Informed Consent

Before research can begin, of primary importance and concern, is the free and informed consent of the participants or subjects in the research. Virtually every set of guidelines, regulations, or code of ethics addressing research with human subjects states that a consent form should include the following:  

• identify the researcher, research institution, and provide contact information
• state the purpose of the research in language that is easy to understand
• state the risks, if any, and the benefits of the research to the participants or subjects, and that subjects are being invited to participate
• clearly indicate that the participants have the right to withdraw at any time, for any reason
• assure confidentiality of the data collected in the research
• state whether or not the subjects may have access to the results of the research
• clearly explain the procedure of the research in easy to understand terms
• research with subjects who may be unable to give consent, for health reasons for example, must have the consent of the guardian or legal representative
• verbal consent is appropriate to respect cultures that do not acknowledge written forms
• state whether or not there is any remuneration and if so what amount
• how full debriefing of the subjects, where appropriate, will be conducted
• research with minors must have the written consent of parents or guardians, and in some cases receive minor's assent
• a copy of the consent form must be signed and a copy given to the participant to keep as a reference
• a statement that the research received ethics approval by an REB, with contact information for same