Documenting Informed Consent
Informed consent provides participants with enough information about the study to allow them to make informed decisions about whether to participate, and whether to continue to participate. It is an on-going process that starts with the researcher's first contact with the individual and continues through study completion/participant withdrawal, and beyond. It includes any verbal exchange about the study, the written informed consent form and any other written documentation given to participants.
Consent must be documented. Whether their consent is to be obtained in writing, orally, or by some other procedure, participants must be given an informed consent document.
- When written consent is obtained, the consent form should be dated and signed by both the researcher and the participant. The participant should receive a copy of the consent form for his or her own reference.
- When consent is obtained orally, the consent form should be provided and/or read aloud to the participant. It should be dated and signed by the researcher(s) indicating that “I have read and explained this consent form to the participant before receiving the participant’s consent, and the participant had knowledge of its contents and appeared to understand it." Alternatively, consent may be audio-recorded.
- When written or oral consent is not obtained, another means must be provided for participants to indicate their consent. For example, in a survey, participants should be given an informed consent document and informed that completion and return of the survey will constitute consent to participate and permission for the researcher to use the data gathered in the manner described.
- The procedures used to seek free and informed consent must be approved by ICEHR before data are collected.
Participants make a vital contribution to research. They must be treated at all times with the highest respect and consideration. All communications, whether written or oral, should be professional, as well as socially and culturally appropriate. Specifically:
- Information letters and consent forms should be presented on the institutional or departmental letterhead of the Principal Investigator.
- Use the second person (i.e., “you”) in the informed consent process.
- The level of language used should be appropriate to participants’ age and comprehension level. Avoid or explain technical terms and jargon. (For people in the general population, a grade 6 to 8 reading level is appropriate. In Microsoft Word the Flesch-Kincaid Grade Level Score can be determined by accessing Tools/Options/Spelling&Grammar and by selecting “Show readability statistics.”)
- Avoid the use of legalistic phrases.
- Use headings, small paragraphs, and spaces between paragraphs to make information easier to read.
- Ensure that spelling, grammar, and punctuation are correct.