Table 3.

Example Descriptions from Consent Forms of Unknown “Theoretical” Risks

Study ID	Excerpts from risk sections
02 GTR	“There may be adverse effects that are presently unknown and unforeseeable…Possible consequences of [intervention] are unknown. It could have no effect or a positive effect…[It] could also possibly cause cancer, or even spread to your reproductive organs and be passed on to any future children you may have. However, to date no such events have been reported…so this risk is still theoretical…a test to monitor this [will be run at various times points during the study].
03 Vaccine	“Unknown frequency or theoretical risks:…insertion of the vaccine DNA into your body's DNA could possibly lead to cancer, or into the DNA of bacteria or virus in your body (which has unknown consequences). This can be serious, but is expected to be rare if it ever occurs. None of these possible risks of DNA vaccines has been seen in laboratory tests or in animals or humans so far, but you need to be aware of these possible risks.”
13 Obser.	“The exact risks or severity of adverse events associated with analytical treatment interruption in patients with HIV who have undergone bone marrow transplantation are not known.” (p. 12)