The following info/consent documents are samples of how other researchers have created documents which provide the necessary consent information to participants. These are NOT meant to be templates but instead, provide samples of how communication of consent information can be approached.
Biomedical Samples
The sample biomedical consent package is an example of how researchers provided complex information about research processes to their participants. It’s always a good idea to keep the body of the info/consent document relatively brief. Longer descriptions of processes and risks can be drawn out of the main body into Appendices attached to the consent form.
Clinical Trials require some of the more complex consent documents – and links are available here to guidelines from Canadian and US sources. Note that these guidelines will likely pertain more readily to high risk pharmaceutical trials. As the risk decreases, so to does the need for stringent adherence to the guidelines.
- Health Canada - Requirements for Informed Consent Documents
- U.S. Food and Drug Administration - Informed Consent Information Sheet
Social Science Samples
Two samples of social science info/consent documents are provided. Researchers are encouraged to consider their participant ‘audience’ and write an info/consent document which will appeal to and be readily understood by that group. If you are interacting with an identifiable participant group, engaging with one or more members of that group to help write the info/consent document might be useful.
Researchers are encouraged to use creativity to communicate with participants. A formal template is not always the best choice.