The guide covers the information that must be provided to subjects and provides sample language that you may adapt. The samples are designed to prompt your thinking. Don't use them uncritically because they may not be right for your study.
When you write your scripts for oral presentation or write a consent form remember that you are engaging in a conversation with your potential subjects. Refer to yourself as "I" and to the subjects as "you."
Use lay language at the appropriate reading or comprehension level. Avoid academic jargon.
Ensure that your consent process is culturally appropriate. You may need to check with sources from the country where you will conduct your research.
Be aware that there may be multiple steps involved in securing informed consent. For example, you may send an introductory email message or letter describing your study and asking interested people to respond so that you can set up a time to meet or talk on the phone. When you meet or talk, you will need to have an informed consent form, or in the case of a telephone interview, a script. The form or script would restate, and perhaps expand upon, the information in the introductory letter.
In another scenario, you may recruit subjects orally and if they indicate interest, you would provide additional information, again orally, to allow them to make a final decision about whether to participate. At the completion of an oral process that involves two steps, potential participants must have all the information they need to make an informed decision about whether to participate.
Be aware that you may need to secure consent at multiple levels. For example, you many need to secure consent from community leaders as well as from individual participants.
To access sample consent forms and scripts, use your Duke NetID to login[2].
Outline of a consent form or script (click the arrow to read the full text):
