CHAPTER 421

FORMERLY

HOUSE BILL NO. 623

AS AMENDED BY HOUSE AMENDMENT NO. 1

AN ACT TO AMEND PART V, TITLE 16 OF THE DELAWARE CODE RELATING TO PHARMACEUTICAL RESEARCH.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend §5161(a)(2)d., Subchapter V, Chapter 51, Title 16 of the Delaware Code by inserting the words "research, investigational, or" between the word "of" and the word "experimental".

Section 2. Amend §5161(a)(7), Subchapter V, Chapter 51, Title 16 of the Delaware Code by striking said subsection in its entirety and substituting in lieu thereof the following:

"(7) A clinical record for each patient shall be maintained, and shall contain complete information on all matters relating to the admission, legal status, care, and treatment of the patient and shall include all pertinent documents relating to the patient. Copies of informed consent forms signed by patients or guardians pursuant to subsection (a)(2)d. of this section shall be kept with each patient's ward chart. The Division of Mental Health shall, by regulation, determine the scope and method of recording information maintained on the clinical records; such regulations shall ensure the completeness and accuracy of data pertaining to admission, legal matters affecting the patient, records and notations of course of care and treatment, therapies, the patient's progress if in research and adverse or other reactions thereto, restrictions on the patient's rights, periodic examinations, and other information required by the Division.

The Division may require that statistical information about patients be reported to the Division, which information shall not contain names of patients.

No information reported to the Division and no clinical records maintained with respect to patients shall be public records, and such information shall not be released to any person or agency outside of the Division except as follows:

Pursuant to an order of a court of record;

To attorneys representing the patient;

With the consent of the patient or someone authorized to act on his behalf;

Where the patient has been transferred to an institution outside of the Division of Mental Health."

Section 3. Amend Chapter 51, Part V, Title 16 of the Delaware Code by creating a new Subchapter VI to read as follows:

"SUBCHAPTER VI. PHARMACEUTICAL RESEARCH

§5171. Definitions

As used in subchapter:

'Department' shall mean the Department of Health and Social Services or its successor.

'Double blind research' shall mean research in which neither the patient nor the physician knows whether the patient is receiving medication or a placebo.

'He,' him,"his,' and all other terms used in the masculine gender shall also include and be equally applicable to the corresponding terms used in the feminine gender.

'Hospital' means the Delaware State Hospital or such other hospital in this State which is certified by the Secretary of the Department of Health and Social Services as being an appropriate facility for the diagnosis, care, and treatment of mentally ill persons.

'Informed consent' means the consent of a patient to the performance of health care services by a health care provider who has informed the patient both verbally and in writing, to an extent reasonably comprehensible to general lay understanding, of the nature of the proposed procedure or treatment and of the risks and alternatives to treatment which a reasonable patient would consider material to the decision whether or not to undergo the treatment.

'Mentally ill person' means a person suffering from a mental disease or condition which requires such person to be observed and treated at the hospital for his own welfare.

'Patient' means any patient at the hospital.

'Psychiatrist' means a physician licensed to practice medicine specializing in the field of psychiatry; or a physician employed by the hospital. registered with the Medical Council of Delaware, and certified by the hospital Medical Director to the Medical Council of Delaware as being qualified in the diagnosis and treatment of mentally ill persons.

§5172. General Procedures

(a) Prior to the participation of any patient in pharmaceutical research, the Department shall adopt rules and regulations governing such research. Such rules and regulations shall conform to the requirements of the Food and Drug Administration and to the provisions of this chapter. In the course of promulgating such rules and regulations, the Department shall request the assistance of the Food and Drug Administration and the State Office of Narcotics and Dangerous Drugs, and shall hold at least one public hearing. The Department shall review the rules and regulations pertaining to pharmaceutical research annually.

(b) Department rules and regulations governing pharmaceutical research shall include but not be limited to the following provisions:

No patient should be approached to participate in a pharmaceutical research program where the most recent certification by a psychiatrist indicates that the patient is incapable of voluntary consent to care or treatment, is unable to make responsible decisions regarding hospitalization, or is mentally incompetent to waive legal rights. Patients who show marked improvement should be reevaluated only by psychiatrists who will receive no financial benefit from the research as to whether the patient is now fully competent before being approached about participation in research.

Diagnosis of a patient's condition prior to his participation in pharmaceutical research shall be done only by psychiatrist(s) who will receive no financial benefit from the research.

Prior to the inclusion of a patient on a research project, examining psychiatrist(s) shall consider whether the patient would respond to accepted pharmaceutical or other therapies.

To ensure that patients retain their capacity to freely consent to participate in research, patients shall be monitored by psychiatrists who will receive no financial benefit from the research.

if any patient participating in a research project shall be found not to be mentally he shall be removed from the research immediately.

(c) Any indemnification agreement which purports to bind the hospital shall be approved by a Deputy Attorney General representing the Department and by the Department before signature by the research psychiatrist.

(d) The use of State time shall be adequately documented so that research compensated by private companies is properly segregated from that time.

§5173. Institutional Review Board

The Department shall establish an Institutional Review Board which shall be composed of 12 members appointed by the Secretary of the Department. No more than 6 members shall be employed by the Department and no more than 3 members shall be employed by the hospital.

The duties of the Institutional Review Board shall include, but not be limited to:

(1) Approval, modification, or disapproval of all proposed pharmaceutical research programs and all written procedures and protocols governing such programs. Final approval of any program shall require an affirmative vote of 8 members. In evaluating any proposed research program, the Board shall consider whether the risks to patients are sufficiently outweighed by the potential benefits and the importance of the knowledge to be gained. In its deliberations, the Board shall be guided by the American Medical Association's 'Ethical Guidelines for Clinical Investigation,' the American Psychiatric Association's 'Ethical and Professional Guidelines Governing Research With Human Subjects,' or similar document.

Ensuring that no patient participates in research who fits any exclusion criteria established by the pharmaceutical protocol or by the Board itself.

Actively monitoring all such research programs on a regular basis. Such monitoring shall include the review of the effects of the research on patients and the review of individual patient records to ensure the continued protection of patient rights and continued compliance with regulations.

Ensuring that the provisions of §5175 of this subchapter are complied with for every patient who participates in pharmaceutical research.

Evaluating, together with the administration of the hospital and the Food and Drug Administration, all reactions and incidents which occur to research participants to determine whether the research pharmaceuticals in any way affected the patient so as to cause the reaction or incident.

In order that the Board be active and effective, notices of meetings shall be sent to all members, minutes shall be maintained and distributed prior to meetings, and all records, documents and correspondence shall be retained by an officer of the Board at the hospital. The Division of Mental Health shall provide administrative and secretarial assistance to support the Board's functions.

No member of the Board shall be permitted to vote on any research project in which he has an active role or financial interest.

§5174. Patients Ineligible to Participate in Pharmaceutical Research

The following patients shall be ineligible to participate in pharmaceutical research:

Any patient who has been placed in the jurisdiction of the hospital under the provisions of Chapter 4 of Title 11, or §5153 of this Title; provided however, that a patient placed in the jurisdiction of the hospital under the provisions of Chapter 4 of Title 11 or §5153 of this Title shall be eligible with the prior approval of Superior Court upon affidavit filed by the medical director of the hospital. Such affidavit shall state that the patient for whom eligibility to participate is sought has given his informed consent and that with respect to that patient, all provisions of 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 subchapter or for any other reason it deems appropriate. Any affidavit filed pursuant to this subsection shall be served upon the Attorney General, and no action shall be taken by the Court for 10 days after the date of such service. Superior Court may by rule prescribe procedures for review of affidavits filed pursuant to this subsection.

Any patient who has been placed in the jurisdiction of the hospital under the provisions of Chapter 50 of this Title; provided, however, that a patient initially committed under the provisions of Chapter 50 of this title shall be eligible if that patient has voluntarily applied for, and has been accepted for hospitalization pursuant to §5123 of this title.

Any patient who has been released from the hospital on convalescent status under the provisions of §5131 of this title.

Any patient who has been placed in the jurisdiction of the hospital under the provisions of Chapter 57 of this title.

§5175. Informed Consent

No patient may participate in any pharmaceutical research, investigation, or experiment unless and until he has given his informed consent.

Informed consent shall be in writing and each patient shall be given a copy of his signed consent form 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 he wishes to withdraw.

Any patient participating in double blind research shall be advised both verbally and in writing that he 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.

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

No patient shall be approached to participate in pharmaceutical research if he is incapable of understanding the nature and consequences of his consent.

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 one 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.

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.

§5176. Waiver of informed consent

The provisions of §5174(2) and §5175 of this subchapter may be waived for a patient under the following conditions:

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

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.

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

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

The proposed waiver has the prior written approval of the patient's legal guardian or, if the patient has no guardian, his next-of-kin.

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."

Section 4. If any provision of this Act or the application of any provision of this Act to any person or circumstances is held invalid, the application of such provision to other persons or circumstances and the remainder of this Act shall not be affected thereby.

Section 5. This Act shall become effective upon enactment.

Approved July 20. 1984.