reglab/housing_qa huggingface dataset:
16 DE Code § 5171. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5171. Definitions.

§ 5171. Definitions. As used in subchapter:  (1) “Department” shall mean the Department of Health and Social Services or its successor. (2) “Double blind research” shall mean research in which neither the patient nor the physician knows whether the patient is receiving medication or a placebo. (3) “Hospital” means the Delaware Psychiatric Center 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. (4) “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. (5) “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 the person's own welfare. (6) “Patient” means any patient at the hospital. (7) “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.64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;  70 Del. Laws, c. 550, §  1;
16 DE Code § 5172. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5172. Rules and regulations.

§ 5172. Rules and regulations. (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 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 Police Drug Diversion Unit and shall hold at least 1 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:  (1) 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. (2) Diagnosis of a patient's condition prior to the patient's participation in pharmaceutical research shall be done only by psychiatrist or psychiatrists who will receive no financial benefit from the research. (3) Prior to the inclusion of a patient on a research project, examining psychiatrist or psychiatrists shall consider whether the patient would respond to accepted pharmaceutical or other therapies. (4) 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. (5) If any patient participating in a research project shall be found not to be mentally ill, the patient 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. 64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;  78 Del. Laws, c. 155, §  7;
16 DE Code § 5173. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5173. Institutional Review Board.

§ 5173. Institutional Review Board. (a) 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. (b) 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 documents. (2) Ensuring that no patient participates in research who fits any exclusion criteria established by the pharmaceutical protocol or by the Board itself. (3) 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. (4) Ensuring that the provisions of § 5175 of this title are complied with for every patient who participates in pharmaceutical research. (5) 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. (c) 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. (d) No member of the Board shall be permitted to vote on any research project in which the member has an active role or financial interest. 64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;
16 DE Code § 5174. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5174. Patient participation restricted.

§ 5174. Patient participation restricted. The following patients shall be ineligible to participate in pharmaceutical research:  (1) Any patient who has been placed in the jurisdiction of the hospital under Chapter 4 of Title 11 or § 5153 of this title; provided, however, that a patient placed in the jurisdiction of the hospital under 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 the patient's 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 subdivision 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 subdivision. (2) Any patient who has been placed in the jurisdiction of the hospital under Chapter 50 of this title; provided, however, that a patient initially committed under Chapter 50 of this title shall be eligible if that patient has voluntarily applied for and has been accepted for hospitalization pursuant to § 5003 of this title. (3) [Repealed.] (4) Any patient who has been placed in the jurisdiction of the hospital under Chapter 57 of this title.64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;  79 Del. Laws, c. 442, §  2;  81 Del. Laws, c. 79, §  28;
16 DE Code § 5175. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5175. Informed consent required.

§ 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. 64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;
16 DE Code § 5176. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VI. Pharmaceutical Research|§ 5176. Waiver of informed consent requirement.

§ 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.64 Del. Laws, c. 421, §  3;  70 Del. Laws, c. 186, §  1;
16 DE Code § 5181. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VII. Community Mental Health Treatment Act|§ 5181. Definitions.

§ 5181. Definitions. As used in this chapter:  (1) “Department” means the Department of Health and Social Services except that Department means the Department of Services for Children, Youth and Their Families in the context of a treatment facility serving minors. (2) “Facility” or “treatment facility” means an entity, other than a licensed hospital, that provides care, supportive lodging or treatment to individuals with a mental condition. This section includes mental health providers serving individuals in both inpatient and outpatient settings, day treatment programs, and supervised apartments. “Facility” does not include the following:  a. A hospital or residential center as defined in § 5161(b) of this title; b. Shelters or leased premises, apart from supervised apartments, solely providing housing without mental health provider services; c. Outpatient practice offices of licensed independent practitioners, including, but not limited to, physicians, psychologists, social workers and counselors. (3) “Mental condition” means a mental disorder as defined in the most recent edition of the American Psychiatric Association's “Diagnostic and Statistical Manual of Mental Disorders.” (4) “Mental health provider” means any professional who provides assessment, care, treatment, counseling, medication, case management, or therapeutic services to an individual with a mental condition, including but not limited to psychiatrists, psychologists, psychiatric nurses and social workers. (5) “Patient” means any individual receiving involuntary or voluntary care, supportive lodging, treatment or other mental health provider services from a facility. (6) “Patient representative” means an individual or entity authorized to act on the patient's behalf by operation of law or express appointment by the patient. (7) “Protection and advocacy agency” means the Community Legal Aid Society, Inc. or successor agency designated the state protection and advocacy system pursuant to the following:  a. Protection and Advocacy for Individuals with Mental Illness Act (42 U.S.C. § 10801 et seq.); b. Developmental Disabilities Assistance and Bill of Rights Act (42 U.S.C. § 15001 et seq.); or c. Protection and Advocacy for Individual Rights (29 U.S.C. § 794e).77 Del. Laws, c. 387, §  1;  78 Del. Laws, c. 179, §§  201-203;
16 DE Code § 5183. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VII. Community Mental Health Treatment Act|§ 5183. Devolution of rights.

§ 5183. Devolution of rights. Consistent with the nature of each right in § 5182 of this title, the entitlement may devolve to the patient representative. Authority to act on behalf of patients who are minors may be exercised by the minor's parent, guardian, or custodian. Authority to act on behalf of an adult patient may be exercised by a guardian acting within the scope of appointment or through an agent acting pursuant to a valid power of attorney, health-care directive, or similar instrument. In the absence of such authorized representative, if the patient's physician determines that the patient is incapable of exercising rights under this subchapter due to mental or physical incapacity, authority to exercise such rights shall devolve to the patient's next of kin. 77 Del. Laws, c. 387, §  1;
16 DE Code § 5184. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VII. Community Mental Health Treatment Act|§ 5184. Reporting requirements.

§ 5184. Reporting requirements. (a) Any employee of a facility or anyone who provides services to a patient of a facility on a regular or intermittent basis who has reasonable cause to believe that a patient in a facility has been abused, mistreated, neglected or financially exploited shall immediately report such abuse, mistreatment, neglect or financial exploitation to the Department by oral and written communication. The written report shall be filed by the employee or service provider within 48 hours after the employee or service provider first gains knowledge of the abuse, mistreatment, neglect or financial exploitation. (b) Any person required by subsection (a) of this section to make an oral and a written report who fails to do so shall be liable for a civil penalty not to exceed $1,000 per violation. (c) In addition to those persons subject to subsection (a) of this section, any other person may make such a report if such person has reasonable cause to believe that a patient of a facility has been abused, mistreated, neglected or financially exploited. (d) No facility shall retaliate or discriminate against any patient or person facilitating submission of a report or cooperating with any investigation prompted by a report under this section. (e) Any correspondence or other written communication from a patient to the Department, the Attorney General's office, the protection and advocacy agency and/or a law-enforcement agency shall, if delivered to or received by a facility, be promptly forwarded, unopened, by the facility to the agency to which it is written. Any correspondence or other written communication from the Department, the Attorney General's office and/or a law-enforcement agency to a patient shall, if delivered to or received by the facility, be promptly forwarded, unopened, by the facility to such patient. Failure to comply with this section shall result in a civil penalty not to exceed $1,000 per violation. 77 Del. Laws, c. 387, §  1;
16 DE Code § 5185. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VII. Community Mental Health Treatment Act|§ 5185. Protection and advocacy agency.

§ 5185. Protection and advocacy agency. (a) The protection and advocacy agency is authorized to complement the role of the Department in promoting the health, safety, and well being of patients under this subchapter through monitoring, investigation, and advocacy. In furtherance of this authority, the protection and advocacy agency may engage in the following functions:  (1) Solicit and receive oral and written reports and complaints of abuse, neglect, mistreatment or financial exploitation of facility patients; and (2) Access a facility; interview patients, residents, facility staff and agents; and inspect and copy records pertaining to a patient with valid consent or as otherwise authorized by federal law. (b) No facility shall retaliate or discriminate against any patient or person submitting a report to the protection and advocacy agency or cooperating with the agency's monitoring, investigation, or advocacy activities. 77 Del. Laws, c. 387, §  1;
16 DE Code § 5186. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VII. Community Mental Health Treatment Act|§ 5186. Enforcement of rights.

§ 5186. Enforcement of rights. This subchapter shall be enforceable by the Attorney General, the protection and advocacy agency, and aggrieved patients and patient representatives. Without limitation, notwithstanding § 342 of Title 10, the Court of Chancery shall have jurisdiction over actions, including those requesting declaratory relief, to enforce or resolve disputes concerning the rights arising out of this subchapter. 77 Del. Laws, c. 387, §  1;
16 DE Code § 5196. (2021)
2021 Delaware Code|Title 16 - Health and Safety|Chapter 51. The Department of Health and Social Services|Subchapter VIII-A. Behavioral Health Consortium; Prescription Opioid Distribution Commission|§ 5196. Organization and composition of the Consortium.

§ 5196. Organization and composition of the Consortium. (a) The Consortium is composed of 27 members, as follows:  (1) Eleven individuals, or their designees, who are members of the Consortium by virtue of their respective positions, as follows:  a. The Lieutenant Governor of the State of Delaware. b. The Chair of the Behavioral and Mental Health Commission. c. The Chair of the Center for Health Innovation. d. The Chair of the Delaware Suicide Prevention Association. e. The Chair of the Overdose Fatality Review Commission. f. The Chair of the Addiction Action Committee. g. The Chair of the Police Chiefs Council. h. The Chair of the Mental Health Association in Delaware. i. The Executive Director of the Ability Network of Delaware. j. The Attorney General, as co-chair of the Prescription Opioid Settlement Distribution Commission. k. The chair of the Local Government Committee of the Prescription Opioid Settlement Distribution Commission. (b) Members serving by virtue of position may appoint a designee to serve in their stead and at their pleasure. (c) Consortium working groups. — The Consortium shall create working groups in accordance with the recommendation of the Consortium. (d) Terms of the Consortium members. — Governor appointed members are appointed for a term of 2 years. (e) Consortium Chair. — The Consortium shall be chaired by an appointment of the Governor from the Consortium membership. The Chair is responsible for guiding the administration of the Consortium by, at a minimum, supervising the preparation and distribution of meeting notices, agendas, minutes, correspondence, and reports of the Consortium. (f) Official action by the Consortium, including making findings and recommendations included in a report issued by the Consortium, requires the approval of a majority of the total members of the Consortium. 81 Del. Laws, c. 125, §  1;  81 Del. Laws, c. 220, § 2;  83 Del. Laws, c. 243, § 5;