Delaware Code Title 16. Health and Safety § 5175. Informed consent required

(a) No patient may participate in any pharmaceutical research, investigation or experiment unless and until the patient has given the patient's informed consent.

(b) Informed consent shall be in writing and each patient shall be given a copy of the patient's signed consent form.

(c) Informed consent must be voluntary, that is, free of any coercion by anyone, including the hospital. Patients shall 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. Participating patients shall be informed both verbally and in writing that they may withdraw from the research at any time. No pressure of any kind shall be exerted upon any patient to continue research from which the patient wishes to withdraw.

(d) Any patient participating in double blind research shall be advised both verbally and in writing that the patient may receive a placebo for the duration of the research instead of medication. The term “placebo” shall be fully defined both verbally and in writing.

(e) Patients shall be encouraged to consult with family, friends and/or physicians prior to signing any consent form and entering the research program.

(f) No patient shall be approached to participate in pharmaceutical research if patient is incapable of understanding the nature and consequences of patient's consent.

(g) All discussions leading to the agreement of a patient to participate in research, including the signing of the consent form, shall be witnessed by at least 1 health-care professional who will receive no financial benefit from the research. Such independent witness shall be qualified to determine whether the patient is competent to consent to participate and whether informed consent was freely given. The presence of the witness shall be noted on the consent form.

(h) The explanation of the proposed research to the patient shall include any explanation of the procedures to be followed and their purposes, a description of any attendant discomforts and risks reasonably to be expected, a description of any benefits reasonably to be expected, a disclosure of any appropriate alternative procedures that might be advantageous to the patient and an offer to answer any inquiries concerning the procedures.