Patient Rights. In this Issue: Patient Rights

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1 In this Issue: Patient Rights FEATURES Keeping a Lid on Pandora s Box: Strategies for Protecting Genetic Privacy 6 by Jane Massey Licata Managing Conflicts of Interest in Human Subject Research 11 by Gary J. Lesneski Patient Rights Psychiatric Advance Directives: A Summary and Analysis of the New Jersey Advance Directives for Mental Healthcare Act 16 by Terri Roth Reicher Effective Discovery and Use of Mental Health Records: Statutory, Regulatory and Strategic Considerations 20 by Christopher R. Barbrack Strategies for Protecting Genetic Privacy Psychiatric Advance Directives Effective Discovery and Use of Mental Health Records New Jersey s Wrongful Death Law Nursing Home Admission Agreements Also in this issue Legal Commentary Legal Practice Lawyer s Bookshelf Practice Tips The Increasing Use of Arbitration and Mediation in Adjudicating Healthcare Cases 25 by Katherine Benesch The Impact of the Community Healthcare Assets Protection Act Upon Consumers Rights 30 by Mark I. Siman and Renée Steinhagen New Jersey s Wrongful Death Law: A Matter of Economics 35 by Michael J. Barrett Nursing Home Admission Agreements: A Review of Key Provisions to Protect Residents and Family Members 39 by Jerold E. Rothkoff DEPARTMENTS President s Perspective 2 Message From the Special Editors 4 Legal Commentary 43 Legal Practice 45 Winning Websites 48 Lawyer s Bookshelf 49 Practice Tips 51 E-Practice 53 Attorney Ethics 56 The Legal Arts 57

2 PRESIDENT S PERSPECTIVE WAYNE J. POSITAN It Was a Very Good Year During my travels around the state over the last year, I kept hearing two questions: 1) the larger firms want to know what the relevance is of having their lawyers be members of the bar association; 2) the solo and small firm practitioners want to know what we do for them. As I near the end of my term as NJSBA president, I can report to you with pride that the past year has been a success on many fronts for our association, thanks in large part to the dedicated efforts of our members. And I am pleased to have a lot of solid answers to those two recurring questions. Above all else, the NJSBA continues to be the voice of our profession. The good we do benefits all lawyers in New Jersey, the justice system, and the public in general. We have spoken out about the importance of the rule of law in our society; the separation of powers; the regulation of our profession and the judicial system by the Supreme Court rather than the Legislature; and the independence of the judiciary and our profession. When the judicial decision-making process came under fire, when law firms were attacked for providing pro bono counsel at Guantanamo, when the chief justices of the United States and New Jersey spoke out about the need for judicial pay raises, we were there. We speak with conviction, and we speak from the strength of our numbers and our positions. We have continued our proud tradition of participating as amicus curaie in cases of importance to the bar, including fighting against mandatory pro bono assignments, arguing successfully against blanket prohibitions on municipal representation of private clients by municipal attorneys, clarifying the application of verbal threshold standards in auto negligence matters, and obtaining a stay in advertising restrictions urged by the Supreme Court Committee on Attorney Advertising. We continue to lobby diligently on behalf of lawyers in the halls and committee rooms of the Statehouse, successfully thwarting a proposal for a professional services tax, improving lobbying regulations, and gaining passage of a new cause of action for divorce based on irreconcilable differences, which will ease the emotional pain of divorce on all those affected. Our relations with the Supreme Court remain strong and productive. In the past few months, we have submitted comments on the budget for the lawyer disciplinary system, made recommendations for changes in court rules and procedures, and discussed with the court a variety of issues of concern to lawyers, ranging from case management practices to the filling of judicial vacancies. Our Judicial and Prosecutorial Appointments Committee (JPAC) continues to provide an independent, nonpartisan evaluation of candidates for the bench and county prosecutor positions. Among my proudest accomplishments has been the appointment of three task forces that have undertaken important initiatives. The Disaster Planning Task Force last month sponsored a summit on disaster planning and response that attracted representatives from the Corzine administration, the judiciary, neighboring state bar associations, law firms, governmental agencies, and numerous bar association leaders. The task force has published a Disaster Planning Guide for law firms that can be downloaded from the NJSBA website ( The Pipeline Diversity Task Force is working to ensure that future generations of lawyers reflect the diversity of their communities by suggesting ways for minority students to continue their education and follow the pipeline into law school and a legal career. With terrific involvement by the New Jersey State Bar Foundation, which does so many great things to fund educational efforts in our state, in January we established a street law initiative with our three New Jersey law schools Taught by law school students, the program brings education on the law, democracy and human rights into inner-city high school classrooms. The task force is actively engaged in future expansion of these efforts. We also have looked inward, through the efforts of the Task Force on Sections, Committees and Infrastructure, which has 2 NEW JERSEY LAWYER April 2007

3 worked diligently on finding ways to improve the performance and responsiveness of sections and committees within the NJSBA, with an eye toward providing more communication and opportunities for members to participate in activities involving their substantive areas of practice. In addition, I am proud to have been involved in the efforts of the Steering Committee of the Law Center Capital Campagin, which will update our great Law Center physical plant and provide opportunities for greater technological capabilities to benefit the profession and the community we serve. Our communications have improved through our website, blasts to the membership, and features in New Jersey Lawyer newspaper and magazine. Many members have taken advantage of the Daily Briefing service provided free by New Jersey Lawyer Newspaper, ing news briefs important to the legal community, and summaries of court opinions, to members every morning. Our upgraded website also includes an online directory for section members; section websites to encourage online discussion and messaging capabilities among section members, and a website for law students to provide access for career assistance, meetings and useful articles and information. We also continue to strive to offer other benefits to assist our members, in the form of many new products that make their practices easier and more cost effective, including reduced telephone costs, teleconferencing and web conferencing services, and discounted data protection services. I have greatly appreciated the opportunity to carry the standard of our great bar association this past year. We live in a world of constant change, a world that has grown smaller, and will continue to do so through the advances of technology. Through all of this, we must not lose our sense of community. From John Adams defending the commander of the British garrison after the Boston Massacre, to the great lawyers who provided the impetus to the civil rights movement, we lawyers have stood with vigilance and duty as officers of the courts and the society we serve. We must stay involved in the organizational fabric of our society. If we are to maintain our fundamental freedoms, it will be through the rule of law. That means vigorously defending our Constitution and the Bill of Rights, the separation of powers, the independence of our profession, and a fully independent and properly compensated judiciary. We lawyers must be vigilant. Is our association relevant? Without us, who will speak up for these cherished rights and traditions; who will fight the good fight? I think you know the answer. Be there. NEW JERSEY LAWYER April

4 MESSAGE FROM THE SPECIAL EDITORS Harold L. Rubenstein Cheryl Baisden Janet Gallo Jeffrey P. Michals Margaret Goodzeit Lawrence R. Jones Kevin J. O Connor Marilyn K. Askin Mitchell H. Cobert James J. Ferrelli Pedro J. Jimenez Jr. Susan R. Kaplan Michele Labrada Brian R. Lehrer Robert Olejar Gianfranco A. Pietrafesa Michael F. Schaff Michael A. Shipp Susan Storch Susan Stryker Richard A. West Jr. STAFF Publisher Managing Editor Graphic Designer Advertising Rep. EDITORIAL BOARD Steven Richman Chair Vice Chair Vice Chair Book Review and Legal Creativity Editor NJSBA EXECUTIVE COMMITTEE Wayne J. Positan Lynn Fontaine Newsome Peggy Sheehan Knee Allen A. Etish Richard H. Steen Susan A. Feeney Stuart Hoberman President President-Elect First Vice President Second Vice President Treasurer Secretary Immediate Past President New Jersey Lawyer Magazine (ISSN ) is published six times per year. Permit number Subscription is included in dues to members of the New Jersey State Bar Association ($10.50); those ineligible for NJSBA membership may subscribe at $60 per year. There is a charge of $2.50 per copy for providing copies of individual articles Published by the New Jersey State Bar Association, New Jersey Law Center, One Constitution Square, New Brunswick, New Jersey Periodicals postage paid at New Brunswick, New Jersey and at additional mailing offices. POSTMASTER: Send address changes to New Jersey Lawyer Magazine, New Jersey State Bar Association, New Jersey Law Center, One Constitution Square, New Brunswick, New Jersey Copyright 2007 New Jersey State Bar Association. All rights reserved. Any copying of material herein, in whole or in part, and by any means without written permission is prohibited. Requests for such permission should be sent to New Jersey Lawyer Magazine, New Jersey State Bar Association, New Jersey Law Center, One Constitution Square, New Brunswick, New Jersey New Jersey Lawyer invites contributions of articles or other items. Views and opinions expressed herein are not to be taken as official expressions of the New Jersey State Bar Association unless so stated. Publication of any articles herein does not necessarily imply endorsement in any way of the views expressed. Printed in U.S.A. Official Headquarters: New Jersey Lawyer Magazine, New Jersey State Bar Association, New Jersey Law Center, One Constitution Square, New Brunswick, New Jersey Advertising Display MARILYN ASKIN MICHAEL F. SCHAFF The doctrine of informed consent sounded the death knell for a healthcare system based on the principle of doctor knows best. Informed consent accords people in a free society the right to receive all information necessary, pro and con, so the patient alone, if competent, can make the decision about the treatment preferred. If the patient lacks decisional capacity, written documentation or surrogate decision-makers can provide advice on what the patient would have wished if able to convey that decision. This issue of the New Jersey Lawyer Magazine will provide lawyers with insight into relatively new topics, aimed at leveling the playing field for patients and the lay public in the expanding practice of what is called health law. Discovery of the human genome has spawned a technology that may determine an individual s genetic makeup and probable medical future. How do we protect genetic privacy? Jane Massey Licata explores strategies to guarantee this fundamental right, which our courts acknowledge belongs to each of us from emanations of the penumbrae of the U.S. Constitution. Gary J. Lesneski raises the specter of personal financial gain in conflict with ethical principles of respect for person, beneficence, and justice when human subject research trials are financed by private industry. He discusses the growing number of lawsuits involving injury or death from participation in clinical trials. Mental health advocates have succeeded in raising mental health as a societal problem, not a problem to be borne by the individual family alone. Two articles in this edition discuss mental health legal issues: Terri Roth Reicher provides a summary and analysis of New Jersey s Advance Directives for Mental Health Care Act, while Christopher R. Barbrack details the use of mental health records and effective discovery, based on statutory, regulatory and strategic considerations. Katherine Benesch discusses the increasing use of alternative dispute resolution to resolve claims where the burgeoning cost of litigation and the time it takes would otherwise bar a claimant from a day in court. The conversion of nonprofit healthcare entities to for-profit status could put patients and the public at risk. Mark I. Siman and Renee Steinhagent analyze the effect of New Jersey s Community Healthcare Protections Act on consumer rights. Current wrongful death law in New Jersey is based on economics alone, and metes out unjust treatment for families of children and older adults, according to personal injury attorney Michael J. Barrett, who, in his article, recommends legislative action to correct inequitable treatment of victims. Finally, as our population continues to age, and as increasing numbers of our older population are faced with diseases that cripple but do not kill, lawyers should be aware of how to protect rights of clients entering long-term care 4 NEW JERSEY LAWYER April 2007

5 facilities. Elder law attorney Jerold E. Rothkoff draws the uninitiated into the realm of nursing home admission agreements in his article. We recognize that this issue and the February 2007 issue focusing on other aspects of health law have not covered all bases, but as this area of law continues to emerge, we hope to devote future issues to topics with which sole practitioners, not only health law attorneys, should become familiar. Marilyn Askin, currently chief legislative advocate for AARP-NJ, was among the first certified elder law attorneys in New Jersey. She was director of Senior Citizens Legal Services of Essex County for 15 years, founded what is now the NJSBA s Elder Law Section in 1985, and has taught elder law at Rutgers Law School-Newark for the past 23 years. Michael F. Schaff is the chair of the corporate and healthcare practice at Wilentz, Goldman & Spitzer, P.A., and past chair and currently a director of the NJSBA Health and Hospital Law Section. He also is on the board of directors of the American Health Lawyers Association and an adjunct associate professor at UMDNJ and St. John s University, as well as a member of the New Jersey Lawyer Magazine Editorial Board. NEW JERSEY LAWYER April

6 Keeping a Lid on Pandora s Box: Strategies for Protecting Genetic Privacy by Jane Massey Licata With the completion of the first map of the human genome, a basis for determining an individual s unique genetic makeup and probable medical future was created. Over a thousand genetic markers have been identified and correlated with human biology and disease. 1 Worldwide, university and pharmaceutical company researchers alike are mining databases of genetic information and developing gene tests. Genetic tests can confirm diagnoses and test pre-symptomatically to predict the possibility of future illness or detect carrier status in unaffected individuals. Genetic testing also is available for prenatal tests and pre-implantation screening of embryos. (Most newborns in industrialized countries are screened for disorders that can benefit from immediate treatment.) 2 Genetic tests identify gene abnormalities or the presence/absence of key proteins that are provided by specific genes. Therefore, genetic testing includes gene tests (DNA tests) and biochemical tests (protein testing). Genetic Testing Technology and Regulation Genetic markers can either be diagnostic or not. Most are not conclusively diagnostic, but rather may indicate a predisposition to a particular disease or condition, or may presently be believed to have a correlation with a particular disease or condition. Relying on these types of genetic markers in making employment or insurance decisions would be especially troublesome. To reduce the chances of inadvertent access to all genetic information or test results, 3 the definitions of genetic information and information relevant in determining the current health status of an individual becomes important. Except when the data is gathered as part of a development process for either a drug, device or biologic product to be used in human therapy, most genetic tests are categorized as a service; therefore, the United States currently provides no regulations in evaluating the accuracy of genetic testing. The FDA has recently provided the industry with a guidance document describing the desired approach for gathering genetic testing data and how the data can and cannot be used in the development of human therapeutics. 4 Even with this FDA oversight, certain types of genetic testing remain unregulated. A consumer alert was issued in Aug by the Federal Trade Commission to educate and warn consumers about the risks of at-home genetic tests, which have expanded in response to privacy concerns. There are limitations to genetic testing that many consumers may not appreciate. For example, genetic testing is not 100 percent predictive. Many genetic tests fail to detect all of the mutations that can cause a disease. A positive test does not mean an individual will necessarily develop a disease and a negative test doesn t mean they won t, due to non-inherited sporadic genetic changes. A positive genetic test also cannot predict severity of the disease. Genetic testing also is expensive, ranging from hundreds to thousands of dollars per test. Tests designed to determine the presence or version of genes that cause diseases or conditions carry with them the most intimate details of an individual s biological past and future, and also provide information about parents, siblings and children that impacts on family privacy. The potential for misunderstanding or misusing this information is so great, 6 NEW JERSEY LAWYER April 2007

7 that it has become essential to establish a national policy for the protection of an individual s privacy interest in their genetic information. Legal Concerns and Mechanisms for the Protection of Genetic Privacy Legal efforts to protect genetic privacy are incomplete. Most states have enacted legislation to prohibit insurers from collecting or using certain types of information to discriminate against insureds or those seeking coverage. 5 However, the scope of this legislation is highly variable, and enforcement mechanisms are inadequate. For example, 47 states prohibit the use of genetic information to determine rates or eligibility for health insurance. Some require actuarial evidence to use genetic information, while others prohibit its use entirely. A total of 27 states require informed consent for a third party to perform or require a genetic test or obtain genetic information. Several states treat genetic information as personal property, and mandate individual access to personal genetic information. A total of 18 states have specific penalties (civil and/or criminal) for violating genetic privacy laws. Some are disease-specific, and the definitions of genetic information vary widely. A notable exception is New Jersey s Genetic Privacy Act; 6 however, employer selfinsured health plans, which are exempt from state regulation under the Employee Retirement and Income Security Act (ERISA), are not covered. 7 New Jersey s Genetic Privacy Act, which was enacted in 1996, declared that genetic information is personal information that should not be collected, retained or disclosed without the individual s authorization. The act prohibits discrimination by employers against employees carrying genetic markers of diseases or behavioral traits. It is unlawful for an employer to refuse to hire or employ, or to discharge or require to retire, an employee because of the employee s genetic information, or atypical hereditary cellular or blood trait, or because the employee refused to submit to a genetic test or make available the results of a genetic test to the employer. It also prohibits the use of genetic information in the fixing of rates or withholding of life insurance, and bans the use of genetic information to establish the amount of insurance premiums, policy fees, or rates charged for a health insurance contract. The penalties for violation of the provisions of the act include fines and prison terms. Actual damages, including economic, bodily or emotional harm proximately caused, also may be recovered for wanton disclosure of genetic information. The author feels the New Jersey act is an important first step in controlling the flow of genetic information; however, federal legislation is still needed. Federal law also is inadequate. 8 There remains a need for federal legislation to assure that insurers cannot use genetic information to deny, limit or cancel coverage, and to prohibit employers from using genetic information against workers or in hiring decisions. Executive Order issued by President Bill Clinton on Feb. 9, 2000, prohibits the federal government from using genetic information in hiring or promotion actions. Under Executive Order federal employers cannot require or request genetic tests as a condition for hiring or receipt of benefits. Federal employers cannot request or require genetic tests to evaluate an employee s ability to perform a job, or use genetic information to classify employees or deny promotion or foreign posts because of genetic predisposition to a disease. The order also provides strong protection for any genetic information for treatment or research. Most employees, however, do not share these types of protections, and must rely on a patchwork of federal laws. For example, the Americans With Disabilities Act of 1990 (ADA) protects individuals with recognized disabilities. While the ADA protects individuals with symptomatic genetic disabilities, it does not protect against discrimination based on unexpressed genetic diseases or conditions. 9 The Health Insurance Portability and Accountability Act of (HIPAA) applies only to employer-based and commercially issued group insurance. While HIPAA prohibits group plans from using genetic information as a basis for denying or limiting eligibility for coverage or charging a higher rate, it does not apply to those seeking health insurance in the individual market. HIPAA covers all personal health information, limits nonconsensual use and release of any such information, and provides rights to patients to access their medical records and to know who has accessed them. HIPAA restricts disclosure of health information to the minimum needed for the intended purpose, and establishes new requirements for access to records by researchers and others. Criminal and civil sanctions also were created under HIPPA for improper use or disclosure of private health information. While there is no specific mention of genetic information, information contained in a medical or research record would be covered. It also has been suggested that Title VII of the Civil Rights Act of 1964 could be applicable to an employer engaged in discrimination based on racially or ethnically linked genetic disorders. 11 However, there are only a few diseases where a strong relationship between race or national origin has been established. The Equal Employment Opportunity Commission (EEOC) has considered a case alleging genetic discrimination. EEOC filed suit against an employer for secretly testing its employees for a genetic condition. The EEOC argued the NEW JERSEY LAWYER April

8 tests were unlawful under the ADA because they were not job related and any condition of employment based on the tests would be cause for illegal discrimination based on disability. The lawsuit settled. 12 The Effort to Establish Federal Legislation Concerning Genetic Privacy and Nondiscrimination There have been efforts to pass federal legislation over the past decade, including a Genetic Information Nondiscrimination Act, which was passed by the U.S. Senate. 13 The House of Representatives version has not passed. The House version could prohibit health insurance and employment discrimination against individuals and their family members on the basis of predictive genetic information or genetic services. Predictive genetic information is defined as: information about an individual s genetic tests (i.e., the analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites in order to detect genotypes, mutations, or chromosomal changes); information about genetic tests of family members; or information about the occurrence of a disease or disorder in family members. Information about the sex or age of the individual, information about chemical, blood, or urine analysis of the individual unless these analyses are genetic tests, and information about physical exams and other information relevant to determining the current health status of the individual are specifically excluded from the definition of predictive genetic information. Genetic services are health services, including genetic tests, provided to obtain, assess, or interpret genetic information for diagnostic and therapeutic purposes, and for genetic education and counseling. Under the House proposal, an insurer would not be able to deny eligibility or adjust premium or contribution rates for a group on the basis of predictive genetic information or information about a request for or receipt of genetic services. An insurer also could not request or require genetic testing. Further, the insurer could not request, require, collect or purchase such predictive genetic information. The insurer also could not disclose predictive genetic information or a request for genetic services; disclosures to the Medical Information Bureau and the individual s employer or plan sponsor are specifically prohibited. However, with respect to payments for genetic services, the insurer could request evidence that services were performed (but not the results) and if the evidence is not provided, could deny payment. An insurer also could request that an individual provide predictive genetic information so long as the information would be used solely for the payment of a claim and limited to information directly related to and necessary for the payment of the claim (i.e. the claim would otherwise be denied). Disclosure would be limited to individuals within the plan who need access to the information for payment of the claim. Prior, knowing, voluntary, written authorization for the collection or disclosure of predictive genetic information would be required. Disclosures between healthcare providers for the purpose of providing treatment would be exempt. Civil actions for legal and equitable relief, including civil attorney fees and the costs of expert witnesses and civil penalties, payable to the United States Treasury, also are provided for. These provisions would not supersede any state law provision that more completely protects confidentiality or privacy, or protects against discrimination with respect to such information. Employers, employment agencies and labor organizations would be prohibited from failing or refusing to hire, discharging or otherwise discriminating on the basis of predictive genetic information. Employees could not be classified on the basis of predictive genetic information or a request for genetic services. Employers could not request, require, collect or purchase predictive genetic information about employees for genetic monitoring without prior, knowing, voluntary and written authorization by the employee, and without informing the employee of the monitoring results. Genetic monitoring is the periodic examination of employees to evaluate changes in their genetic material (e.g. chromosomal damage or evidence of increased occurrence of mutations) that may have developed during the course of employment due to exposure to toxic substances in the workplace in order to deal with adverse environmental exposures in the workplace. Any monitoring must conform to Occupational Safety and Health Administration (OSHA) or Federal Mine Safety and Health Act (FMSHA) requirements. The results of the monitoring may not disclose the identity of an employee. Any predictive information about an employee must be treated or maintained as part of the employee s confidential medical records. A federal or state court may award any appropriate legal or equitable remedy that may include payment of attorneys fees and costs, including the costs of experts. The EEOC also could enforce. Possible Approaches to Increasing Protection for Genetic Information in the Insurance and Employment Arena Healthcare providers are accustomed to dealing with sensitive, confidential information. However, given the unique nature of genetic information, heightened concern about the confidentiality and distri- 8 NEW JERSEY LAWYER April 2007

9 bution of such information is warranted. Results of genetic tests are usually maintained in medical records; therefore, when an individual applies for disability, health or life insurance, an insurer could access and examine this information. Accordingly, an individual s prior written consent to make the information available to insurers and between healthcare providers should be required. Presently there is no special consent required in many states, and the information is released as part of a general medical record release. 14 Segregating this information, or clearly identifying it as information that cannot be disclosed without explicit consent, while possibly viewed as burdensome by healthcare providers, is something that can be done (e.g. much as HIV testing information is protected), and the author believes, should be done given the significant potential of use of genetic information to stigmatize or discriminate. Those seeking individual health insurance protection who may be at the greatest risk for discrimination. While there are provisions that cover individual policies in some instances, individuals require the same protections as group participants. The author feels there should be significant penalties for any knowing violation by an insurer or employer. Under the current scheme, the employee or insured, who may not have reasonable access to legal representation, may not be able to effectively protect their privacy interests. The government shall, therefore, take a proactive role and provide substantial civil penalties provided for in the event there is a breach of confidentiality. This is provided for to some extent under state law and proposed federal legislation; however, strengthening the role for government enforcement could be helpful. Setting federal law for protecting genetic information in health and life insurance and employment decisions would allow states to pass, or maintain, more extensive laws if they wish. Making sure that both group and individual markets are covered is important. Providing consistency in coverage, protections afforded and enforcement strategies would protect individual privacy interests and reduce the likelihood of stigmatization or discriminate in insurance and the workplace. The author believes it is essential to establish a consistent, national policy to protect against genetic discrimination in employment and insurance, and to protect the privacy of this sensitive personal information. These issues cross state boundaries and affect all citizens. Until recently, access to genetic testing was limited to those who could afford to pay for it privately. By paying for it themselves, individuals also could have greater assurance of confidentiality concerning the testing and the results. While wider acceptance of the need and validity of genetic testing has made insurers more comfortable with reimbursement for this type of service, there is a huge risk to the insured or employee that sensitive information, which could easily be subject to misinterpretation, may be widely distributed as part of the insurance information system. Given the substantial gaps in federal and state law to protect against employment and insurance discrimination, federal legislation is needed to ensure that genetic technology and research are used to improve the health and lives of individuals and to prevent denial of employment opportunities and benefits. Federal legislation that establishes minimum protection could be supplemented by state laws, but would provide a needed threshold level of protection. Endnotes 1. As of Aug. 2006, the National Institutes of Health (NIH) report that there are genetic tests for 1,283 diseases (991 clinical and 292 research only); 2. For example, in the U.S. newborns are screened for Phenylketonuria (PKU), a genetic defect that causes an enzyme deficiency which results in mental retardation if untreated. 3. Genetic disorders can be caused by a variation or mutation of a gene. Genetic disorders may be caused by an alteration in a single gene (e.g. Sickle Cell disease, Cystic Fibrosis, Tay-Sachs disease). Chromosome disorders are the result of too many or too few genes (e.g., Down Syndrome). Most diseases are caused by a combination of small genetic variations and environment (e.g., heart disease, cancer, Alzheimer s disease) fnl.pdf 5. Forty-seven states have enacted laws related to genetic privacy. Most states restrict insurers or employers from carrying out particular actions without consent. For example, 17 states require informed consent for a third party to either perform or require a genetic test or to obtain genetic information; 27 states require consent to disclose genetic information; five states define genetic information as personal property and one state extends personal property rights to DNA samples; four states mandate individual access to personal genetic information; 18 states have specific penalties (civil and/or criminal) for violations. (http:/ programs/health/genetics/prt.htm). 6. N.J.S.A. 10:5-43 to 10: U.S.C ; ERISA preempts state regulation of large, selfinsured plans. 8. To date, no federal legislation has been passed concerning genetic discrimination in individual insurance or in the workplace. 9. ADA cannot prevent requirements or requests to provide genetic information after a conditional offer of NEW JERSEY LAWYER April

10 employment has been made but before an individual begins work that is a concern because genetic samples can be stored and maintained for later study; ADA cannot prevent requirements to provide medical information that is job related and consistent with business necessity 42 U.S.C (2002). 10. C.F.R For example, Sickle Cell disease and Tay-Sachs disease. 12. EEOC v. Burlington Northern Santa Fe (BNSF) Railroad No. Col-4013-MWB (N.D. Iowa 2001). 13. The U.S. Senate passed S on February 18, 2005 by a vote of The act prohibits employers, employment agencies and labor organizations from using genetic information in hiring, firing and training decisions and from soliciting or purchasing genetic information. 14. Special consent provisions similar to those that exist for HIV testing could be considered. Like HIV status, genetic information can significantly impact on an individual s insurance and employment status. Therefore, confidential information that can be linked to an identifiable patient should be disclosed without the patient s authorization only when necessary to protect third parties from harm or when disclosure is compelled by law (e.g., reporting HIV tests results to public health authorities or sexual partners). Jane Massey Licata is a partner with Licata & Tyrrell P.C., and teaches patent and FDA law at Rutgers School of Law-Camden. 10 NEW JERSEY LAWYER April 2007

11 Managing Conflicts of Interest in Human Subject Research by Gary J. Lesneski It has been estimated that nearly $100 billion is spent annually on medical research in the United States, nearly 60 percent of which comes from private industry. 1 Research is big business, creating opportunities for investigators and the institutions that employ them to collaborate with drug and device manufacturers to share in the financial fruits of successful product development. Human subject research trials are conducted in compliance with three basic ethical principles: respect for persons, beneficence, and justice. 2 These principles risk compromise where the investigator s conduct may be affected by considerations of personal financial gain. Several well-publicized lawsuits have been filed involving injuries or death resulting from participation in clinical trials, most notably Gelsinger v. Trustees of the University of Pennsylvania, where the defendants settled both a private civil action and a Department of Justice False Claims Act 3 suit after 18- year-old Jesse Gelsinger died during a gene therapy trial. 4 There, the plaintiffs alleged, among other things, a failure of informed consent based on nondisclosure of university and investigator equity and other financial interests in the industry sponsor. Despite these well-publicized concerns over research conflicts of interest, new revelations continue to be reported. Recently, two major medical journals Neuropsychopharmacology and the Journal of the American Medical Association admitted that in published studies they failed to disclose the authors financial ties to drug and device makers. 5 A bipartisan group of congressional leaders has asked the National Institutes of Health (NIH) to provide details of a senior researcher s ties to several pharmaceutical companies, professing a need to evaluate whether NIH s conflicts of interest policies are adequate. 6 Both regulatory and industry initiatives have addressed research conflicts of interest, with the goal of eliminating or minimizing them. This article will address those initiatives. Federal Responses Overview Federal law provides the regulatory framework for identifying and managing conflicts of interest in the research setting. New Jersey has not adopted any statutes or regulations addressing these issues. Federal guidance and regulations come from various sources, lacking a unified approach, and thus creating the potential for different rules depending on the context in which the research is performed. Moreover, these pronouncements are limited to federally regulated research, that is, research sponsored by federal agencies or conducted to obtain Food and Drug Administration (FDA) approval of a drug, device, or biologic. Institutions do have the option, as part of their federal-wide assurance (FWA), which qualifies them for participation in federally sponsored research, to voluntarily agree to apply certain federal standards to all research performed, and many do so. Conflicts of Interest Involving Members of Institutional Review Boards Under the federal regulatory scheme, research is conducted under the auspices of either the so-called common rule, a series of regulations promulgated by the Department of Health and Human Services (HHS) that apply to research sponsored by a cohort of Executive Branch departments and agencies, or the regulations adopted by the FDA for approval of products falling under its jurisdiction. 7 Both the common rule and the FDA regulations require that human subject research be approved and reviewed on a contin- NEW JERSEY LAWYER April

12 uing basis by institutional review boards (IRBs). IRBs are either independent or institutionally connected bodies of five or more members who have appropriate scientific and non-scientific representation enabling them to evaluate whether the research is soundly designed and otherwise adequately protective of the interests of the research subjects. Recognizing that the IRB members themselves might have a conflict of interest, both sets of regulations preclude the participation of any IRB member in the initial or continuing review of a research protocol, except to provide information to the IRB. 8 However, the regulations do not determine what constitutes a conflicting interest, or outline the process an IRB should follow to identify, evaluate and manage potential conflicts. HHS Guidance Document In May 2004, HHS issued its final guidance document for IRBs, investigators, research institutions and other interested parties, which raises points to consider in determining whether specific financial interests in research could affect the rights and welfare of human subjects, and if so, what actions could be taken to protect those subjects. 9 The guidance document is not a regulation, and thus, as expressly noted by HHS in its preamble, does not confer any rights for or on any person, and does not bind HHS or any other federal agency. It does, however, state general principles that, as will be seen later in this article, complement initiatives in the private sector. The guidance document recommends that the IRBs remind members of conflict of interest policies at each meeting, document any actions taken by the IRB in response to a conflict of interest for a particular protocol, and periodically educate members on conflict of interest topics. Without specifying a definition of a conflict of interest, the guidance document counsels that IRBs, institutions and investigators determine what financial relationships should be deemed of concern, and at what level conflicts of interest should be managed or eliminated, and develop procedures to manage the actual or potential conflict. The guidance document additionally suggests that research institutions have true separation between research activities and the management of the institutions financial interests, and counsels that each institution establish a separate conflicts of interest committee that should function independently from the IRB, but with clear channels of communication between the two bodies. Other HHS recommendations include use of independent organizations to hold or administer institutional financial interests in research and/or to provide review and oversight of potential conflicts of interest. The guidance document presumes that there will be variability in institutional approaches to the various questions raised. To this extent, guidelines promulgated by industry groups (discussed below) may provide more practical solutions to some of the issues raised in the guidance document. Public Health Service The Public Health Service (PHS), which encompasses such HHS agencies as the National Institutes of Health, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration and the Health Resources and Service Administration, has promulgated conflict of interest regulations that apply to grantee institutions and contractors. 10 These standards also are applied to grantees of the National Science Foundation. Institutions covered by these regulations must maintain and enforce conflict of interest policies, and designate an institutional official to solicit and review investigator financial disclosures for PHS-funded research. Investigators are required to disclose significant financial interests that would be reasonably affected by the research. The regulations define a significant financial interest as anything of value, included, but not limited to, salary or other payments for services, equity interests, and intellectual property rights. The regulations create thresholds for equity interests ($10,000 as determined through public prices or other reasonable measures of fair value and representing no more than a five percent stake in any single entity), as well as other income, such as consulting fees, honoraria, and royalties (expected to exceed $10,000 over the next 12 months). The regulations except certain income (such as honoraria from teaching at programs sponsored by public or nonprofit agencies and salary, royalties or other remuneration from the applicant institution). Financial interests of the investigator s spouse and dependent children are counted in determining whether these thresholds are met. Covered institutions are expected to take steps to manage, reduce or eliminate identified conflicts of interest, such as public disclosure of the conflict, modification of the research plan, disqualification of the investigator from all or part of the research, or mandating divestiture of the interest in question. The institution s policies also must include mechanisms for sanctioning non-compliance. FDA Regulations The FDA regulations require that sponsors of a regulated product must, as part of the marketing approval process, disclose financial interests of clinical investigators conducting the underlying research on the product. 11 The FDA particularly focuses on arrangements where the clinical investigator receives payments that rise or fall depending on the outcome of the study or has a proprietary interest in 12 NEW JERSEY LAWYER April 2007

13 the product being studied. FDA disclosure thresholds include any compensation (whether in cash or in kind) that exceeds $25,000 (exclusive of the costs of conducting the study), any proprietary interest in the study article (e.g., royalties), and any equity interest in the sponsor worth more than $50,000. Along with the disclosure, the sponsor must specify any steps taken to minimize potential bias resulting from the financial interest. Industry Initiatives The American Association of Medical Colleges The American Association of Medical Colleges (AAMC), which counts among its membership some 125 accredited U.S. medical schools and over 400 major teaching hospitals, has adopted policies and guidelines for oversight of individual and institutional financial interests in human subject research. 12 The guidelines present a unified approach for identifying conflicts of interest and managing them. They share similarities with the federal pronouncements, but approach the problem by positing that all significant financial relationships are potentially problematical and, where identified, create a rebuttable presumption that the research should not be conducted by the affected individual or institution, absent compelling circumstances. The guidelines counsel that a finding of compelling circumstances requires a case-by-case analysis that considers the science, the unique qualities of the affected investigator or institution, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. The guidelines define individual investigator significant financial interests as including: compensation arrangements that exceed the $10,000 threshold contained in the PHS regulations, any equity interest in a non-publicly traded company, any equity interest in publicly traded companies over the PHS threshold, royalty rights where the research is directly related to the licensed technology or work, any payments in connection with the research that are not directly related to the reasonable costs of the research, and any service as an officer, director or other fiduciary for the sponsor, whether or not remuneration is received for the effort The guidelines recommend that conflicts be vetted by a separate conflict of interest committee. All investigators would have a duty to disclose their interests to this committee before the IRB considers the research. If the conflicts of interest committee concludes that the interest precludes the investigator s participation, that determination may not be overridden by the IRB considering the research. However, the IRB can take more stringent action than the conflicts committee. The guidelines further counsel that in those instances where the committees determine that despite the conflict there is a compelling need for the research to go forward, appropriate steps must to be taken to manage the conflict, such as requiring full disclosure of the interest to the research subjects, requiring that subject informed consent be obtained by a clinician with no financial ties to the research, or having the research overseen by an independent monitoring board. The guidelines also address conflicts at the institutional level. An institutional conflict is present whenever the financial interests of the institution or an institutional official might affect, or reasonably appear to affect, institutional processes for the conduct, review or oversight of human subject research. Examples of such institutional conflicts would include royalty arrangements with the sponsor, equity interests in a non-publicly traded sponsor, a significant equity position (exceeding $100,000 in value) in a publicly traded company, or receipt of a substantial gift or grant from the sponsor. As with individual investigator conflicts, the guidelines state that institutional conflicts should be vetted by a separate conflicts of interest committee, with the same rebuttable presumption against the research if the conflict is present, unless compelling circumstances dictate otherwise. Where compelling circumstances are found, the AAMC recommends a variety of approaches for managing the conflict, such as designating another institution as the primary research site, use of external monitoring, use of affiliated organizations to conduct the research, and recusal of institutional officials from the research process. Beyond process, the AAMC also asserts other core values that minimize potential conflicts and diminish undue influence by the sponsor on the objectivity of the research. These include prohibiting payment to investigators based on particular results, prohibiting payments that do not reflect the fair value of the services being performed, and precluding research agreement provisions that would enable a sponsor to interfere with an investigator s access to data or ability to analyze data independently. The American Medical Association The American Medical Association (AMA) has promulgated two ethical codes that deal with research conflicts of interest. AMA Code E counsels that all medical centers develop specific guidelines for their clinical staff on conflicts of interest, which should, at a minimum, include the following: NEW JERSEY LAWYER April

14 a ban on stock trading in the sponsor until the researcher s involvement ends and the results of the research are published or otherwise disseminated to the public; prohibition of any payment arrangement that involves compensation beyond what is commensurate with the efforts of the researcher; policies requiring researchers to disclose to the medical center, any other funding organizations, and any journals that will publish the research, the specifics of any material ties to the company whose product is being investigated. 13 AMA Code E establishes additional guidelines for physicians involved in research. 14 Physicians should only participate in clinical trials related to their scope of practice and area of medical expertise. Physicians should be familiar with principles of research ethics and should only participate in IRBapproved research. Someone other than the treating physician should, where possible, obtain the informed consent for the research protocol, if the subject s treating physician is the researcher. Payments to researchers should not exceed fair market value, and should not vary based on the volume of subjects the physician enrolls. (Thus, physicians should not accept any payment simply for referring patients to research studies.) Physicians should ensure that protocols include provisions for the funding of the subjects medical care in the event of complications associated with the research. The researcher should disclose the nature and source of funding and financial incentives to the research subjects. Physicians should ensure that their research contracts do not permit the sponsor to unduly delay or obstruct the publication of results. Other Sources There are a variety of other groups that have promulgated guidelines on financial conflicts of interest in research, including the American Association of Universities, 15 the American College of Emergency Physicians, 16 and the American Society of Gene Therapy. 17 Conclusion The cited regulations and industry guidelines evidence a national consensus that adequate protection of research subjects and promotion of objectivity in research requires an organized, welldocumented and specific process that assures disclosures of financial interests in the research are made and evaluated, and conflicts found are appropriately managed/minimized. However, the continued reports of undisclosed conflicts affecting significant research projects demonstrates that internal and external enforcement of these standards still leaves much to be desired. Any organization involved with human subject research is well advised to have conflicts policies in place that are commensurate with the recurring general principles evident in the cited materials and contain adequate monitoring and enforcement provisions. Failure to do so creates liability risks in the event of subject injury, and, where noncompliance with federal regulations is at issue, potential sanctions from the agencies involved. Endnotes 1. MSNBC report, at (last visited 8/23/2006). 2. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979) (a/k/a The Belmont Report). 31 USC 3729 et seq. 4. Gelsinger v. Trustees of University of Pennsylvania, Phila. Cty. Ct. of Common Pleas, filed Sept. 18, 2000, at (last visited 7/26/2006). 5. MSNBC report, at (last visited 8/23/2006). 6. Los Angeles Times report, at (last visited 8/23/2006). 7. The common rule is codified at 45 C.F.R., Part 46, Subpart A, (2005), 46 C.F.R (2005), et seq. The FDA counterpart is codified at 21 C.F.R (2006), et seq and 21 C.F.R (2006), et seq C.F.R (e) (2005); 21 C.F.R (e) (2006). 9. Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, 69 Fed. Reg (May 12, 2004) C.F.R (2005), et seq and 45 C.F.R (2005), et seq C.F.R (2006), et seq. 12. The two reports are Promoting Subjects, Preserving Trust and Promoting Progress Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research (Dec. 2001), at firstreports.pdf (last visited 7/26/2006) and Promoting Subjects, Preserving Trust and Promoting Progress II: Principles and Recommendations for Oversight of an Institution s Financial Interests in Human Subjects Research (Oct. 2002), at coi/2002coireport.pdf (last visited 14 NEW JERSEY LAWYER April 2007

15 7/26/2006). 13. American Medical Association, E Conflicts of Interest: BioMedical Research, at (last visited 7/26/2006). 14. American Medical Association, E Managing Conflicts of Interest In the Conduct of Clinical Trials, at org/ama/pub/category/8471.html (last visited 7/26/2006). 15. American Association at Universities Report on Individual and Institutional Financial Conflict of Interest (Oct. 2001), at (last visited 7/26/2006). 16. American College of Emergency Physicians Policy # Financial Conflicts of Interest in Biomedical Research, at ancialconflictsinterestbiomedical- Research.htm (last visited 7/26/2006). 17. Policy of the American Society of Gene Therapy Financial Conflict of Interest in Clinical Research (April 5, 2000), at org/position_statements/conflict_of_interest.html (last visited 7/26/2006). Gary J. Lesneski is president of Archer & Greiner, P.C., in Haddonfield. He is currently vice chair and formerly chair of the Health and Hospital Law Section of the NJSBA. NEW JERSEY LAWYER April

16 Psychiatric Advance Directives: A Summary and Analysis of the New Jersey Advance Directives for Mental Healthcare Act by Terri Roth Reicher Effective March 21, 2006, New Jersey adopted a law that affords a patient the opportunity to specify treatment preferences for mental health services in the event that he or she is subsequently determined to lack decision-making capacity. The New Jersey Advance Directives for Mental Healthcare Act 1 allows a person of sound mind to help define their care, including limits on medication and preferences regarding physicians and institutions, should they become mentally ill. At first glance, the form of the new act is quite similar to the one used in 1991, when the Legislature passed the New Jersey Advance Directive for Healthcare Act (Living Will Act); 2 but its focus is different. The New Jersey Bill Passage, Amendments and Omissions A major goal of the bill that was enacted on Sept. 22, 2005, is to assure respect for the rights of patients with mental illness. 3 Supporters of the act included the Mental Health Association of New Jersey, the New Jersey Protection and Advocacy, Inc. (NJPA), the National Alliance for the Mentally Ill (NAMI) and the Community Health Law Project. This coalition of mental health organizations was instrumental in bringing the special needs of the behavioral health community to the attention of legislators. This vulnerable population often finds its due process protections compromised, and frequently lacks resources. It is further disadvantaged by the lack of awareness exhibited by physicians and attorneys regarding the specific issues a person with mental illness may face in time of crisis. From a public policy perspective, the Legislature identified the behavioral health community as a group in need of special statutory protections. Despite the act s unanimous passage, during the legislative process several items dealing with terminology required committee amendments. 4 Responsible mental healthcare professional was the preferred term used to describe the healthcare provider who had primary responsibility for the behavioral health treatment of the patient, and not attending mental healthcare professional. When describing a patient who no longer possessed decision-making capacity, the term of choice became incapacitated patient rather than incompetent patient. The definition of psychiatric facility was expanded to include a hospital or community-based mental healthcare center. The significance of the expansion is its impact on the patient s revocation rights. The Legislature streamlined certain procedures that other states required. New Jersey did not require a qualified mental health professional to certify that a patient is competent to complete a psychiatric advance directive (PAD), nor does it require a qualified mental health professional to pre-approve the content or the appropriateness of an advance directive for mental healthcare. A court need not determine that a patient 16 NEW JERSEY LAWYER April 2007

17 is legally incapacitated for a PAD to take effect during a crisis. In order to effectuate a PAD in New Jersey, the responsible mental healthcare professional makes the determination of a patient s incapacity and it must be confirmed by at least one other mental healthcare professional. Only in the event of disagreement do the parties need to consider dispute resolution via the courts. In such cases, the act calls for the use of an institutional ethics committee, or a person designated by the psychiatric facility to handle disputes to avoid court intervention. When constructing an ideal instruction directive for mental healthcare decision making, the Bazelon Center for Mental Health Law, the nation s leading legal advocate for people with disabilities, identifies additional recommended components that are not found in the New Jersey forms. 5 New Jersey does not provide preferences for: 1. notification of others immediately upon admission to a psychiatric facility, 2. care and temporary custody of minor children, 3. participation in experimental studies or drug trials, or 4. a list of visitors to be prohibited from visiting during admission to a psychiatric facility. Bazelon also advocates a record of psychiatric advance directive, which identifies the proxy s name, address, and phone number but also lists the name, address, and phone number of each person who was given a copy of the PAD. New Jersey does not provide for this additional checklist, which could be very helpful. Such a list also highlights that maintaining numerous, accessible copies of PADs is a desirable practice. Though New Jersey does provide for a registry, no provisions were made to have a standard wallet-sized card available. This card immediately advises any treating team of the existence of an advance directive for mental healthcare, where it is registered and the name and contact information of the designated agent. The issues raised above are often encountered by the psychiatric facility, and would be advantageous in determining the patient s wishes. The goal is to create a concise picture of the patient s requests during a time of lucid decision-making capacity, which will be relied upon at a future date when the person lacks capacity to make such decisions. If the patient s articulated desires are more inclusive, perhaps the instruction directive will be consistently honored, and there will be less need for the healthcare proxy to be called upon to surmise the best interests of the patient. National Use of Advance Directives for Mental Healthcare The act is consistent with a nationwide movement in which persons with mental illness and their psychiatric needs warrant enactment of a distinct statute. Currently, half the states have some form of a psychiatric advance directive statute. 6 In 1993, Oregon was one of the earliest states to enact such a statute. 7 North Carolina enacted Advance Instruction for Mental Health Treatment in 1997, which served as an early example of legislation giving legal authority for PADs, including the use of the registry. 8 Two significant developments have generated awareness in PADs: 1) the passage of the federal Patient Self-Determination Act (PSDA), and 2) the increased use of mandated psychiatric treatment. 9 The PSDA, euphemistically referred to as the federal Living Will Act, provides that all healthcare facilities that receive Medicaid or Medicare funding must implement advance directive policies. 10 It applies to both general hospitals and psychiatric hospitals. The federal act requires institutions to inform patients of their right to formulate an advance directive that allows them to accept or refuse medical treatment, document the existence of an advance directive in a patient s medical record, formulate policies that ensure compliance with an advance directive, and educate the staff and community about the rights and obligations associated with advance directives. The intent of the PSDA is to codify a patient s right to retain control over future medical treatment if they later become unable to communicate their wishes. Contemporaneously with the growth of the acceptance of advance directives, the nonconsensual treatment of the mentally ill also expanded. As outpatient commitment policies created an increasingly deleterious pattern of fragmented and often involuntary treatment for the behavioral health community, the need for PADs further evolved. In theory, the preparation of a PAD while competent could benefit the patient at a later date. It would facilitate the treatment process; improve adherence with beneficial therapies; advance communication between providers, caregivers, and patients; and ultimately avert psychiatric crises or improve management of such crises without resorting to involuntary commitment. PADs seemed to create an option that increased patient autonomy and produced an alternative to coercive treatment. The Role of the Division of Mental Health Services The Division of Mental Health Services in the New Jersey Department of Human Services (NJDMHS) is a leader in circulating information about the existence of an advance directive for mental healthcare. Under the new act, as with the Living Will Act, one can execute a proxy directive, an instruction directive or both. The NJDMHS website provides three basic forms for the public to use: NEW JERSEY LAWYER April

18 1) declaration of mental healthcare representative, 2) mental health instruction directive, and 3) registration. 11 NJDMHS emphasizes the voluntary aspects of completing an advance directive for mental healthcare, and the benefit it affords the declarant in planning for decisions in advance. The declarant is defined as a competent adult who executes an advance directive for mental healthcare. Persons seeking additional information beyond that provided by NJDMHS are encouraged to contact a trusted individual or a patient advocacy group such as NJPA. 12 NJPA has prepared a helpful worksheet to be used prior to completing the directive. It encourages at least the execution of a proxy directive to identify a trusted individual to be consulted in a crisis, especially if one is ambivalent about completing the exhaustive instruction directive. Key Highlights and Unique Features of the Act Mental Healthcare Representative A declarant has the right to appoint a mental healthcare representative, i.e. a proxy, an agent or a spokesperson, who will act consistently with his or her wishes, and, in the absence of clearly articulated preferences, will be consulted to determine the patient s desired treatment. NJDMHS encourages declarants to notify the proxy of the appointment and provide the proxy with a copy of the document, but are warned that the appointed representative has the right to withdraw at any time. Declarants are urged to provide several alternate representatives in the event that the person designated cannot or does not wish to serve. Acceptance of appointment as agent is optional. From a practical standpoint, however, the New Jersey form calls for the representative and the two alternates to sign the same form, which may be cumbersome. The act does not provide for the use of the advance directive to consent to a civil commitment. 13 However, the healthcare proxy can consent to a voluntary commitment under particular conditions. Health Insurance Portability and Accountability Act (HIPAA) considerations are exhibited by authorizing the agent to receive all of the patient s medical information, including any treatment for HIV/AIDS, as well as alcohol and substance abuse. Instruction Directive The NJDMHS directive is quite comprehensive in its treatment choices. The declarant may specify preferences regarding physicians, other providers, medications, voluntary hospitalization, acceptable facilities, emergency interventions and electroconvulsive therapy (ECT or shock therapy). The detailed checklists provided to declarants attempt to anticipate most common behavioral health events. Such extensive treatment specificity is, however, not generally recommended in a traditional living will. Instruction directives are triggered only if the declarant has lost the ability to provide an informed consent. The statute recognizes that some instructions are not feasible, and that clinicians cannot be bound to treatment instructions they deem clinically inappropriate, and in some situations may override some individual PAD instructions. Registration A state-run registry of advance directives for mental healthcare overseen by NJDMHS is a unique feature of the act. Oversight of the registry by NJDMHS requires consultation with the Department of Health and Senior Services (DHSS). The registration form provides access to the treating licensed healthcare providers as well as individuals who are given a password by the patient. The registration form provides that at their discretion NJDMHS also may accept other related forms, such as a healthcare advance directive (living will) or guardianship orders. The registry appears to be patterned after a national registry such as the U.S. Living Will Registry, which developed a streamlined method to store and transmit advance directives. 14 Though the registration form is currently accessible on NJDMHS s website, as of the writing of this article, no advance directives for mental healthcare have been filed in Trenton. Revocation A declarant has a general right to modify, reaffirm, revoke or suspend a PAD. Revocation was of considerable concern to the advocacy community. A declarant may not revoke or change the directive when incapacitated unless he or she has specifically reserved that right in the written document. If the declarant does exercise the right to revoke, he or she is warned that the document has no binding effect. The clinicians will ignore the PAD and treat the patient according to their best medical judgment. Furthermore, the healthcare professionals will no longer have the authority to contact the declarant s proxy, and the designated representative will no longer have the authority to make decisions on the patient s behalf. Duration Declarants may choose to specify an expiration date, although one is not necessary. Conversely, traditional living wills do not generally have a stated expiration date. A legislative safeguard provides that if the patient is incapacitated at the time the advance directive for mental healthcare expires, the document will remain in effect until capacity is regained. Witnesses The act creates a two-tiered system of 18 NEW JERSEY LAWYER April 2007

19 witnesses. Only one witness is required if he or she is a disinterested person. However, if the first witness is related to the declarant, entitled to any part of the declarant s estate, or the operator, administrator or employee of a rooming or boarding house or residential healthcare facility in which the declarant resides, than the second signatory must be an independent person. This provision differs from the Living Will Act, which provides for two witnesses, a notary or an attorney. The other witness provisions are consistent with the Living Will Act. The witness is asked to attest that the declarant appears to be of sound mind and not under duress, fraud or undue influence. Such a blanket assertion may prove to be a problematic requirement in the execution of a psychiatric advance directive. Lay witnesses may not have the ability to make an accurate assessment. No notarization of the document is necessary to be valid, which also is consistent with the Living Will Act. The Future In Sept. 2006, preliminary rules and regulations governing this act were promulgated by NJDMHS after consultation with the commissioner of health and senior services. 15 Initial written comments were due Nov. 4, The rules are intended to encourage the use of advance directives for mental healthcare, assure they are executed, recorded, and invoked appropriately, and establish a voluntary registry. The goal is to assure universal standards for implementation in New Jersey so the rules are useful to both consumers of mental health services and service providers who must abide by them. The psychiatric facilities will be required to inform current patients of the availability of a PAD and require that individual service plans (ISPs) include discussions of advance directives for mental healthcare. In addition, the psychiatric facilities will be obligated to train their staff about their responsibilities under the act, including the requirement that screeners consult the NJDMHS registry. The anticipated social benefit of these rules is to encourage patient participation in treatment, whereas the economic impact of the rules will enable more individualized, efficient treatment planning and implementation. This will reduce the number of more expensive and restrictive psychiatric hospitalizations. The new rules will impose some additional reporting, recordkeeping and compliance requirements on the facilities. This will likely include the creation of a dispute resolution process. The main purpose of these rules is to standardize the use of advance directives for mental healthcare, and to foster the self-directed recovery of persons who have mental illnesses. The goal of the New Jersey Advance Directives for Mental Healthcare Act is to empower the patient to improve communication regarding treatment options and influence decisions about care during a psychiatric predicament. By executing a valid advance directive for mental healthcare, the patient s objective is to increase the likelihood that his or her treatment preferences will be honored. The clinician s perceived legal and ethical dilemma may create potential conflicts. On the one hand, a provider is obligated to abide by the patient s stated wishes regarding acceptance of recommended treatment, but on the other hand, a provider is charged with the duty of providing specific treatment consistent with a best interest of the patient standard. Such a conflict may be exacerbated in the behavioral health arena. A person who suffers from psychiatric disorders may at times have significantly impaired judgment and limited ability to recognize the gravity of his or her condition and the need for intervention. Whether advance directives for mental healthcare prove to be a help or a hindrance in resolving such conflicts remains to be seen. Endnotes 1. N.J.S.A. 26:2H-102 et seq. 2. N.J.S.A. 26:2H-53 et seq. 3. Advance Directive for Mental Health Care Act P.L c Senate Committee Statement, 211th Legislature, NJ S. Comm. State, S.B. 2369, May 23, National Resource Center on Psychiatric Advance Directives, a collaboration between the Dept. of Psychiatry and Behavioral Sciences, Duke University Medical Center and the Bazelon Center for Mental Health Law 7. ORS et seq. 8. N.C. Gen Stat. 122C U.S.C (1990) dmhs/advance N.J.S.A. 30: et seq N.J.A.C. 10:32 et seq. Terri Roth Reicher is the bioethics attorney for Chilton Memorial Hospital, and maintains a commercial alternative dispute resolution practice in northern New Jersey dealing with civil matters including healthcare disputes. She taught healthcare law at Thomas Jefferson University School of Medicine and William Paterson University Graduate School of Nursing, and currently serves as a consultant to the William Paterson University IRB and teaches at its Cotsakos School of Business. NEW JERSEY LAWYER April

20 Effective Discovery and Use of Mental Health Records: Statutory, Regulatory and Strategic Considerations by Christopher R. Barbrack Sciences that are most familiar to attorneys tend to be constrained by specific principles and rules. Adherence to these principles and rules by practitioners for example, orthopedists, neurologists, architects, engineers and others does not preclude radically different interpretations of the same data. However, such interpretative differences usually fit within the framework of the applicable scientific rules and related scientific knowledge. Advocacy tends to amplify divergent opinions in forensic situations, usually in direct proportion to the science s immaturity and low level of empirical and conceptual development. frustrating and bewildering. Since MHPs are an entrenched part of the forensic scene in New Jersey and nationally, plaintiff and defense attorneys need to develop knowledge and skills to cope with them. This article discusses considerations and strategies for discovering and using confidential documents generated and maintained by MPHs in light of the Health Insurance Portability and Accountability Act (HIPAA) 2 and Crescenzo v. Crane. 3 Objective Data are Essential to an Effective Discovery Strategy Effective discovery involving adverse MHPs is greatly facilitated by forcing the inquiry onto an objective level. Objectivity offers the best opportunity to rein in the MPH who is inclined to testify to almost anything. In the mental health field, a modicum of objectivity can be established with records that are made and kept by MHPs: 1) clinical notes, and 2) standardized psychological test data. Obtaining Confidential Clinical Notes 4 Unlike most business records and similar documents, mental health records are confidential and privileged. 5 In litigation, this status creates tension between the belief that just legal outcomes require unlimited access to evidence and individual privacy rights. Personal injury attorneys and others are very familiar with N.J.S.A. 2A:84A-22.4, to wit: In the forensic mental heath environment there are few universal rules, a situation that permits extraordinary latitude in what mental health professionals (MHPs) do and say. In the mental health field there is no uniformity in the application of diagnostic procedures, no uniformity in the interpretation of clinical data, and very little reliance on the extant empirical knowledge base, sparse as it is. 1 Therefore, deposing a MPH can be There is no privilege under this act in an action in which the condition of the patient is an element or factor of the claim or defense of the patient or of any party claiming through or under the patient or claiming as a beneficiary of the patient through a contract to which the patient is or was a party or under which the patient is or was insured. If a privileged medical record is no longer privileged by 20 NEW JERSEY LAWYER April 2007

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