Improving informed consent in bioinformatics research: a design-for-understanding approach.
Legally and ethically, researchers are required to ensure laypeople understand the informed consent process. Characteristics of the potential participants, their situation, and the study have been shown to affect laypeople's understanding. We propose a seven-step design-for-understanding approach to the development of an understandable informed consent document. Results from application of the approach to a large bioinformatics field study, HeartCare II, are provided.
Valdez
Rupa S
RS
Industrial and Systems Engineering, University of Wisconsin, Madison, USA.
Valdez
Rupa Sheth
RS
Marquard
Jenna L
JL
D035843:Biomedical Research / Q000379:methods*; D019295:Computational Biology / Q000379:methods*; D003194:Computer-Assisted Instruction / Q000379:methods*; D032962:Consent Forms; D054626:Consumer Health Information / Q000379:methods*; D007258:Informed Consent; D010353:Patient Education as Topic / Q000379:methods*; D014922:Wisconsin