Informed Consent

In discussing research related issues with patients, clinic staff takes into consideration that patients with schizophrenia have cognitive symptoms that can interfere with their thinking.  They frequently suffer from attentional difficulties, intrusive hallucinations and thought disorder.  Staff, therefore, realize that obtaining informed consent for research participation is a process- not something accomplished quickly in one session. 

An explanation of the rationale for a study, clarification of the risks to the patient and what will be expected of him/her during the protocol are discussed repeatedly in a variety of settings.  Staff trained in obtaining informed consent meets with the subject in a variety of setting, including  individual and group sessions ( where other members may participate) and, when appropriate, in sessions with the potential subject’s family, care givers or other significant people in their lives. 

Information is presented slowly, straight-forwardly, and most importantly, on repeated occasions.  Various educational techniques are used to help each individual understand the risks, benefits, side-effects, what he/she needs to do to get out of the study, and what will be required of him/her during the study.  Prior to actually signing consent, patients are required to verbalize what they have learned, including specific risks and benefits of the protocol.

More Information about Informed Consent

Informed Consent and Schizophrenia

Previous Studies in Research Ethics and Informed Consent in Schizophrenia

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