exceptions, to be informed about the research and its effects, as well as be able to freely decide whether they wish to participate. This is a condition in the Good Clinical Practice Guidelines as well as being established in the fundamental codes as described in the section on research involving humans.

Empirical research has shown that forms providing information to study participants can sometimes be faulty. Some are not specific enough; for example, it often happens that they do not provide enough information on risks and the difference between treatment and research is not presented. Often, they are simply too difficult to understand when it comes to wording and content. They sometimes contain so much information that the reader is not able to absorb the essential parts. Great care should thus be exercised in this phase of the research.

The information one should give

Which information should people be given before asking for consent? The basic requirement of good information is that the researcher ensure that the intended patient or subject be informed in a way and with language that he or she understands. As a rule, the information is to be provided both in writing and verbally. The main ethical principle is that the information should contain everything that can be reasonably considered to have an effect on the subject's decision to participate.

Most codes, regardless of discipline, take their lead from the Helsinki Declaration on what information should be given to research subjects:

• Aims
• Methods
• Sources of funding
• Any possible conflicts of interest
• Institutional affiliations of the researcher
• The anticipated benefits and potential risks of the study and the discomfort it may entail
• Any other relevant aspects of the study
• The right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal

According to Good research practice, the information is also to comprise:

• A description of how collected data will be handled so that unauthorized persons will not have access to them
• What will be done to compensate a subject if his or her participation results in injury or discomfort
• The fact that, in the case of randomized clinical trials, intended subjects will be informed about the procedure and why it is being used, as well as understand clearly the implications of possible involvement of a control group, which entails treatment with a placebo

Research on those unable to consent

Most codes agree that research may be conducted also with those unable to consent, if it is believed that it will offer knowledge that is impossible to obtain through research with consent, and if the research is expected to be of direct benefit to the subject. Even if the latter condition is not met, the research may often be conducted if its aim is to contribute to a result that can be of benefit to another person suffering from a similar disease, and if the research poses only an insignificant risk of injury or discomfort to the subject. Note that research should not be initiated if the subject of the research has indicated in any way that he or she does not wish to participate or if a custodian or relative is opposed to the undertaking. Various European countries might of course have different enactments in place to regulate such research.

Personal Data

For research that includes the handling of personal information additional data legislation might demand that researchers inform about and/or collect consent for the handling of the information. The information is in many EU countries to include the identity of the person responsible for handling the personal information, the aim of the treatment, and all other information needed for the subject to exercise his or her rights in connection with the treatment (for example information on the person who receives the personal information and the right to request information and obtain redress). See the introduction to research on personal data for more on this.

Last updated: 2010-01-01