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.
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.