|NIH Guidance on Informed Consent For Gene Transfer Research NIH
GUIDELINES: "How will the major points covered in Appendix M-II,
Description of Proposal, be disclosed to potential participants
and/or their parents or guardians in a language that is
understandable to them?" Improving Comprehensibility of the
Consent Form: Comprehensibility of the consent form is promoted
by: The text of the consent form can then provide detailed
information about the particular study, and may repeat some of
the summarized issues in the context of the particular study.
Sometimes, "research" and "treatment" terms are used
interchangeably in consent forms. Consistent use of terms is
preferred, however, to help minimize the potential for
confusion. For example, one term should be used to describe the
experimental gene transfer intervention, instead of calling it,
at various places, study injection, delivery of a modified virus
vector, or gene shot. One term should be used to refer to the
investigator (instead of using, for exampl