Friday, October 18, 2013
Even health law professors who do not teach a class in research law may be asked to participate in their university's programs for training researchers. Now that the government is back in business, this seemed like a good time to feature some resources to help bring you up to speed. The information below focuses on some of the main Federal Government sources of not just information but very high quality educational material. All of this information is accurate as of today--but any web resource can suffer from link rot, and a direct Google search should lead you to all of these sources and more.
The most general place to start is actually not in the Federal Government, but rather CITI on-line training resources. Although today their website says that these materials are no longer available to the public for free, it is likely that anyone associated with an institution that conducts federally funded research is a subscriber. The unavailability of CITI to the public is unfortunate, but the amount of training provided for free by the federal government is beyond the scope of any individual human's ability to absorb information--everything from this point on is free!
The Federal Government's regulation of research misconduct, research integrity and protection of human and animal subjects of research (yes, all of these things are different) is scattered not just among the various entities sponsoring research, but also within agencies. While all have adopted "The Common Rule" when it comes to humans, in fact there can be significant differences in policies and regulations (especially in situations not involving humans). Here are some places to start looking.
The location of this information depends both on the kind of research and the source of funding. For research funded by the department of health and human services (biomedical research primarily) the relevant agency is the Office for Research Integrity (ORI) which " oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration" and this is the website that tracks cases they are and have investigated.
If the research safety violations involves people, you need to go to the entity within HHS currently known as the Office for Human Research Protections (OHRP)(remembering the "s" at the end of "Protections" shows you to be an insider). This is a vast repository of both reference material and current reports of active cases--you might want to look at this overview first.
If you are getting funding directly from the National Institutes of Health, you will want to check in with Human Subject Research Protections (HSRP) program (note the "s") and their rules and guidance. More information to be found here.
Research under the supervision, although not necessarily funding, of the FDA is monitored its Bioresearch Monitoring (BIMO) program is a comprehensive program of
on-site inspections and data audits designed to monitor all aspects of the
conduct and reporting of FDA regulated research. This is not to be confused with the FDA's Office of Criminal Investigations which has a broader scope and covers not just research but all FDA monitored activities.
Actually, "all" is an understatment because Recalls, Market Withdrawals and Safety Alerts are tracked elsewhere and there may be some spillover. Ditto MedWatch: The FDA Safety Information and Adverse Event Reporting Program. If the violations directly concern human safety you should check here and in general at the Center for Drug Evaluation and Research
The National Science Foundation (NSF) is another major source of information. The research it sponsors differs from that sponsored by NIH because it extends far beyond biomedical activities. Indeed, NSF is the place to look for information about social science or behavioral research.
The National Academy of Engineering has devoted considerable resources to issues of research ethics, misconduct and integrity which are available in its online Ethics Center. Texas Tech University also provides extensive resources in Engineering Ethics through the Murdough Center.
The Institute of Medicine is often asked by Congress to investigate issues in Biomedical and Health Research.
The Department of Energy is a major player in the field of research ethics/human subject protection (it does considerable nuclear and genetics research) and has many resources.
It's very hard to distinguish between "bioethical" issues and "legal" issues when it comes to research, so another very important source of information is the Presidenial Commission for the Study of Bioethics. which recently put out a remarkable report on Human Subject Research Violations which took place during the 1940's in Guatemala. (spoiler, the U.S. Public Health Service was giving people syphillis).
In future posts, I will dig deeper and provide more governmental and private sector resources.
Thursday, September 5, 2013
Don't miss a fascinating article in the August 30th issue of Science, "Poverty Impedes Cognitive Function." The article contends that there is a causal explanation for the correlation between poverty and disfunctional behavior, such as the failure to keep medical appointments or to employ healthy behaviors. Put crudely, the connection is that people in poverty have to think about so much just to keep going that they don't have the cognitive bandwidth to make carefully reasoned decisions.
The authors of the article, Anandi Mani, Sendhil Mullainanthan, Eldar Shafir, and Jiaying Zhao, present two studies in support of their claim. The first study involved four experiments in which shoppers at a New Jersey mall were paid participants. The income level of the shoppers varied, from the bottom quartile of US income to over $70,000. In the first experiment, participants were asked to think about a decision about how to pay for car repairs, and were randomized to inexpensive ($150) or expensive ($1500) costs of the repair. They were then asked to perform simple cognitive tests on a computer. Among those asked to think about the inexpensive repair, there were no significant differences by income level in performance of the cognitive task. By contrast, there were significant differences in performance by income among those confronted with the more expensive repair. Variations on this experiment involved problems where sums of money were not involved (to control for math anxiety), incentives in the form of getting paid for getting the right answers on the cognitive tests, and situations in which participants came to a decision about the financial problem, engaged in intervening activities, and then were asked to perform the cognitive tests. Each of these variations produced results similar to the initial experiment: the performance of people in poverty on the cognitive tests was significantly associated with the expensive repair, but the performance of those in higher income groups was not.
In the authors' second study, participants were a random sample of sugar cane farmers in Tamil Nadu in southern India. They were interviewed before and after the cane harvest. Pre-harvest the farmers faced more significant financial pressures (as measured by criteria such as numbers of pawned items, numbers of loans, and the like) than post-harvest. Performance on cognitive function tests was significantly higher post-harvest than pre-harvest. Because the cane harvest extends over a considerable time period, the authors were able to control for calendar effects; the difference was similar early or later in the 5 month period of the harvest. The authors conclude that poverty has about the same cognitive consequences as the loss of a night's sleep.
To be sure, other variables might explain the authors' findings. They are careful to discuss many of these such as physical exertion, stress, nutrition, or training effects. If the authors are right, however, their findings have some impressive implications for health policy. One, which they note, is that it may just be more difficult for people who are poor to perform complex tasks needed to apply for eligibility for programs such as Medicaid (why are we surprised that so many who are eligible don't sign up?). Another is that programs designed to incentivize healthy behaviors may just not work very well if they ignore cognitive loads.
September 5, 2013 in Access, Affordable Care Act, Consumers, Health Care Costs, Health Care Reform, Health Economics, Health Reform, Medicaid, Obesity, Prevention, Public Health, Uninsured | Permalink | Comments (0) | TrackBack (0)
Tuesday, September 3, 2013
Faculty Fellowships in Public Health Law - Call for Applications
Applications are invited for 10 faculty fellowships in public health law education.
Georgia State University College of Law and its Center for Law, Health & Society are leading an initiative funded by the Robert Wood Johnson Foundation for a faculty fellowship program to promote public health law education. Ten faculty members from law schools or schools/programs of public health will be selected to participate in a yearlong fellowship program designed to foster innovations in educational programming (including clinical, externship, and other experiential learning) and to build a strong learning community among faculty who teach in the public health law field.
All fellows, with their deans’ support, will design and implement a project for curricular change in public health law education at their home institutions. Each fellow will be paired with a faculty mentor in public health law. The fellows will begin their fellowship year by attending an intensive 10-day educational Summer Institute on July 16-26, 2014 in Park City, Utah. Over the course of the academic 2014-2015 fellowship year, the fellows and their mentors will regularly share ideas, experiences and models for public health law teaching, providing opportunities for professional growth and leadership development.
• Applicants must have a J.D. degree and be employed in a full-time faculty position at a law school or school/program of public health, or be a full-time faculty member affiliated with a law school or school/program of public health, with a tenure-track, tenured, clinical-track, joint, or comparable faculty appointment;
• Applicants must have at least three years of full-time teaching experience at a graduate- or professional-school level by July 2014; previous background in health care law, public health law, or related subjects is preferred;
• A dean’s transmittal letter of support for the proposal is required, as well as
two letters of reference.
For the complete list of eligibility and selection criteria and to review the full Call for Applications, visit www.law.gsu.edu/PHLFellowship.
HOW TO APPLY
• The application period opens Tuesday, Sept. 3, 2013. The deadline for applications is Friday, Dec. 13, 2013. Letters of reference are due Friday, Dec. 6, 2013.
• For instructions on how to apply and complete information about the program, download the full Call for Applications at www.law.gsu.edu/PHLFellowship.
Questions? Contact Stacie Kershner, associate director for the Center for Law, Health & Society, at firstname.lastname@example.org or 404-413-9088.
Friday, June 21, 2013
I am just back from Austin where I was privileged to attend the "launch" meeting of the Scholars in Residence Program, one of five fellowship programs funded by the Robert Wood Johnson Foundation in order to enhance and promote public health law. This press release put out by the Network for Public Health Law gives more detail on the scholars (I'm proud to say I'm one of them) and our projects. They are:
Jennifer S. Bard, Alvin R. Allison Professor of Law and Director of the Health Law Program and JD/MD program at Texas Tech University School of Law, will explore the interface between property rights and public health needs relating to nuisance and disease-spreading insects such as bed bugs and mosquitos. She will work with the City of Lubbock, Texas.
Alex Capron, University Professor at the University of Southern California and the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the Gould School of Law, will examine federal rules on human subjects research relating to the surveillance of pathogens and viruses. He will work with the Los Angeles County Department of Public Health.
Mary Crossley, Professor of Law and former Dean at the University of Pittsburgh School of Law, will identify innovative ways in which California health officials can use their legal authority to address the growing burden of chronic diseases through interventions targeting risk behaviors and social and economic factors that impact health. She will work with the San Francisco Department of Public Health.
Sharona Hoffman, Edgar A. Hahn Professor of Law and Professor of Bioethics at Case Western Reserve University, as well as Co-Director of the Law School’s Law-Medicine Center, will develop enforcement guidance for regulation of in-home care agencies in order to improve compliance and protect the well-being of the vulnerable individuals served by these agencies. She will work with the Oregon Health Authority in Portland.
Browne Lewis, Leon & Gloria Plevin Professor of Law and Director of the Center for Health Law & Policy at Cleveland-Marshall College of Law, will focus on current state and federal preemption issues regarding local government regulation of the labeling, marketing and sale of small cigars. She will work with both the Cleveland Department of Public Health and the Shaker Heights Department of Public Health.
Polly J. Price, Professor at Law at Emory University School of Law, will address the coordination of public health agencies in providing long-term tuberculosis therapy among migrants along the U.S. border with Mexico. She will work with public health agencies in El Paso, Texas and Las Cruces, New Mexico.
The meeting gave the six scholars, their supervisors from health departments all over the country, project leader Professor Fran Miller, RWJ liason and senior program officer Angela K. Mcgowan and consultant Nancy Kaufman and the team from the Network for Public Health Law, Judy Schector and Jackie Rose (Sara Rohde stayed behind to keep things running) a chance to meet and learn about the exciting projects and plans.
If anyone is not yet familiar with the Network for Public Health Law or their work, take a minute right now to join (its free). This is how it describes itself: "The Network for Public Health Law provides insightful legal assistance, helpful resources and opportunities to build connections for local, tribal, state and federal officials; public health practitioners; attorneys; policy-makers; and advocate." And indeed the assistance it provides is remarkable--it has put together a group of experts available to answer, free of charge, public health law questions.
The Network is linked with an impressive array of other RWJ funded public health law programs specifically:
- The National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN), a project of ChangeLab Solutions, provides leaders in the childhood obesity prevention field with educational resources and technical assistance on legal issues related to policies to improve nutrition and physical activity.
- The Northwest Center for Public Health Practice (NWCPHP) promotes excellence in public health by linking academia and the practice community, including developing training materials for public health law professionals.
- The Public Health Law Association (PHLA), a non-profit membership organization, serves as a vibrant and active community of public health law practitioners and stakeholders and provides opportunities for all members to learn and share ideas, best practices and research on public health law.
- Public Health Law Research (PHLR) builds the evidence for and increases the use of effective regulatory, legal and policy solutions to protect and improve population health and the public health system.
- Tobacco Control Legal Consortium, America’s tobacco control legal network, provides technical assistance to support public health professionals, attorneys and advocates as they develop, implement, interpret and defend tobacco control policies.
In addition to the Scholars in Residence, RWJ has already launched the the Visiting Attorney Fellows Program
There is also an active, and free of charge, students network designed to support law students interested in public health.
In the fall, a program directed by Charity Scott, Catherine C. Henson Professor of Law and center director, and
Stacie Kershner (J.D. ’08), associate director at The Georgia State College of Law's Center for Law, Health and Society will start accepting applications for "an intensive summer institute, work on course development, and create and direct
externships, clinics and other experiential-learning opportunities in public
health law. Experienced faculty mentors will guide these efforts, which will be
supplemented with connections to resources and organizations focused on public
health law in the practice setting."
Anyone with an interest in using the law to protect the public's health should be closely following the RWJ Foundation's innovative programing.
The Supreme Court decided Agency for International Development v. Alliance for Open Society International yesterday, a lower-profile case about unconstitutional conditions placed on federal funding. My initial reaction is that the opinion can be read in at least two ways. On the surface, this decision reads like the long line of First Amendment unconstitutional conditions cases such as Rust v. Sullivan and Legal Services Corp. v. Velazquez. Chief Justice Roberts' majority opinion held that the "Leadership Act" could offer federal funding to eradicate HIV/AIDS throughout the world, and that funding can express discouragement of prostitution by refusing to allow the funds to be used for the promotion of prostitution, but the Court held that the conditions on the funds cannot go so far as to require the organizations using the federal funds to explicitly oppose prostitution. (Fund recipients had expressed the fear that taking an overt stance against prostitution would harm their public health efforts by scaring those in the sex trade away from their doors.) The majority's opinion is a non-controversial read of that line of cases and even attempts to make sense of the somewhat inconsistent application of the doctrine by describing the difference between "conditions that define the limits of the government spending program" and "conditions that seek to leverage funding to regulate speech outside of the contours of the program itself." I don't necessarily buy this distinction. After all, conditions by necessity define the contours of a program - unless they are nongermane, which seems to underly the Chief Justice's leveraging concept but was never explicitly stated. But, it is one way to describe the differing outcomes in this line of cases that is worth considering.
But then I come to a second possible take: this case reiterates the Roberts Court's willingness to rein in congressional exercises of the spending power. On the heels of NFIB v. Sebelius, the spending aspect of this case is notable, given that this is the second case in two years to express disapproval of conditions on federal spending. Unlike NFIB, which created a novel coercion doctrine without contours, this decision tread familiar ground in its conclusion that conditions on spending cannot violate First Amendment rights. However, even during oral arguments, there were shadows of the ACA controversy from last term. And, although NFIB was not cited in the opinion, both the majority and the dissent (authored by Justice Scalia) contained familiar language about leveraging, coercion, and offers that can't be refused. It is unclear why Justices Scalia and Thomas would uphold this condition on federal funding when they so readily and forcefully rejected the Medicaid expansion last year. The simplest answer is probably that these justices have long rejected the unconstitutional conditions doctrine. (Another possibility is that the dissenting justices agree with the policy of rejecting prostitution (see Justice Scalia's bizarre "free love" comparison) but disagreed with the policy of universal health coverage.)
While the spending power is still robust, I am not sanguine about the conversation the Court is trying to have with Congress about the Spending Clause. It will be interesting to see how the Court furthers this project in the same-sex marriage cases that are sure to be handed down next week. If the cases turn on the doctrine of federalism, then read in combination, the Roberts Court may be continuing its adventures in the Federalism Revolution, once thought done and gone, and now revived through the spending power.
Saturday, May 25, 2013
It's no secret that the night staff of a hospital are both over-worked and over-tired. Nor is it any secret that many medical errors occur at night. But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it. A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.
The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.
I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.
It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety. The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load. So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.
The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts. A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.” See also this and this article by the Joint Commission. Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day. The information is both anecdotal and research based. But no one seems to be listening.
An article in Nursing World does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns. It advises nurses working the night shift to “take control of sleep.” In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.” This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time. Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep. Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.
Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone. But given the unlikeliness of medical staff to convert to a permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either) the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night. But that’s not where the problem solving is going.
May 25, 2013 in Cost, Effectiveness, Health Care, Health Care Costs, Health Care Reform, Health Economics, Health Law, Hospital Finances, Hospitals, Insurance, Medical Malpractice, Nurses, Patient Safety, Payment, Physicians, Policy, Public Health, Quality, Quality Improvement, Reform, Research, Science and Health, Substance Abuse | Permalink | Comments (0) | TrackBack (0)
Friday, May 17, 2013
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)
Saturday, May 11, 2013
Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again
The controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when "aids specific" laws emerged. My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics. It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.
What Happened in Kansas
As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens. It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found. Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection.
One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS. This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected. Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics.
In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.” Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.” He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.
Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS. Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.”
What Kansas Can Teach
Public Health Students Today
Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy deserves attention and study just as would thediscovery of a “living fossil.” It gives us direct access to studying the past.
For anyone else looking for ways to bring that time alive, here are a few words about my experience