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.
Monday, September 16, 2013
Criminal Charges Sustained Against Chemistry Professor for Death of Assistant in Lab Accident Requires New Focus on Lab Safety Laws
Many of us who teach and write in the area of "research law" area are far more familiar with the regulations protecting human subjects of research than the more general safety of those who conduct research. We, and our students, need to become familiar with the patchwork of laws and agencies regulating safety in labs and other research settings. For example, until we had an accident on our own campus, I had never heard of the U.S. Chemical Safety Board which is “an independent federal agency charged with investigating industrial chemical accidents” but whose jurisdiction also extends to colleges and universities. It's like the NTSB for labs.
We all need to be following the criminal trial of Dr. patrick G. Harran, a professor of chemistry at the University of California, Los Angeles. The case involves the horrific and tragic death in 2008 of Sheharbano (Sheri) Sangji, a 21 year old college graduate working in Dr. Harran's lab while applying to law school. In other words, she was not a UCLA student.
Following her death, the University, its Board of Regents and Dr. Harran all faced criminal charges based on violations of the California state labor code. The charges against the University and the Regents were dropped based on a lab safety agreement between the University and the Los Angeles County District Attorney’s Office, but a California court has rejected Dr. Harran’s motion to dismiss the charges and scheduled a pre-trial hearing for October 3rd.
The defendant moved to dismiss, but the court denied his motion. This case also provides an important link between health law and employment law since it is theCalifornia Labor Code that is the source of the criminal charges against Dr. Harran. Against his strong protests, the case is going forward on an interpretation of the law finding him, not the university, the employer of his lab assistant.
For anyone not yet using "Google Alerts" this is a great way to keep track of a story that is not well covered by the national press.
Tuesday, July 2, 2013
Teaching the regulation of human subject research gives me the ability to demonstrate, just about every class period, how blurry the line can be between what is legal and what is ethical. What individuals must do as a matter of law and what they cannot do as a matter of law are very different from what they should do. I tell my students that outside the assessment of legal risk, "should" is a business decision, a science decision, an ethics decision, a public relations decision or some combination of all four--and it's one other people (clients) are going to make for themselves.
A tip of the hat Fran Miller who clued me in to some very recent events that provide a perfect example of the relationship between law, ethics and science in human subject research. Many will have read the New York Times article about a letter sent by the Office of Research Protection (OHRP) to the lead researcher University of Alabama at Birmingham (UAB) criticizing a study they had run in 23 major medical centers involving infants requiring oxygen support in the neonatal intensive care unit (NICU). Called the SUPPORT Study (and please follow the links--the complexities here are beyond a blog post), it was intended to find out the safe, but effective, limits for providing a premature infant supplemental oxygen. Too little oxygen, of course, affects breathing but too much oxygen, we have known for a long time, causes blindness. The babies were randomized to receive different levels of oxygen and the results measured.
Whether or not the study should have ever been approved is a matter of debate-the fact that many of the babies involved had worse results than they would have under standard of care and even the fact that one of the babies involved does not, in and of itself, mean that the study was illegal or unethical. Here's the explanation by the researchers themselves. This is the Government version.
The issue under dispute is not the study itself--it's the consent process. Soon after the letter became public and OHRP began the process of assessing wehther there should be sanctions, what in theory is OHRP's sister institution, the NIH which provided funding for the study, criticized the warning and supported the SUPPORT study (these puns are invevitable). And soon afterwards OHRP backed down--agreeing to hold a public hearing.
What's so interesting about this dispute for lawyers is cogently explained by Lois Shepherd, the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia in her analysis posted at the Hasting's Center Bioethics Forum Blog. She points out that the ethicists and scientists supporting UAB don't necessarily disgree that the parents lacked complete information about the risks. That the law, in other words, wasn't complied with. But, they argue, the importance of the study outweighed a flawed consent process--and moreover, in a letter published by the New England Journal of Medicine they challenge OHRP's ability to, in essence, substitue it's judgment of whether disclosure was sufficient for that of the IRB giving initial approval.
That's a big deal. 45 CFR 46.116 specifies that consent for human subject research funded by the federal government must include (among other things--read the whole thing yourself) that "a description of any reasonably foreseeable risks or discomforts to the subject”; and “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.” According to OHRP and those who support it, UAB's experiment did not meet that standard because, among other things, it did not disclose to the parents that there was a risk of death.
But who decides whether or not the information was sufficient?
As a lawyer, I would say that the fact that Congress, in its infinite wisdom, set up a system in which OHRP has the power to review the decisions of individual IRB's answers this question immediately. Of course OHRP can substitute its judgment for that of the individual IRBS approving this study-that's what it's there for.
But in the real world, things are not so clear and it's always possible for Congress to change the balance of power. In my view that would be a huge mistake--it's hard to imagine what else has to happen in order to prove the point that when it comes to protecting human research subjects science cannot reglate itself. There must be outside oversight that reflects the view of the electorate at large--the general population of human subjects--rather that of those whose primary goal is to advance science.
Is it possible to have a system where the needs of the many outweigh those of the few? Where in the face of great benefit to all future premature infants it is acceptable to give some premature infants less than the standard of care? Sure--it's possible. But it's not how, so far, the United States has chosen to regulate human subject research.
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)