by Robert R. Rich

It's important that we as stewards of taxpayer dollars do what we can to provide the greatest research benefit within an efficient and effective regulatory environment. This stewardship includes efforts to reduce or eliminate regulations that cost money or time without providing commensurate additional protection.

Accountability in research implies not only the appropriate use of funds but also integrity in the processes of research. The public has a right to expect that research be carried out and reported honestly, and the government is correct in implementing regulations to assure this. We are all aware that fabrication, falsification, and plagiarism are not only morally wrong but are against the law and carry heavy penalties when discovered. We are perhaps less cognizant of personal conflicts of interest that might subtly and even unconsciously influence experimental design, observation, or reporting of results.

• Legislation regulating a particular activity may be inherently problematic or may have unexpected consequences. Such legislation may be ambiguous in intent or may have been intended for one purpose and then, after the fact, applied to another. Too often, Congress grants regulatory authority with redundant or even conflicting language to more than one federal agency.
• When regulatory legislation is enacted, it becomes the responsibility of an agency to translate the legislation into specific language that is ultimately published in the Federal Register and carries the weight of law. Obviously, if the agency misinterprets or overinterprets congressional intent, compliance with the resulting regulations may become more difficult and more expensive than intended.
• Agency inspectors and auditors with different levels of training and expertise may unevenly enforce regulations. This becomes particularly problematic when occasional overzealous inspectors allow their personal views to interfere with actual regulations and attempt to impose those views on researchers and research institutions.
• Finally, responsibility for assuring compliance with regulations generally falls to certain employees within a research institution. Such employees may be overly concerned that their continuing employment depends on the institution's compliance. Consequently, with a "CYA mentality," they may require more of individuals within their institution than is actually required by the government.

When, for whatever reason, regulations exceed the level of protection intended by the responsible authority (usually Congress), the result is "regulatory burden."

The working group is focusing initially on regulations in five areas specified by Congress: human research, experimental animal research, use and disposal of radioisotopes and hazardous materials, conflicts of interest, and research integrity. I hope to add a sixth area, namely the application of cost accounting standards (a system devised for procurement of materials and accounting for the military but recently extended to the academic research enterprise).

Some early accomplishments of regulatory burden review are gratifying:

• The newly instituted "just-in-time" process of review for human subjects protocols eliminates a need for review of grant applications and protocols that are unlikely to be funded.
• The Office of Research Integrity (ORI) will no longer review -- and possibly second-guess -- investigations of alleged scientific misconduct carried out by university committees unless the university process lacks rigor.
• Under the leadership of the Howard Hughes Medical Institute, Congress has instructed the Environmental Protection Agency to re-evaluate certain processes and procedures for disposal of hazardous materials. Current processes and procedures were designed for industrial wastes but are inappropriate when applied to the relatively miniscule amounts of the same materials that may be generated in a university research laboratory.

Intent to the contrary, federal rules, regulations, and new, often burdensome interpretations have proliferated at an increasing rate over the past two years. Some, particularly regulations relating to human subjects research and investigator financial conflicts of interest, are easy to understand.

Universities must do a better job of reviewing research that potentially puts patients at risk. The well-publicized recent tragedy at the University of Pennsylvania, involving the death of a young patient as a consequence of a gene therapy experiment, is a dramatic case in point. Restrictions on clinical research imposed on a number of medical schools by the federal Office of Human Research Protection (formerly the Office of Protection from Research Risks) provide evidence that the issue deserves attention from anyone engaged in clinical research.

We have responded at Emory by doubling the number of our human investigation committees and by substantially increasing staff support to those committees. Additionally, we have recently initiated an education program for all Emory personnel engaged in the conduct, supervision, or review of research in human subjects.

In every case, as new regulations are imposed someone must pay for them. In principle, this should be a responsibility that research universities and the government share. In practice, however, the cost of new regulations falls almost exclusively on universities. This is because the government caps administrative costs that support research programs, including the costs of research compliance, at 26% of the direct costs of the grants. Most research-intensive universities have actual costs in excess of the cap. In fact, a recent study from the RAND Corporation estimates that on average universities recover only about 70% of their true administrative and facilities (indirect) costs.

This trend of the government imposing substantial new regulations and then expecting universities to bear the costs of implementing them urgently needs to be addressed. Fortunately, both the administration and Congress have recognized this increasingly serious problem of "unfunded mandates." I will be making its resolution a point of personal effort in coming months.

USDA's proposals represent regulation of the worst kind -- regulation that is intended to make research more difficult and more costly.

One of the proposed regulations is a consequence of litigation brought by an animal-rights organization, the Alternatives Research and Development Foundation (ARDF), against USDA. The intent of the suit is to force the department to include rodents under reporting requirements of the Animal Welfare Act, which presently governs the use of larger animals. More than 90% of the animals used in biomedical research are rodents.

Almost certainly, the reason the ARDF has brought the litigation is to drive up the cost of using experimental animals and to increase the "hassle factor" for investigators, review committees, and animal husbandry personnel. If successful, the resulting regulations would require tracking and reporting every mouse and rat used in research. The Association of American Medical Colleges (AAMC) and the Federation of American Societies for Experimental Biology (FASEB) vigorously oppose the ARDF position. AAMC has estimated that the cost of such requirements, if imposed, could exceed $250 million per year "[without improving] the welfare of research animals one iota."

This is an example of regulation as a political tool. It needs to be explained for what it is and should be opposed by those who understand that the responsible use of experimental animals is vital to biomedical research progress -- now more than ever.

Regulations also become "ugly" when they are implemented (at least in part) to perpetuate a bureaucracy. We all know how much easier it is to create a new federal office or enlarge an existing one than it is to dissolve or shrink one. Perhaps when the ORI had its role redefined away from investigation of alleged misconduct and toward provision of educational materials, those of us who had urged this change should have been smarter and predicted the consequences.

The result has been a new ORI proposal requiring education of all individuals involved in any way in the conduct of an NIH grant to be trained in the "responsible conduct of research," regardless of specific duties or previous experience. The menu of required training areas would extend from the ORI legislative mandate on research misconduct into such areas as peer review, mentoring, and research involving human subjects.

I don't dispute the desirability of training in these areas for our new researchers, and in fact, we currently do it. I submit, however, that "one-size-fits-all" training for everyone from graduate students, technicians, and secretaries to full professors would waste a huge amount of money and would simply lead to cynicism rather than educating those required to participate. Additionally, it would represent a major government intrusion into an area that is properly within the purview of a research university, namely training our students in the responsible conduct of research because it's the right thing to do rather than because it's a federal mandate.

Although on its face well intended, I can't help but wonder whether this new proposal from ORI might also reflect an interest in preserving jobs in a federal agency that might otherwise be downsized. I am committed to the responsible conduct of research and to our obligation to teach such conduct to our trainees. But this ORI initiative, as presently proposed, is ill conceived and intrusive, and I will oppose it.

From the Director  /  Letters

Connecting the Dots

The Doctor is Always In

Governmental Regulation
of Research: The Good,
the Bad, and the Ugly

Moving Forward  /  Noteworthy

Second Chance for
Boarder Babies

Nevertheless, it is worthwhile to work hard to change or eliminate those regulations that serve to increase costs or impede research progress without a commensurate increase in intended protection. Everyone affected can help, both researchers and patients. Federal agencies really do read (and count) letters, so when it is time for a comment on a proposed new regulation, your voice should be heard.

And let me know your opinion as well. Together we can preserve and, as desirable, extend the good, decrease the bad, and prevent the ugly.

Robert Rich is executive associate dean for research and strategic initiatives for the Emory School of Medicine. As president-elect of FASEB, he will head the nation's largest coalition of biomedical research associations and one of the most influential scientific organizations in the world.