16 Del. C. § 5176: Waiver of informed consent requirement.

Sections 5174(2) and 5175 of this title may be waived for a patient under the following conditions:

(1) An unsuccessful attempt has been made to secure the informed consent of the patient.

(2) No accepted pharmaceutical or other therapy exists for the type of illness affecting the patient or the patient has not responded to accepted pharmaceutical or other therapies.

(3) The performance of pharmaceutical research on the patient would be in the best interest of that patient.

(4) The proposed waiver has been approved in writing by the Institutional Review Board after thorough review of the patient’s clinical records.

(5) The proposed waiver has the prior written approval of the patient’s legal guardian or, if the patient has no guardian, patient’s next-of-kin.

(6) The proposed waiver has been approved by Superior Court upon affidavit filed by the medical director of the hospital. Such affidavit shall state that, with respect to the patient for whom the waiver is sought, all provisions of this section and this subchapter have been and will continue to be complied with. The Court may deny approval for failure to comply with any provision of this section or this subchapter or for any other reason it deems appropriate. Superior Court may by rule prescribe procedures for review of affidavits filed pursuant to this section.