I noticed very early that people with schizophrenia seem to be less compromised in the informed consent process by the need to adhere to social expectations. We've begun research in the informed consent process. The most fascinating finding so far is that it's not how psychotic a person is that determines their capabilities nearly so much as it is their cognitive impairments. And, if they have cognitive impairments we are able to educate them over a longer period of time in order to obtain their informed consent. We have extremely good data that show we're able to do this successfully, even though we're dealing with people with chronic and severe diseases.
Patients make rational, self-interested decisions about a huge number of things every day.
The key is whether the false belief system is subsuming the information relevant to the research in a way that they lack decisional capacity. We've been cited for national leadership in developing procedures for informed consent, for documenting informed consent, and for the protection of subjects from research risk. Formal reviews and investigations have praised us about how we conduct this process.