Bill Text: NJ A1996 | 2010-2011 | Regular Session | Introduced
Bill Title: Requires Commissioner of Health and Senior Services to adopt uniform informed consent form for clinical demonstration projects approved by DHSS.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2010-02-08 - Introduced, Referred to Assembly Health and Senior Services Committee [A1996 Detail]
Download: New_Jersey-2010-A1996-Introduced.html
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington and Camden)
SYNOPSIS
Requires Commissioner of Health and Senior Services to adopt uniform informed consent form for clinical demonstration projects approved by DHSS.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning clinical demonstration projects approved by the Department of Health and Senior Services and supplementing Title 26 of the Revised States.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. The Legislature finds and declares that:
a. New Jersey has positioned itself as a national leader with respect to advances in biotechnology and medical research and development, and desires to continue its leadership role in these key areas while protecting the health and safety of its residents;
b. New Jersey residents seeking information related to medical conditions and available treatments must often sort through a wide array and overwhelming quantity of information, whether due to the increased availability and usage of Internet resources, increased advertising, changes in health care benefits, or advances in medical technology that have made new health care treatments available;
c. Despite the proliferation of information related to medical treatment options, medical information technology has not yet advanced to the point where health care providers and patients can be confident that accurate information related directly to a patient's particular condition or treatment options has been accessed and understood by the patient;
d. When patients seek medical care in an acute care hospital or other licensed health care facility setting, they often require specialized and interventional treatment that is not available in a physician's office or other outpatient setting, and often involves a greater degree of medical risk to the patient;
e. The necessity for obtaining a patient's informed consent before providing medical care or treatment, particularly when the care or treatment involves a certain degree of risk to the patient, is a widely-accepted and long-standing principle in the medical profession.
f. When non-emergent medical treatment rendered in a licensed hospital or other health care facility involves a deviation from State licensure requirements or standards of care recognized by a large segment of the medical industry, such as when the treatment is rendered in conjunction with a clinical demonstration project or clinical trial, the need to obtain a patient's prior, fully-informed, written consent to obtain the treatment in the manner proposed is imperative. Full disclosure of treatment options is essential, particularly when a research protocol is testing the efficacy of clinical procedures that are at a variance from accepted standards of medical care, such as those published in clinical guidelines issued by professional medical societies; and
g. Patients cannot provide adequately informed consent unless they are advised of the standard of care generally applicable to the proposed medical treatment, if there is an applicable standard of care that has been endorsed by a consensus of medical experts in the particular medical field, or by the majority of physicians or experts if no consensus exists, and of any State laws or regulations related to that standard of care, such as applicable facility or professional practice licensure requirements.
2. As used in this act:
"Department" means the Department of Health and Senior Services.
"Informed consent" means a patient's written agreement to undergo a recommended medical treatment or procedure.
"Medically accepted standard of care" means the current published practice guidelines, recommendations, or standards espoused by medical experts within a particular specialty or field of medicine related to the treatment of specific diseases or conditions, when those guidelines, recommendations, or standards have been developed and endorsed by a medical specialty organization recognized by the Accreditation Council for Graduate Medical Education; and a medical treatment or procedure shall be considered to deviate from the medically accepted standard of care when the treatment or procedure itself, or the circumstances under which the treatment or procedure is rendered, is contrary to a specifically stated guideline, recommendation, or standard as set forth in the most recently published practice guidelines of the organization. In addition, the term, "medically accepted standard of care" shall include standards related to the provision of medical services contained in State or federal law or regulations related to the licensure of health care facilities or physicians; and a medical treatment or procedure shall be considered to deviate from the standard related to the provision of medical services contained in the law or regulation when the treatment or procedure itself, or the circumstances under which the treatment or procedure is rendered, is contrary to a specific statutory or regulatory licensure requirement.
3. A general hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) and a physician licensed pursuant to Title 45 of the Revised Statutes participating in a clinical demonstration project approved by the Department of Health and Senior Services, which requires approval by an institutional review board pursuant to State or federal law or regulation, shall not provide medical services to a patient in connection with the clinical demonstration project without first having obtained the patient's informed consent to participate in the project.
4. a. The Commissioner of Health and Senior Services shall adopt a uniform form for obtaining informed consent from patients for required use in clinical demonstration projects approved by the department.
b. The form shall be designed so as to ensure that the patient is provided with information, in a manner and in terms the patient understands, that includes, but is not limited to, the following:
(1) if the recommended treatment or procedure deviates, in any way, from the medically accepted standard of care, clear information describing that standard of care and alternative treatments or procedures available that comport with that standard of care;
(2) a clear statement of the risks and benefits that may result from the clinical demonstration project that are distinguishable from the risks and benefits of treatments or procedures that the patient would receive if not participating in the research; and
(3) the identity, function, location, and qualifications of any health care facility or physician who may provide medical treatment to the patient under the clinical demonstration project.
5. This act shall take effect immediately and shall apply to a demonstration project approved by the department on or after January 1, 2010.
STATEMENT
This bill is designed to ensure that patients participating in clinical demonstration projects approved by the Department of Health and Senior Services (DHSS) are fully informed about the medical treatments and procedures that they would receive under those projects.
The bill provides specifically as follows:
· A licensed general hospital and physician participating in a clinical demonstration project approved by DHSS, which requires approval by an institutional review board pursuant to State or federal law or regulation, are not to provide medical services to a patient in connection with the clinical demonstration project without first having obtained the patient's informed consent to participate in the project.
· The Commissioner of Health and Senior Services is to adopt a uniform form for obtaining informed consent from patients for required use in clinical demonstration projects approved by DHSS on or after January 1, 2010.
· The form is to be designed so as to ensure that the patient is provided with information, in a manner and in terms the patient understands, that includes, but is not limited to, the following:
-- if the recommended treatment or procedure deviates, in any way, from the medically accepted standard of care, clear information describing that standard of care and alternative treatments or procedures available that comport with that standard of care;
-- a clear statement of the risks and benefits that may result from the clinical demonstration project that are distinguishable from the risks and benefits of treatments or procedures that the patient would receive if not participating in the research; and
-- the identity, function, location, and qualifications of any health care facility or physician who may provide medical treatment to the patient under the clinical demonstration project.
