Tuesday, November 26, 2013
Some of us are celebrating the unusual confluence of Thanksgiving and Hanukkah this season. The first night of Hanukkah is the night before Thanksgiving, requiring me to make sweet potato latkes to satisfy the sacred requirements of both holidays. It also raises once-in-a-lifetime questions like, "Can you recycle latke oil to deep-fry a turkey?" And "Can you really use pumpkin to fill jelly donuts (sufganyot)?"
The Supreme Court has gotten into the holiday spirit as well, handing the health law, constitutional law, and law and religion scholars a lovely present in the form of granted cert. petitions in the Hobby Lobby and Conestoga Woods challenges to the ACA's mandate for coverage of contraceptive devices and drugs. Although there were several other cases pending cert., these two cases will give the court the opportunity to opine on both the constitutional free exercise rights of for-profit corporations, and whether for-profit corporations are "persons" under RFRA.
Unlike the marathon oral arguments scheduled for the NFIB v. Sebelius last year,the Court has only allotted the standard one hour for consolidated arguments on these cases. This may be an indication that the Court does not intend to reach any of the subsidiary questions that would be raised by a holding that for-profit corporations do have religious exercise rights, or by holding that for profits are "people" under RFRA. Or it may mean nothing at all. We shall see. Should be another suspenseful June. Happy holidays!
Saturday, November 23, 2013
Yesterday's reports on the annual meeting of the Republican Governors Association indicated disarray over the Medicaid expansion, and an opinion piece in the NYT highlighted the common story that only half of states are expanding their Medicaid programs. If CMS is counting, then this tally is correct, as the federal agency can only account for those states that have submitted the proper documentation for expansion. But this is not the only way to consider the states' decisionmaking regarding the expansion. I have just posted a short essay preliminarily detailing research I have performed over the last several months, which reveals that many states currently counted as "not participating" are acting to expand their Medicaid programs. Here is the abstract:
November 23, 2013 in Affordable Care Act, CMS, Constitutional, Health Care Reform, Health Law, Health Reform, HHS, Medicaid, Obama Administration, PPACA, Spending | Permalink | Comments (0) | TrackBack (0)
Sunday, November 17, 2013
At the University of Utah, our Center on Law and Biomedical Sciences was fortunate to be able to hold a recent symposium on the future of gene patenting. Our speakers included Ken Chahine and Amelia Rinehart, both faculty at the College of Law, presenting accounts of the science and patent law; Brian Dawson, co-director of the molecular genetics lab at the Mayo Clinic, and Elaine Lyon, co-director of pharmacogenomics at ARUP and incoming president of the Association of Molecular Pathologists, speaking from the perspectives of laboratory directors and the Association of Molecular Pathologists; John Meija, legal director of the ACLU of Utah, speaking on patients' rights; Wendy Kohlmann, manager of genetic counseling at the Huntsman Cancer Center, considering the ethical dilemmas for genetic counselors confronted by intellectual property restrictions; and Benjamin Jackson, senior director of legal affairs at Myriad Genetics, speaking from the perspective of Myriad. A recording of the symposium can be found here.
For those wishing to follow ongoing developments in gene patenting, we have prepared a libguide with resources on the Myriad decision and ongoing gene patenting cases.
Rishika Arora, Rising Issues Relating to Balancing Public Access with Patentability in the Field of Human Embryonic Stem Cell Research in India, 6 OIDA Int'l J. of Sustainable Dev. 65 (2013).
Kayte Spector-Bagdady, Elizabeth R. Pike, Consuming Genomics: Regulating Direct-to-Consumer Genomic Interpretation, 92 NEB. L. REV. ___ (Forthcoming 2014).
Subhash Chandra Singh, Non-Consensual Medical Treatment: The Legal Justification, 2013 3 IUP L. Rev. 28 (2013).
Nicolle Strand, Comment: A Constitutional Right to Know: Are Research Participants Entitled to Results of Genetic Tests?, 15 U. of Pa. J. of Const. L. 1299 (2013).
Charles R. McManis, Jorge L. Contreras, Compulsory Licensing of Intellectual Property: A Viable Policy Lever for Promoting Access to Critical Technologies?, Forthcoming, TRIPS and Developing Countries – Towards a New World Order? (Marco Ricolfi, Gustavo Ghidini & Rudolph J.R. Peritz eds., Edward Elgar 2014).
Gordana Kovaček Stanić, State Regulation of Surrogate Motherhood: Liberal or Restrictive Approach, 4 Int'l J. of the Jurisprudence of the Fam. (Forthcoming).
Thaddeus Mason Pope, The Growing Power of Healthcare Ethics Committees Heightens Due Process Concerns, 15 Cardozo J. of Conflict Resol. (Forthcoming 2013).
Professors Chirba and Noble - President Obama’s “Fix” for the Cancellation Debacle: A Simple Waiver May Not Be So Simple
President Obama’s past assurance to the American public that people could keep their plans if they so desired, and the inaccuracy of that statement has generated the current outcry for the President to do better on his past apologies and to “do something” about the looming individual mandate and the loss of plans people would prefer to keep.
In his announcement on November 14, 2013 the President attempted to do better on past apologies and do something about the rollout fiasco. Contrary to a deluge of early media reports that he has delayed the individual mandate for a full year, the details of his statement reveal a more incremental approach: effectively granting a waiver to certain people in the individual market.
This is not the first time a waiver has been granted for individual policies. Secretary Sebelius granted certain plans, even those with woefully inadequate limits on annual coverage (known as “mini-med” plans) a waiver from the ACA’s new restrictions on annual limits. This waiver permitted these limited benefit plans to be sold up until January 1, 2014, allowing individuals to retain coverage until more affordable and comprehensive policies became available with the rollout of the exchanges. It is possible that some of these “mini-med” plans will continue to be sold as part of the new waiver applicable to cancelled policies.
Despite news reports to the contrary, this latest waiver does not extend beyond those individuals who have received cancellation notices. The individual mandate in all other ways remains---all individuals must obtain coverage or be penalized for failing to do so. That obligation is just as in tact now as it was before this latest announcement. We consider what this new waiver does, does not do, and the potential ramifications of both. First:
What did NOT happen?
Friday, November 15, 2013
Solving Two Federal Problems at Once: Lets Mail Information to Those Losing Their Inadequate Health Insurance
The efforts by both Congress and the President to ensure that people can keep individual health care policies which do not meet the Obamacare minimum coverage standards are so misguided that if it weren't for the fact that vulnerable people are being caused needless suffering it would be comical.
so far, there is no evidence that anyone is going to be worse off with the coverage now available to them on the exchange than they were with the policies being cancelled. In fact, information available to us from sources like the Kaiser Family Foundation, Business Insider, and Families USA about the characteristics of the policies being cancelled is that whatever peace of mind they provided to those paying for them was illusory.
The fact that this insurance did not meet Obamacare criteria means that it is highly likely that the coverage they had:
- Excluded the conditon for which they were most likely to need care
- Had a far higher deductible than the policies now available on the exchange
- And if it covered mental illness at all, did not do so at the same level as other covered illness.
Moreover, these policies were subject to cancellation as soon as they were needed (for example after a diagnosis of cancer or after a debilitating accident).
Yet these facts are of no help to people without access to information about their alternatives.
Here's one thought--instead of requiring insurance companies to continue making these inadequate plans available, why couldn't they be required to send individualized information about alternatives on the exchange at the same time they send the cancellation letters?
The fact that they already have the relevant information about their policy owners means that those individuals don't need the web site to find out about their options.
In retrospect, depending on any web site to provide all the information to everyone who needed it was a bad idea from the beginning. But letting people continue to pay good money for bad coverage is not the right solution.
Here's a win/win idea--why don't we activate an already existing but underused government resource to get individualized information out quickly to those who need it---the U.S. Postal System.
An article in the New York Times nicely illustrates a point I usually make when I discuss living wills in class or other settings. I typically advise my audience that it is probably more important for patients to read their physicians' living wills than to write their own. As a practical matter, the views of physicians about end-of-life care are much more important than the preferences of their patients when end-of-life decisions are made. (For a discussion of this point, click here.)
Just as patients with cancer often consider whether different oncologists are aggressive or conservative in their approaches to cancer treatment, so should patients contemplating their end-of-life care consider whether different physicians are aggressive or conservative in their approaches to treatment at the end of life. Finding a physician with a similar perspective may be the most important way to ensure that a patient is treated as s/he would want to be treated.
Tuesday, November 12, 2013
It appears that the first lawsuit in the country protesting the narrow networks that many health insurance plans being offered on the exchanges are using to control costs has been filed here in my home state of Washington. Seattle Children's Hospital is suing the Washington Office of Insurance Commissioner for approving a number of exchange plans that exclude Seattle Children's from their networks of providers. The hospital is also pursuing administrative relief for exclusion from the networks. Presumably, the cost of care at Seattle Children's is significantly higher than care at other institutions. Seattle Children's points to the fact that it offers many pediatric specialty services not available elsewhere in the area, as a reason for its higher cost of care.
Seattle Children's makes an interesting standing argument in the case, claiming that patients enrolled in the plans that exclude Seattle Children's will only go to that hospital when they are very ill, and therefore those patients will consume more resources. This will reduce resources available for other patients, and impair Seattle Children's ability to serve the "pediatric healthcare needs of the region." As a Constitutional Law and Federal Courts professor, I think this injury may be a little too attenuated to satisfy standing, but we shall see.
I am guessing that this lawsuit is the forerunner of many other legal, administrative, and political challenges to the narrow networks that many plans on the exchanges are using in order to control costs. It remains to be seen if there is the type of consumer backlash to these plans that we saw in the 1990's when consumers rebelled against tightly controlled HMOs with narrow networks.
Saturday, November 9, 2013
Here is news from W. Eugene Basanta, Southern Illinois Healthcare Professor and Director, Center for Health Law and Policy, Southern Illinois University School of Law:
The 2013-14 National Health Law Competition was held at the Southern Illinois University School of Law in Carbondale on November 1 and 2, 2013. In its twenty second year, the Competition was again sponsored by SIU’s Center for Health Law and Policy, the SIU School of Medicine’s Department of Medical Humanities, the American College of Legal Medicine, and the ACLM Foundation. Twenty nine teams from twenty three law schools competed this year.
The team of Alex Silagi and Christina Yousef from Seton Hall University School of Law won the competition in an outstanding final round against Elizabeth Isaacs and Elsie Puma from University of Oklahoma College of Law. The team from Georgia State University College of Law, including Kara Gordon, Janelle Alleyne, and Nivi Shah finished third. The team of Jessica Robinson, Brandon Jackson, and Matthew Ward representing Faulkner University School of Law submitted the best appellate brief. The ACLM’s Journal of Legal Medicine will publish the winning brief in the December, 2014 issue.
The second best brief was submitted by the Seton Hall team, while the best preliminary round and overall oralist awards went to Alex Silagi from Seton Hall.
The judges for the final round included Judge Julio Fuentes of the U.S. Court of Appeals for the Third Circuit; Judge Patrick Murphy of the Federal District Court for the Southern District of Illinois; Professor Anita Bernstein from Brooklyn Law School, who authored this year’s problem (which involved the use of social media and a physician’s First Amendment free speech rights as well as Health Care Quality Improvement Act immunity); and Victoria Green, MD, JD, the current president of the American College of Legal Medicine.
Thanks to all of the teams and coaches and congratulations to the winning teams.
The 2014-15 Competition is tentatively scheduled for November 7 and 8.
Friday, November 8, 2013
is that most of what I do is in the "no spin zone." I may agree or not with a holding or a policy, but my job is to explain--not (in my view) editoralize.
Unless something is really wrong--and this headline is really wrong. Obama: ‘I’m Sorry’ About Americans Who Are Losing Current Health Plans
Yes, I heard President Obama say he was "sorry" that people who "liked" their health insurance were losing it. But there are no facts to support the implied conclusion that they were reasonable in their affection.
So--are people "losing" health insurance they had because it provided so little coverage (so little value for money) that it was as good as being uninsured? Yes. But are there any identifiable people who experienced an illness, were satisfied with the level of coverage they had from these policies? Not that I've heard speak in any form that can be recorded for review.
I'm from Connecticut and to say that people are losing coverage they "liked" is to suggest that those unlucky enough to pay a peddler for a piece of wood shaped like a nutmeg "liked" it well enough to continue putting sawdust in their eggnog for years to follow. Sure, maybe they had thought they got a bargain and at the time could not have afforded a real nutmeg. But there's a solid old time English word for what they experienced: they were swindled. And would in no sense describe their feeling about the old block of wood as "liking."
What's missing here is any definition--let alone understanding--of what it means to "like" insurance coverage for which you are paying a monthly premium only to discover on needing it that it's not worth what you paid for it. People who had this insurance did so either because they were defrauded or because they had no other access to health insurance and were hoping for the best from it.
Here's my concern--I'm not qualified to assess the politics of this or even the longterm economics. But I do know that many vulnerable people who either now have solid, excellent insurance through Medicare, the VA or their jobs believe that they could lose it because of Obamacare. And that's simply not true.
All of us who are health law professors field questions from students, friends, relatives, colleagues and acquaintances about Obamacare all the time--and my answer to almost everyone until very recently was, "I don't know--we'll have to see what happens when it actually takes effect."
But here is something I do know---the people who are "losing" healthcare are losing something that was never worth having--and which, by the way, they would surely have lost instantly the first time they made a claim. Thus putting them in the same catagory of people from whom we have heard no complaints--those without access to health insurance because of pre-existing conditions or prohibitive premiums and now find it available and affordable.
Folks who are finding out that the coverage they had did not meet minimum standards and who now have the option of buying insurance that is worth what it costs may well not know the details yet--because they haven't been able to get on line to read about it. And if they were lucky enough to never have had to use their policies, they may never have known how little they had.
But lets not forget that the system we had was responsible for 62% of personal bankruptcies due to medical bills. And that includes a lot of people who had health insurance they "liked" but which proved inadequate when needed.
Not being a pundit--let alone an expert on presidential speech writing--I can't imagine how President Obama thought it was a good idea to make a promise that he had as much power to keep as that it wouldn't rain on anyone's Fourth of July Parade or that the entire United States would be covered by an even blanket of new snow on Christmas Eve.
Most people with "good" insurance through work face changes in doctors, hospitals, and covered medications just about everytime their employer re-negotiates their contract. It's a reality we all live with.
But are people who had adequate and affordable insurance losing coverage? To switch states for a moment, we have to all be from Missouri. Show us.
Until we see what options are available to these folks who were paying monthly premiums to plans, now being cancelled, which would not be there when needed, lets stop scaring people by telling them that the adequate insurance they do have is going to be taken away. And that they will become uninsured.
Sure, the roll out is a disaster--and in retrospect predictable once it became apparent how many states were declining the opportunity to set up their own exchanges and shifting the burden onto the woefully unprepared department of Health and Human Services.
But lets not confuse the messenger with the message. The actual insurance available is from private insurance companies--which for the first time must by law provide comprehensive health insurance for a fair price. There's no reason to think it will be worse than the expensive and inadequate plans it replaces. And certainly it will be far better than nothing. And it seems like the people directly affected by these cancellations know that because with all the glitches and apologies, the majority of Americans continue to support the increased access to affordable care insurance at the same rate they did when the bill was passed--three years ago!.
Getting back to being a professor, one of the biggest problems in explaining this topic is that it's a moving target and a substantial mistrust about sources of information. Once again, I recommend the non-profit and non-partisan Kaiser Family Foundation which continues to gather and explain facts. If indeed the people "losing" their insurance do not soon have access to better coverage at an affordable price, then there is a serious problem far past computer glitches. Lets wait and see.
Sunday, November 3, 2013
Media coverage of PPACA over the past week or so has been a mess. Fortunately, a few outlets are investing in technical coverage of HealthCare.Gov by people who actually know what they are talking about. Former programmer David Auerbach has a great series of pieces at Slate about the fiasco. I found this insight particularly important:
[On]ly 30% [of users] have been able to complete an actual insurance application. And that’s not even to say that the application is correct, owing to reports of children getting listed as multiple spouses and the like. . . . [W]hy on earth is the website still up? So people can play insurance-application roulette with 7–3 odds against them? Why not take the site down until it works?
Well, remember how there was very little testing done on the system? It seems that not only was very little testing done, but testing frameworks weren’t set up. That means the team fixing healthcare.gov not only has a lot of bugs to fix, but they don’t have infrastructure in place to identify and reproduce the bugs, which are the first step to fixing them. Under a tight deadline, any such infrastructure will be ad hoc and inadequate. So it’s important that healthcare.gov stays open simply so that potential applicants can run into bugs and report them.
One thing I plan to do over the next few weeks is to compare the types oftesting of health IT that is required of IT vendors' software (before the providers that buy it can obtain "meaningful use" subsidies for health IT), and the types of testing that CMS did before launching the exchanges. On one level, this is an apples and oranges comparison: software for providing actual care is different than software that is guiding people through a maze of agencies, insurers and data brokers. On the other hand, the testing and certification of health IT involves a multistep process of delegation that has come under some criticism in the past. The larger, common issue is that a federal government that has become so reliant on contractors may be losing its ability to assess the functionality and value of contractors' handiwork.
On the other hand, an Obama Administration critic contends that the failure may have lain in CMS's refusal to give logs to contractors tasked with debugging. And only six people registered the first day--a big red flag for anyone in the know. Meanwhile, many state exchanges steam ahead with minimal problems. And Bill Moyers points out that the Administration asked for more money for the exchange, but was rebuffed by Republicans who want to "end it, not mend it."
Jessica Mantel, The Myth of the Independent Physician: Implications for Health Law, Policy, and Ethics, Case W.
Mark Strasser, The Next Battleground? Personhood, Privacy, and Assisted Reproductive Technologies, 65 Okla. L. Rev. 177 (2013).[KVT]
Part of my recent legal research and writing focuses on state regulation, accountability, and resident rights at Continuing Care Retirement Communities or CCRCs. In one of my early articles I wrote about what I thought might be a niche for elder law attorneys who could advise prospective CCRC residents about the ins and outs of CCRCs, particularly on contracting issues.
Turns out a Financial Planner and CPA have decided to make a business out of offering advice to consumers on CCRCs. Recently I had the chance to talk to Brad Breeding (the financial planner) and Ken Taylor (the accountant). The idea started when they were getting questions from clients about CCRCs near their base in North Carolina and realized there was a wider consumer market for critical information. In 2009 they started working on a web-based consulting tool for prospective CCRC residents and others who are thinking about retirement options.
The resulting company is LifeSite Logics, offering "a central database of objective data" about CCRCs across the country. Sounds like Brad and Ken have the start on a strong data set, and are already offering comparable data on several hundred CCRCs. The search price is about $40. Most important, the two seem determined to stay objective about their data points; they report they aren't backed by any CCRC operators or developers.
In addition, their LifeSite Logics website offers some free background and educational documents on CCRCS, including some information on contract (A, B, C or "other") types.
I have to say I've often thought "A, B & C" labels are potentially confusing to the public. This is especially true for the financial risks assoicated with "refundable fee" contracts which may look to the average consumer like "life-care" contracts that are usually associated with the "A" label, but are closer to "Type C" fee-for-service contracts when carefully analyzed. Further, these letters are not "grades" for the facilities or contract types, another point of potential confusion.
Saturday, October 26, 2013
Call for Applications for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy
Touro College Jacob D. Fuchsberg Law Center invites applications from experienced health law teachers and scholars for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy. Touro is seeking a nationally-known professor in the field of health law and policy to fill the chair for the spring semester in 2015. The Gitenstein visiting professor will teach at least one course at the law school, deliver public lectures, and participate fully in faculty and student life.
Touro Law Center is part of Touro College, which includes New York Medical College—one of the largest private health sciences universities in the nation. The visiting chair will have the opportunity to develop collaborative initiatives with the medical profession in general and New York Medical College in particular. Women, members of minority groups and others whose background will contribute to the diversity of the faculty are encouraged to apply.
Touro Law Center is a dynamic institution that is at the forefront of legal education in this country, dedicated to producing practice-ready graduates. Touro’s students have the unique opportunity to take advantage of the first-ever law campus in the United States—a law school adjacent to and working with both a federal courthouse and a state courthouse. The law school is located in Suffolk County, Long Island, approximately an hour outside of New York City.
Interested candidates should send a cover letter and resume at the earliest possible date for full consideration. Contact: Samuel Levine, Appointments Committee Chair and Director of the Jewish Law Institute, at email@example.com.
Touro College is committed to the principles of equal employment opportunity. Our practices and employment decisions regarding employment, hiring, assignment, promotion, compensation, and other terms and conditions of employment are not to be based on an employee's race, color, sex, age, religion, national origin, disability, ancestry, military discharge status, sexual orientation, marital status, genetic predisposition, housing status, or any other protected status, in accordance with applicable law. Our policies are in conformance with Title IX, 1972 Education Amendments.
Thursday, October 24, 2013
According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:
On Monday, October 22, at the urging of Governor Kasich, the Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5 billion in federal funding to expand Medicaid in the State of Ohio. Under the laws of Ohio this action was valid.
The Controlling Board is a state agency created by statute. The agency has two principal powers: it can transfer funds and authorize purchases by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code states: “Controlling board authorization for a state agency to make an expenditure of federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”
Two advocacy organizations (the Buckeye Institute and the 1851 Center for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the Controlling Board. They contend that the action of the Board violates Section 127.17 of the Ohio Revised Code, which provides that the Board is bound by the intent of the Ohio General Assembly. The challengers quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich vetoed this bill, but the challengers argue that despite the Governor’s veto it’s clear that the General Assembly did not want the Controlling Board to accept federal funding to expand Medicaid.
Section 5163.03 of the Ohio Revised Code authorizes the state’s Medicaid program to cover any “optional Medicaid group” unless state statutes expressly prohibit such coverage. If state statutes are silent, this law says that the state is permitted to expand Medicaid to that group. Section 5163.03 is the prevailing law – the vetoed bill that would have prohibited Medicaid expansion is not.
The action of the Governor and the Controlling Board was authorized by statute and was not prohibited by the legislature. If the legislature wishes to prevent Medicaid expansion then it must pass a law prohibiting this action over the veto of the Governor.
To listen to a debate on Ideastream between Professor Huhn and one of the the plaintiffs in the lawsuit, go here.
Wilson R. Huhn is a Professor at the University of Akron School of Law and the author of the book ObamaCare: Is It Necessary, What Will It Accomplish, Is It Constitutional? and The Five Types of Legal Argument.
Tuesday, October 22, 2013
Sunday, October 20, 2013
Dorit Rubinstein Reiss, Compensating the Victims of Failure to Vaccinate: What are the Options?, 23 CORNELL J. OF L. & PUB. POL'Y __ (2014).
Saturday, October 19, 2013
The PPACA rollout has been termed a disaster (at least on the federal level). What went wrong? Both firms and governments find big software projects hard to manage. The federal procurement process is a mess. But perhaps the biggest problem is the level of complexity that American politics & law imposed on the project.
As Garance Franke-Ruta observes:
Obamacare was damaged at the outset by the political tug-of-war over its very existence, and the conflicts at its creation have had serious downstream effects, placing the federal government in charge of far more than it was supposed to be doing. It also has also suffered from what Johns Hopkins University political scientist Steven Teles calls “kludgeocracy”—the tendency of interest groups, lobbyists, bureaucracy, and bad management to combine to create highly complex legislation and giant public-administration kludges, a term defined as “an ill-assorted collection of poorly-matching parts, forming a distressing whole.”
That is what Obamacare is proving to be, though it has its bright spots, too among the 14 state exchanges. The law passed in March 2010, but final rules governing how the exchanges were to work were not issued until March 2013. A bid from the main IT contractor, CGI Federal, was accepted in September 2011, but the company did not start critical work until this spring because it was waiting for specifications from the government, leaving too little time to troubleshoot the enormously complex systems CGI and others were setting up.
It’s hard to believe that the whiz kids behind NSA data gathering and analysis couldn’t have done some good here. HealthCare.Gov cost less than 1% of spy agencies’ budgets. But to suggest health IT should command even a fraction of the resources of the intelligence apparatus is a heresy in Schmayek's Town.
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.