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.