Del. Code Ann. tit. 16, § 5175 - Informed consent required

A patient must provide written informed consent prior to pharmaceutical research. The patient must be given a copy of his or her signed consent form. A patient’s participation in pharmaceutical research must truly be voluntary. Patients must be advised both verbally and in writing that no threats, promises, special privileges or payments of any kind will be made for their participation in pharmaceutical research. Patients must be informed both verbally and in writing of their right to withdraw from the research at any time. Any patient participating in double blind research must be advised both verbally and in writing that the patient may receive a placebo instead of medication. Patients must be encouraged to consult with family, friends and physicians prior to signing any consent form and entering the research program. A patient who is incapable of understanding the nature and consequences of the patient’s consent may not be approached to participate in the research program.