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, June 10, 2013
Although it's probably true that with some imagination every Supreme Court decision could be related back to some aspect of Health Law, today's Post (which, yes, was supposed to be up Friday) is intended to highlight the as yet unreleased Supreme Court decisions of particular interest to Health Law. We don't know exactly which cases will be announced but Scotus believes this will
happen on Thursday June 13th--and they will be "live-blogging" starting "shortly before" 10 AM EST in anticipation of the announcements-- but we do know which ones are left.
Below is an email I sent out today to both our Health Law Certificate Students here at Texas Tech School of Law and to the students enrolled in my new class Constitutional Issues in Health Law. As a side note, I would certainly be interested in hearing from anyone who is/has taught this particular class. My model for it is the one taught by Mary Anne Bobinski when she was at the University of Houston Law Center.
Here, in relevant part, is what I sent out:
" Unlike last year where everyone was a health care lawyer and had something to say about National Federation of Independent Business v. Sebelius (the Affordable Care Act decision) (me included), the cases yet to be decided are not all waving the banner "Health Law"--but are likely to have significant impact in the practice of health law. There are so many sources of information about these cases and what they mean that it would almost be impossible to give a complete list.
Each decision will be posted almost immediately to the Supreme Court's website--and what I recommend is that you read it yourself--and then compare it to the press coverage! CNN will long remember this episode and Jon Stewart's take on it!
Also, it is never possible to avoid the "spin" that anyone describing an issue inevitably puts on it. I've included information when an organization or media outlet has created clarifying material but at this point. Here's an NPR Overview and one from Fox News.
Here are the cases (with parentheticals from Scotus):
Association for Molecular Pathology v. Myriad Genetics Inc.("whether human genes are patentable")
("Whether the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of
2003, 22 U.S.C. § 7631(f), which requires an organization to have a policy explicitly
opposing prostitution and sex trafficking in order to receive federal funding to provide HIV
and AIDS programs overseas, violates the First Amendment. (Kagan, J., recused.)")
("Whether the First Circuit Court of Appeals erred when it created a circuit split and held – in
clear conflict with this Court’s decisions in PLIVA v. Mensing, Riegel v. Medtronic, and
Cipollone v. Liggett Group – that federal law does not preempt state law design-defect
claims targeting generic pharmaceutical products because the conceded conflict between
such claims and the federal laws governing generic pharmaceutical design allegedly can be
avoided if the makers of generic pharmaceuticals simply stop making their products.")
The press is most interested in Hollingsworth v. Perry “gay marriage” and Fisher v. University of Texas (“affirmativeaction” )cases—and we should be interested too. In Hollingsworth because it is possible (although not certain) that the court will add to our understanding of the Constitutionality of statutes (like the one in Texas) which only allow a married couple consisting of a man and a woman to enter into a binding contract with a surrogate mother. It may also change the ability of physicians in states to refuse to treat patients on the basis of sexual orientation, gender identity or any other factor not currently required by Federal Law or a previous decision of the Supreme Court. LAMBDA Legal has put together an infographic for those wanting to get up to speed quickly.
And in Fisher because it may well affect medical school admissions even though it is a case about undergraduates.
There are also some cases involving important employment law issues—which are often the biggest part of a health lawyer’s case load.
You may not want to be poised at your computer 10 AM Thursday EST to hear what decisions the court is releasing—but you will certainly want to read them for yourself when they are available online.